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Cullinan cancer drug trial meets Phase 3 endpoint
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Cullinan cancer drug trial meets Phase 3 endpoint

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  • Cullinan Therapeutics (NASDAQ:CGEM), Taiho Oncology, and Taiho Pharmaceutical reported that the REZILIENT3 Phase 3 trial met its primary progression-free survival endpoint.
  • The trial showed a statistically significant improvement in progression-free survival for zipalertinib plus chemotherapy compared with chemotherapy alone in EGFR exon 20 insertion NSCLC patients.
  • The companies said they plan to seek U.S. regulatory approval for the combination treatment, subject to discussions with the FDA.

Cullinan Therapeutics (NASDAQ:CGEM), Taiho Oncology, and Taiho Pharmaceutical announced that the global Phase 3 REZILIENT3 trial of zipalertinib plus platinum-based chemotherapy met its primary endpoint of progression-free survival in previously untreated patients with EGFR exon 20 insertion non-small cell lung cancer.

The planned interim analysis showed a statistically significant and clinically meaningful improvement in progression-free survival for patients receiving the zipalertinib combination compared with chemotherapy alone, with safety results described by the companies as manageable.

The Independent Data Monitoring Committee recommended unblinding the trial after reviewing the interim results, while the study will continue monitoring efficacy and safety outcomes, with full results planned for presentation at an upcoming international medical conference.

The REZILIENT3 study enrolled 285 adults with previously untreated, locally advanced, or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations and compared zipalertinib plus chemotherapy against chemotherapy alone.

Zipalertinib, also known as CLN-081/TAS6417, is an investigational oral small molecule designed to target EGFR exon 20 insertion mutations and has not been approved by any health authority.

Cullinan Therapeutics is developing zipalertinib in collaboration with Taiho Oncology and Taiho Pharmaceutical, with the companies planning regulatory discussions with the U.S. Food and Drug Administration regarding potential approval in the first-line treatment setting.

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