August 13, 2019
Get insight from inThought Research experts on the recent approval of Keytruda Monotherapy for 2L+ Esophageal cancer:
- Merck has announced that FDA has approved Keytruda (pembrolizumab) as a monotherapy for patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (Combined Positive Score [CPS] ≥ 10), with disease progression after one or more prior lines of systemic therapy.
- PD-L1 positivity will be determined by an FDA-approved companion diagnostic.
- The approval is based on data from KEYNOTE-181 and KEYNOTE-180.
- In KEYNOTE-181, the mOS for PD-L1+ esophageal squamous cell carcinoma (ESCC) patients treated with Keytruda was 10.3 months vs. 6.7 months in the chemotherapy arm (HR=0.64; p not provided).
- The mPFS was 3.2 months for Keytruda treated patients vs. 2.3 months for the chemotherapy arm (HR=0.66, p not provided).
- An ORR of 22% (CR rate=5%) was observed in Keytruda treated patients compared with 7% (CR rate=1%) in the chemotherapy arm.