First KRAS-Targeted Therapy Receives FDA Approval for Lung Cancer
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 (https://www.nejm.org/doi/10.1056/NEJMoa2103695) 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 (https://www.mdpi.com/2072-6694/13/6/1204) 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. (https://voice.ons.org/news-and-views/oncology-drug-reference-sheet-sotorasib)