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- 2026-04-30 22:36:09
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- Targeting EZH1·2…Hanmi unveils next-gen anticancer agent
- by Hwang, byoung woo Oct 22, 2025 06:10am
- Hanmi Pharmaceutical has unveiled another pillar of its new anticancer pipeline at the ESMO Congress 2025 (European Society for Medical Oncology). The company presented Phase 1 clinical trial results of 'EZH1/2 dual inhibitor (HM97662),' suggesting possibilities for a new anticancer mechanism that could overcome drug resistance. DailyPharm met with Young Su Noh, Director of Hanmi's Oncology Clinical Team, and heard about the clincal significance of HM97662 and the company's future development strategy. Young Su Noh, Director of Hanmi "Evidence confirmed for resistance inhibition and maintained response… proving the value of EZH1 co-inhibition" According to the poster presentation, HM97662 secured safety and tolerability and confirmed initial anti-tumor responses in a Phase 1 clinical trial involving patients with advanced or metastatic solid tumors. A total of 28 patients received treatment across seven dose cohorts (50 to 350mg QD). Partial response (PR) and long-term stable disease (SD) were observed in some patients. Director Noh said, "HM97662 was developed based on a mechanism that simultaneously inhibits both EZH1 and EZH2, showing superiority over single inhibition in terms of resistance suppression and response durability." He explained, "Since EZH1 is compensatorily activated, leading to resistance when EZH2 is inhibited alone, the approach of targeting both is favorable." Noh also stated, "Long-term SD was also confirmed in the clinical trial, which shows the possibility that EZH1 co-inhibition contributes to maintaining the response," and added, "Although we are still in the early stages, we plan to continue establishing clinical evidence." The presentation highlighted a PR observed in a patient with SMARCA4 deficiency. Noh said, "The observation of PR in a patient with a SMARCA4 mutation is highly significant," and explained, "This patient group is high-risk with typically low response rates to existing treatments, and the results suggest that the EZH1/2 dual inhibition strategy has the potential to show therapeutic activity even in patients with molecular mutations." He added, "In solid tumors, PRC2 (Polycomb Repressive Complex 2) complex abnormalities are often involved, while EZH2 mutations are directly implicated in blood cancers. HM97662 is a candidate that reflects these molecular characteristics and can expand treatment possibilities even in solid tumors." Hanmi Pharmaceutical is currently conducting the Phase 1 trial of HM97662 in Korea and Australia and is considering expanding to the U.S. Noh said, "Hanmi Pharmaceutical is focusing on small cell carcinoma, ovarian cancer, and prostate cancer as cancer types where EZH1/2 dual inhibition may be particularly effective. Although we started with a broad scope of metastatic solid tumors, we will gradually narrow down to cancer types with clearer responses." "Combining global collaboration and in-house development… building the Hanmi oncology portfolio" Although Hanmi Pharmaceutical's presentation at ESMO Congress 2025 focused on HM97662, the company is building a diverse portfolio of other anti-cancer pipelines. Young Su Noh, Director of HanmiNoh said, "Out-licensing (L/O) is an important process, but it is not the only goal." He added, "We are also considering a strategy of simultaneously pursuing in-house development and commercialization to target areas where patient access is limited in Korea and Asia." Noh stated, "Global pharmaceutical companies are showing interest, and we are preparing for combination clinical trials," and added, "We have confirmed the possibility of synergy in preclinical studies when combining with immunotherapies, targeted therapies, or chemotherapy, and we plan to expand this into clinical trials." Hanmi plans to strengthen the clinical evidence for the EZH1/2 mechanism based on these results while also entering combination clinical trials with immunotherapies. Noh said, "We plan to secure dose and tolerability with monotherapy first, and then expand to combination strategies." He explained, "We are securing preclinical data that suggests the possibility of synergy when used in combination with chemotherapy and immunotherapy." Noh particularly mentioned Hanmi Pharmaceutical's ongoing oncology research efforts, noting that the company is pursuing a long-term, sustainable commercialization strategy. "Hanmi Pharmaceutical is known for obesity and metabolic diseases, but we also have long-standing research experience and accumulated capabilities in the oncology field," he said. "Our past clinical and research experience is driving our current anti-cancer pipeline." Noh also expressed confidence, stating, "Hanmi has already had multiple global technology transfer experiences, and we are developing returned projects in-house. We are building the foundation to complete new drugs with proprietary capacity, such as the EZH1/2 dual inhibitor." Following this trend, Hanmi is also accelerating its expansion into next-generation research areas. Noh commented, "In addition to immunotherapy combinations, we are also conducting research on next-generation platforms like mRNA and TPD (Targeted Protein Degradation)," and added, "Even after ESMO, we will continue to make subsequent presentations at major conferences like SITC to bring our oncology portfolio into public view.
