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- 2026-03-10 07:55:20
- InterView
- ‘Leclaza can occupy 50% of mkt if used as combination'
- by Jung, Sae-Im Jul 28, 2023 05:30am
- Yuhan Corp’s Leclaza (lazertinib) was the first homegrown new drug to be approved as a first-line treatment for EGFR mutation-positive non-small-cell lung cancer. The industry’s eyes are now on how the drug will fare in the global market. Will Leclaza be able to rise as a new contender to AstraZeneca’s ‘Tagrisso (osimertinib)’ that is dominating the global market? The key lies in the clinical results of 'MARIPOSA', which is being conducted by Janssen. The Phase III MARIPOSA study directly targets the current first-line standard-of-care Tagrisso with Janssen’s ‘Rybrevant (amivantamab)’ and Leclaza combination. If the Rybrevant+Leclaza combination demonstrates a progression-free survival (PFS) superior to that of Tagrisso, this could bring major change to the current treatment environment. The interim results of MARIPOSA phase 3 are expected to be presented at the European Society for Oncology (ESMO) Congress 2023 which will be held in October. “If the MARIPOSA trial ends a success, third-generation options for the first-line treatment of EGFR-mutation-positive NSCLC will increase to 3 (Tagrisso, Rybrevant+Leclaza, Leclaza). I think it's very significant that two-thirds of the options include the use of Leclaza." Professor Byoung-Chul Cho (Medical Oncology, Yonsei Cancer Center) and Professor Ki Hyeong Lee (Hemato-Oncology, Chungbuk National University Hospital) Professor Byoung-Chul Cho (Medical Oncology, Yonsei Cancer Center) and Professor Ki Hyeong Lee (Hemato-Oncology, Chungbuk National University Hospital) met with the reporter at the LASER Symposium that was held on the 22nd for medical oncologists and relayed their anticipation on Leclaza’s potential as a global new drug. According to clinicaltrials.gov, a registry and results database of clinical studies, the MARIPOSA study divided 1,074 patients around the world into three treatment arms. Treatment Arm A will receive Rybrevant+Leclaza and Arm B and C will each receive Tagrisso and Leclaza as monotherapy. The study seeks to demonstrate that the Rybrevant+Leclaza combination therapy is superior to Tagrisso. Tagrisso has settled as the global standard of care with progression-free survival (PFS) of 19 months when used in the first-line. Therefore, achieving a statistically significant superiority will be very difficult. Conversely, if the clinical trial produces good results, it would also be that much of a game-changer. Professor Cho said, “The standard for statistical significance was set quite high in the clinical trial that compared Rybrevant+Leclaza and Tagrisso. I have high expectations for the study because I believe the cancer treatment paradigm will shift from the use of monotherapy to combination therapies. After the results of the MARIPOS clinical trial are presented, the company will sequentially start its approval process in the US. If approved, two of the three options in the field will include the use of Leclaza, and simple arithmetic can tell us that the drug can occupy up to 70% of the market share. "This will have a significant impact on prescriptions," he predicted. Although it is not the main point of the trial, the study may also serve as an opportunity to recognize the effect of Leclaza once again as it also evaluates Leclaza and Tagrisso as monotherapy in one trial. Leclaza demonstrated a long progression-free survival of 20.6 months in the global Phase III LASER301 trial that was presented last year. Although this is longer than what Tagrisso had achieved in its Phase III trial, the two are not directly comparable due to the different patient groups enrolled in each study. The MARIPOSA study includes Tagrisso and Leclaza monotherapy arms, which allows for the efficacy between the two to be examined. Professor Lee said, “I want to know if the results from the LASER301 clinical trial and its subgroup analysis will show consistently in the MARIPOSA study. If we see positive results in that trial, it would be an opportunity for HCPs to recognize the efficacy of Leclaza. If successful, I believe Leclaza would be able to take over 50% of the market.” Tagrisso is also seeking to expand its indication through the FLAURA2 trial, which examined Tagrisso’s use in combination with chemotherapy. The combination obtained statistically significant top-line results recently and will announce the results in the second half of the year. However, the professors believe the FLAURA2 trial will not cause a major change in the current treatment landscape. Professor Cho held the 1st generation gefitinib+chemotherapy combination in the past as an example. The combination had shown a significant improvement in overall survival (OS), and a related paper was published in the Journal of Clinical Oncology (JCO) published by the American Society of Clinical Oncology (ASCO) and also listed in international guidelines. However, no one has been actually prescribing this combination on-site. Cho added, “Those who have experience dealing with a lot of EGFR mutations are confident that they can achieve the same results with monotherapy without adding chemotherapy. Adding chemotherapy is effective with immunotherapy, but the situation is different in EGFR-mutation-positive NSCLC, as we are already achieving high response rates with targeted therapies alone. The MARIPOSA trial is at another level compared with the FLAURA2 trial.” Professor Lee said, “Chemotherapy not only brings side effects, but I'm just personally not sure if it works. I think chemotherapy will disappear from the market in the future. With the advent of targeted therapy, there is no reason for us to go back and use chemotherapy, so it is difficult to understand why we should consider using it again even as a combination.”
