Daiichi Sankyo and Merck have voluntarily withdrawn their US Biologics License Application (BLA) seeking accelerated approval for ifinatamab deruxtecan (I-DXd) in adults with extensive-stage small cell lung cancer (ES-SCLC) whose disease has progressed during or after platinum-based chemotherapy.

 

The decision follows discussions with the U.S. Food and Drug Administration (FDA), which indicated that the data submitted in support of the application—including findings from the Phase 2 IDeate-Lung01 trial—do not meet the requirements for accelerated approval in the proposed indication.

 

The withdrawal does not halt development of I-DXd in ES-SCLC. Enrollment is continuing in the Phase 3 IDeate-Lung02 trial, which is comparing the drug with physician’s choice of chemotherapy—amrubicin, lurbinectedin or topotecan—in patients with relapsed ES-SCLC after progression following a single 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, 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.”

 

Merck said the companies remain focused on evaluating the drug in ES-SCLC and other difficult-to-treat cancers.

 

“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, senior vice president and head of oncology, global clinical development, Merck Research Laboratories. “We would like to thank the patients, their families and investigators who have participated or continue to participate in these studies.”

 

The drug's development extends beyond small cell lung cancer. Two additional Phase 3 studies are underway in advanced or metastatic cancers: IDeate-Prostate01, evaluating I-DXd in castration-resistant prostate cancer (CRPC), and IDeate-Esophageal01, studying the drug in esophageal squamous cell carcinoma (ESCC).

 

The companies said the ongoing Phase 3 studies will provide further data to assess the potential role of ifinatamab deruxtecan across these cancer types.