July 8, 2020
- FDA has issued a CRL (Complete Response Letter) in response to the sBLA for the combination of Keytruda/Lenvima (pembrolizumab/lenvatinib) to treat first-line (1L) unresectable HCC (hepatocellular carcinoma). This application was supported by Merck and Eisai.
- The application was based on data from the phase 1b single-arm KEYNOTE-524 (Study 116; NCT03006926) trial. The combination had previously received Breakthrough Therapy Designation and the companies sought Accelerated Approval. Key efficacy data from -524 were presented at ASCO 2020 and included:
- mOS: 22 months
- ORR (Objective Response Rate): 36% (CR rate: 1%)
- mDoR (median Duration of Response): 12.6 months
- According to the press release, the main reason for the CRL was that Keytruda/Lenvima did not represent a meaningful advantage over currently available therapies in 1L HCC. Notably, the combination of Tecentriq/Avastin (atezolizumab/bevacizumab) in 1L HCC was approved 4 weeks earlier on the basis of benefits observed for mOS (median Overall Survival) and mPFS (median Progression-Free Survival) in a phase 3 active comparator study.
- Merck/Eisai still plan to submit for a full approval of Keytruda/Lenvima based on the LEAP-002 trial in 1L HCC. This trial is fully enrolled.