Merck announced on March 1 the voluntary withdrawal of the U.S. indication for Keytruda (pembrolizumab) for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.
Merck presented new data from the Phase III CLEAR trial (KEYNOTE-581/Study 307) at the virtual 2021 Genitourinary Cancers Symposium of the company’s checkpoint inhibitor Keytruda (pembrolizumab) and Eisai’s tyrosine kinase inhibitor Lenvima (lenvatinib) in renal cell carcinoma.
The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted against recommending Merck’s checkpoint inhibitor Keytruda (pembrolizumab) as neoadjuvant treatment for high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy after surgery.
Findings from the Phase III KEYNOTE-042 study show improvements in overall survival (OS), PFS and ORR in patients treated with Merck’s Keytruda (pembrolizumab) as a monotherapy.