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Preliminary data from a Phase 1b/2 clinical trial evaluating Merck's (NYSE:MRK) Keytruda (pembrolizumab) plus Eisai's (OTCPK:ESALY) Lenvima (lenvatinib) in patients with metastatic non-small cell lung cancer (NSCLC), metastatic melanoma and metastatic urothelial carcinoma showed a treatment effect. The results are being presented at the SITC annual meeting in Washington, DC.
- The trial, Study 111/KEYNOTE-146, is a single-arm, open-label basket study. Participants were not selected based on PD-L1 expression. The primary endpoint of the first phase was maximum tolerated dose. The primary endpoint of the second phase is objective response rate (ORR) at week 24.
- At data cutoff, the ORR in NSCLC patients who had received up to two prior lines of therapies was 33.3% (n=7/21). The ORR in melanoma patients who had received up to two prior treatments was 47.6% (n=10/21). The ORR in urothelial cancer patients who had received up to two prior treatments was 25.0% (n=5/20).
- Pembrolizumab is a PD-1 inhibitor and lenvatinib is a kinase inhibitor.
- The study is ongoing.