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Bristol-Myers Squibb (New York Stock Exchange:BMY) announced Saturday that its FDA-cleared cancer therapy Krazati (adagrasib), acquired with the $4.8 billion purchase of Mirati (MRTX) this year, met its lead goal in a late-stage cancer trial of lung.
Citing a presentation of data from your Phase 3 study KRYSTAL-12 for the first time, said the company Krazati, which belongs to a class of drug called KRASG12C inhibitors, improved cancer-free survival with a statistically significant and clinically significant effect.
Bristol Myers (BMY) noted that the measure known as progression-free survival was a median of 5.5 months in Krazati's group compared with 3.8 months in the comparison group, meeting the primary endpoint. of the study.
KRYSTAL-12 was designed to evaluate Krazati versus standard of care chemotherapy as a late option in patients with KRASG12C-Muted non-small cell lung cancer.
Regarding safety, 94% of patients treated with KRAZATI and 86.4% with chemotherapy experienced 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 US FDA greenlit Krazati as a late-stage option for NSCLC patients with KRAS.G12C mutations. The decision granted under the agency's accelerated approval pathway was based on data from Mirati's Phase 2 KRYSTAL-1 study.
