Bristol Myers Squibb (NYSE:BMY) announced Saturday that its FDA-authorized cancer therapy Krazati (adagrasib), acquired with its $4.8B Mirati (MRTX) buyout this year, reached its main goal in a late-stage trial for lung cancer.
Citing a data presentation from its Phase 3 KRYSTAL-12 study for the first time, the company said Krazati, which belongs to a drug class called KRASG12C inhibitors, improved cancer-free survival with a statistically significant and clinically meaningful effect.
Bristol Myers (BMY) noted that the measure known as progression-free survival stood at a median of 5.5 months in the Krazati arm compared to 3.8 months in the comparator, thus meeting the study’s primary endpoint.
KRYSTAL-12 was designed to evaluate Krazati against standard-of-care chemotherapy as a late-line option in patients with KRASG12C-mutated non-small cell lung cancer.
As for safety, 94% of patients treated with KRAZATI and 86.4% with chemotherapy witnessed treatment-related adverse events, while there were no new safety signals. The trial is ongoing to evaluate the key secondary endpoint of overall survival.
In 2022, the U.S. FDA greenlighted Krazati as a late-line option for NSCLC patients with KRASG12C mutations. The decision granted under the agency’s accelerated approval pathway was based on Mirati’s Phase 2 KRYSTAL-1 study data.