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- ‘Age-specific vaccination needed to address unmet needs'
- by Son, Hyung Min Oct 22, 2025 06:09am
- Professor Jung-Hyun Choi, Division of Infectious Diseases, Eunpyeong St. Mary A new vaccine targeting the largest number of serotypes in the pneumococcal market has been introduced in Korea. MSD Korea plans to address unmet needs in pneumococcal disease through age-specific prevention strategies, following the release of its adult vaccine, which follows pediatric vaccines. On the 21st, MSD Korea held a press conference at the JW Marriott Hotel Seoul to mark the domestic approval of the pneumococcal vaccine Capvaxive and introduced the vaccine's clinical evidence and preventive efficacy. Capvaxive, which was approved in Korea in August, is indicated for adults aged 18 and older to prevent invasive disease and pneumonia caused by 21 pneumococcal serotypes (3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F, 35B). Notably, it covers 8 unique serotypes (15A, 15C, 16F, 23A, 23B, 24F, 31, 35B) not included in Pfizer’s Prevnar 20, which recently entered the Korean market. These serotypes are clinically significant for preventing pneumococcal disease in adults, as they are detected in over 30% of infected adults aged 65 and older. Pneumococcal disease is an infection caused by Streptococcus pneumoniae, which has approximately 100 different serotypes. In the United States, over 150,000 adults are hospitalized annually for pneumococcal pneumonia. As a result, pharmaceutical companies have continued competition to develop vaccines that cover more serotypes, and the emergence of the 21-valent vaccine Capvaxive represents an evolution in this serotype coverage competition. Capvaxive demonstrated non-inferiority compared to the existing 20-valent protein-conjugated vaccine (PCV20) in the Phase III STRIDE-3 trial. In this study involving 2,662 adults with no prior pneumococcal vaccination history, Capvaxive showed non-inferior immune responses to the 20-valent vaccine for shared serotypes and even higher antibody responses for unique serotypes. Furthermore, enhanced immune responses were observed in certain serotypes when administered as a booster to individuals previously vaccinated with 13-valent, 15-valent protein-conjugated vaccines, or the 23-valent polysaccharide vaccine. Professor Jung-Hyun Choi of the Division of Infectious Diseases at Eunpyeong St. Mary's Hospital emphasized, “Herd immunity formed solely through the National Immunization Program (NIP) for children is insufficient to prevent adult infections completely. The need for adult-specific vaccines is growing as serotypes with high antibiotic resistance and those not included in existing vaccines are increasing.” He further noted, “The 21-valent vaccine has a completely different coverage spectrum compared to existing vaccines. This is expected to provide approximately 20-30% higher preventive efficacy in adults.” Serotype replacement phenomenon causes prevention gaps…Need for separate pediatric/adult strategies highlighted Jaeyong Cho, Executive Director of MSD Korea’s Vaccine Business Unit MSD Korea has clearly differentiated its vaccine strategy by age group. It has obtained approval for the pediatric ‘Vaxneuvance (15-valent)’ and the adult ‘Capvaxive (21-valent)’ separately to establish a tailored prevention system considering age-specific immune characteristics and infection risks. This strategy pursues an age-optimized approach, differing from Pfizer's Prevnar series, which uses the same vaccine across all age groups. MSD Korea emphasizes that Capvaxive is specifically tailored for adults. While the overall pneumococcal infection rate has decreased due to the availability of various vaccines, a prevention gap still exists due to serotype replacement. Analysis indicates that infections caused by serotypes not included in vaccines developed since 2014 are increasing, necessitating a new response focused on the adult population. Reflecting this global trend, the U.S. Centers for Disease Control and Prevention (CDC) recently updated its pneumococcal vaccination guidelines, recommending vaccination for adults aged 50 and older, expanding the age range from the previously recommended 65 and older. The CDC specifically emphasized the need for broader serotype coverage, stating that even individuals who previously received the 13-valent vaccine should consider additional vaccination with the 20-, 21-, or 23-valent vaccines. Professor Choi stated, "Compared to PCV20, the preventive efficacy of Capvaxive against invasive pneumococcal disease caused by unique serotypes is expected to be 21-30%. The preventive effect against PCV20-specific serotypes when using Capvaxive appears to decrease by about 8%.“ He further emphasized, ”While the preventive effect is similar for some common serotypes, additional protection can be secured through Capvaxive’s unique serotypes. Ultimately, an age-specific customized vaccine strategy is the most realistic and efficient approach." Jaeyong Cho, Executive Director of MSD Korea’s Vaccine Business Unit, said, “By providing age-specific vaccines, we will reduce the risk of hospitalization and death from adult pneumococcal disease, alleviate healthcare costs, and ease the socioeconomic burden of an aging society. Capvaxive will become the new standard for adult pneumococcal prevention.” He added, “We plan to launch Capvaxive in the first or second quarter of next year and pursue collaboration with domestic pharmaceutical companies for its rollout at an appropriate time.”
