FDA approved Keytruda (pembrolizumab) with chemoradiotherapy for patients with FIGO 2014 stage 3-4A cervical cancer.
Merck and Moderna Inc. have initiated the phase III randomized INTerpath-002 trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda as adjuvant treatment in patients with completely resected (R0) Stage II, IIIA or IIIB (with nodal involvement [N2]) non-small cell lung cancer.
FDA has approved Padcev (enfortumab vedotin-ejfv) in combination with Keytruda (pembrolizumab) for patients with locally advanced or metastatic urothelial cancer (la/mUC).
FDA approved Keytruda (pembrolizumab) with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Keytruda (pembrolizumab) in combination with gemcitabine and cisplatin, for the first-line treatment of adult patients with locally advanced unresectable or metastatic biliary tract carcinoma.
FDA revised the existing indication of Keytruda (pembrolizumab) 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.
FDA approved Keytruda (pembrolizumab) to be used with gemcitabine and cisplatin for locally advanced unresectable or metastatic biliary tract cancer.
In exploratory analyses of results from the SWOG S1801 trial in patients with stage III-IV resectable melanoma, researchers saw a major pathologic response in more than half of surgical specimens taken from patients who had been treated with neoadjuvant Keytruda (pembrolizumab).
The phase III KEYNOTE-671 trial investigating Keytruda, Merck’s anti-PD-1 therapy, as a perioperative treatment regimen for patients with resectable stage 2, 3A or 3B non-small cell lung cancer met its dual primary endpoint of overall survival.
A single-arm, open-label, phase II trial of BXCL701, an oral innate immune activator, in combination with Keytruda (pembrolizumab) in patients with small cell neuroendocrine prostate cancer showed positive overall survival data. As of a data cutoff of Sept. 6, evaluable patients with SCNC showed a median OS of 13.6 months, and a 12-month survival rate of 56.5%.
