Daiichi Sankyo and Merck have voluntarily withdrawn their Biologics License Application seeking accelerated approval in the United States for ifinatamab deruxtecan as a treatment for adult patients with extensive-stage small cell lung cancer. The decision follows discussions with the U.S. Food and Drug Administration indicating that current data, including results from the IDeate-Lung01 Phase 2 trial, do not meet the criteria required for accelerated approval in this indication.
Regulatory Discussions and Trial Data
The U.S. Food and Drug Administration informed the companies that the existing dataset is insufficient to support an accelerated approval pathway. Accelerated approval allows for earlier access to medicines addressing serious conditions with high unmet medical need by relying on surrogate endpoints. The data submitted from the IDeate-Lung01 Phase 2 trial, which evaluated the investigational antibody-drug conjugate in patients with extensive-stage small cell lung cancer who received prior platinum-based chemotherapy, ultimately fell short of regulatory benchmarks for this specific pathway.
“While we are disappointed that the current dataset are not supportive of an approval at this time, we are continuing to evaluate the role of ifinatamab deruxtecan in patients with extensive-stage small cell lung cancer and other types of difficult-to-treat cancer,” said Marjorie Green, MD, senior vice president and head of oncology, global clinical development, Merck Research Laboratories.
Ongoing Phase 3 Clinical Development
Despite the withdrawal of the Biologics License Application, clinical evaluation of the therapy continues. Patient enrollment is near completion for the IDeate-Lung02 Phase 3 trial. This study compares ifinatamab deruxtecan against a physician’s choice of chemotherapy, which includes amrubicin, lurbinectedin, or topotecan, in patients with relapsed extensive-stage small cell lung cancer following disease progression after one prior line of platinum-based chemotherapy.
“Extensive-stage small cell lung cancer is a challenging disease to treat, leaving patients in need of new options,” said Abderrahmane Laadem, MD, head, therapeutic area oncology development, Daiichi Sankyo. “Enrollment into the IDeate-Lung02 Phase 3 trial is near completion and we look forward to assessing the potential for a future filing of ifinatamab deruxtecan with the FDA and other global regulatory authorities based on those results.”
Ifinatamab deruxtecan is a potential first-in-class B7-H3 directed antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed with Merck. Beyond the small cell lung cancer trial, the global development program includes two additional Phase 3 trials in advanced/metastatic disease: IDeate-Prostate01 for castration-resistant prostate cancer and IDeate-Esophageal01 for esophageal squamous cell carcinoma.
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