- InterView
- Immunotherapy for early lung cancer was used
- by Jun 29, 2023 05:56am
- As immuno-anticancer drugs can be used in early lung cancer, the prognosis of patients is improving. Unlike before, when chemotherapy and concurrent chemoradiation were all, it is evaluated that the number of cases of 'complete pathological remission' has increased. Opdivo was approved by the Ministry of Food and Drug Safety in October of last year for adjuvant therapy before non-small cell lung cancer surgery. This is the first case in which immuno-oncology drugs have advanced into adjuvant therapy before surgery. Specifically, Opdivo can be used along with chemotherapy in non-small cell lung cancer patients with tumors larger than 4 cm or with positive lymph nodes. The treatment proceeds by using 3 cycles of Opdivo + chemotherapy and undergoing surgery. Prof. Lee Kun-guk (left), Prof. Ahn Byeong-cheol (right), National Cancer Center Lee Kun-Guk, a professor of pathology at the National Cancer Center, gave a positive evaluation, saying, "The introduction of immuno-anticancer drugs has greatly increased the number of cases of pathological CR, which were rarely seen before." "CR was observed in 5 out of 7 cases at our hospital. Through a conversation with Professor Lee and Professor Ahn Byeong-Cheol of the Department of Hematology and Oncology at the National Cancer Center, Daily Pharm examined the changes brought about by the advent of immuno-anticancer drugs in adjuvant therapy before lung cancer surgery. -We know that the way to expect a complete cure for early lung cancer is through surgical treatment. What is the percentage of patients who can undergo surgery by stage? There are cases of recurrence even after surgery. What if there has been an unmet need? =Professor Ahn Byeong-Cheol (referred to as Professor Ahn): Looking at each stage, 80% of stage 1, 60% of stage 2, and 50% of stage 3A can be operated. It is known that all stages 1 to 3A can be operated, but not all patients can operate because of the complex effects of various factors, such as the patient's psychological burden for surgery and the state of the disease, in addition to the stage. Lung cancer is a carcinoma with a high recurrence rate, with studies showing that even stage 1 patients recur up to 40%. Three out of four patients with stage 3 disease with a high stage show recurrence. Therefore, there has always been an unmet need for therapies that can reduce the recurrence rate and improve the prognosis. There have been many attempts to increase the success rate of surgery by reducing the size of the tumor as an adjuvant therapy before surgery for patients with a difficult surgery. However, chemotherapy, which was a representative preoperative adjuvant therapy, did not show a therapeutic effect to such an extent that the pathological CR ratio remained in the single digits. Simultaneous chemoradiation had limitations due to toxicity and side effects such as pneumonia, decreased lung function, and adhesions. -Recently, immuno-anticancer drugs appeared in adjuvant therapy before lung cancer surgery in combination with chemotherapy. I am curious to see how much treatment has been achieved with the experience of actually prescribing this therapy. =Professor Lee Kun-Guk (Professor Lee): So far, immunotherapy was used as an adjuvant therapy before surgery in 7 cases, and in 5 of them, so-called pathological CR, in which lung cancer was not found, although lumps remained, could be confirmed. Certainly, it shows a significantly improved treatment effect compared to previous preoperative adjuvant therapy. Previously, pathological CR was rarely reached. Therefore, it was difficult to evaluate the treatment effect. If complete pathological remission is frequently achieved, as in the combination of Opdivo and chemotherapy, a significant part of the worry can be relieved from the perspective of medical staff. If it is confirmed that there is no cancer mass when observed under a microscope, a lot of burdens is relieved for pathologists who have to quantify the treatment effect. -Are there any concerns about missing the right time for surgery when treated with adjuvant therapy before surgery? =Professor Ahn: I think it is homework to be solved in the preoperative adjuvant treatment. Statistically, less than 10% of patients who were able to undergo surgery may miss the timing due to adjuvant therapy before surgery and may not be able to undergo surgery. However, the ratio of patients who underwent surgery in clinical trials with this immunotherapy was 83.2%, higher than 75.4% of the chemotherapy alone group. Ultimately, I think it is important for medical staff to select and treat patients who are suitable for preoperative adjuvant therapy. -Opdivo + chemotherapy combination therapy has been approved for use regardless of the PD-L1 expression rate and major gene mutations. Is there any difference in actual effect? =Professor Ahn: The higher the PD-L1 expression rate, the higher the therapeutic effect of immuno-anticancer drugs. The higher the PD-L1 expression rate, the lower the risk of recurrence and the higher the pathological complete response rate. However, since it showed a significant improvement effect in all patient groups regardless of the PD-L1 expression rate, it is prescribed regardless of the actual clinical setting. =Professor Lee: In patients with target gene mutations, the effect of immuno-anticancer drugs is relatively low, and a follow-up study on this is likely to be necessary. However, I think it is meaningful in that the opportunity for adjuvant therapy before immuno-oncology surgery is open to all patients. -It is expected that the importance of pathological examination will be further emphasized in lung cancer treatment. What do you think the pathological diagnosis system needs to change in the future? =Professor Lee: I think the pathology examination fee needs to be improved. About 400 genes are identified by the NGS test at medical institutions, and the fee is 1.5 million won based on the main hospital, which is a secondary hospital. This is a very small amount compared to about 6 million won in the United States. In Korea, the number of genes required to be tested is low compared to the number of genes that need to be tested, making it difficult for NGS testing to be universalized. Personally, I think NGS testing will become more common in more hospitals if NGS testing is lightweight and appropriately priced so that only necessary genes are tested rather than testing all 400 genes.
