Merck and Daiichi Sankyo have voluntarily withdrawn their U.S. application seeking accelerated approval of ifinatamab deruxtecan for adults with extensive-stage small-cell lung cancer whose disease progressed during or after platinum-based chemotherapy.
The companies said Sept. 25 that discussions with the Food and Drug Administration showed the supporting data, including results from the Phase 2 IDeate-Lung01 trial, did not meet the requirements for accelerated approval in the proposed indication.
Development of the investigational drug will continue. Enrollment is ongoing in the Phase 3 IDeate-Lung02 trial, which compares ifinatamab deruxtecan with a physician’s choice of amrubicin, lurbinectedin or topotecan in patients whose cancer relapsed after one prior line of platinum-based chemotherapy. Daiichi Sankyo said enrollment was nearly complete.
Ifinatamab deruxtecan is an antibody-drug conjugate designed to target B7-H3, a protein found on many cancer cells. It combines an anti-B7-H3 antibody with a topoisomerase I inhibitor payload intended to deliver the drug to tumors.
The withdrawn application drew on IDeate-Lung01, a randomized, open-label Phase 2 study that enrolled 187 patients across Asia, Europe and North America. Participants had received at least one prior platinum-based chemotherapy regimen and no more than three previous lines of treatment. The trial’s primary endpoint was objective response rate assessed by independent review.
Two other Phase 3 trials are evaluating ifinatamab deruxtecan in castration-resistant prostate cancer and esophageal squamous cell carcinoma.
Merck and Daiichi Sankyo agreed in 2023 to jointly develop and commercialize ifinatamab deruxtecan outside Japan, where Daiichi Sankyo retains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply.
The companies did not announce a new U.S. filing date.
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