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- FutureChem to apply for cond approval of Ludotadipep in KOR
- by Hwang, byoung woo Oct 22, 2025 06:08am
- Results for FutureChem's next-generation radioligand therapy (RLT) ‘Ludotadipep (FC705)’, presented at the European Society for Medical Oncology (ESMO 2025), are drawing significant attention. In a multiple-dose clinical trial for patients with metastatic castration-resistant prostate cancer (mCRPC), the cumulative radiation dose to major organs was found to be below international safety standards, and tolerability was maintained even with repeated administration. DailyPharm met with Chansoo Park, Executive Director of Development at FutureChem, in Berlin to discuss the significance of these results and the company's future development strategy. ESMO2025 Poster Presentation by Chan-soo Park, Executive Director of Development, FutureChem " “Albumin-binding structure extends …alleviates safety concerns" Director Park stated, “This data proves that the albumin-binding structure extends the substance’s half-life in the body while enhancing tumor accumulation without increasing exposure to normal organs.” The study, a Phase II clinical trial that was conducted in Korea, analyzed a total of 68 treatment cycles in 20 mCRPC patients. At the first dose, the highest absorbed doses were observed in the salivary glands (1.22±0.53 Gy/GBq) and kidneys (0.674±0.33 Gy/GBq), while the lowest dose was in the bone marrow (0.053±0.011 Gy/GBq). After repeated administration, the salivary gland dose decreased significantly (p
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- 'Will accelerate innovation through AI and clinical focus'
- by Hwang, byoung woo Oct 21, 2025 06:20am
- “AI is now at the heart of drug development. We must make our clinical support system more flexible and manage budgets more efficiently.” At the 2025 European Society for Medical Oncology (ESMO)—one of the world’s largest cancer conferences—Dr. Yeong-Min Park, Director of the Korea Drug Development Foundation (KDDF), stressed the importance of practical support measures to keep pace with global drug development trends. “Trends rapidly shifting around AI and oncology... an unavoidable trend for Korea as well” Director Park cited ‘AI (Artificial Intelligence)’ as the most notable keyword at this year's ESMO 2025. “Understanding global R&D trends is essential to identifying competitive fields. As KDDF prepares its next 5-year plan, this conference has provided valuable insights for discussion.” Indeed, many global pharmaceutical companies showcased AI-based drug candidate discovery, virtual clinical data utilization, and combination therapy optimization at this year’s meeting. Notably, ESMO also released official guidance titled “ESMO Guidance on the Use of Large Language Models in Clinical Practice (ELCAP)”, outlining the use of large language models (LLMs) in clinical practice. Director Park remarked, "The number of AI-related sessions was remarkably high, and the presentation quality was exceptionally strong. The government is also shifting its focus to AI starting next year, and the use of AI in the field of oncology will become an unavoidable trend. We also need to connect AI with our clinical and data businesses to accelerate innovation." At the ESMO2025 conference Hall in Berlin, booths from Korean companies like Lunit and Prestige Biopharma were set up throughout the conference halls. Additionally, the Korea National Enterprise for Clinical Trials (KoNECT) set up a booth to support domestic companies in securing investors and global partnerships. The Korea Drug Development Fund (KDDF) also participated in this support effort. Director Park said, “We have seen domestic companies actively engaging on-site. At this ESMO, which has grown to rival ASCO in scale, the presence of Korean companies was distinctly felt.” “KDDF plans to focus on clinical strengthening measures in its next five-year plan” For KDDF, participation in ESMO 2025 served not merely as observation but as a key step in policy planning. Director Park noted that the organization is currently meeting with industry leaders on-site to refine its future support framework. KDDF’s upcoming five-year plan is expected to include “enhanced clinical support” and “establishing an AI-driven drug development foundation” as its core initiatives. Director Park stressed execution and flexibility as critical elements for success, identifying three key factors in drug development: clinical support systems, budget management, and responsiveness to emerging trends. To this end, he stated that discussions are underway to allow clinical support funding to be flexibly adjusted within the scope of the preliminary feasibility study (PFS), rather than being constrained by a fixed budget. To enable this, KDDF is considering expanding the authority of evaluation committees and adjusting weightings based on clinical stage. Director Park mentioned, "Even if the total budget remains unchanged, we can adjust its allocation per project. We should allocate more to projects that require more funding and reduce allocations to those that require less. This approach will lead to tangible results.“ Finally, he added, ”Ultimately, new drug development hinges on the flexibility of the clinical support system and budget management. KDDF must chart a course that keeps pace with current trends while ensuring our companies gain competitiveness on the global stage."
