Benzinga | Jun 7, 2021 09:33AM EDT

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

* Amgen Inc (NASDAQ: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.