- InterView
- The use of HTN combi tx in Korea is the highest in the world
- by May 23, 2023 05:53am
- Park Chang-kyu, Chairman of the Society of Hypertension (Korea University Guro Hospital) (photo by Dailypharm) Korea is the best in the world for complex drugs related to hypertension and hyperlipidemia. The drugs prescribed for each patient’s condition will change, but recently there is a growing trend to use complex drugs that are convenient to take.” Park Chang-gyu, chairman of the Society for Hypertension (Professor, Cardiovascular Center, Korea University Guro Hospital, 64), met with Dailypharm at the '2023 Korean Society of Hypertension Spring Conference' held at Exco in Daegu on the 20th and said this. Park Chang-gyu, president of the Society, graduated from Korea University College of Medicine and received a master's degree from the graduate school. He received a doctorate in internal medicine from Korea University School of Medicine. He was an exchange professor at the University of Ottawa, Canada. Since 2014, he has been the head of the cardiovascular center, the head of internal medicine, and the chairman of the faculty council at Korea University Guro Hospital. Since last year, he has been serving as the president of the Hypertension Society. Hypertension is one of the chronic diseases that most require lifelong treatment. This disease can lead to a healthy life through management and treatment. If it is judged asymptomatic and not treated, it can lead to fatal complications. Essential hypertension occurs in 90% of hypertensive patients. It is a disease that is difficult to treat because the cause is unknown. Efforts to control blood pressure to normal should be made for the rest of pt's life. "The trend of prescribing high blood pressure drugs has changed to prescribing a combination drug rather than giving individual drugs such as ARB or CCB," said Park. "It has already been published in papers that the combination drug is beneficial for patient treatment," Park said. Park also presented his opinion on areas where pharmaceutical companies can secure competitiveness in the complex drug market where competition is overheated. “To strengthen the competitiveness of complex drugs, first of all, the scientific basis for the treatment effect or safety is the most important,” said Chairman Park. There will be," he said. Park also said, "Some companies can coat drugs well so that side effects such as gastrointestinal disorders do not appear, and some companies can develop improved formulations for drugs that are weak to moisture and can show reasonable drug prices by improving the production process." "Considering various factors such as technology and price competitiveness, we will be able to secure the competitiveness of high blood pressure combination drugs," he said. With an increasing number of young hypertensive patients, “We will engage in community education and exchanges with global societies” Park also introduced that the number of young hypertensive patients is increasing and that active management and treatment are needed, as well as strengthened treatment guidelines. According to HIRA's health care big data, hypertensive patients aged 20 to 29 increased from 29,123 in 2017 to 42,048 in 2021, a 44.4% increase. During the same period, the number of hypertensive patients aged 30 to 39 increased by 26.6% from 166,644 to 210,890. Park plans to further publicize the revised treatment guidelines in November last year for the increasing number of young hypertensive patients and health care at the age of 100 years old. The revised 2022 hypertension treatment guidelines recommended lowering the target blood pressure to 130. The target blood pressure was lower than the previous guideline. The Society of Hypertension also gave a recommendation grade for the appropriate use of combination drugs through an amendment. This means that it is recommended to consider treatment more actively than before. Park said, “Now, except for simple hypertension, most hypertension meets the enhanced blood pressure standard.” “It was announced in November 2022, but education that introduces the reason for lowering the standard and research needs to be known more starting this year.” "he said.
- InterView
- ‘Even a 0.2 vision is a miracle to some’
- by Eo, Yun-Ho May 15, 2023 05:41am
- Professor Suk Ho Byeon The reason for the slow development of new drugs in a specific disease can usually be attributed to one of the following two reasons. Low disease awareness or difficulty in developing the drug itself. The one-shot gene therapy Novatis’s ‘Luxturna (voretigene neparvovec)’ is a drug that overcame both barriers. Luxturna, which is a treatment for IRD (Inherited Retinal Dystrophy) caused by the mutation in both copies of the RPE65 gene, is the first treatment option developed for the difficult rare genetic condition. IRD is a rare intractable disease caused by a mutation in the gene responsible for the structure and function of retinal visual cells. It includes over 20 types of ophthalmologic conditions, and around 270 causal genes are known to be implicated in IRD. RPE65-IRD, caused by the mutation in both copies of the RPE65 gene, causes abnormalities in the visual cycle of the retina that converts visual information into a neural signal and delivers it to the brain. The mutation in the RPE65 gene reduces the RPE65 protein essential to the visual cycle and destroys the retinal cell, gradually narrowing the field of vision to eventually result in loss of vision. With only 6 patients found with IRD in Korea, patients with the condition reach legal blindness in their adolescence, at about 16 to 18 years of age, then progress to complete blindness. Due to the lack of a fundamental cure, only conservative treatment that could temporarily delay symptoms was available until now. WIth its release, Luxturna became the first drug introduced into the field that could prevent blindness. Dailypharm met with Professor Suk Ho Byeon, Department of Ophthalmology at Sinchon Severance