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- Pluvicto demonstrates first-line efficacy in prostate cancer
- by Hwang, byoung woo Oct 21, 2025 06:19am
- Novartis’ radioligand therapy Pluvicto (lutetium vipivotide tetraxetan; [¹⁷⁷Lu]Lu-PSMA-617) has demonstrated a clinically meaningful benefit as first-line treatment in patients with metastatic hormone-sensitive prostate cancer (mHSPC). This is considered the first Phase III evidence confirming Pluvicto's potential to extend beyond existing castration-resistant prostate cancer (mCRPC) into the first-line (mHSPC) setting. Results of the Phase III PSMAddition trial are being presented at ESMO 2025 The findings from the Phase III PSMAddition trial, presented on October 19 at the ESMO 2025 Congress by Professor Scott T. Tagawa of Weill Cornell Medicine (U.S.), confirm the potential for Pluvicto to move earlier in the prostate cancer treatment paradigm. This study enrolled 1,144 patients with PSMA-positive mHSPC who were either treatment-naive (≤45 days) or had received minimal prior therapy. Patients were randomized 1:1 to either the combination group (572 patients) receiving Pluvicto + androgen deprivation therapy (ADT) + ARPI, or the ADT + ARPI monotherapy group (572 patients). Pluvicto was administered at 7.4 GBq every 6 weeks for up to six cycles, with stratification by disease volume (high vs low), age (≥ 70 years), and prior local treatment history of the primary tumor. The primary endpoint was radiographic progression-free survival (rPFS), with secondary endpoints including overall survival (OS), objective response rate (ORR), safety, and quality of life (QoL). At a median follow-up of 23.6 months, neither group had reached median rPFS, but the Pluvicto combination group showed a 28% lower risk of disease progression or death. Overall survival (OS) also had not reached its median, but showed an improvement trend in the Pluvicto group. The objective response rate (ORR) was 85.3% vs 80.8%, and rPFS improvement was consistent across all predefined subgroups. Safety profile consistent with existing data… No impact on quality of life Treatment-emergent adverse events (TEAEs) were reported in 98.4% vs 96.6% of patients, with grade ≥ 3 events occurring in 50.7% vs 43.0%, respectively. The most common AEs were dry mouth (46.5%), fatigue, and nausea, which were mostly mild (Grade 1–2). Hematologic toxicities (anemia, neutropenia, thrombocytopenia) were more frequent in the combination group but were generally manageable. There were no significant differences between groups in quality of life measures (Fact-P, BPI-SF, etc.). Scott T. Tagawa, Weill Cornell Medicine, USA Professor Tagawa stated, “Combination therapy with Pluvicto plus ADT and ARPI significantly improved radiographic progression-free survival (rPFS) in PSMA-positive mHSPC patients. The effect was consistent across subgroups, safety was consistent with the existing profile, and no deterioration in patient quality of life was observed.” He further emphasized, “These results provide evidence that an early combination strategy with Pluvicto may offer clinical benefit.” Professor Ana C. Garrido-Castro (Dana-Farber Cancer Institute/Harvard Medical School), who served as a discussant in the same session, noted, “PSMAddition is the first large-scale Phase III trial demonstrating that PSMA-targeted radiotherapeutics achieve meaningful efficacy even in the hormone-sensitive stage.” PSMAddition demonstrated that Pluvicto has emerged as a candidate for a new standard of care as a combination therapy in the early stages of prostate cancer using radioligand therapy (RLT). These findings are expected to serve as key evidence supporting future label expansion into the hormone-sensitive setting.
