Mirati CEO David Meek steps down after Krazati setback

Mirati Therapeutics chief executive David Meek has agreed to step down by mutual agreement with the company's board, to be replaced on a temporary basis by founder and former CEO Charles Baum.

Meek has held the top job at Mirati since 2021, overseeing the company as it successfully brought KRAS inhibitor Krazati (adagrasib) to market in the US as a second-line treatment for non-small cell lung cancer (NSCLC) with KRAS G12C mutations.

His departure comes shortly after Mirati's plans to bring Krazati to the EU market were thrown into disarray by a rejection from the EMA's human medicines committee. The CHMP said the data for the drug wasn't strong enough for it to recommend conditional approval, given that Amgen's rival KRAS inhibitor Lumykras (sotorasib) is already available for that indication.

Baum thanked Meek for "helping to advance Mirati as a leading biotech," noting that the former CEO will stay on as a consultant until 15th October. Baum had been planning to retire at the end of June, but will step in during the search for a permanent CEO replacement.

"I am proud of the accomplishments Mirati has achieved with the successful launch of KRAZATI and advancing an innovative pipeline," remarked Meek. "I had the pleasure of working with an accomplished team, and together we have helped to improve the lives of many people, which is and will continue to be a purpose and passion going forward."

The news emerged alongside Mirati's second-quarter results, in which it reported Krazati sales of just over $13 million, which topped analyst expectations of less than $11 million, as well as plans to start a phase 3 trial of the drug with MSD's Keytruda (pembrolizumab) in first-line non-small cell lung cancer patients.

The study will focus on patients with high PD-L1 expression of at least 50% on the tumour proportion score (TPS), with the combination compared to Keytruda monotherapy, which Mirati says is the standard for these patients, who represent around 40% of the KRAS-mutated first-line NSCLC population.

It comes on the back of data from the mid-stage KRYSTAL-7 study and phase 1b KRYSTAL-1 trial, reported last year, which showed that the combination may provide a chemotherapy-free option for this group.

In an update to the KRYSTAL-7 data, Mirati said that the objective response rate (ORR) for the combination was 63%, against a benchmark for standard Keytruda-based therapy of 39% to 45%.

For patients with TPS scores below 50%, the data suggests that the doublet approach will not be sufficient to displace the existing standard of care for these patients, which is Keytruda plus chemo.