- Phase 2b trial of zipalertinib met primary endpoint of overall response rate.
- Efficacy demonstrated in NSCLC patients with EGFR exon 20 mutations, showing manageable safety.
- Results to be presented at ASCO 2025, signifying a significant milestone for Cullinan Therapeutics (CGEM, Financial).
Cullinan Therapeutics (CGEM) has announced that the results from their Phase 2b REZILIENT1 trial, evaluating zipalertinib as a monotherapy, will be presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. This study focused on patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have progressed after receiving platinum-based chemotherapy.
The trial met its primary endpoint, demonstrating a clinically meaningful overall response rate along with a manageable safety profile. This is significant given the challenging prognosis and limited treatment options for this particular subset of NSCLC patients, which represents roughly 2-3% of cases.
Dr. Helena A. Yu from Memorial Sloan Kettering Cancer Center is set to present these findings on June 1, 2025, in an oral abstract session. The oral presentation at ASCO highlights the importance of the findings, as these slots are typically reserved for studies with impactful results.
In addition to the presentation, Cullinan Therapeutics will hold an investor event where Dr. Danny Nguyen from City of Hope National Medical Center will discuss the study data. This indicates the company's confidence in zipalertinib's potential to become a significant treatment option for NSCLC patients, including those previously treated with amivantamab.
For a more detailed look at the full dataset, participants can attend the live investor event or access it via a webcast available on the company's investor relations website.
