(Lung Cancer, Gastric Cancer, Urothelial Carcinoma) Efficacy of Keytruda + Cyramza?
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- September 18, 2019
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On July 10, 2019, Roy S. Herbst published results in The Lancet Oncology from a Phase 1a/b clinical trial evaluating the efficacy and safety of the anti-PD-1 antibody Keytruda (pembrolizumab) plus the anti-VEGFR-2 antibody Cyramza (ramucirumab) in 92 previously treated patients with non-small cell lung cancer (NSCLC), gastric and gastroesophageal junction (GEJ) adenocarcinoma, and urothelial carcinoma.
This international, multicenter, non-randomized Phase 1a/b trial enrolled previously treated patients with NSCLC (cohort C, N=27), gastric/GEJ adenocarcinoma (cohorts A+B, N=41), and urothelial carcinoma (cohort D, N=24). Primary endpoints were safety and dose-limiting toxicity; secondary endpoint was objective response rate (ORR).
- Cohorts A+B: Keytruda 200 mg on Day 1 + Cyramza 8 mg/kg on Days 1 and 8 every 21 days
- Cohorts B+C+D: Keytruda 200 mg on Day 1 + Cyramza 10 mg/kg on Day 1 every 21 days
This trial was initiated based on preclinical evidence confirming that combining PD-1 antibody with VEGFR-2 antibody enhances antitumor activity.
Results at median follow-up of 32.8 months:
Dose-Limiting Toxicity (Primary Endpoint): Among 11 patients enrolled in Phase 1a, one patient experienced Grade 3 adverse events including abdominal pain, colitis, hepatitis, interstitial lung disease, and jaundice, as well as Grade 4 cholestasis. Another patient died due to disease progression.
In Phase 1b with 81 additional patients enrolled, the overall adverse event rate was 82% (N=75/92). The most common adverse event was fatigue (36%). Grade ≥3 adverse events occurred in 24%, primarily hypertension (7%) and colitis (5%).
Objective Response Rate (Secondary Endpoint): ORR was: gastric/GEJ adenocarcinoma 7%, NSCLC 30%, urothelial carcinoma 13%.
Based on the Phase 1a/b trial results, Roy S. Herbst concluded that pembrolizumab plus ramucirumab demonstrated favorable antitumor activity with manageable tolerability in previously treated NSCLC, gastric/GEJ adenocarcinoma, and urothelial carcinoma patients.
Source: Ramucirumab plus pembrolizumab in patients with previously treated advanced non-small-cell lung cancer, gastro-oesophageal cancer, or urothelial carcinomas (JVDF): a multicohort, non-randomised, open-label, phase 1a/b trial (Lancet Oncol. 2019 July 10. doi:10.1016/S1470-2045(19)30458-9)
#LungCancer #GastricCancer #UrothelialCarcinoma
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