Positive results from Sellas Life Sciences Group’s Phase I/II trial using galinpepimut-S (GPS) as a combination therapy with pembrolizumab (Keytruda) were announced shortly after similarly positive news was issued from a combination study in which GPS was evaluated as a treatment for mesothelioma.
Merck announced positive results from the late-stage KEYNOTE-522 study for Keytruda as a neoadjuvant treatment for triple negative breast cancer, which should support the company’s previous attempt for U.S. approval that was stymied by a regulatory advisory committee in February and rejected by the Food and Drug Administration in March.
The U.S. Food and Drug Administration approved Merck’s Keytruda in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma. Keytruda is the first anti-PD-1 therapy approved in combination with anti-HER2 therapy and chemotherapy as a first-line treatment for these patients.
GlaxoSmithKline halted two mid-stage studies assessing feladilimab combined with Merck’s Keytruda as a potential treatment in different oncology settings.
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) to Merck for the company’s supplemental Biologics License Application for Keytruda (pembrolizumab) in high-risk early-stage triple-negative breast cancer.
Six former FDA commissioners – Scott Gottlieb, Robert Califf, Mark McClellan, Margaret Hamburg, Jane Henney and Andrew von Escehenbach – signed a joint letter urging the U.S. president to nominate a permanent commissioner soon.
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.