CONTEXT: Report of a retrospective cohort study publish in JAMA Network Open describing the use of Keytruda (Pembrolizumab) alone and in combination with chemotherapy in the treatment of NSCLC | US Medicare data only.
IMPACT: Medium
READ TIME: 4 mins
Quality Level Mean [1 – 10]: 8
1. “In 2019, the FDA expanded the approval for pembrolizumab monotherapy for the frontline treatment of patients with stage III NSCLC, who are ineligible for surgery or definitive chemoradiation, or metastatic NSCLC, with a PD-L1 expression of at least 1%.4. Pembrolizumab in combination with platinum-based chemotherapy and pemetrexed is approved for use in patients with metastatic nonsquamous NSCLC regardless of PD-L1 expression based on findings from the KEYNOTE-189 trial.3 The study demonstrated a median OS of 22.0 months with the combination vs 10.7 months with chemotherapy plus placebo (HR, 0.56; 95% CI, 0.45-0.70).”
2. “Pembrolizumab (Keytruda) alone and in combination with chemotherapy was associated with shorter overall survival (OS) compared with the data demonstrated in the registrational clinical trials in older Medicare patients with advanced non–small cell lung cancer (NSCLC), providing real-world insight into the prognosis of older patients with NSCLC who are treated with immunotherapy, according to findings from a retrospective cohort study that were published in JAMA Network Open.”
3. “1. The unadjusted median OS was 11.4 months (95% CI, 10.5-12.3) with single-agent pembrolizumab, which was about 15 months shorter than the survival findings from the phase 3 KEYNOTE-024 trial (NCT02142738), a study that evaluated pembrolizumab-treated patients.2. The unadjusted median OS was 12.9 months (95% CI, 11.8-14.0) with the combination of platinum, pemetrexed, and pembrolizumab, which was about 10 months shorter than the survival findings with the same combination from the KEYNOTE-189 trial (NCT02578680).3. “These comparative effectiveness results are interesting and have to be interpreted cautiously.”
4. “Similar adjusted RMST was observed between patients who received pembrolizumab (adjusted RMST, 11.0 months; 95% CI, 10.6-11.4) and patients who received platinum/pemetrexed (adjusted RMST, 11.1 months; 95% CI, 10.9-11.3; RMST difference, -0.2 months; 95% CI, -0.5 to 0.2; P = .30).”
5. “Patients who received pembrolizumab had statistically worse survival compared with patients who received platinum/taxane, but the difference was small (adjusted RMST difference, -0.7 months; 95% CI, -1.0 to -0.4; P < .001).”