FDA has accepted for priority review a new supplemental Biologics License Application seeking approval for Keytruda (pembrolizumab) in combination with external beam radiotherapy plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment with definitive intent for newly diagnosed patients with high-risk, locally advanced cervical cancer.
The European Medicines Agency’s Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of Keytruda (pembrolizumab) for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy.
Merck and Moderna have initiated a phase III randomized V940-001 clinical trial evaluating V940 (mRNA-4157), an investigational individualized neoantigen therapy (INT), in combination with Keytruda (pembrolizumab) as an adjuvant treatment in patients with resected high-risk (Stage IIB-IV) melanoma.
The European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of Keytruda (pembrolizumab) in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2-positive gastric or gastroesophageal junction adenocarcinoma in adults whose tumors express PD-L1.
Adjuvant treatment with mRNA-4157 (V940), an investigational individualized neoantigen therapy (INT), in combination with Keytruda (pembrolizumab) demonstrated a statistically significant and clinically meaningful improvement in distant metastasis-free survival (DMFS) for patients with resected high-risk melanoma (stage III/IV) in a phase IIb study.
After four years of follow-up, Keytruda (pembrolizumab) plus Lenvima (lenvatinib) maintained a clinically meaningful overall survival benefit versus sunitinib in the phase III CLEAR (Study 307)/KEYNOTE-581 trial of first-line treatment in patients with advanced renal cell carcinoma.
FDA has accepted for review a new supplemental Biologics License Application seeking approval for Keytruda (pembrolizumab) in combination with standard of care chemotherapy (gemcitabine and cisplatin) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer.
After four years of follow-up, final pre-specified overall survival analysis from the pivotal phase III CLEAR/KEYNOTE-581 trial showed that Keytruda plus Lenvima maintained a clinically meaningful OS benefit versus sunitinib for the first-line treatment of patients with advanced renal cell carcinoma, reducing the risk of death by 21%.
Moderna, Inc. and Merck announced April 16 the first presentation of detailed results from the phase IIb KEYNOTE-942/mRNA-4157-P201 trial evaluating mRNA-4157 (V940), an investigational individualized neoantigen therapy, in combination with KEYTRUDA, Merck’s anti-PD-1 therapy, in patients with resected high-risk melanoma (stage III/IV).
In a phase III NRG‑GY018 trial investigating Keytruda (pembrolizumab) in combination with standard of care chemotherapy (carboplatin and paclitaxel) for the first-line treatment of patients with stage III-IV or recurrent endometrial carcinoma whose cancer was either mismatch repair proficient or mismatch repair deficient, the Keytruda regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival for patients, regardless of mismatch repair status.
