First KRAS-Targeted Therapy Receives FDA Approval for Lung Cancer

November 24, 2021 by Elisa Becze BA, ELS, Editor

Sotorasib offers a durable clinical benefit without new safety signals in patients with previously treated KRAS p.G12C-variant non-small cell lung cancer, according to the results of a clinical trial that led to the therapy’s U.S. Food and Drug Administration (FDA) approval. The researchers reported the findings in the New England Journal of Medicine.

In the phase II, single-arm trial, researchers evaluated responses from 124 patients who received 960 mg of sotorasib orally once daily. The majority (81%) had previously received both platinum-based chemotherapy and PD-1 or PD-L1 inhibitors.

A total of 46 patients (37.1%) had an objective response for a median of 11.1 months. Comparatively, 100 patients (80.6%) achieved disease control. The median progression-free survival was 6.8 months and median overall survival 12.5 months. Treatment­related adverse events occurred in 88 patients (69.8%), including grade 3 events in 25 patients (19.8%) and a grade 4 event in 1 (0.8%).

Although the study was conducted only among patients with non-small cell lung cancer, the findings have broader implications for other types of cancer and disease sites. KRAS variants are involved in approximately 25% of all cancers across sites like non-small cell lung, colorectal, and pancreatic cancer. Until sotorasib’s approval for non-small cell lung cancer, clinicians had no pharmaceutical options to treat KRAS-variant cancers.

For more information about sotorasib and its nursing considerations, review ONS’s oncology drug reference sheet.


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