Hospital to hear about the significance of RPE65-IRD and Luxturna. Professor Byeon had recently coauthored a consensus paper on RPE65-IRD published in the Korean Journal of Ophthalmology, an English journal published by the Korean Ophthalmological Society. -The consensus paper you released recently seems to have covered the whole content on RPE65 mutation-associated IRD starting from its concept. It felt more like a clinical practice guideline. Does the fact that this paper was published signify the lack of content on the diagnosis and management of RPE65-IRD in Korea? It can be said so. Due to the characteristics of the disease, treatment is rare in any form of IRD. Not many doctors have experience using drugs to treat the disease. So we tried to relay the existence of such a disease and the need to look for the disease. With the first drug released fRPE65-IRD, hope is rising among all IRD patients including those with genetic mutations other than the RPE65 mutation. However, since there was little information arranged on the disease itself as well as its diagnosis and treatment, we decided to bring together experts who had experienced or were familiar with the disease in Korea to arrange the information on the disease. The consensus paper includes information on what RPE65-IRD is, what kind of patients are considered to have IRD, its global epidemiology and epidemiology in Korea, to which extent genetic mutations are reported, and how and whom should receive gene tests for the disease. -As you’ve mentioned, the consensus paper includes content on finding the subjects that should receive genetic testing. Which parts should the doctor check during gene testing? One of the most prominent characteristics in these patients is that they had poor eyesight from an early age. This may be difficult to notice during infancy, but over time, the patient’s eyesight decreases significantly compared to normal people and is accompanied by night blindness. However, with so many areas bright at night, night blindness is sometimes discovered late these days. Patients with severe symptoms also experience eye tremors. However the features of the disease can vary even among patients affected with the same genetic mutation. Some patients show fewer symptoms and some do not have night blindness. Therefore, the disease is difficult to identify based solely on symptoms. Therefore, in pediatric patients, I think it is better to proceed and conduct a genetic test even if at the smallest suspicion. -So Luxturna was released in the field that had no available drugs. The drug received attention as the first gene therapy for ophthalmic diseases. What is your opinion on the value of the drug? That would be difficult for general ophthalmologists to judge. I can better explain its significance because I have experience treating patients with Luxturna. Patients with poor eyesight ever since childhood rarely visit the hospital, so doctors often do not know how these patients are faring. In that sense, it is difficult to estimate how much a patient's life would have improved with improved eyesight. Ophthalmologists measure both visual acuity and visual fields. This index of visual acuity and field of view measures how far off the patients’ eyesight is from those of normal people. Patients who were treated with Luxturna showed much improvement in the visual field and visual acuity. The improved visual acuity was about 0.2. For non-patients, visual acuity of 0.2 may feel like a poor condition, but for those that had almost no vision, even a 0.2 vision can be of great benefit. I was very surprised to see a patient I treated working part-time at a coffee shop. A patient who could go blind escaped the danger with Luxturna. In this sense, the effect of such treatment should not be judged based on standards set for normal eyes. - Luxturna received the non-reimbursement decision last month from the National Health Insurance Review and Assessment Service’s Drug Reimbursement Evaluation Committee. The committee pointed to how the condition is not life-threatening and is a high-priced drug as a barrier to reimbursement. There also seems to be a difference between the government and pharmaceutical companies regarding reimbursement standards. Reimbursement is a complex issue that requires broad and serious considerations. Since Luxturna is a gene replacement therapy, I know there have been disagreements on the remaining target cell and the criteria for recognizing its effect. As a doctor, I can definitely say that there can be no crystal-clear standard for evaluating living cells. Some cases can only be determined after treatment. Since it is such a rare condition, it is difficult to even estimate how many cases there will be.
- InterView
- Samsung Bio, investing in Swiss ADC bio company
- by Hwang, Jin-joon Apr 13, 2023 05:43am
- Panoramic view of Samsung Biologics. (Photo Samsung Biologics) Samsung Biologics announced on the 12th that it invested in Araris Biotech AG through the 'Samsung Life Science Fund' along with Samsung C&T. This investment was conducted exclusively by Samsung as a strategic investor (SI) prior to Araris Biotech AG's Series A phase. The investment is expected to be used for the further development of antibody-drug conjugate (ADC) candidates by Araris Biotech AG. ADC is a drug that combines a drug with an antibody and is one of the next-generation treatments. Araris Biotech AG is a company established in 2019 through the Federal Institute of Technology in Zurich, Switzerland. It has next-generation ADC linker technology. Araris Biotech AG's next-generation ADC linker technology has the advantage of attaching drugs to off-the-shelf antibodies without the need to redesign the antibody. This can reduce the time and cost required for drug development. Samsung plans to cooperate with Araris Biotech AG in the field of ADC treatment production and development. Previously, in July 2021, Samsung created a life science fund worth 150 billion won to discover new businesses in the biofield.