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- Eliquis 13%, Xarelto 49% of DOAC Generics mkt
- by Kim, Jin-Gu Oct 21, 2025 06:19am
- In Korea’s direct oral anticoagulant (DOAC) market, Eliquis (apixaban) generics have regained a 13% market share within a year of re-entering the market. However, that figure remains roughly half the level prior to their withdrawal. By contrast, Xarelto (rivaroxaban) generics have continued to expand their presence, reaching a 49% market share, has raised its market share to around 49%, poised to overtake the original. Analysis suggests that when Eliquis generics withdrew from the market, the focus shifted to Xarelto generics, making market penetration difficult for the Eliquis generics. 1 year after the re-entry of Eliquis generics... Market share around 13% According to the market research institution UBIST on the 20th, Eliquis generics recorded combined prescription sales of KRW 1.9 billion in Q3. Its market share in the apixaban-based DOAC treatment market stands at around 13%. Eliquis generics re-entered the DOAC market in Q4 last year. Eliquis generics initially entered the market in June 2019, when several companies launched products following first- and second-instance patent rulings in their favor. However, the situation reversed in April 2021 when the Supreme Court overturned the lower court rulings and sided with the originator, BMS. As a result, generic manufacturers immediately withdrew their products. This led to a three-and-a-half-year gap before their re-entry in September 2023, just ahead of the patent expiration on the apixaban compound. Quarterly prescriptions of Eliquis and Eliquis generics Since re-entering, Eliquis generics have struggled to regain momentum. Before withdrawal (in Q1 2021), total prescriptions had reached KRW 3.7 billion, representing a 24% share of the apixaban DOAC market. Compared to just before withdrawal, prescription sales are at half the level, and market share shows a difference exceeding 10% points. Although prescription sales have gradually increased since its market re-entry, evaluations indicate this growth falls short of expectations. Share of Xarelto generics' surged after Eliquis generics withdrawn from the market Analysis suggests that the market momentum shifted decisively toward Xarelto generics during Eliquis generics’ three-year absence, The first Xarelto generics were launched in Q2 2021, coinciding with the Supreme Court’s reversal in the Eliquis case. Although Xarelto’s substance patent did not expire until October 2021, five companies entered the market early. After patent expiry in Q4 2021, Xarelto generics rapidly expanded both prescription volume and market share. By Q1 2023, total prescriptions had reached KRW 3.7 billion, capturing over 30% of the rivaroxaban DOAC market. In Q3 this year, prescription sales further increased to KRW 7.2 billion. Its market share in the rivaroxaban market rose to around 49%. The pharmaceutical industry anticipates that it will soon surpass the original drug's market share. Quarterly prescriptions of major DOAC drugs in Korea Consequently, the positions of Eliquis generics and Xarelto generics have reversed. After Eliquis generics withdrew from the market due to the Supreme Court's reversal ruling, generic companies shifted their marketing focus to Xarelto generics, leading to increased prescription volume and market share, according to analysis. Reversed fortunes…Eliquis generic sales halted·focus on Xarelto generic sales intensifies In fact, some companies have not launched generics even after Eliquis' substance patent expired. Yuhan Corporation sold its Eliquis generic ‘Yuhan Apixaban’ before the Supreme Court ruling, achieving cumulative prescriptions worth over KRW 2.5 billion. However, it has stopped selling the product since the patent gap emerged. Instead, Yuhan has focused on selling its Xarelto generic ‘Yuhan Rivaroxaban’, achieving cumulative prescriptions worth KRW 3.3 billion. Hanmi Pharmaceutical made a similar shift, halting sales of its Eliquis generic ‘Apixban’ and focusing on its Xarelto generic, Riroxaban, which recorded KRW 2.2 billion in Q3 — the highest among all Xarelto generics. Chong Kun Dang and Samjin Pharmaceutical continue to market both Eliquis and Xarelto generics, though the latter’s performance is nearly twice as strong. Chong Kun Dang’s Eliquis generic Liquisia recorded KRW 600 million in Q3 prescriptions, compared to the KRW 1.2 billion made with its Xarelto generic Riroxia. Similarly, Samjin’s Eliquis generic Elxaban posted KRW 700 million, while its Xarelto generic Rivoxaban reached KRW 1.2 billion.
