CGEM - Cullinan Therapeutics Announces Positive Initial Data from Pivotal Phase 2b REZILIENT1 Study of Zipalertinib | Benzinga
CAMBRIDGE, Mass., June 01, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (NASDAQ:CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today announced positive initial data in patients receiving zipalertinib after prior treatment with amivantamab enrolled in its pivotal Phase 2b REZILIENT1 clinical trial.
As of a January 12, 2024 data cut-off, 31 patients had been enrolled. Patients had received a median of three prior systemic anti-cancer regimens, including prior platinum-based chemotherapy, prior anti-PD1/L1 therapy, and prior epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) therapy.
At data cut-off, 18 patients were evaluable for response and showed similar anti-tumor activity compared with those post prior chemotherapy in the previously reported Phase 1/2a part of the study.
| ? |
| Module C (post chemo and Ami+/- other exon20ins treatment)? (N=18)? |
| Phase 1/2a results (post chemo)1? (N=39)? |
| ORR (confirmed)? |
| 39%? |
| 41%? |
| DCR2? |
| 94%? |
| 97%? |
| DOR (months)? |
| NE? |
| NE? |
| PFS (months)? |
| NE? |