Early trial data shows that a combination of Mirati Therapeutics experimental drug adagrasib and Merck & Co's immunotherapy Keytruda helped about half of previously untreated metastatic lung cancer patients, with manageable side effects, Mirati said on Monday.
The company expects the largest advantage in patients with lower levels of PDL1, the protein targeted by Keytruda, and plans to launch a phase-three trial enrolling only those patients soon, Mirati chief executive officer David Meek told Reuters.
Wall Street analysts called the early results encouraging, but shares of Mirati were down more than 8% at $84.50 after hours on Monday. More trial details will be presented on Wednesday.
"We believe the data continue to support the regimen's differentiated positioning relative to standard of care and are far more favorable than that of Lumakras plus (immunotherapy)," JP Morgan analyst Eric Joseph said in a research note on Monday, referring to a rival drug sold by Amgen Inc.
Both drugs target a mutated form of a gene known as KRAS that occurs in about 13% of non-small cell lung cancers (NSCLC), the most common form of the disease.
Mirati's phase-three trial will compare adagrasib and Keytruda with chemotherapy plus Keytruda. The initial treatment for patients with higher levels of PDL1 is Keytruda alone, and Mirati will likely begin planning next year for a combination study in those patients, Meek said.
Recent data shows that 19% of NSCLC patients treated with Keytruda plus chemotherapy were alive after five years, compared with 11% of patients treated with a placebo and chemotherapy.
Out of seven phase-two trial patients given the adagrasib combination, four (57%) had tumor shrinkage, and none had tumor growth, Mirati said.
A preliminary analysis of 53 patients showed that 49% of them had responded to the combination treatment.
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