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- 'Rezurock' for cGVHD enters NHIS drug price negotiation
- by Eo, Yun-Ho Oct 20, 2025 06:08am
- Product photo of Rezurock 'Rezurock,' a treatment for the treatment of chronic graft-versus-host disease (cGVHD), has entered the last stage for insurance reimbursement listing. Sanofi Korea and the National Health Insurance Service (NHIS) are currently under negotiations for the drug pricing of the ROCK2 inhibitor 'Rezurock (belumosudil). Rezurock is a pharmaceutical that received Fast Track designation from the U.S. Food and Drug Administration (FDA). It was approved in Korea in August of last year and launched as a non-reimbursed drug in November. Rezurock is notable for selectively inhibiting ROCK2, a signaling pathway modulating chronic graft-versus-host disease (cGVHD)'s inflammatory response and fibrotic process. cGVHD is a complication that occurs in half of patients who received autologous stem cell transplantation. Patients with cGVHD may be few due to the disease's nature, but the disease occurs in half of the patients who receive the transfer. It is a severe and life-threatening disease that requires treatment. cGVHD is a major factor that accounts for 37.8% of the deaths of blood cancer patients, excluding recurrence. Notably, the treatment of chronic cGVHD is becoming more important as the cases of hematopoietic stem cell transplant are increasing every year in Korea (a total of 1,794 cases as of 2023). 42% of the transplant patients experience chronic cGVHD on average within 3 years, and 66% of the patients already experience acute cGVHD. However, there is a gap in the treatment strategy. Steroids, recommended as a first-line treatment in both Korean and overseas treatment guidelines, are difficult for long-term use. When used for an extended period, it may cause osteoporosis, joint damage, organ failure, hypertension, upset stomach, and growth suppression. Ninety-six percent of patients with chronic cGVHD use steroids as their first-line treatment. 70% of patients receive second-line treatment, and about 50% pursue third-line treatment. Currently, there are no effective third-line treatment options available when second-line treatments fail, forcing patients to rely on combinations of steroids and immunomodulator drugs. Furthermore, 97% of patients with cGVHD who receive steroid treatment experience one or more side effects, and the most frequent side effect is infection (79.5%). Infections in multiple organs significantly lower a patient's quality of life. A host immune response in the lung or liver is fatal. It is to be watched whether Rezurock will become a solid new treatment option with the reimbursement coverage. Meanwhile, Rezurock's clinical trial involved patients who failed to respond to two or more lines of systemic therapy. Patients treated with Rezurock recorded an overall response rate (ORR) of 75%, demonstrating superior effects compared to conventional treatment. Notably, in areas where improvement is difficult with conventional therapy, such as joints, liver, and lung, it also showed ORR of 71%, 39%, and 26%, respectively. Professor Hee-Je Kim in the Department of Hematology at Seoul St. Mary's Hospital (Hematology Hospital's Director) said, "42% of patients with cGVHD have symptoms across the whole body, leading to significant worsening of quality of life. Since the host response that occurs in lung and liver can critically affect patients with blood cancer, treatments that would effectively manage such response have been in need."
