On September 10, 2021 Amgen reported that is first-in-class KRAS G12C inhibitor Lumykras (sotorasib) has been received a conditional marketing authorisation in the UK (Press release, Amgen, SEP 10, 2021, View Source [SID1234587519]).

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The UK Medicines and Healthcare products Regulatory Agency (MHRA) has conditionally approved Lumykras under Project Orbis – an international collaborative programme between the US Food and Drug Administration and regulatory agencies across the world.

KRAS G12C is one of the most common identified or known drivers in non-small cell lung cancer (NSCLC).

Amgen’s med binds with a mutated KRAS G12C protein in a bid to ‘switch off’ the signals it sends to trigger cell division and cancer cell growth.

The MHRA review of Lumykras considered data from the Phase II CodeBreaK 100 clinical study, which evaluated the drug in 126 patients with KRAS G12c-mutated advanced NSCLC.

Results from this trial demonstrated a confirmed objective response rate (ORR) of 37.1% and a disease control rate (DCR) of 80.6% for Lumykras-treated patients.

Recently published data also showed a median overall survival (OS) of 12.5 months among 124 evaluable patients, with the median duration of response (DoR) – evaluated in 46 patients – shown to be 11.1 months.

"Today’s conditional marketing authorisation by the MHRA marks an important moment in treating lung cancer patients, with a new targeted therapy, who have failed first-line treatment and face extremely poor outcomes with limited further treatment options," said Tony Patrikios, executive medical director, Amgen UK and Ireland.

"This reflects the clinical investigation programme, demonstrating the use of sotorasib in adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have progressed on, or are intolerant to, platinum-based chemotherapy and/or anti PD-1/PD-L1 immunotherapy," he added.