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Otsuka Subsidiary's Lung Cancer Drug Trial Meets Primary PFS Endpoint

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Otsuka (TYO:4578) subsidiary Taiho Pharmaceutical, its unit Taiho Oncology, and Cullinan Therapeutics' global Phase three Rezilient3 trial evaluating zipalertinib plus platinum-based chemotherapy met its primary endpoint of progression-free survival (PFS) at an interim analysis.

The trial enrolled adults with previously untreated, locally advanced or metastatic non-small cell lung cancer with previously untreated epidermal growth factor receptor exon 20 insertion-positive mutations, according to a Tokyo bourse filing on Thursday.

Taiho Pharmaceutical, Taiho Oncology, and Cullinan Therapeutics plan to seek approval for the combination as a first-line treatment, subject to discussions with the U.S. Food and Drug Administration.

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