News & Events zu Cullinan Therapeutics Inc (CGEM)CGEMCullinan Therapeutics Inc

Taiho Oncology and Cullinan Announce REZILIENT2 Trial Results

Taiho Oncology and Cullinan Therapeutics announced results from Cohort C of the Phase 2 REZILIENT2 trial evaluating zipalertinib monotherapy in patients with locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion mutations or other uncommon EGFR mutations and active central nervous system metastases. The data will be presented at the European Society for Medical Oncology Congress 2026, October 23-27, in Madrid, Spain. Mature results from the first prospective study evaluating intracranial activity of an EGFR tyrosine kinase inhibitor in this patient population demonstrated clinically meaningful intracranial antitumor activity. Among 43 evaluable patients, zipalertinib achieved an intracranial objective response rate of 30% and an intracranial disease control rate of 72%, with a median intracranial duration of response of 9.7 months. Zipalertinib was well tolerated. Cohort C of REZILIENT2 enrolled patients with NSCLC harboring EGFR ex20ins or other uncommon EGFR mutations and active CNS metastases, including leptomeningeal disease, irrespective of prior therapy. At the data cutoff, 59 patients were enrolled, with a median follow-up of 9.2 months. Intracranial efficacy was evaluated by Response Assessment in Neuro-Oncology Brain Metastases, and systemic response was measured by RECIST v1.1. Among 43 RANO-BM-evaluable patients, including 9 with LMD, 29 had EGFR ex20ins mutations. The median number of prior lines of therapy was two, and 19 patients had received prior EGFR tyrosine kinase inhibitor therapy. In these 43 patients, zipalertinib achieved an intracranial objective response rate of 30.2%, an intracranial disease control rate of 72.1%, and a median intracranial duration of response of 9.7 months. Among 24 patients without prior EGFR tyrosine kinase inhibitor exposure, iORR was 37.5%. Systemic efficacy was consistent with intracranial outcomes. Zipalertinib 100 mg twice daily was well tolerated. Common treatment-related adverse events included paronychia and diarrhea. Grade greater than or equal to3 TRAEs occurred in 9 patients, including dermatitis acneiform in 4.7% of patients.

Cullinan Therapeutics Doses First Patient in Phase 2 Study of CLN-049

Cullinan Therapeutics announced that the first patient has been dosed in its Phase 2 study of CLN-049, an investigational FLT3 T cell engager, in patients with relapsed/refractory acute myeloid leukemia, or AML. In parallel, the company is initiating a Phase 1/2 study evaluating the combination of CLN-049, azacitidine, and venetoclax in patients with newly diagnosed AML.

Cullinan Therapeutics Submits NDA for Non-Small Cell Lung Cancer Treatment

The company stated: "Cullinan Therapeutics announced the initiation of a New Drug Application submission to the U.S. Food and Drug Administration for zipalertinib in combination with platinum-based chemotherapy for the treatment of patients with previously untreated, locally advanced or metastatic non-small cell lung cancer harboring epidermal growth factor receptor exon 20 insertion (ex20ins) mutations under the FDA's Real-Time Oncology Review program. The RTOR program allows sponsors to submit clinical data in advance of the complete application to facilitate earlier review of efficacy and safety results. Completion of the NDA submission is expected by year-end 2026. The NDA submission is based on data from the Phase 3 REZILIENT3 trial, which met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in median progression-free survival for zipalertinib plus chemotherapy compared to chemotherapy alone. These results were recently presented at the International Association for the Study of Lung Cancer's 2026 World Conference on Lung Cancer during a Presidential Symposium, where potentially practice-changing clinical data are highlighted."