Cullinan climbs as lung cancer drug meets late-stage trial goal
CGEM•
CGEM•Shares of Cullinan Therapeutics (CGEM.O) rose 6% to $20.77 premarket after the company said its experimental cancer drug, zipalertinib, when combined with platinum-based chemotherapy, met the main goal of improving progression-free survival in a late-stage trial.
The combo significantly delayed disease progression compared with chemotherapy alone in previously untreated, locally advanced or metastatic non-small cell lung cancer patients with EGFR exon 20 insertion mutations.
"The early stop suggests this may have occurred and zipa could become the new standard in 1L exon20+ NSCLC" - TD Cowen analysts.
Taiho Oncology and Japan's Taiho Pharmaceutical are co-developing zipalertinib with Cullinan in the U.S., and all three companies plan to seek U.S. regulatory approval for the combination as a first-line treatment after discussions with the FDA.
Safety in the zipalertinib arm was manageable and an independent data monitoring committee recommended unblinding the study.
As of last close, CGEM was up 89.4% year to date.