Amgen’s KRAS inhibitor Lumakras scores positive overall survival data

Amgen has presented new data on overall survival (OS) for its KRAS inhibitor Lumakras in previously treated non-small cell lung cancer (NSCLC) at the 2021 American Society of Clinical Oncology (ASCO) annual meeting.

The Phase II results of the CodeBreaK 100 study for Lumakras (sotorasib) showed a median OS of 12.5 months among 124 evaluable patients – most of the participants were previously treated with both platinum-based chemotherapy and immunotherapy.

In addition, the results confirmed an objective response rate (ORR) of 37.1% as well as duration of response of (DoR) of 11 months and disease control rate (DCR) f 80.6%.

Exploratory analyses also found tumour response to Lumakras was consistently observed across a range of biomarker subgroups, including those with baseline PD-L1 expression levels and those with STK11 mutation.

In patients separated by baseline PD-L1 expression, tumour response and tumour shrinkage were observed across the range of baseline PD-L1 expression levels, with a response rate of 48% for the PD-L1 negative group.

Amgen added that Lumakras also improved efficacy among the STK11-mutant patient group with concurrent wild-type KEAP1, with median progression free survival (PFS) of 11 months and a median OS of 15.3 months observed in these patients.

"Patients with KRAS G12C-mutated non-small cell lung cancer face poor outcomes so we are pleased with these overall survival results and the impact Lumakras may have for patients with this devastating mutation," said David M. Reese, executive vice president of research and development at Amgen.

"The results published in the New England Journal of Medicine further confirm the deep and durable responses we have seen with Lumakras throughout the CodeBreaK clinical trial programme, the most advanced KRAS G12C clinical trial programme with the longest follow-up,” he added.

In May, the US Food and Drug Administration (FDA) approved Lumakras for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC, as determined by an FDA-approved test, who have received at least one prior systemic therapy.