October 1, 2019
- Merck and Eisai have announced that FDA has granted an accelerated approval to the combination treatment of Keytruda/Lenvima (pembrolizumab/lenvatinib) for patients with advanced endometrial carcinoma that is not MSI-H (microsatellite instability-high) or dMMR (mismatch repair deficient), who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation.
- This accelerated approval is based on ORR and duration of response data from the Phase 2 KEYNOTE-146 trial (NCT02501096).
- ORR = 38.3% (CR rate = 10.6%)
- mDoR (median duration of response) = not reached (1.2+ to 33.1+ months)
- % with duration of response ≥ 6 months = 69%
- This accelerated approval was reviewed under FDA’s Real-Time Oncology Review (RTOR) pilot program (submission on June 17, 2019; accelerated approval on September 17, 2019).
- Additionally, this review was conducted under Project Orbis. Project Orbis allows for a concurrent review process from multiple international regulatory agencies. For this approval, FDA, Australian Therapeutic Goods Administration (TGA) and Health Canada collaboratively reviewed the submission and made a simultaneous decision in all 3 countries.