Sat Sep 14 08:15:44 UTC 2024: ## Cullinan Therapeutics Reports Positive Zipalertinib Data for Lung Cancer Patients

**CAMBRIDGE, Mass., Sept. 14, 2024** – Cullinan Therapeutics, a biopharmaceutical company focused on developing targeted therapies, announced promising updated data for zipalertinib, a drug being developed for non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations. The data was presented at the European Society for Medical Oncology Congress 2024.

The study, part of the ongoing pivotal Phase 2b REZILIENT1 clinical trial, evaluated zipalertinib in patients who had progressed after prior treatment with amivantamab, another drug used for this type of lung cancer.

Key findings include:

* **Significant Response Rate:** 40% of patients achieved a complete or partial response to zipalertinib.
* **Manageable Safety Profile:** Side effects were generally mild and manageable, with no grade 4 or 5 treatment-related adverse events reported.
* **Enrollment Completed Ahead of Schedule:** The pivotal Phase 2b trial has completed enrollment ahead of schedule, highlighting the momentum behind zipalertinib’s development.

“These data continue to strengthen our confidence in the potential of zipalertinib,” stated Jeffrey Jones, MD, MBA, Chief Medical Officer of Cullinan Therapeutics. “We remain focused on rapid execution and are pleased to observe consistent positive results throughout the study.”

Zipalertinib is a unique oral tyrosine kinase inhibitor specifically targeting EGFR exon 20 insertion mutations, offering a potential treatment option for patients with a significant unmet medical need.

Cullinan and its partner Taiho are actively pursuing the development of zipalertinib through a suite of REZILIENT studies in various patient populations.

“This is the first presentation to systematically characterize the anti-tumor activity of zipalertinib in heavily treated patients with advanced or metastatic NSCLC harboring EGFR exon 20 insertions-mutation, who have received prior amivantamab,” said Antonio Passaro, MD, PhD, Division of Thoracic Oncology, European Institute of Oncology. “In this setting, zipalertinib demonstrated promising efficacy, including a high overall response rate, and a manageable safety profile.”

With the completion of enrollment in the pivotal Phase 2b trial and the promising data presented, zipalertinib has the potential to become a significant treatment option for patients with EGFR exon 20 insertion mutations, who have limited treatment options.

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