- InterView
- CDK4/6 latecomer Kisqali exudes confidence in its effect
- by Jung, Sae-Im Apr 11, 2023 06:11am
- Novartis’s Kisqali (rivociclib), a latecomer CDK4/6 inhibitor used in metastatic breast cancer, is taking on an unexplored path, away from other CDK4/6 inhibitors. The drug has demonstrated efficacy in aggressive forms of breast cancer, which had not been attempted by other CDK 4/6 inhibitors. Aggressive breast cancers appear relatively often in Korea where the proportion of younger aged patients is large, but the patients’ only available option was to use highly toxic chemotherapy. In a recent interview with Dailypharm, Seock-Ah Im, Professor of Hemato-Oncology at Seoul National University Hospital said, “Younger breast cancer patients have a higher probability of accompanying visceral metastasis because of their rapid cancer growth and aggressive clinical pattern. However, due to the clinical practice guidelines that recommended using chemotherapy for the past 20 to 30 years, there were doubts about whether to use CDK4/6 inhibitors. However, Kisqali's recent study convinced me of the viability of using CDK4/6 therapies." The recent study mentioned by Professor Im is the RIGHT Choice trial that was released in December last year. The trial studied aggressive hormone receptor–positive, HER2-negative advanced breast cancer patients that had symptomatic visceral metastasis, rapid disease progression or impending visceral compromise, or marked symptomatic nonvisceral disease. Although the CDK4/6 inhibitor+ endocrine therapy is currently used as the standard treatment for breast cancer in the first line, chemotherapy was still used in patients with rapid disease progression or visceral metastasis. Metastatic breast cancer often spreads to the lungs, liver, or brain, and when metastasis occurs, symptoms such as shortness of breath and pain may arise. In such cases, it is difficult to quickly reduce tumor size with hormone therapy alone. CDK4/6 inhibitors have been introduced as a new option in this field, but no data existed demonstrating their effectiveness in these patients. Kisqali is the only CDK4/6 inhibitor class drug to demonstrate an improved effect over combined chemotherapy in aggressive breast cancer. Results showed that the median progression-free survival (PFS) of the Kisqali + endocrine therapy combination was 24.0 months, a 1-year extension over the 12.4 months recorded by the control group (HR=0.54). The median time to treatment failure in the Kisqali combination group was 18.6 months, which was at least 10 months longer than that of the control group (HR=0.45). In terms of safety as well, the Kisqali combination group had a lower rate of treatment-related serious adverse reactions and treatment discontinuation rate compared to the combination chemotherapy group. Professor Lim said, "The scope of use of CDK4/6 inhibitors including Kisqali in HR+ breast cancer has increased significantly over the past two years. In line with the broadened scope of use of CDK4/6 inhibitors that changed the treatment paradigm of HR+ breast cancer, the ground is being laid to allow their more active use.” Professor Seock-Ah Im-I heard that Asian doctors first suggested the initiation of the RIGHT Choice trial = I am a member of a group of researchers that seek to improve the treatment of young breast cancer patients. As members, specialists from Asian countries, including Korea, Taiwan, Hong Kong, and Singapore, gather together to discuss and study how to improve the treatment environment for young breast cancer patients. During a meeting, the researchers suggested that a combination therapy that uses a CDK4/6 inhibitor could improve the quality of life and have a better antitumor effect than combination chemotherapy, and a research proposal was sent to pharmaceutical companies based on the suggestion. We proposed a study because young patients in their 40s and 50s occupy the majority population in Asia, compared to the West, which is dominated by elderly patients in their 60s and 70s. Breast cancer often takes on an aggressive form among young patients due to the fast cancer growth rate and relatively faster cell division. This means patients are highly likely to have accompanied liver or lung metastases. These doctors had been using chemotherapy as the first-line treatment for HR+ patients because it takes a long time to improve the patient’s symptoms by reducing cancer size with hormone treatment. Chemotherapy allows the tumor size to reduce within 1 to 2 months and the symptoms improve. However, it is also highly toxic. Therefore, a consensus was reached on how combining hormone therapy and targeted therapy instead of chemotherapy, which is difficult to be approved, would yield better results. Novarits’s Kisqalit team accepted the request, and so the RIGHT Choice study was conducted to demonstrate the actual improvement effect.. -How would you interpret the RIGHT Choice trial results? s= There had been clinical trials comparing hormone therapy and CDK4/6 inhibitors with oral anticancer drugs. However, this study is the first to show improvement compared to a combination therapy that is administered in two injections of cytotoxic anticancer drugs. In general, if a patient starts anticancer therapy, the tumor size is first reduced and then starts to grow again. The time until disease progression, that is, the time to symptom relief after chemotherapy and relapse is about 5 to 6 months. In clinical practice, the median time to treatment failure in the Kisqali combination group was 18.6 months, about twice as large as 8.5 months in the control group. Median progression-free survival was also extended by about 1 year compared to the control group. In particular, this study brings more significance because it includes premenopausal women and proves that a more comfortable initial treatment can be performed in premenopausal patients with more aggressive liver cancers or those with lung metastases. The limitation is that the study enrolled patients whose control group could be either one of two cytotoxic anticancer drugs and have a normal range of liver function and daily performance ability to some extent. The study did not include patients whose daily performance is so poor that they are almost bedridden. There are some cases we feel it’s inappropriate to conduct chemotherapy in some patients with visceral metastasis. However, on the other hand, there were many questions about whether it was really okay to use CDK4/6 inhibitor combination therapies. The study convinced me of the potential held by 'CDK4/6 therapy.’ -Kisqality was the last of the three CDK4/6 inhibitors to be introduced to the market. However, if you look at the recent sales records reported by the market research institution IQVIA, Kisqali made notable sales. How reliable are new drugs like Kisqali? =The data was interesting. Having participated in the trial of all three CDK4/6 inhibitors, Ibrance, Verzenio, and Kisqali, I am well aware of the benefits and disadvantages of each drug. Therefore, doctors tend to select drugs after comprehensively considering each patient’s safety, the patient's environment, and condition. In the case of postmenopausal women, side effects such as age, presence or absence of pulmonary embolism or venous thrombosis, and probability of pneumonia are considered. In addition, bone marrow function, liver function, electrocardiogram abnormality, and diarrhea are also considered. However, re-menopausal breast cancer patients didn't have as many options to choose from. Before Ibrance, the patient had to first remove both ovaries to use Ibrance. Fortunately, the combination therapy with Ibrance after ovariectomy did not require chemotherapy, and had only a few side effects other than a slight decrease in white blood cell count, so this method was mainly used. Later, the MONALEESA-7 study played a significant role.in allowing premenopausal women to use Kisqali combination therapy without ovarian resection.
