Rilvegostomig
- Generic Name
- Rilvegostomig
Compugen Announces Key Leadership Transition: CEO Cohen-Dayag to Become Executive Chair as CSO Ophir Takes Helm
• Compugen Ltd. has announced significant leadership changes effective September 2025, with current CEO Anat Cohen-Dayag transitioning to Executive Chair and CSO Eran Ophir being appointed as the new President and CEO.
• Under Cohen-Dayag's 15-year leadership, Compugen transformed into a clinical-stage cancer immunotherapy company with a pipeline built on its proprietary AI/ML-driven Unigen™ computational discovery platform.
• The company maintains a strong position with multiple clinical-stage assets, including partnerships with AstraZeneca and Gilead, and reports a cash runway extending into 2027.
GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure
• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients.
• The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments.
• iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.
BeiGene Discontinues Ociperlimab Development After Failed Phase III Lung Cancer Trial
• BeiGene has terminated development of its anti-TIGIT antibody ociperlimab following a futility analysis showing the drug was unlikely to meet overall survival endpoints in non-small cell lung cancer.
• The decision comes after Novartis ended its $300 million licensing partnership with BeiGene in July 2023, forcing the biotech to reevaluate the drug's development pathway.
• This setback adds to mounting challenges in the TIGIT inhibitor space, following Merck's recent discontinuation of two Phase III trials of its anti-TIGIT candidate vibostolimab due to safety and efficacy concerns.
CHMP Recommends ENHERTU® Approval for HER2 Low/Ultralow Metastatic Breast Cancer in EU
• The European Medicines Agency's CHMP has recommended approval of ENHERTU® for patients with HER2 low or ultralow metastatic breast cancer who have received prior endocrine therapy.
• This regulatory milestone expands treatment options for metastatic breast cancer patients with lower HER2 expression levels, addressing an important unmet medical need.
• The recommendation follows successful clinical trials demonstrating ENHERTU's efficacy in this patient population, marking a significant advancement in targeted breast cancer therapy.
TROPION-Lung12: Phase 3 Trial of Datopotamab Deruxtecan in Early-Stage NSCLC Initiated
• The TROPION-Lung12 phase 3 trial has begun, assessing adjuvant DATROWAY® (datopotamab deruxtecan) with or without rilvegostomig in resected stage 1 NSCLC patients.
• The trial targets patients with ctDNA-positive status or high-risk pathological features, aiming to improve outcomes after surgery for early-stage non-small cell lung cancer.
• DATROWAY®, a TROP2-directed antibody-drug conjugate, is being evaluated against standard of care to prevent disease recurrence in this high-risk population.
• This global, multicenter trial will enroll approximately 660 patients across Asia, Europe, North America, and South America to evaluate disease-free survival.
Cogent Bio Presents Bezuclastinib Data Highlighting Long-Term Benefits in Non-Advanced Systemic Mastocytosis
• Cogent Biosciences will present a poster on bezuclastinib at the AAAAI Annual Meeting, focusing on long-term symptomatic benefits in NonAdvSM patients.
• The poster highlights efficacy and safety results from the ongoing SUMMIT trial in adult NonAdvSM patients receiving 100mg of bezuclastinib.
• Cogent anticipates top-line results from the SUMMIT trial in July 2025 and plans to submit an NDA for bezuclastinib by the end of 2025.
• Expanded Access Programs for bezuclastinib are expected to launch in the U.S. in Q1 2025 for Systemic Mastocytosis and Gastrointestinal Stromal Tumors patients.
Asher Bio and Amgen Collaborate to Evaluate Etakafusp Alfa in Combination with IMDELLTRA® for Extensive-Stage Small Cell Lung Cancer
• Asher Bio and Amgen have entered a clinical trial collaboration to assess etakafusp alfa with IMDELLTRA® in extensive-stage small cell lung cancer (ES-SCLC).
• The Phase 1b study, sponsored by Amgen, will evaluate the safety and early efficacy of the combination therapy in ES-SCLC patients.
• Etakafusp alfa, a CD8+ T cell targeted IL-2 immunotherapy, aims to enhance the efficacy of T cell engagers like IMDELLTRA®.
• This collaboration seeks to improve outcomes for ES-SCLC patients, who currently face poor survival rates with existing treatments.
Compugen's COM503, an Anti-IL-18 Binding Protein Antibody, Enters Phase 1 Trial for Advanced Solid Tumors
• Compugen's COM503, a potential first-in-class anti-IL-18 binding protein antibody licensed to Gilead, has entered Phase 1 clinical trials.
• The Phase 1 trial will assess the safety, tolerability, and pharmacokinetics of COM503 as a monotherapy and in combination with zimberelimab in advanced solid tumors.
• COM503 aims to enhance anti-tumor immune responses by blocking the IL-18 binding protein, releasing naturally occurring IL-18 within tumors.
• Compugen is responsible for the Phase 1 trial, with Gilead holding exclusive rights for further development and commercialization of COM503.
