Stay Up
to Date
Stay Up
to Date
Breaking News,
Updates, & More
Breaking News,
Updates, & More
Click Here to
Subscribe
Click Here to
Subscribe

Keytruda plus Lenvima Combo FDA Approved for Advanced Endometrial Carcinoma with No MSI-H or dMMR Tumors

Web Exclusives - FDA Updates

On September 17, 2019, the FDA accelerated the approval of a new combination of pembrolizumab (Keytruda; Merck) plus lenvatinib (Lenvima; Eisai) for patients with advanced endometrial carcinoma that is not associated with microsatellite instability high (MSI-H) or mismatch repair–deficient (dMMR) tumors in patients whose disease progressed after systemic therapy and who are candidates for curative surgery or radiation. The FDA granted this application priority review and a breakthrough therapy designation.

The approval of this combination was based on Study 111/KEYNOTE­146, a single-arm, multicenter, open-­label, multicohort clinical trial of 108 patients with metastatic endometrial carcinoma that had progressed after ≥1 systemic therapies. Patients received oral lenvatinib 20 mg daily plus intravenous pembrolizumab 200 mg every 3 weeks, until disease progression or unacceptable toxicity.

Of the 108 patients, 94 had non–MSI-H or non-dMMR tumors, 11 patients had MSI-H or dMMR tumors, and 3 patients had unknown MSI-H or dMMR status. Efficacy was measured by objective response rate (ORR) and duration of response.

In the 94 patients without MSI-H or dMMR tumors, the ORR was 38.3% (95% confidence interval, 29%-49%), including 10 (10.6%) complete responses and 26 (27.7%) partial responses. The median duration of response was not reached at the time of data cutoff, and 25 (69%) responders had responses lasting ≥6 months.

Side effects with this combination were similar to those previously seen with each treatment.

Related Items
Lynparza First Targeted Therapy Approved for Metastatic Prostate Cancer with HRR Mutation
Web Exclusives published on May 26, 2020 in FDA Updates, Prostate Cancer
Tecentriq Approved as First-Line Therapy for Metastatic NSCLC with High PD-L1 Expression
Web Exclusives published on May 26, 2020 in FDA Updates, Lung Cancer
FDA News
TOP - May 2020, Vol 13, No 3 published on May 21, 2020 in FDA Updates
Opdivo-Yervoy First Immunotherapy Combo Approved for First-Line Therapy of Patients with Metastatic NSCLC
Web Exclusives published on May 18, 2020 in FDA Updates, Lung Cancer
Tabrecta First FDA-Approved Targeted Therapy for Metastatic NSCLC and MET Exon 14 Skipping
Web Exclusives published on May 11, 2020 in FDA Updates
Retevmo First Therapy Approved for 3 Types of Cancers with RET Mutations
Web Exclusives published on May 11, 2020 in FDA Updates
FDA Approves Darzalex Faspro as Subcutaneous Formulation for All Patients with Multiple Myeloma
Web Exclusives published on May 5, 2020 in FDA Updates
Zejula First PARP Inhibitor Approved as First-Line Maintenance Treatment for All Patients with Ovarian Cancer
Web Exclusives published on May 4, 2020 in FDA Updates
FDA Approves New 400 mg Every-6-Weeks Dosing Regimen of Keytruda for All Indications
Web Exclusives published on April 30, 2020 in FDA Updates
Jelmyto First FDA-Approved Therapy for Low-Grade Upper-Tract Urothelial Cancer
Web Exclusives published on April 21, 2020 in FDA Updates, Urothelial Cancer
Last modified: April 27, 2020