- InterView
- The rebate effect is not just employee deviation
- by Kim JiEun Mar 22, 2023 05:47am
- The pharmaceutical company, which was suspended from sales due to the confirmation of the salesperson's suspicion of providing rebates, argued that there was no reason for the disposition, saying that it was only an employee's deviance, but the court did not accept it. The Suwon District Court recently dismissed a request for cancellation of a disposition to suspend sales of pharmaceuticals filed by a pharmaceutical company against the Gyeongin Food and Drug Administration. The reason for the disposition of pharmaceutical company A is as follows. Mr. B, who was a salesperson at this company, provided a total of 41 million won worth of economic benefits to the hospital administration manager several times from October 2013 to January 2016. As the charges were confirmed, Mr. B received a summary order of a fine of 10 million won for violating the Pharmaceutical Affairs Act around February 2017. The Gyeongin Food and Drug Administration issued a three-month suspension of drug sales to Pharmaceutical Company A in October 2021, four years after going through the prior notification procedure. The reason for the disposition was in accordance with Mr. B's summary order. Regarding this disposition, Pharmaceutical Company A argued that there was no reason for the disposition and that the KFDA's disposition violated and abused its discretion. First of all, the pharmaceutical company said the reason why there is no reason for disposition, "(Rebate) is only Mr. B's personal deviation, and the company has never been involved." "There is a legitimate reason for not being a person who provided economic benefits, or for not being able to blame for the neglect of duty." “It was difficult for the company to know Mr. B’s rebate act, and it was only after four years had elapsed since the summary order, in this case, was finalized,” he said. Considering that the education was conducted and Mr. B's act was an aberrant act, this disposition violates the principle of proportionality and responsibility, and is illegal as it deviates from and abuses discretion.” However, the court completely refuted the claim of pharmaceutical company A. First of all, it was emphasized that Mr. B's kickback behavior was not regarded as Mr. B's individual act and that the company was also responsible for it. The court said, “Mr. B, who was an employee of a pharmaceutical company A, committed an act in this case in which he provided economic benefits to medical personnel, etc. in the process of carrying out sales duties entrusted by the company.” is ultimately vested in the company. The responsibility for the violation of administrative obligations that occurred in the process is also acknowledged as partly attributable to the company.” The pharmaceutical company said that it did not fulfill its obligations even if it provided education related to fair trade self-compliance to its employees. While pointing out that the 3-month suspension of business was not excessive as the company claims, the court also effectively reviewed the precedent in which the company was previously suspended for 3 months due to illegal kickbacks. The court said, "It is acknowledged that the company conducted regular CP (Compliance Program) training for its salespersons, but the contents of the training only seem to be of a general level." It is difficult to admit a legitimate reason that cannot be blamed for neglect of duty based on circumstances alone.” The court continued, “Although all of the 35 million won in cash that Mr. B provided to the hospital administration manager does not appear to be a rebate to promote the drug sales of this pharmaceutical company, considering the purpose of the case that the standard, in this case, did not determine the degree of disposition in proportion to the amount of the rebate. If so, it is difficult to conclude that the disposition, in this case, is unfair.” Company A’s claim is dismissed without reason.”
- InterView
- ‘Reimbursing Revlimid as maintenance therapy beneficial’
- by Eo, Yun-Ho Mar 16, 2023 05:45am
- Professor Hyeon-Seok Eom The multiple myeloma treatment ‘Revlimid’ has finally been listed for reimbursement after 4 long years of await as maintenance therapy, starting from the new year of 2023. Reimbursement of Revlimid as maintenance therapy had undergone various twists and turns in Korea. Since 2019, BMS Korea had actively sought to list the drug for reimbursement, but was unable to make progress. The agenda has been deliberated by the Cancer Disease Drug Committee during meetings that were held in September 2019, June 2020, then again in September last year. The last meeting gained attention due to its deliberation of the CAR-T therapy ‘Kymriah (tisagenlecleucel),’ but to no avail for Revlimid. After passing CDDC deliberations in June last year, Revlimid’s reimbursement was finally extended to cover its use as maintenance therapy after 4 years. That a drug can prevent or delay the recurrence of cancer is an extraordinary concept that all cancer survivors would opt for. Revlimid has presented such an option for the first time in the field of multiple myeloma, a type of blood cancer that has a recurrence rate of 70-80%. Dailpharm met with Hyeon-Seok Eom, Professor of Hemato-Oncology at the National Cancer Center to seek insight into the significance and value brought by Revlimid's reimbursement as maintenance therapy. -It took a long time for Revlimid to receive the reimbursement extensions. How do you believe the reimbursement extension will affect the field? When considering how research on Revlimid’s use as maintenance therapy started in the mid-2000s, quite some time had been taken for its reimbursement approval. After the 5-year, and 10-year study data were published, I remember demand started to rise for the reimbursement of the drug as maintenance therapy around 2015. Even patients recognized the need and filed petitions to the National Assembly. Despite such efforts, it took quite some time for Revlimid to receive reimbursement as maintenance therapy. Patients were unable to use the drug as maintenance therapy or had to pay the full non-insured price for such use. In fact, from the late 2000s to early 2010s, this difference in treatment options led to a difference in the 5-year survival rate of multiple myeloma patients in Korea and the U.S. This is an example of how access to drugs directly affected the survival rate of patients. In the same context, patients in Korea will enjoy an improvement in their survival rate with the reimbursement extension. Improvement in the patient's quality of life and survival rate is of the greatest significance in terms of treatment as well. -The reimbursement approval of RVd (lenalidomide+bortezomib+ dexamethasone) therapy last year has greatly changed the prescription pattern of HCPs in Korea. The reimbursement of the maintenance therapy will also bring much change in the prescription environment. I believe the reimbursement of Revlimid as maintenance