Targeted Therapy

Mirati’s adagrasib and Keytruda show promise for KRAS G12C-mutated NSCLC with a 49% tumor shrinkage in trials.

KRAS battle heats up as Mirati pressures Amgen with Keytruda combo show in lung cancer

In a potential key battleground for KRAS inhibitors that involves combination with Merck’s PD-1 king Keytruda, Mirati Therapeutics’ adagrasib appears to be pulling ahead of Amgen’s first-to-market Lumakras in the latest clinical data revelation. And Mirati’s CEO wasn’t shy about his optimism.

Adagrasib, given in tandem with Keytruda, shrank tumors in 49% of 53 patients with newly diagnosed KRAS G12C-mutated non-small cell lung cancer (NSCLC) in a phase 2 trial, according to data to be presented at the ESMO Immuno-Oncology Congress 2022. The combo also showed relatively low liver toxicity, relieving a major safety concern.

With the new Keytruda combination results from the KYRSTAL-7 trial and other clinical data, “I think we’re the KRAS leader, and we will set the direction where this KRAS agent goes,” CEO David Meek said in an interview with Fierce Biotech ahead of the data release.

Based on the phase 2 results, Mirati is moving the adagrasib-Keytruda regimen into phase 3 testing in front-line NSCLC soon. The company met with the FDA in September, and the agency has agreed with the trial design, Meek said. Mirati will initially target patients with low PD-L1 expression for a phase 3, he said.

“We believe a trial evaluating adagrasib + [Keytruda] in the TPS <50% represents a reasonable initial path forward in an area of unmet need,” Meek told Fierce Biotech in a statement.

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