Cullinan Therapeutics Presents Positive Updated Data from Module C of Zipalertinib Pivotal Phase 2b Study at ESMO 2024

Updated data show consistent objective response rate of 40% and manageable safety profile in patients with non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations treated with zipalertinib who progressed on or after prior amivantamab treatment

Enrollment of pivotal Phase 2b trial complete ahead of schedule

CAMBRIDGE, Mass., Sept. 14, 2024 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM), a biopharmaceutical company focused on developing modality-agnostic targeted therapies, today shared updated data in patients with non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations receiving zipalertinib after prior treatment with amivantamab enrolled in Module C of its pivotal Phase 2b REZILIENT1 clinical trial. Findings from the clinical trial were presented in a Mini Oral session today at the European Society for Medical Oncology Congress 2024 (Presentation Number 1245MO).

As of a March 29, 2024 data cut-off, 45 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/or prior EGFR tyrosine kinase inhibitor (TKI) therapy, in addition to amivantamab.

At data cut-off, 30 patients were evaluable for response, of which 1 patient (3%) had a complete response (CR), 11 patients (37%) had partial response (PR), and 15 patients (50%) had stable disease (SD), showing similar anti-tumor activity compared with patients receiving zipalertinib after prior chemotherapy in the previously reported Phase 1/2a part of the study.

​	Module C (post chemo and amivantamab+/- other ex20ins treatment)​ (N=30)​	Phase 1/2a results (post chemo)1​ (N=39)​
ORR (confirmed)	40%​	41%​
DCR2​	90%​	97%​
DOR (months)​	NE​	NE​
PFS (months)​	9.7	12​

NE: Not estimable
ORR: Objective response rate; DCR: Disease control rate; DOR: Duration of response; PFS: Progression-free survival
¹ Piotrowska Z, et al. JCO 2023
² DCR= (CR+PR+SD) / response-evaluable patients

Zipalertinib demonstrated a manageable safety profile, similar to what has been previously reported. The most common treatment-related adverse events in greater than 10% of patients (n=45) were rash (38%), paronychia (36%), anemia (24%), dry skin (20%), dermatitis acneiform (16%), nausea (16%), and stomatitis (11%), the majority of which were grade 1/2. There were no grade 4 or grade 5 treatment-related adverse events.