Ifinatamab Deruxtecan Biologics License Application for Certain Patients with Previously Treated Extensive-Stage Small Cell Lung Cancer Voluntarily Withdrawn

Merck and Daiichi Sankyo withdrew their lung cancer drug filing after FDA deemed the data insufficient for accelerated approval. The partners may refile with phase 3 trial data. The withdrawal follows prior setbacks in their $4B partnership, including an FDA rejection and a voluntary withdrawal of another ADC. Phase 3 trials for the drug in other cancers are ongoing, with completion dates in 2028.

Merck and Moderna reported positive Phase 3 trial results for their personalized mRNA vaccine, intismeran autogene (mRNA-4157), combined with pembrolizumab, showing longer recurrence-free survival in high-risk melanoma patients. The vaccine is tailored to each patient's tumor mutations. Detailed data and regulatory review are pending. Accessibility in regions like India may be challenging due to high costs and infrastructure needs.

Daiichi Sankyo and Merck withdrew their BLA for ifinatamab deruxtecan in treating extensive-stage small cell lung cancer (ES-SCLC) after the FDA deemed trial data insufficient. The Phase 2 trial showed a 48.2% ORR, but the FDA required more evidence. The companies continue Phase 3 trials and plan to evaluate future regulatory filings based on those results. Ifinatamab deruxtecan is an investigational B7-H3-directed ADC.

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Merck (MRK) and Eisai received FDA approval for Welireg plus Lenvima to treat advanced kidney cancer after prior immunotherapy. The approval is based on Phase 3 trial data. Merck, valued at $367.1b, aims to expand its oncology portfolio with this new regimen, positioning it against competitors like cabozantinib. Investors will watch how quickly the new treatment gains market share.

Merck and Daiichi Sankyo withdrew the Biologics License Application for ifinatamab deruxtecan in treating extensive-stage small cell lung cancer. The decision follows discussions with the FDA, but enrollment continues in a phase 3 trial. The drug is a B7-H3 directed antibody drug conjugate being jointly developed by the companies. Both firms expressed disappointment but remain committed to evaluating the drug's potential in other cancer types.