CHMP recommends Rybrevant in combination with chemotherapy for advanced EGFR-mutated NSCLC
- The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the approval of Rybrevant (amivantamab) in combination with chemotherapy for advanced non-small cell lung cancer (NSCLC) with EGFR mutations.
- The recommendation is based on the Phase 3 MARIPOSA-2 study, which showed a 52% reduction in the risk of disease progression or death compared to chemotherapy alone.
- The study also demonstrated significant intracranial efficacy, reducing the risk of intracranial progression or death by 45%.
- Next steps include awaiting the European Commission's decision on the approval.
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CStone announces European Commission approval of sugemalimab as first-line treatment for non-small cell lung cancer
- Sugemalimab is the first anti-PD-L1 monoclonal antibody approved in Europe for first-line treatment of both squamous and non-squamous NSCLC.
- The approval is based on the GEMSTONE-302 Phase 3 trial, which showed significant improvement in progression-free and overall survival.
- CStone has partnered with Ewopharma for commercialization in Central & Eastern Europe and Switzerland, with further partnerships in other regions under discussion.
- CStone plans to submit additional Marketing Authorization Applications (MAAs) for new indications, including Stage III NSCLC and first-line gastric cancer.
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Immorta Bio files investigational new drug application for first in class senolytic immunotherapy SenoVax for treatment of advanced lung cancer
- Immorta Bio has filed an Investigational New Drug (IND) application with the FDA for SenoVax, a senolytic immunotherapy.
- The clinical trial will evaluate safety, immunogenicity, and efficacy in patients with advanced non-small cell lung cancer who have failed standard therapies.
- SenoVax uses dendritic cell technology to target senescent cells, which protect tumors from immune attack.
- Preclinical studies have shown SenoVax can reduce lung cancer growth in animal models and induce immune responses that selectively kill senescent cells.
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Merck receives positive EU CHMP opinion for Keytruda plus Padcev as first-line treatment for urothelial carcinoma
- The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of Keytruda in combination with Padcev for first-line treatment of unresectable or metastatic urothelial carcinoma.
- The recommendation is based on the Phase 3 KEYNOTE-A39 trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-based chemotherapy.
- Keytruda plus Padcev reduced the risk of death by 53% and the risk of disease progression or death by 55% versus platinum-based chemotherapy.
- The CHMP’s recommendation will be reviewed by the European Commission, with a final decision expected in Q3 2024.
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Astellas receives positive CHMP opinion for zolbetuximab in combination with chemotherapy for treatment of advanced gastric and gastroesophageal junction cancer
- Zolbetuximab, a CLDN18.2-targeted monoclonal antibody, recommended for approval by the CHMP.
- If approved, it will be the first CLDN18.2-targeted therapy in the EU for HER2-negative gastric or GEJ adenocarcinoma.
- The positive opinion is based on Phase 3 SPOTLIGHT and GLOW clinical trials.
- A decision from the European Commission is expected by October 2024.
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CEL-SCI’s phase 3 population analysis for upcoming confirmatory registration study in head & neck cancer demonstrates well balanced patient population, confidence in clinical results
- CEL-SCI conducted a bias analysis for its concluded Phase 3 study of Multikine in head and neck cancer.
- The analysis confirmed that the treatment group demographics and baseline characteristics were comparable between the Multikine treated and control arms.
- No bias was detected, ensuring the study data are reliably interpretable and statistically significant.
- CEL-SCI will conduct a 212-patient confirmatory registration study with the FDA’s agreement, targeting a population with a 5-year survival rate of 73% in Multikine treated patients vs. 45% in the control group.
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Astellas receives positive CHMP opinion for PADCEV in combination with KEYTRUDA for first-line treatment of advanced bladder cancer
- The combination of enfortumab vedotin and pembrolizumab could become the first alternative to platinum-containing chemotherapy for unresectable or metastatic urothelial cancer.
- The positive opinion is based on Phase 3 EV-302 trial results, showing a significant improvement in median overall survival and progression-free survival compared to chemotherapy.
- The European Commission will review the CHMP's recommendation for approval in the EU and associated countries.
- The combination was approved by the U.S. FDA in December 2023 for the same indication.
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Compugen announces FDA clearance of IND for COM503 for the treatment of solid tumors
- FDA clears IND application for COM503, a high affinity anti-IL-18 binding protein antibody.
- Clearance triggers a $30 million milestone payment from Gilead.
- Phase 1 trial to start in Q4 2024, focusing on safety and tolerability in advanced solid tumors.
- Compugen and Gilead's license agreement includes up to $848 million in potential payments.
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Akeso's sBLA for ivonescimab in 1L treatment of PD-L1 positive NSCLC accepted by NMPA
- Akeso's sBLA for ivonescimab as a monotherapy for first-line treatment of PD-L1 positive NSCLC has been accepted by the NMPA.
- Ivonescimab is the world's first bispecific antibody drug approved for the 'tumor immunotherapy + anti-angiogenesis' mechanism.
- The application is based on the HARMONi-2 study, which showed highly positive results in prolonging progression-free survival (PFS).
- Ivonescimab is expected to become a new standard of care for both first-line and second-line lung cancer therapy.
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BerGenBio announces selection of 2nd dose in phase 2a first line STK11m non-small lung cancer trial
- BerGenBio received a positive recommendation from the independent Data and Safety Monitoring Board (DSMB) to initiate the second dose in Phase 2a of the BGBC016 trial.
- The DSMB confirmed acceptable safety at the highest dose tested in Phase 1b, allowing the trial to proceed without additional patients in Phase 1b.
- The Phase 2a part of the study is open for enrollment and will evaluate the efficacy of bemcentinib combined with pembrolizumab (Keytruda) and doublet chemotherapy in NSCLC patients with STK11 mutations.
- An interim analysis of the Phase 2a trial is expected to be presented in the second half of this year.
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