therapy will change how HCPs progress with treatment in the first line as well as the second line for multiple myeloma. For example, a patient’s overall survival may improve further if he or she uses Revlimid as maintenance therapy after VRd (bortezomib+lenalidomide+dexamethasone) therapy. This is why many studies abroad investigated the use of Revlimid as maintenance therapy following VRd therapy. In this aspect, the reimbursement approval of Revlimid has great significance. -Ultimately, how well the disease can be cared for in the front line (as first-line therapy) seems to be key in managing multiple myeloma as well. That’s true. Despite the increasing diversity of treatment options available in the field, it is still most important to see a good prognosis in the earlier stages. Considering how about 30% of patients die while transitioning from first-line treatment to second-line treatment and the prognosis of patients generally worsens with later lines of treatment, it is very important to increase the time to recurrence and survival rate of patients by treating patients well in the earlier stages. Therefore, it is most important to improve the prevention of recurrence, PFS, and OS with first-line treatment after considering various treatment options. Many HCPs abroad use many drugs in the first line to prolong the treatment period as much as possible. -What improvements do you wish for in treating multiple myeloma? The reimbursement of Revlimid as maintenance therapy has improved the front-line treatment environment, therefore, we now need to focus on improving the second-line treatment environment. We need to use more diverse options to treat multiple myeloma in the second line as well. The survival period of the patients is greatly reduced when patients go through further lines of treatment. The PFS is only a few months, and even the OS does not exceed 1 year in later lines of treatment, so it is important to use drugs well in the earlier stages. Also, good drugs remain unreimbursed in Korea. It is a pity that these effective drugs cannot be used earlier due to environmental issues like lack of reimbursement and are therefore used in the later stages of treatment. As in the United States, we should allow the use of effective drugs in earlier lines of treatment, and discretion should be given to the doctors for the combined use of drugs with reimbursement. - Are there any drugs you are looking forward to in the field of multiple myeloma in the future? With treatments continuing to evolve, I expect new treatment methods like CAR-T therapies would also eventually be introduced to the field. Development of such treatments will significantly improve the OS and quality of life of patients in the earlier lines of treatment, in the first- or second-line. Currently, patients with multiple myeloma generally recieve chemotherapy and autologous hematopoietic stem cell transplantation. However, some patients may experience side effects such as hair loss due to strong drugs and the process itself is also cumbersome as it requires weekly hospitalization. I hope that positive changes would come to foster a better treatment environment for patients in the future.
- InterView
- SGLT-2 I is a great help in the treatment of heart failure
- by Kim, Jin-Gu Feb 06, 2023 05:51am
- SGLT-2 inhibitors developed for the purpose of treating diabetes are speeding up the expansion into the area due to heart failure. The use of SGLT-2 inhibitors targeting heart failure is expanding not only in university hospitals but also in the local area. This trend has been expanding since the revision of the domestic heart failure guidelines last year. Although benefits are still limited, expectations for the drug are said to be very high at the front-line prescription site. Jung Young-jin (37), head of the cardiovascular center at Yongin Myeongju Hospital, said, "SGLT-2 inhibitors are very helpful in treating heart failure. He said, "The effect of improving major symptoms of heart failure, including difficulty breathing, is visible," adding, "Personally, we are more actively prescribing SGLT-2 inhibitors to heart failure patients than in the past." ◆SGLT-2 Inhibitor, Improvement of Heart Failure Symptoms Visibly The Korean Heart Failure Association revised the guidelines for heart failure treatment in July last year. The revised guidelines recommended SGLT-2 inhibitors as the main treatment for heart failure treatment regardless of the presence or absence of diabetes. It was used limitedly only to reduce heart rate and mildness during heart failure, but the revision of the guidelines added an area to preserve heart rate. The pharmaceutical industry predicts that SGLT-2 inhibitors will become the basic treatment for heart failure. SGLT-2 inhibitors have previously been known to be diabetes treatments that benefit cardiovascular diseases. Still, their status has risen significantly as the results of solo clinical trials on heart failure patients were announced in 2019. Expectations for this drug are high even at the front-line prescription site. Jung Young-jin, head of the cardiovascular center at Yongin Myeongju Hospital, said, "It is prescribed a lot to patients with heart failure who do not have diabetes," adding, "Improvement of major heart failure symptoms, including difficulty breathing, is visible." Jung, head of the center, said, "It was often used in heart failure patients in the past, but I have been using it more actively since a paper was published last year that it is effective in heart failure patients whose heart function is preserved." He added, "We are seeking consent from patients and prescribing them because the salary has not yet been applied." The pharmaceutical industry also predicts that SGLT-2 inhibitors will be able to further expand their areas in the future. SGLT-2 inhibitors are mechanisms that selectively inhibit SGLT-2 transporters involved in the reabsorption of glucose. Through this, blood sugar is controlled by blocking the reabsorption of glucose discharged into the urine into the bloodstream. In this process, SGLT-2 inhibitors also inhibit the secretion of inflammatory cytokines, which has the effect of treating heart failure. Considering this mechanism alone, it is estimated to be effective not only for heart failure but also for cardiovascular disease as a whole. This means that SGLT-2 inhibitors can be used to treat heart failure and other cardiovascular diseases such as myocardial infarction. Already in the United States and Europe, a paper has been published on the effect of SGLT-2 inhibitors on the treatment of myocardial infarction. AstraZeneca and Beringer Ingelheim, which have major drugs, are undergoing phase 3 clinical trials for myocardial infarction. The two clinical results are scheduled to be released this year. He also agreed with the possibility. Since the most common cause of heart failure is ischemic heart failure, I think it will be effective in other cardiovascular areas, said he, head of the center. "There is a possibility in terms of the mechanism."
