KEYTRUDA is the first and only PD-1 inhibitor to improve PFS compared to platinum doublet chemotherapy for these patients in a Phase 3 trial Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the Phase 3 KEYNOTE‑C93 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, met its primary endpoint of progression-free survival (PFS) for the treatment of patients with mismatch repair deficient (dMMR) advanced or recurrent endometrial cancer who had not previously received systemic chemotherapy or who experienced recurrence more than six months after completing prior adjuvant therapy. KEYTRUDA is the first and only PD-1 inhibitor to show a statistically significant and clinically meaningful improvement in PFS as monotherapy compared to platinum doublet chemotherapy for these patients in a Phase 3 trial. At a pre-specified interim analysis conducted by an independent Data Monitoring Committee, a trend toward improvement in overall
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First and only PD-1 inhibitor plus antibody-drug conjugate regimens approved for patients with MIBC regardless of cisplatin eligibility Approvals based on Phase 3 KEYNOTE-B15 trial, combined with previous approvals based on Phase 3 KEYNOTE-905 trial, bring forward new options for these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with Padcev ® (enfortumab vedotin-ejfv), as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). These approvals represent the first and only PD-1 inhibitor plus antibody-drug conjugate (ADC) regimens approved for adults with MIBC regardless of cisplatin eligibility. These approvals are based on data from the
First approval of PD‑1 inhibitors in combination with a Trop-2-directed antibody-drug conjugate (ADC) in advanced TNBC, marking a potentially practice‑changing treatment option Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Trodelvy ® (sacituzumab govitecan-hziy), Gilead’s Trop-2-directed antibody-drug conjugate (ADC), for the first-line treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10) as determined by an FDA-authorized test. These approvals represent the first PD-1 inhibitors plus Trop-2-directed ADC regimen in advanced TNBC. These approvals are based on data from the Phase 3 KEYNOTE-D19/ASCENT-04 trial demonstrating that KEYTRUDA plus Trodelvy
Approval based on results from the Phase 3 KEYNOTE-905 trial in which perioperative KEYTRUDA plus Padcev reduced the risk of event-free survival events by 60% and risk of death by 50% versus surgery alone in these patients Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev ® (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), is approved in the European Union (EU), as neoadjuvant treatment and then continued after radical cystectomy (RC) as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This approval, which also covers KEYTRUDA SC ® [known as KEYTRUDA QLEX TM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this combination the first and only PD-1 inhibitor plus ADC regimen available for these patients in the EU. This approval is based on
Marks the first approved combinations of a PD-1 and HIF-2α inhibitor Approvals based on Phase 3 LITESPARK-022 trial that showed KEYTRUDA in combination with WELIREG reduced the risk of disease recurrence, metastasis or death by 28% compared to KEYTRUDA plus placebo Represents the first and only global Phase 3 study to have demonstrated an improvement in disease-free survival over KEYTRUDA monotherapy in adjuvant ccRCC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX TM (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapies, each in combination with WELIREG ® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the adjuvant treatment of adult patients with renal cell carcinoma with a clear cell component (ccRCC) at intermediate-high or high risk of recurrence following nephrectomy,
At a median 5-year (60.3 months) planned follow-up of the Phase 2b KEYNOTE-942/mRNA-4157-P201 study, intismeran autogene in combination with KEYTRUDA demonstrated a 49% reduction in the risk of recurrence or death and a 59% reduction in the risk of distant metastasis or death compared to KEYTRUDA alone Intismeran autogene in combination with KEYTRUDA demonstrated an encouraging trend toward overall survival in an exploratory analysis compared to KEYTRUDA alone (HR=0.471; [95% CI, 0.165–1.345]) CAMBRIDGE, MA and RAHWAY, N.J. / Access Newswire / June 1, 2026 / Moderna, Inc. (NASDAQ: MRNA) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced detailed results from a planned five-year follow-up analysis of the Phase 2b randomized KEYNOTE-942/mRNA-4157-P201 study evaluating intismeran autogene (mRNA-4157 or V940), an investigational mRNA-based individualized neoantigen therapy (INT), in combination with KEYTRUDA ® (pembrolizumab), Merck's
Opinion granted based on positive event-free survival, overall survival and pathologic complete response rate results from the Phase 3 KEYNOTE-905 trial If approved, this combination would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen for this patient population in the European Union Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with Padcev ® (enfortumab vedotin-ejfv), an antibody-drug conjugate (ADC), as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment, for adults with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy. This recommendation, which also includes KEYTRUDA SC ® [known as KEYTRUDA QLEX™ (pembrolizumab
If approved, these would be the first and only immunotherapy plus antibody-drug conjugate perioperative treatment regimens for patients with MIBC regardless of cisplatin eligibility Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX ™ (pembrolizumab and berahyaluronidase alfa-pmph), Merck’s anti-PD-1 therapy, each in combination with Padcev ® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy based on results from Phase 3 KEYNOTE-B15. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of August 17, 2026. If approved, these indications would expand the use of KEYTRUDA and KEYTRUDA QLEX, each in combination with Padcev, as the first perioperative
The KEYTRUDA regimen is the first and only PD-1 inhibitor-based treatment approved in the European Union for these patients Approval supported by data from the Phase 3 KEYNOTE-B96 trial in which the KEYTRUDA regimen demonstrated a statistically significant improvement in progression-free and overall survival compared to placebo plus paclitaxel, with or without bevacizumab Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced that KEYTRUDA ® (pembrolizumab), in combination with paclitaxel, with or without bevacizumab, is approved in the European Union (EU) for the treatment of platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal carcinoma in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1 and who have received one or two prior systemic treatment regimens. This approval, which also covers KEYTRUDA SC ® [known as KEYTRUDA QLEX TM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], makes this regimen
This is the first positive Phase 3 trial for WELIREG in earlier-stage disease, the first positive results for a HIF-2α inhibitor and immunotherapy combination and the first study in earlier-stage disease, regardless of tumor type, to demonstrate a disease-free survival improvement compared to KEYTRUDA Based on these data, the U.S. FDA has accepted for priority review supplemental applications for WELIREG in combination with KEYTRUDA or KEYTRUDA QLEX™ for the adjuvant treatment of certain patients with RCC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the presentation of results from the pivotal Phase 3 LITESPARK-022 trial evaluating KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with WELIREG ® (belzutifan), Merck’s first-in-class, oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, given in the adjuvant setting, for patients with clear cell renal cell carcinoma (RCC) following