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- 2025-12-18 03:41:57
- Company
- 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
- Company
- '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."
- Company
- 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.
- Company
- 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.
- Policy
- Parliamentary inspection of the MFDS to highlight
- by Lee, Jeong-Hwan Oct 21, 2025 06:19am
- President Lee Jae Myung During the upcoming parliamentary inspection of the Ministry of Food and Drug Safety (MFDS), the National Assembly is expected to highlight the need to increase the number of reviewers and support the formation of dedicated teams to provide customized approval services, all aimed at shortening the review period for domestically developed new drugs. This move follows President Lee Jae Myung's directive to increase the number of drug reviewers by 300 to foster the K-Bio industry. On October 20, both ruling and opposition members of the National Assembly's Health and Welfare Committee are focusing on the issue of increasing and expanding the new drug approval review staff, which is deemed necessary for developing the domestic pharmaceutical and bio-industry, during the MFDS parliamentary inspection scheduled for October 21. President Lee Jae Myung ordered the expansion of the new drug review workforce, including biopharmaceuticals, during the 2nd Core Regulation Rationalization Strategy Meeting held at the Presidential Office in Yongsan, Seoul, on October 16. President Lee specifically emphasized the increase in MFDS review staff, stating, "The Ministry of the Interior and Safety may object, asking why we are increasing the number of public officials, but let's disregard that and proceed." This was a response to MFDS Minister Yu-Kyoung Oh's previous announcement to significantly expand the review workforce and strengthen existing review services, including prior consultation, face-to-face consultation, and supplementary meetings, to transform the MFDS into a regulatory service agency centered on demand, focusing on the pharmaceutical companies seeking new drug approvals. Minister Oh requested an increase of 300 MFDS reviewers to accelerate the review process (targeting 240 days), a request which President Lee accepted. Members from the Democratic Party of Korea and the People Power Party on the Health and Welfare Committee agree on the need to improve the review environment for rapid domestic new drug marketing authorization. They are expected to pursue related questioning during the parliamentary inspection. Rep. Nam In-soon (Democratic Party) plans to highlight the necessity of increasing the hiring of not only pharmacists but also physicians for dedicated review roles, following President Lee and Minister Oh's push for expanded review staff. The increase of 300 MFDS reviewers requires an annual labor cost of KRW 15 billion, and the plan is to cover this cost by increasing review service fees. Members on the Health and Welfare Committee are expected to specifically question MFDS on its plan to secure the necessary funding by raising the review fees for both synthetic drugs and biopharmaceuticals. A Health and Welfare Committee official said, "The MFDS review staff, at about 300 people, is much smaller compared to the U.S. FDA's approximately 9,000 staff and the European EMA's approximately 4,000 staff," and added, "Given the future blueprint of creating domestic global new drugs and fostering global pharmaceutical companies, we plan to question the need to foster new drug approval review team and the specific policy direction."
- InterView
- "GI Innovation challenges melanoma"
- by Hwang, byoung woo Oct 21, 2025 06:18am
- GI Innovation is accelerating its entry into the global market. The company unveiled clinical data for its new immunotherapy drug candidate, 'GI-102,' at the ESMO Congress 2025 (European Society for Medical Oncology). GI-102 is drawing attention for its potential to overcome resistance, as it showed clinical improvement, including tumor shrinkage of more than half, even in melanoma patients who did not respond to PD-1 antibody monotherapy. Based on the latest results, the company has strategized to expand collaboration with global pharmaceutical companies for joint clinical trials and aims for first-line treatment for melanoma. DailyPharm met with Myoung Ho Jang, CEO of GI Innovation, and Nari Yun, Director, at the ESMO Congress 2025 to hear about the significance of the GI-102 poster presentation and the company's future strategy. (from left) Na Ri Yun, Executive Vice President (Clinical Dev & Strategy) and Myoung Ho Jang, CEO of GI Innovation "Demonstrated activity in patients refractory or resistant to immunotherapies…potential to overcome Keytruda resistance" The new drug candidate GI-102 is a fusion protein developed using the company's proprietary "Immune-cytokine" platform. It is structured to maintain the anti-cancer immune activation function of IL-2 (Interleukin-2) while reducing toxicity by combining it with the immunomodulatory protein CD80. It works by a differentiated mechanism that directly activates immune cells and suppresses regulatory T-cells (immunosuppressive cells), thus being assessed as an innovative candidate that can compensate