Cullinan Therapeutics has announced that its lead asset has aced a midstage lung cancer trial—but the biotech is keeping the data close to its chest for now.
The drug in question, zipalertinib, is an EGFR ex20ins inhibitor that the Cambridge, Massachusetts-based biotech has been investigating in a phase 2b trial in collaboration with Japan’s Taiho Pharmaceutical. The study enrolled patients with non-small cell lung cancer (NSCLC) harboring EGFR exon 20 insertion mutations who have received prior therapy.
The primary endpoint of the phase 2b portion of the trial was the overall response rate at 24 months, and the biotechs announced in a post-market release Jan. 28 that the study has hit this endpoint.
“The safety profile was generally consistent with previous data presentations,” added the companies, who are withholding all data from the trial for “an upcoming international medical conference.”
Still, Cullinan and Taiho clearly liked what they saw—their plan now is to submit an approval application to the FDA in the second half of this year.
The signs were promising as far back as September 2024, when Cullinan presented data at the European Society for Medical Oncology Congress from patients with EGFR ex20ins NSCLC who have progressed on or after prior amivantamab treatment. The presentation showed a “consistent objective response rate of approximately 40% and a manageable safety profile,” the company explained.
Cullinan rebranded from Cullinan Oncology last year as the biotech became the latest CD19-focused cancer company to dip its toe into the autoimmune space. The biotech used the same April 2024 announcement to disclose it had brought in $280 million via a private placement of its shares, which it estimated would stretch out its cash runway through to 2028.