Amgen's Sotorasib is First KRAS Inhibitor to Show Overall Survival Benefit in Lung Cancer With KRAS Mutations

Amgen Inc AMGN presented data on overall survival from the Phase 2 results of the CodeBreaK 100 clinical study for Lumakras (sotorasib) in previously treated non-small-cell lung cancer (NSCLC) patients.
Data were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting and simultaneously published in the New England Journal of Medicine.
The study showed that treatment with Lumakras induced a 37% objective response rate in patients and 12.5 months of median overall survival.
In the trial, sotorasib demonstrated a median progression-free survival of 6.8 months.
An additional patient achieved complete response (bringing the total to four complete responses and 42 partial responses) compared to previously reported results.
Data from a separate study were also presented discussing patient-reported outcomes on Lumakras, which is a once-daily oral medication. Treatment-related adverse events were mostly mild and manageable with care.
In exploratory analyses, tumor response to Lumakras was consistently observed across a range of biomarker subgroups.
In the patient subsets separated by baseline PD-L1 expression (n=86), response and tumor shrinkage were observed across the range of baseline PD-L1 expression levels, with a response rate of 48% for the PD-L1 negative group.
Improved efficacy with Lumakras was seen in the STK11-mutant group with concurrent wild-type KEAP1 (n=22) with median progression-free survival of 11.0 months and median overall survival of 15.3 months.
Last month, sotorasib received FDA accelerated approval for use in adults with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systematic therapy.
Price Action: AMGN shares are trading lower by 0.41% at $235.87 on the last check Monday.

Market News and Data brought to you by Benzinga APIs

Get Our Top Trade Ideas Delivered Daily - 65% Off Now

Get Our Top Trade Ideas Delivered Daily - 65% Off Now

Comments

Earnings Calendar

Never Miss Important Catalysts