Cullinan's Lung Cancer Drug Shows Promise in Phase 2 Trial, FDA Application Planned

Cullinan Therapeutics has announced positive results from a phase 2b trial of its lead asset, zipalertinib, in non-small cell lung cancer (NSCLC) patients with EGFR exon 20 insertion mutations. The biotech company, in collaboration with Japan's Taiho Pharmaceutical, is now planning to submit an approval application to the FDA in the second half of 2025.

Trial Success and Data Embargo

The phase 2b trial, which enrolled patients who had received prior therapy, met its primary endpoint of overall response rate at 24 months. While the companies are withholding specific data for presentation at an upcoming international medical conference, they reported that the safety profile was generally consistent with previous data presentations.

This success follows promising results presented at the European Society for Medical Oncology Congress in September 2024, where zipalertinib demonstrated a consistent objective response rate of approximately 40% in patients who had progressed on or after prior amivantamab treatment.

Strategic Shift and Financial Positioning

Cullinan, which rebranded from Cullinan Oncology in 2024, has recently pivoted to include autoimmune diseases in its portfolio. This strategic shift was accompanied by a significant financial boost, with the company securing $280 million through a private placement of shares. This influx of capital is expected to extend Cullinan's cash runway through 2028, providing ample resources for the development and potential commercialization of zipalertinib.

Implications for EGFR-Mutated NSCLC Treatment

The advancement of zipalertinib represents a potentially important development in the treatment landscape for NSCLC patients with EGFR exon 20 insertion mutations. As an EGFR ex20ins inhibitor, the drug targets a specific subset of lung cancer patients who have limited treatment options, especially after progression on existing therapies. The planned FDA submission later this year could mark a significant step forward in addressing this unmet medical need.