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Cullinan Therapeutics Announces Positive Initial Data from Pivotal Phase 2b REZILIENT1 Study of Zipalertinib
Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"Objective response rate of 39% with manageable safety profile in patients with non-small cell lung cancer (NSCLC) harboring EGFR Exon 20 insertion mutations treated with zipalertinib who had progressed after prior amivantamab treatment\nCAMBRIDGE, 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%DCR294%97%DOR (months)NENEPFS (months)NE12 NE: Not yet estimable ORR: Objective response rate; DCR: Disease control rate; DOR: Duration of response; PFS: Progression-free survival1 Piotrowska Z, et al. JCO 20232 DCR= (PR+SD) / response-evaluable patientsPR: Partial response; SD: Stable disease Zipalertinib demonstrated a manageable safety profile, similar to what has been previously reported. There were no grade 4 or grade 5 treatment-related adverse events. “In an evolving treatment landscape, this is the first ever clinical data to systematically characterize the potential of an irreversible and selective EGFR exon20 insertion mutation TKI such as zipalertinib in patients who were heavily pre-treated and had received amivantamab. Given the recent approval of amivantamab as a first line treatment in combination with chemotherapy, we are encouraged by the initial results of the Phase 2b portion of the REZILIENT1 clinical trial, which show that in a post-amivantamab setting, zipalertinib demonstrated promising efficacy, similar to that in patients who progressed after platinum-based chemotherapy alone, and had a ...