- In patients with advanced, previously treated nonsquamous NSCLC, KRAS mutation-positive status had no significant effect on key efficacy endpoints, but was associated with increased risk of grade 3-4 toxicity.
Why this matters
- KRAS mutations are the most prevalent oncogenic mutation in this setting, harbored in approximately 30% of cases of nonsquamous NSCLC.
- Study to investigate nivolumab in 530 previously treated patients with advanced NSCLC; 206 patients were KRAS-positive; 324 were KRAS-negative.
- Data was sourced for patients who received nivolumab via the Italian expanded access program (EAP) between 2015 and 2017.
- Funding: None disclosed.
- 8.0 (range, 0.1-25.9) and 7.4 (range, 0.2-27.4) months median follow-up in KRAS-positive and KRAS-negative patients, respectively.
- Key outcomes in KRAS-positive vs KRAS-negative patients, respectively:
- Objective response rate (ORR): 20% vs 17% (P=.39).
- Disease control rate (DCR): 47% vs 41% (P=.23).
- Median PFS: 4 (95% CI, 3.6-4.4) vs 3 (95% CI, 3.6-4.4) months (P=.56).
- Median OS: 11.2 (95% CI, 9.3-13.1) vs 10 (95% CI, 9.3-13.1) months (P=.86).
- Significant association between KRAS-positive status and grade 3-4 toxicities (OR=2.25; 95% CI, 1.14-4.44; P=.02).
- Retrospective data.