Bristol Myers Squibb (BMS) has announced that its Phase III KRYSTAL-12 clinical trial of KRAZATI (adagrasib) for treating non-small cell lung cancer (NSCLC) with KRASG12C mutations met key endpoints.

An oral small-molecule inhibitor, KRAZATI is designed to sustain target inhibition, crucial for treating KRASG12C-mutated cancers, given the KRAS protein’s rapid regeneration rate.

The open-label, multicentre, randomised Phase III trial compared KRAZATI monotherapy to standard-of-care chemotherapy in patients with KRASG12C-mutated NSCLC.

The study’s primary endpoint was progression-free survival (PFS), with secondary endpoints including overall survival (OS), overall response rate (ORR), duration of response (DOR), and safety.

According to the final analysis findings, the trial met the primary endpoint of PFS and the key secondary endpoint of ORR.

While the study is still ongoing for the additional key secondary endpoint of OS, the results so far indicate a meaningful benefit of KRAZATI over standard chemotherapy.

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No new safety signals linked to KRAZATI were reported in the trial with its safety profile in line with the already reported data.

In December 2022, the US Food and Drug Administration (FDA) granted accelerated approval for KRAZATI as a targeted treatment for KRASG12C-mutated NSCLC in people who have undergone systemic therapy previously.

This was followed by conditional marketing authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) last year, and subsequently by the European Commission (EC) earlier this year.

Beyond NSCLC, KRAZATI-based combination regimens demonstrated promise in Phase II clinical trials for various tumours, including advanced colorectal cancer, pancreatic cancer, and other solid tumours.

Bristol Myers Squibb KRAZATI global programme lead and vice-president Abderrahim Oukessou said: “The news is an important reinforcement of the power of a targeted therapy for patients with locally advanced or metastatic KRASG12C-mutated lung cancer.

“FDA approval of KRAZATI in the US has allowed us to provide a new treatment option for these patients, and topline results of the KRYSTAL-12 confirmatory study will build greater trust in the medical and patient community.

“We are encouraged by the results from KRYSTAL-12 and look forward to helping more patients with KRASG12C-mutated lung cancer.”

Recently, the US FDA accepted the company’s supplemental new drug application (sNDA) for KRAZATI (adagrasib) plus cetuximab to treat colorectal cancer, for priority review.