Represents the first PD-1 inhibitor plus ADC regimens for this patient population Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) 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) who are ineligible for cisplatin-based chemotherapy. These approvals represent the first PD-1 inhibitor plus ADC regimens for this patient population. These approvals are based on data from the Phase 3 KEYNOTE-905 trial (also known as EV-303), which was conducted in collaboration with Pfizer and Astellas. Results, which were presented at the recent European Society for Medical Oncology (ESMO) Congress, showed that after a median follow-up of 25.6
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This marks the approval of the first and only subcutaneous immune checkpoint inhibitor in Europe that can be administered by a health care provider in as little as one minute Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved a new subcutaneous (SC), or under the skin, route of administration and a new pharmaceutical form (solution for injection) of KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy. KEYTRUDA SC™, as it will be marketed in the European Union (EU), [known as KEYTRUDA QLEX TM (pembrolizumab and berahyaluronidase alfa-pmph) in the U.S.], is a subcutaneous injection containing pembrolizumab and berahyaluronidase alfa and has been approved for use across all 33 KEYTRUDA indications for adult patients in Europe. Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. For a list of select indications for which KEYTRUDA and KEYTRUDA QLEX are
KEYTRUDA monotherapy now approved as neoadjuvant treatment, continued as adjuvant treatment combined with radiotherapy with or without concomitant cisplatin then as monotherapy Based on results of KEYNOTE-689, this represents the first and only approval in the European Union for an anti-PD-1 treatment option for adults with resectable LA-HNSCC whose tumors express PD-L1 (CPS >1) Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the European Commission (EC) has approved KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, as monotherapy for the treatment of resectable locally advanced head and neck squamous cell carcinoma (LA-HNSCC) as neoadjuvant treatment, continued as adjuvant treatment in combination with radiation therapy with or without concomitant cisplatin and then as monotherapy in adults whose tumors express PD-L1 with a Combined Positive Score (CPS) ≥1. This approval marks the first and only anti-PD-1 treatment
First combination regimen to demonstrate improvement in DFS compared to KEYTRUDA monotherapy for these patients in the adjuvant setting LITESPARK-022 is the second positive Phase 3 study for WELIREG as part of a combination regimen in RCC Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced positive topline results from the Phase 3 LITESPARK-022 trial in patients with clear cell renal cell carcinoma (RCC) following nephrectomy. In this study, 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, demonstrated a statistically significant and clinically meaningful improvement in disease-free survival (DFS), the study’s primary endpoint, compared to KEYTRUDA in combination with placebo. The trial will continue to evaluate overall survival (OS), a key secondary endpoint. "KEYTRUDA monotherapy given
Applications based on Phase 3 KEYNOTE-905 results showing the combination improved event-free survival by 60%, reduced the risk of death by 50% and increased pathologic complete response rates by 48% compared with surgery alone If approved, these would be the first and only perioperative regimens to have improved survival in this patient population Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has granted priority review for two supplemental Biologics License Applications (sBLA) for KEYTRUDA ® (pembrolizumab) and KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph), each in combination with Padcev ® (enfortumab vedotin-ejfv), for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy. The FDA set a Prescription Drug User Fee Act (PDUFA), or target action, date of April 7, 2026, marking the first concurrent
Five-year exploratory follow-up analysis of KEYNOTE-671 continued to show clinically meaningful improvements in overall survival and event-free survival with KEYTRUDA plus chemotherapy before surgery, and then continued as a single agent after surgery Eight and 10-year findings from analyses of KEYNOTE-001, KEYNOTE-010, KEYNOTE-024 and KEYNOTE-042 show that KEYTRUDA monotherapy continued to improve survival for certain patients with locally advanced or metastatic NSCLC, supporting its role as a standard of care Results presented at the European Society for Medical Oncology (ESMO) Congress 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced new long-term data highlighting the sustained survival benefits of KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, in treating non-small cell lung cancer (NSCLC). The results are based on the exploratory five-year analyses of KEYNOTE-671 evaluating KEYTRUDA as part of a neoadjuvant followed
Results from the first and second interim analyses of the Phase 3 KEYNOTE-B96 trial were selected for presentation during a Presidential Symposium session at the European Society for Medical Oncology Congress 2025 With these results, KEYNOTE-B96 is the first trial of an immune checkpoint inhibitor-based treatment regimen in platinum-resistant recurrent ovarian cancer to show statistically significant improvements in progression-free survival for all comers and overall survival for patients whose tumors express PD-L1 versus placebo plus chemotherapy with or without bevacizumab Based on these data, the U.S. FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) for KEYTRUDA plus chemotherapy with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the first presentation of results from the pivotal Phase 3 KEYNOTE-B96
First and only systemic regimen to demonstrate durable survival benefit in this patient population KEYNOTE-905 marks the fifth study of a KEYTRUDA-based regimen in an earlier stage of cancer to demonstrate an overall survival benefit Results from the Phase 3 KEYNOTE-905 trial were selected for an official Press Briefing and will be presented during a Presidential Symposium session at the European Society for Medical Oncology (ESMO) Congress 2025 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced landmark results demonstrating KEYTRUDA ® (pembrolizumab) plus Padcev ® (enfortumab vedotin-ejfv) reduced the risk of event-free survival (EFS) events by 60% and reduced the risk of death by 50% when given before and after surgery (radical cystectomy) versus surgery alone, the current standard of care, in patients with muscle-invasive bladder cancer (MIBC) who are not eligible for or declined cisplatin-based chemotherapy. These late-breaking data will be
At five years, KEYTRUDA plus LENVIMA showed a 16.7% overall survival (OS) rate for these patients with mismatch repair proficient (pMMR) advanced endometrial carcinoma versus 7.3% for chemotherapy alone in the pivotal Phase 3 KEYNOTE-775/Study 309 trial Five-year OS results in the pMMR subgroup were consistent with the all-comers study population, which demonstrated an OS rate of 19.9% for KEYTRUDA plus LENVIMA versus 7.7% for chemotherapy Merck (NYSE: MRK), known as MSD outside of the United States and Canada, and Eisai today announced long-term follow-up data continued to show durable benefit of KEYTRUDA ® (pembrolizumab), Merck’s anti-PD-1 therapy, plus LENVIMA ® (lenvatinib), the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, compared to chemotherapy for patients with advanced endometrial carcinoma following at least one prior platinum-based regimen in any setting. The findings, based on five years of follow-up from the Phase 3
KEYTRUDA QLEX is the first and only subcutaneously administered immune checkpoint inhibitor that can be given by a health care provider in as little as one minute Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA QLEX™ (pembrolizumab and berahyaluronidase alfa-pmph) injection for subcutaneous administration in adults across most solid tumor indications for KEYTRUDA ® (pembrolizumab). Berahyaluronidase alfa is a variant of human hyaluronidase developed and manufactured by Alteogen Inc. KEYTRUDA QLEX must be administered by a health care provider (HCP). Merck expects to have KEYTRUDA QLEX (pronounced key-TRUE-duh Q-lex) available in the U.S. in late September. For a full list of the 38 indications for which KEYTRUDA QLEX is approved, see “KEYTRUDA QLEX Indications” below. “This approval is significant for patients and health care providers like me who