CHICAGO — The combination of lenvatinib and pembrolizumab conferred benefit to previously treated patients with metastatic endometrial cancer, according to study results presented at the ASCO Annual Meeting.
Researchers reported no additional safety concerns beyond what had been observed in prior studies of each agent, and toxicities were managed with dose modification or interruption.
Vicky Makker, MD,
medical oncologist at Memorial Sloan Kettering Cancer Center, and colleagues conducted a multicenter, open-label study of 23 patients (median age, 64 years; range, 51-80; 87% white) with metastatic endometrial cancer who progressed after previous treatment (median prior therapies, 2). All patients had measurable disease and ECOG performance status of 1 or less.
All study participants received lenvatinib (Lenvima, Eisai) — a novel multikinase inhibitor that targets both the vascular endothelial growth factor receptor and fibroblast growth factor receptors — in combination with the anti–PD-1 antibody pembrolizumab (Keytruda, Merck).
Patients received oral lenvatinib 20 mg daily, plus pembrolizumab 200 mg administered via IV every 3 weeks.
Objective response rate served as the primary endpoint. Secondary endpoints included PFS, disease control rate, clinical benefit rate, duration of response and safety.
Researchers reported a 47.8% ORR at 24 weeks per investigator assessment. They reported median PFS of 9.7 months by investigator assessment, but median PFS by independent radiologic review had not been reached.
Investigators reported disease control rates of 95.7% by investigator assessment and 91.3% by independent radiologic review.
All patients experienced treatment-emergent adverse events, the most common of which were hypertension, fatigue, arthralgia, diarrhea and nausea.
“We are encouraged by the results of this study, in which nearly half of the patients who have received prior systemic therapy for the treatment of recurrent advanced or metastatic endometrial cancer responded to this combination therapy,” Makker said in a press release. “Women whose endometrial cancer has recurred [need] additional therapeutic options, and we look forward to learning more regarding the potential of this combination regimen for these women.” – by Ryan McDonald
Makker V, et al. Abstract 5598. Presented at: ASCO Annual Meeting; June 2-6, 2017; Chicago.
Disclosure: Makker reports no relevant financial disclosures. Please see the full study for a list of all other researchers’ relevant financial disclosures.