Bristol Myers Squibb said its KRAS cancer drug Krazati met the primary endpoint in a Phase 3 confirmatory trial in patients with non-small cell lung cancer, according to new data shared at the American Society of Clinical Oncology’s annual meeting on Saturday.
Krazati first gained accelerated approval in 2022, becoming the second KRAS-targeting drug to be approved after Amgen’s Lumakras in 2021. Mirati developed Krazati until Bristol Myers Squibb bought the company for $4.8 billion last year. Bristol Myers announced topline results at the beginning of April.
In the KRYSTAL-12 trial, patients with KRAS G12C-mutated forms of non-small cell lung cancer who had already undergone treatment were randomized to receive Krazati, also called adagrasib, or a type of chemotherapy called docetaxel. The patients taking the drug showed progression-free survival of 5.49 months versus 3.84 months for those on chemo, with a p<0.0001. The median duration of response was 8.31 months for patients Krazati patients and 5.36 months for those on chemo.
The trial also met a secondary endpoint. Krazati’s overall response rate was “significantly higher,” the company said. The BMS drug showed a 31.9% overall response rate, and chemotherapy had a 9.2% ORR rate, earning a p-value of p<0.0001.
Bristol Myers said 94% of Krazati patients had adverse events, with 7.7% of them discontinuing treatment. For those on chemo, 86.4% had adverse events, and 14.3% stopped chemo.
Bristol Myers CMO Samit Hirawat said that overall the safety profile is in line with what the company expected, and it’s preparing to speak with regulators about converting Krazati to a full approval, though he declined to say when it will apply. He also pointed out that Krazati can be combined with other treatments like PD-1 inhibitors such as Merck’s Keytruda and chemotherapy.
“From a safety perspective, this molecule is so far ahead,” Hirawat told Endpoints News. “A competitor could not combine their drug with a background therapy of a PD-1 inhibitor, so it limits the exploration trying to get into the first-line non-small cell lung cancer, whereas we have our Phase 3 study already ongoing combining adagrasib with pembrolizumab.”
Krazati generated $27 million in sales in the first three months of the year.