The Gynecologic Oncology Institute reviews all recent advances for cancer treatment and this is a significant step forward, now part of the NCCN Guidelines for recurrent advanced endometrial cancer.
The combination of pembrolizumab (Keytruda) plus lenvatinib (Lenvima) resulted in statistically significant and clinically meaningful improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) compared to chemotherapy when treating patients with advanced endometrial cancer following prior systemic therapy in Phase 3 clinical KEYNOTE-775 / Study 309 (NCT03517449), according to a press release from Merck and Esai, developers of the regimen
The dual primary endpoints of OS and PFS and the secondary efficacy endpoint of ORR were met with the combination of anti-PD-1 therapy and lenvatinib, an orally available tyrosine kinase inhibitor with multiple receptors. The researchers observed these positive results in both the Mismatch Repair Proficient (pMMR) subgroup and the Intention-to-Treat (ITT) group. This included patients with endometrial cancer (pMMR) as well as patients with high microsatellite instability (MSI-H). / Mismatch repair defective (dMMR).
The combination also appeared to have a safety profile consistent with previous findings for the pembrolizumab plus lenvatinib regimen.
The most common toxicities of the regime were fatigue, high blood pressure, musculoskeletal pain, diarrhea, decreased appetite, hypothyroidism, nausea, stomatitis, vomiting, decreased weight, abdominal pain, headache, constipation, urinary tract infection, dysphonia, hemorrhagic events, hypomagnesemia, palmar-plant erythema, Difficulty breathing, cough, and rash.
1. The combination of Keytruda® (pembrolizumab) and Lenvima® (lenvatinib) showed a statistically significant improvement in overall survival, progression-free survival and objective response rate compared to chemotherapy in patients with advanced endometrial cancer after prior systemic therapy in the phase 3 study. Press release. Merck. December 16, 2020. Accessed December 16, 2020. https://yhoo.it/2WjJ8b6
2. Makker V., Rasco D., Vogelzang NJ, et al. Lenvatinib plus pembrolizumab in patients with advanced endometrial cancer: an interim analysis of a multi-center, open-label, single-arm phase 2 study. Lancet Oncol. 2019; 20 (5): 711- 718. doi: 10.1016 / S1470-2045 (19) 30020-8.