Amgen files KRAS inhibitor sotorasib with EMA

Amgen has submitted a marketing authorisation application the European Medicines Agency (EMA) for its investigational KRAS inhibitor sotorasib for previously-treated KRAS G12C-mutated non-small cell lung cancer (NSCLC).

The EMA submission is supported by results from a phase II study, CodeBreaK 100, which is evaluating sotorasib in KRAS G12C-mutant NSCLC patients who have failed a median of two prior lines of anti-cancer therapies.

In this study, sotorasib demonstrated an objective response rate consistent with previously reported phase I data. Additional measures of efficacy, including duration of response, were ‘promising’ and over half of responders were still on treatment and continuing to respond as of the data cutoff date.

"Just over two years since the first patient was dosed, sotorasib is now on track to potentially be the first approved targeted therapy for patients with previously treated NSCLC harbouring the KRAS G12C mutation," said David M. Reese, executive vice president of research and development at Amgen.

"With this submission to EMA, Amgen is continuing to rapidly advance the KRAS G12C inhibitor clinical programme to bring this innovative potential therapy to patients globally as quickly as possible,” he added.

KRAS G12C is the most common KRAS mutation in NSCLC, with approximately 13% of patients possessing this mutation.

Each year, around 33,000 new patients in the EU are diagnosed with KRAS G12C-mutated NSCLC. These patients often have poor outcomes in the second line-treatment of their disease as currently there are no KRAS G12C targeted therapies approved.