CDSCO Panel Approves Novartis Protocol Amendment for TIN816 Study in Sepsis-Associated Acute Kidney Injury
The Central Drug Standard Control Organization's Subject Expert Committee has approved Novartis's protocol amendment for the TIN816 study, aimed at investigating the safety and efficacy of TIN816 in treating sepsis-associated acute kidney injury.
Daiichi Sankyo and AstraZeneca Launch Phase III Trials of Datopotamab Deruxtecan Combinations in Advanced NSCLC
• Daiichi Sankyo and AstraZeneca have initiated three Phase III clinical trials (TROPION-Lung 10/14/15) to assess datopotamab deruxtecan (Dato-DXd) combinations in advanced nonsquamous NSCLC.
• TROPION-Lung 10 evaluates Dato-DXd plus rilvegostomig versus rilvegostomig alone or pembrolizumab, with PFS and OS as primary endpoints, enrolling approximately 675 patients.
• TROPION-Lung 14 studies Dato-DXd plus osimertinib versus osimertinib alone in about 580 patients, focusing on PFS, CNS PFS, ORR, and OS.
• TROPION-Lung 15 compares Dato-DXd alone or with osimertinib against platinum-based chemotherapy, with PFS as a primary endpoint, enrolling around 630 patients.
Daiichi Sankyo and AstraZeneca Initiate Three Phase 3 Trials of Datopotamab Deruxtecan Combinations in NSCLC
• Three new Phase 3 trials (TROPION-Lung10, TROPION-Lung14, and TROPION-Lung15) will evaluate datopotamab deruxtecan (Dato-DXd) in combination with other agents for non-small cell lung cancer (NSCLC).
• TROPION-Lung10 will assess Dato-DXd plus rilvegostomig versus pembrolizumab in previously untreated, advanced NSCLC with high PD-L1 expression.
• TROPION-Lung14 will evaluate Dato-DXd plus osimertinib versus osimertinib alone in previously untreated, advanced NSCLC with EGFR mutations.
• TROPION-Lung15 will investigate Dato-DXd monotherapy or in combination with osimertinib versus chemotherapy in EGFR-mutated NSCLC progressing after osimertinib treatment.
Phase 3 Trials Launched to Evaluate Datopotamab Deruxtecan Combinations in Advanced NSCLC
• Three Phase 3 trials are underway to assess datopotamab deruxtecan-based combinations for advanced nonsquamous non-small cell lung cancer (NSCLC).
• TROPION-Lung10 evaluates datopotamab deruxtecan plus rilvegostomig versus pembrolizumab in NSCLC patients with high PD-L1 expression.
• TROPION-Lung14 assesses datopotamab deruxtecan plus osimertinib versus osimertinib alone in EGFR-mutated NSCLC patients.
• TROPION-Lung15 examines datopotamab deruxtecan with or without osimertinib versus chemotherapy in EGFR-mutated NSCLC after osimertinib progression.
AstraZeneca's Imfinzi and Imjudo Combo Shows Sustained Survival Benefit in Liver Cancer
• The STRIDE regimen (Imfinzi plus Imjudo) demonstrated a 24% reduction in the risk of death compared to sorafenib in unresectable hepatocellular carcinoma (HCC).
• Approximately 19.6% of patients treated with the STRIDE regimen were alive at five years, compared to 9.4% treated with sorafenib.
• The safety profile of the STRIDE regimen was consistent with the known profiles of each medicine, with no new safety signals observed.
• These results reinforce the use of this novel dual immunotherapy regimen and are an important milestone for patients with this devastating disease.
Imfinzi and Imjudo Combo Shows Unprecedented Survival in Liver Cancer
• The combination of Imfinzi and Imjudo demonstrated an unprecedented overall survival rate in advanced hepatocellular carcinoma (HCC).
• The STRIDE regimen, combining a single dose of Imjudo with Imfinzi, showed one in five patients surviving five years, a significant milestone.
• The safety profile of the STRIDE regimen was consistent with the known profiles of each medicine, with manageable adverse events.
• Imfinzi plus Imjudo is approved for advanced or unresectable HCC in the US, EU, Japan, and other countries, offering a new treatment option.
Imfinzi Plus Imjudo Shows Unprecedented 5-Year Survival in Advanced Liver Cancer
• AstraZeneca's Imfinzi plus Imjudo (STRIDE regimen) demonstrated a significant overall survival benefit in patients with unresectable hepatocellular carcinoma (HCC).
• At five years, 19.6% of patients on the STRIDE regimen were alive compared to 9.4% on sorafenib, marking the longest survival follow-up in a Phase III immunotherapy trial for HCC.
• The STRIDE regimen reduced the risk of death by 24% compared to sorafenib (HR 0.76; 95% CI: 0.65-0.89), establishing a new benchmark in advanced liver cancer treatment.
• The safety profile of the STRIDE regimen was consistent with previous findings, reinforcing its potential as a first-line treatment option for advanced HCC.
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