Adagrasib Receives Positive CHMP Opinion in Advanced KRAS G12C+ NSCLC

Adagrasib was assessed as part of the open-label phase 1/2 KRYSTAL-1 study (NCT03785249) alone and combined with other anti-cancer therapies in those diagnosed with KRAS G12C–mutated advanced solid tumors.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has expressed a positive opinion of adagrasib (Krazati) for the treatment of KRAS G12C–mutant, advanced non–small cell lung cancer that has progressed following a minimum of 1 line of previous systemic therapy, according to a press release from Mirati Therapeutics.¹

“Today’s positive opinion from the CHMP for [adagrasib] marks an important step on the path to providing access to a potentially best-in-class therapeutic option to patients living with this difficult-to-treat disease,” Alan Sandler, MD, chief medical officer at Mirati Therapeutics, Inc, said in the press release. “We look forward to approval from the European Commission and the opportunity to positively impact the lives of eligible patients living in the European Union.”

Adagrasib was assessed as part of the open-label phase 1/2 KRYSTAL-1 study (NCT03785249) alone and combined with other anti-cancer therapies in those diagnosed with KRAS G12C–mutated advanced solid tumors.

In a readout at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, investigators reported an objective response rate of 42.9% (95% CI, 33.5%-52.6%) among those treated with adagrasib in the phase 2 KRYSTAL-1 study; the median duration of response was 8.5 months (95% CI, 6.2-13.8). Forty-two percent of patients achieved a partial response and 37% had stable disease. Investigators reported a disease control rate of 80%.²

The study included 112 patients who received 600 capsules of adagrasib twice daily.

Adagrasib received accelerated approval from the FDA for those with KRAS G12C–mutant non–small cell lung cancer based on data from the phase 2 KRYSTAL-1 study.³

"This is an important day for the oncology community as we step closer to a new therapeutic option being available to patients living with KRAS G12C–mutated NSCLC in the European Union,” Martin Reck, MD, PhD, head of the department of thoracic oncology and the Clinical Trial Department, Department of Thoracic Oncology at Lung Clinic Grosshansdorf, Germany, concluded.¹ “Every patient has a slightly different case so as more options become available, physicians will better be able to tailor their treatment for each patient.”

References

1. Mirati Therapeutics Receives Positive Opinion from CHMP for KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Advanced Non-Small Cell Lung Cancer (NSCLC) with a KRASG12C Mutation Following a Re-Examination Procedure. News release. Mirati Therapeutics. November 13, 2023. Accessed November 13, 2023. https://bit.ly/49ycKWu
2. Jänne PA, Riely GJ, Gadgeel SM, et al. Adagrasib in non-small-cell lung cancer harboring a KRASG12C mutation. N Engl J Med. 2022;387(2):120-131. doi:10.1056/NEJMoa2204619
3. FDA grants accelerated approval to adagrasib for KRAS G12C-mutated NSCLC. News release. FDA. December 12, 2022. Accessed November, 13 2023. https://bit.ly/3UUVphS