- InterView
- Takeda will lead industry with focus on Oncology
- by Eo, Yun-Ho Feb 02, 2023 05:47am
- A company has achieved evolution through aggressive investment in line with the current trend. Through such evolution, Takeda Pharmaceuticals has become renowned as a 'Big Pharma' rather than a 'Japanese company' from some point. The company had previously focused on OTCs and chronic diseases such as diabetes and hypertension. However, through various small and large M&As, the company quickly secured pipelines for anticancer drugs and rare diseases. Until now, the company conducted four M&As, starting with Millennium Pharmaceutical in 2008, Nycomed in 2012, ARIAD Pharmaceuticals in 2017, then Shire in 2018. As a result, the company has been actively releasing advanced anticancer drugs in the oncology market, including the PARP inhibitor ‘Zejula and the’ EGFR Exon 20 insertion mutation targeting ‘Exkivity.’ Also, the company has made constant progress in treating hematologic cancers with products such as ‘Ninlaro,’ and ‘Adcetris.’ Dailypharm met with Sun Jin Lee, Head of the Oncology Business Unit at Takeda Pharmaceuticals Korea to seek insight into the company’s vision and future. Sun Jin Lee, Head of Oncology BU at Takeda Pharmaceuticals Korea-Could you give us a brief introduction of yourself? I first started my career in the industry as a peritoneal dialysis Product Manager at Baxter. Since then, I also was in charge of high blood pressure treatment products for 3 years and then served as a marketing manager for the circulatory system division for 3 years at Boehringer Ingelheim. After joining Takeda Pharmaceuticals in 2017, I first worked for over 3 years in the hemophilia BU and was involved in the domestic launch of ‘Adynovate,’ etc. After that, I was assigned to Takeda’s Asia-Pacific office and worked in Singapore for 1 year. Last year, I returned to Korea after being appointed the head of Oncology BU at Takeda Pharmaceuticals Korea. In other words, I have worked in marketing throughout my entire career in the pharmaceutical industry. - Takeda has been known to have undergone many changes. In the Oncology BU, the role of its head would have increased significantly with the reimbursement listing and prescriptions of the company’s oncology products. What area did you focus most greatly on last year? I have been with the Oncology BU for about 7 months now. As the head of the BU, I feel the greatest responsibility in performance delivery. This is the basic goal for all business units. Takeda’s fiscal year begins in April, therefore we are in our last quarter right now. Currently, we are focusing on achieving the performance target we set for the last year. My next area of focus was in strengthening the organization. After being assigned to the unit, I had a certain observation period, then focused on strengthening the internal capability of our unit. So I am focusing externally on performance, and internally on our human resources. In particular, only one manager had been assigned to manage all our oncology products despite our increasing portfolio. So we appointed additional managers and divided the work by disease area to increase efficiency. - What do you think is the most important competency required to be a marketer in the Oncology BU? Brand managers (BMs) in each unit have their own strengths and weaknesses as well as various abilities. Having experienced Primary Care and rare diseases firsthand, I believe anticancer drug brand managers should basically have an underlying respect for the patients and their life. In the Oncology BU, we consider various activities such as patient programs and directions to improve access to treatments. Many of these programs cannot be carried out if we are profit-focused or sales-focused. Therefore, I thought it would be difficult for our managers to understand how we carry out our activities if they do not have experience and patient-centricity at heart. Also, our managers need to have the ability to quickly acquire, examine widely, and draw out the essence of the flood of information. There is always a lot of up-to-date data on anticancer drugs. So you have to be able to read out the trend of the entire therapeutic area, including those about competing drugs. Otherwise, you will not be able to communicate with healthcare professionals. sb-The word all-comer is mentioned often during discussions on the reimbursement of anticancer drugs in Korea. Zejula was one representative example of such a drug last year, and more are expected to come this year. However, Korea has been conservative in reviewing these drugs for being less effective and having lower-level results. That is a very difficult issue. Our primary consideration is what will benefit the patient the most. This is also true on the doctors’ part. Pharmaceutical companies obtain permission based on clinical data and then promote drugs based on approved indications. And this will continue to be the same in the future. Doctors as clinicians will use the drug when they feel that the drug is beneficial and needed by the patient. The decision is entirely at the discretion of the doctor. - Exkivity was released this month and is receiving much attention from academic societies. The company would also have rising expectations for the product. Exkivity was approved in Korea last July and released on the 1st of this month. One significant aspect of the release is that we released the drug for the first time in Asia in Korea. Also, Korea is the 5th country in the world to obtain marketing authorization for Exkivity. Being the first oral anticancer drug that targets the EGFR exon 20 insertion mutation, we expect eligible patients to benefit greatly from our release.