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- Enhertu redefines the standard in early-stage breast cancer
- by Hwang, byoung woo Oct 20, 2025 06:08am
- The antibody-drug conjugate (ADC) Enhertu (trastuzumab deruxtecan, T-DXd) has taken center stage as a new cornerstone in the treatment strategy for early-stage breast cancer. Both the DESTINY-Breast05 and DESTINY-Breast11 trial results that were presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin showed significant results, positioning T-DXd as a potential new standard of care across both neoadjuvant (pre-surgical) and adjuvant (post-surgical) settings. Professor Dr. Charles E. Geyer of the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center T-DXd reduces risk of recurrence by 53% compared to Kadcyla as postoperative adjuvant therapy DESTINY-Breast05 is a Phase III head-to-head trial directly comparing Enhertu with the standard therapy Kadcyla (trastuzumab emtansine, T-DM1) in patients with HER2-positive early breast cancer who had residual invasive disease after neoadjuvant therapy (chemotherapy and targeted therapy before surgery). Professor Dr. Charles E. Geyer of the University of Pittsburgh Medical Center (UPMC) Hillman Cancer Center, who presented the data at ESMO, emphasized, “In high-risk patients with residual disease, T-DXd demonstrated a clear survival benefit over T-DM1.” At the interim analysis, 3-year invasive disease-free survival (IDFS) was 92.4% for T-DXd (95% CI 89.9–94.4) versus 83.7% for T-DM1 (80.2–86.7), reflecting a 53% reduction in risk of events (HR 0.47, p
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- 'Keytruda+Padcev' proposed as a new standard trt for MIBC
- by Hwang, byoung woo Oct 20, 2025 06:07am
- Keytruda (pembrolizumab) and Padcev (enfortumab vedotin) have demonstrated synergistic effects in muscle-invasive bladder cancer (MIBC), opening up new possibilities. Analysis suggests that the combination of enfortumab vedotin and pembrolizumab may shift the perioperative standard of care for MIBC patients who are ineligible for or refuse cisplatin. The KEYNOTE-905/EV-303 results were presented at the ESMO Congress 2025. On October 18 (local time), the Phase 3 KEYNOTE-905/EV-303 results (LBA2) were presented at the ESMO Congress 2025 (European Society for Medical Oncology). The study evaluated the combination of Padcev and Keytruda before and after radical cystectomy + pelvic lymph node dissection (RC+PLND), the current standard of care, in MIBC patients who were ineligible for or refused cisplatin. Perioperative EV + pembrolizumab combination therapy improved the survival index significantly선 Professor Christof Vulsteke of AZ Maria Middelares Hospital in Belgium delivered the Phase 3 clinical trial results as an oral presentation during the Presidential Symposium I. Professor Christof Vulsteke of AZ Maria Middelares Hospital in Belgium The study randomized 344 patients ineligible for or refusing cisplatin, comparing the Padcev + Keytruda combination therapy group (170 patients) with the surgery-only control group (174 patients). Patients were tracked for a median follow-up of 25.6 months. The study results showed that the Padcev + Keytruda combination therapy demonstrated statistically significant improvements in event-free survival (EFS), overall survival (OS), and pathological complete response rate (pCR) compared to RC+PLND monotherapy. First, EFS was significantly improved in the combination group, with the median not yet reached, compared to 15.7 months in the control group (Hazard Ratio [HR] 0.40; 95% CI 0.28–0.57; P < 0.0001). Overall survival (OS) also showed a statistical advantage in the combination group, with the median not yet reached, compared to 41.7 months in the control group (HR 0.50; 95% CI 0.33–0.74; P = 0.0002). This performance garnered significant applause during the presentation of EFS and OS results. The pCR also showed a stark difference: 57.1% in the combination arm versus 8.6% in the control arm, a difference of nearly 48 percentage points (P < 0.000001). Event-free survival (EFS) was significantly improved in the combination group, with the median not yet reached, compared to 15.7 months in the control group (Hazard Ratio [HR] 0.40; 95% CI 0.28–0.57; P < 0.0001). Professor Vulsteke said, "This study is the first randomized Phase 3 result to clearly demonstrate a survival benefit from perioperative combination therapy in patients with resectable, cisplatin-ineligible MIBC," and explained that "the Padcev + Keytruda combination demonstrated the potential to replace the existing chemotherapy-centric treatment paradigm." The median age of the patients was 74, and the reasons for cisplatin ineligibility varied, including reduced kidney function, hearing impairment, and neuropathy. However, the benefit of the Padcev + Keytruda combination was consistently maintained across subgroup analyses by age and comorbidity. However, the incidence of Grade 3 or higher adverse events was higher in the combination group (71.3%) compared to the control group (45.9%), emphasizing the importance of patient selection and management during clinical application. "Clarity needed on stage-specific contribution of treatment before and after surgery" Jonathan Rosenberg, Professor at Memorial Sloan Kettering Cancer Center in the U.S.Jonathan Rosenberg, Professor at Memorial Sloan Kettering Cancer Center in the U.S., who participated as a guest speaker, said, "This study showed impressive results with an HR for both EFS and OS in the range of 0.4-0.5 in elderly and cisplatin-ineligible or refusing patients," and assessed that "the Padcev + Keytruda combination is ready to become a realistic new standard of care." Professor Rosenberg further stressed, "Clearly defining the contribution of treatment in the neoadjuvant and adjuvant stages, and optimizing therapy through circulating tumor DNA (ctDNA) analysis, will be important future tasks." Regarding the management of relapsed and metastatic patients, he suggested, "Platinum-based chemotherapy may still be considered the standard for patients who relapse early after Padcev + Keytruda," and proposed that "research into new treatment orders is needed in the post-EV combination era." Experts analyzed that, based on these results, the focus of bladder cancer treatment is shifting from traditional cisplatin chemotherapy to EV-based combination therapy, assessing this as a signal for a paradigm shift in the treatment of MIBC.
