Merck & Co Stock Price, News & Analysis

Merck (NYSE: MRK) announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of KEYTRUDA combined with chemotherapy for treating persistent, recurrent, or metastatic cervical cancer in adults with PD-L1 expressing tumors (CPS ≥1). This recommendation follows the Phase 3 KEYNOTE-826 trial, which showed significant improvements in overall survival (HR=0.64) and progression-free survival (HR=0.62), with a 68% objective response rate compared to 50% for chemotherapy alone. A final decision from the European Commission is anticipated in Q2 2022.

Merck (NYSE: MRK) announced the retirement of Dr. Roy D. Baynes, Chief Medical Officer, effective July, with Dr. Eliav Barr succeeding him on April 1, 2022. Dr. Baynes has significantly contributed to Merck's oncology leadership, notably through the development of KEYTRUDA. Under Dr. Barr, who has over two decades with Merck, the company aims to continue advancements in clinical development, particularly in oncology and vaccines. This leadership transition aims to ensure ongoing growth and innovation in Merck’s pipeline.

Merck (NYSE: MRK) presented findings at the 48th Annual European Society for Blood and Marrow Transplantation Meeting, revealing that PREVYMIS™ (letermovir) significantly lowers the risk of cytomegalovirus (CMV) reactivation in CMV-seropositive patients undergoing allogeneic hematopoietic cell transplantation. The meta-analysis of 48 studies showed a 87% reduction in CMV reactivation and a 91% reduction in clinically significant CMV infections at 100 days. Results were consistent at 200 days, reinforcing PREVYMIS as a critical prophylactic treatment in this high-risk patient population.

Merck (NYSE: MRK) has received FDA approval for KEYTRUDA as a treatment for patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR). The approval is based on data from the KEYNOTE-158 trial, which demonstrated a 46% objective response rate (ORR) with a 12% complete response and 33% partial response among patients treated with KEYTRUDA. This marks KEYTRUDA's fourth indication in gynecologic oncology, emphasizing its potential in addressing advanced endometrial cancer.

Merck (NYSE: MRK) announced pivotal results from the Phase 3 KEYNOTE-091 trial for the adjuvant treatment of non-small cell lung cancer (NSCLC). The study showed that KEYTRUDA significantly improved disease-free survival (DFS) by 24% compared to placebo, with a median DFS of 53.6 months versus 42.0 months. These data will be shared with regulatory authorities globally. Despite positive outcomes, the study noted that improvement in DFS for high PD-L1 expression patients was not statistically significant. The safety profile was consistent with previous studies.

Merck (NYSE: MRK) and AstraZeneca have released positive data from the Phase 3 OlympiA trial, highlighting LYNPARZA's effectiveness as an adjuvant treatment for patients with germline BRCA-mutated early breast cancer. The trial demonstrated a 32% reduction in the risk of death (HR=0.68) compared to placebo, with three-year survival rates of 92.8% for LYNPARZA versus 89.1% for placebo. These findings will be showcased at the European Society for Medical Oncology Virtual Plenary, marking a significant advancement for early breast cancer treatment.

Merck (NYSE: MRK) announced the discontinuation of the Phase 3 KEYLYNK-010 trial, which studied KEYTRUDA with LYNPARZA for metastatic castration-resistant prostate cancer. The independent Data Monitoring Committee recommended stopping the trial after an interim analysis revealed no overall survival benefit compared to control treatments. The combination also showed a higher incidence of serious adverse events. Despite this setback, Merck continues to explore other KEYTRUDA combinations across various cancers, maintaining a strong clinical development program.

Merck (NYSE: MRK) announced that LYNPARZA received FDA approval as the first targeted adjuvant therapy for patients with BRCA-mutated, HER2-negative high-risk early breast cancer. This is a significant milestone as LYNPARZA demonstrated a 42% reduction in the risk of invasive breast cancer recurrence and a 32% reduction in the risk of death compared to placebo, based on the Phase 3 OlympiA trial. Merck will make a $175 million payment to AstraZeneca under their collaboration agreement following this approval, potentially enhancing the market position of LYNPARZA.

Merck (NYSE: MRK) will host a virtual investor event on April 5, 2022, at 10:00am ET, after the American College of Cardiology Scientific Session 2022. The event will provide insights into Merck’s extensive cardiovascular portfolio and pipeline. Cardiovascular disease remains a significant global health issue, claiming approximately 18 million lives annually. Merck highlights its commitment to innovation and research in this field, aiming to improve patient outcomes. For more details, visit Merck's investor relations website.