for the limitations of existing PD-1 antibodies. According to the GI-102 poster presentation at ESMO Congress 2025, the drug showed significant anti-cancer activity in a combination trial targeting patients refractory or resistant to PD-1 antibodies. In the initial combination trial, 10 melanoma patients who were refractory to PD-1 antibodies, the combination of GI-102 and Keytruda (pembrolizumab) recorded an objective response rate (ORR) of 40% and a disease control rate (DCR) of 70%. Notably, a case was presented where a patient whose disease had progressed just two months after initial Keytruda treatment achieved a partial response (PR), with the tumor shrinking by approximately 59%, after the GI-102 combination therapy. In this case, the tumor reduction (cPR, -59%) and progression-free survival (PFS) of 3.9 months were observed when GI-102 was combined with the same drug backbone. Na Ri Yun, Executive Vice President of GI Innovation (Clinical Dev & Strategy), explained, "The fact that the tumor shrank by more than half in a patient who did not respond to PD-1 antibody monotherapy signifies the potential to overcome refractoriness," and added, "The key finding is that GI-102 dramatically increases the number of immune cells (lymphocytes) that determine the response rate of immunotherapies." The GI-102 combination group also showed an increasing trend in anti-cancer immune cells, such as CD8⁺ and CD4⁺ T-cells, as treatment progressed. Yun mentioned, "We confirmed a clear increase in anti-cancer immune cells, such as CD8⁺ and CD4⁺ T-cells, following the GI-102 combination," and added, "When the number of immune cells increases, there are more targets for the PD-1 antibody to bind to, which ultimately strengthens the anti-cancer effect." Notably, no dose-limiting toxicities (DLT) were observed in this combination trial. Most adverse events, such as fever and chills, were mild (Grade 1-2). Although elevated liver enzymes occurred transiently in some patients during the first treatment cycle, they recovered to the normal range. The company explained that "global pharmaceutical companies also assessed these to be manageable through meetings." Yun said, "The frequency of side effects was significantly low compared to conventional IL-2 class drugs, and patients tolerated the treatment well." She added, "We have obtained very positive data in terms of safety." Myoung Ho Jang, CEO of GI Innovation, said, "This data confirmed that GI-102 monotherapy shows activity comparable to global blockbuster immunotherapies," and assed that "The combination therapy was confirmed to induce a response even in patient populations that existing PD-1 antibodies could not reach." Jang added, "GI-102 is garnering high interest from global pharmaceutical companies because it is an IL-2-based immunocytokine that suppresses regulatory T-cells." Active discussions with global pharma..."A head-to-head challenge in first-line melanoma treatments" GI Innovation engaged in discussions with global pharmaceutical companies at the conference regarding collaborative clinical trials for first-line melanoma treatment. Currently, PD-1 antibodies like Keytruda and Opdivo (nivolumab) are approved as first-line monotherapies for melanoma. Jang said, "We are having positive discussions with global pharmaceutical companies here at ESMO 2025," and added, "We are reviewing a randomized clinical design to 'head-to-head' compare the efficacy of the GI-102 combination effect against PD-1 monotherapy." Yun added, "Melanoma is the only cancer type where PD-1 monotherapy is the standard of care. Proving the superiority of GI-102 here will increase its potential for expansion into other solid tumors." The fact that the company is considering a direct comparison clinical trial against a first-line monotherapy is evidence of its confidence in the results. Notably, GI Innovation stated that it is considering developing GI-102 not merely as a technology transfer (L/O) but as a co-clinical/co-commercialization model with global pharmaceutical companies. Jang stressed, "While we are in discussions for the technology transfer of GI-101A, we prefer a model where the company retains certain rights and co-develops GI-102 with a global pharmaceutical company," and stressed, "Our goal is to increase long-term value through a direct commercialization structure, creating direct revenue rather than just royalty income." Yun added, "We favor a partnership structure where the company proactively secures rights so as not to be swayed even if a global pharmaceutical company's internal priorities change." In conclusion, the analysis suggests that the discussions held at ESMO Congress 2025 confirmed GI-102's competitiveness in the global market. Finally, Jang said, "Although we are starting with melanoma, we expect a rapid expansion into other solid tumors through off-label use as clinical evidence accumulates," and added, "The conference provided us with confidence that GI-102 possesses genuine competitiveness in the global market."
- Company
- '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."
- Company
- 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
- Company
- '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.
- Company
- 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.”