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- Alecensa achieves 81-month median overall survival
- by Hwang, byoung woo Oct 20, 2025 06:07am
- Roche's ALK inhibitor Alecensa (alectinib) has demonstrated long-term survival benefits exceeding 7 years in patients with ALK-positive advanced non-small cell lung cancer (NSCLC). In the final overall survival (OS) analysis of the Phase III ALEX study, Alecensa showed a clear survival benefit over existing treatments, reaffirming its status as the standard first-line therapy. ALEX Study Final Results (LBA73) Presentation Median survival 81 months...“Changes the patient survival curve in the first-line treatment landscape” According to the updated ALEX results (LBA73) presented on October 17 (local time), the median OS with Alecensa was 81.1 months (95% CI 62.3–NE) compared to 54.2 months (95% CI 34.6–75.6) with crizotinib, representing an improvement of approximately 27 months. Professor Tony S.K. Mok of the Chinese University of Hong Kong, who presented the findings, stated, “Alecensa reduced the risk of death by about 22% (HR 0.78, 95% CI 0.56–1.08). Although OS was a secondary endpoint, the improvement is clinically meaningful and clearly directional.” Professor Tony S.K. Mok, The Chinese University of Hong KongImportantly, the final analysis confirmed sustained survival benefits even among patients with brain metastases. Professor Mok stated, “Among patients with brain metastases who received radiotherapy, median OS reached 92 months with alectinib versus 39 months with crizotinib, which is more than double.” Additionally, in patients with brain metastases who had not undergone radiation therapy, alectinib showed a survival period of 47 months, demonstrating a clear advantage over crizotinib (approximately 24 months). Furthermore, in the patient group without brain metastases, the median survival period reached 94 months with alectinib treatment, drawing a long-term survival curve exceeding 7 years. Professor Mok emphasized, “Alectinib's efficacy was maintained regardless of brain metastasis status or prior radiotherapy. The strong CNS penetration of alectinib likely contributed to this durable control and fundamentally changed the survival trajectory for these patients.” Response duration 4 times longer… Long-term treatment tolerability also ‘good’ The duration of response (DoR) in the alectinib group was 42.3 months (95% CI 31.3–51.3), approximately 4 times longer than the 11.1 months (95% CI 7.9–13.0) observed in the crizotinib group. Prof. Mok said, “This once again demonstrates alectinib's strength in providing a long and stable treatment response. Safety analysis also showed it maintained a stable safety profile during long-term administration.” The 7-year OS rate was 48.6% with Alecensa and 38.2% with crizotinib. Compared to the historical chemotherapy era (median survival ~8 months), this represents a tenfold improvement. “The fact that half of the patients with advanced lung cancer survived for more than 5 years demonstrates a complete paradigm shift in first-line treatment.” Professor Christine M. Lovly, Vanderbilt University, USAHowever, Professor Christine M. Lovly of Vanderbilt University in the US, who led the invited discussion that followed the presentation, also mentioned some limitations of the study. Professor Lovly pointed out, “25% of the crizotinib group subsequently used alectinib, and this crossover made it difficult to achieve statistical significance (p=0.132).” Nevertheless, Professor Lovly stated, “The trend toward survival extension is clear, and the consistent benefit observed in patients with brain metastases is undeniable. The ALEX study is a landmark study that ushered in the era of ALK inhibitors. Now, we must evolve toward precision therapy that reflects molecular characteristics such as TP53 mutations and baseline ctDNA status.” Concluding the presentation, Professor Mok said, “The ALEX study sets a new benchmark—showing that 7-year survival is now an attainable goal for ALK-positive lung cancer patients. Alecensa will continue to extend survival safely and stably as the first-line standard of care.”
