Daiichi Sankyo and Merck Withdraw US Filing for Ifinatamab Deruxtecan in Small Cell Lung Cancer

Daiichi Sankyo and Merck have decided to withdraw their US Biologics License Application (BLA) for ifinatamab deruxtecan (I-DXd) in adults with extensive-stage small cell lung cancer (ES-SCLC). The decision comes after discussions with the FDA, which stated that the data submitted did not meet the requirements for accelerated approval.

The Phase 2 IDeate-Lung01 trial's findings were among those submitted to support the application. However, the companies are continuing their development of I-DXd in ES-SCLC through the ongoing Phase 3 IDeate-Lung02 trial. This trial is comparing the drug with physician’s choice of chemotherapy, amrubicin, lurbinectedin or topotecan, in patients who have relapsed after progression following a single prior line of platinum-based chemotherapy.

The companies remain focused on evaluating I-DXd in ES-SCLC and other difficult-to-treat cancers. They plan to assess the potential for future filings with the FDA based on results from the Phase 3 trials, including those in castration-resistant prostate cancer (CRPC) and esophageal squamous cell carcinoma (ESCC).