Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) announced promising results from the Phase 3 KEYNOTE-716 trial, showing that KEYTRUDA reduced the risk of disease recurrence or death by 35% in patients with resected high-risk stage II melanoma compared to placebo. This marks the first anti-PD-1 therapy to improve recurrence-free survival (RFS) in this setting. After 14.4 months, 11.1% of KEYTRUDA patients experienced recurrence or death versus 16.8% in the placebo group. The FDA has accepted these findings for priority review, indicating potential for new treatment options for a high-risk patient population.

Merck (NYSE: MRK) announced positive results from the Phase 3 KEYNOTE-826 trial for KEYTRUDA, its anti-PD-1 therapy, in treating persistent, recurrent, or metastatic cervical cancer. The results were presented at the ESMO Congress 2021 and published in the New England Journal of Medicine. KEYTRUDA combined with chemotherapy showed a 33% reduction in mortality (median OS: 24.4 months vs. 16.5 months) and improved progression-free survival (PFS) at 10.4 months versus 8.2 months. KEYTRUDA also demonstrated a 65.9% overall response rate (ORR), marking it as the first anti-PD-1/PD-L1 regimen to show such improvements in this setting.

Merck (NYSE: MRK) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended KEYTRUDA, its anti-PD-1 therapy, for treating locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) in adults with PD-L1 expression (CPS ≥10) who haven't had prior chemotherapy for metastatic disease. This recommendation is based on positive results from the Phase 3 KEYNOTE-355 trial, which showed significant improvements in progression-free survival and overall survival when KEYTRUDA is combined with chemotherapy. Approval is pending a review by the European Commission.

Merck (NYSE: MRK) announced key data from its oncology research program to be presented at the ESMO Congress 2021, occurring from Sept. 16–21. The highlights include Phase 3 results for KEYTRUDA in stage II melanoma (KEYNOTE-716) and metastatic cervical cancer (KEYNOTE-826), both chosen for the ESMO Presidential Symposium. These trials showed significant improvements in recurrence-free and overall survival, respectively. Merck is committed to advancing treatments for challenging cancers, with a focus on collaborative research for better patient outcomes.

On September 13, 2021, Merck (NYSE: MRK) will participate in a virtual fireside chat at the Morgan Stanley 19th Annual Conference at 11:00 a.m. EDT. Rob Davis, CEO, and Dr. Dean Li, President of Merck Research Laboratories, will represent the company. Interested parties can watch the live video webcast at Merck's investor website. Merck has been innovating for 130 years, focusing on vaccines and medicines for critical diseases globally.

Merck (NYSE: MRK) announced that KEYTRUDA has been approved in China for first-line treatment of advanced esophageal and gastroesophageal junction cancers. This groundbreaking approval allows for the use of KEYTRUDA in combination with chemotherapy, based on positive outcomes from the Phase 3 KEYNOTE-590 trial, which showed a 27% reduction in the risk of death and a 35% reduction in disease progression compared to chemotherapy alone. With this indication, KEYTRUDA is now approved for eight indications across five cancer types in China.

Merck (NYSE: MRK) and Ridgeback Biotherapeutics have launched the Phase 3 MOVe-AHEAD clinical trial to assess molnupiravir, an oral antiviral for COVID-19 prevention. The study targets individuals 18 and older living with someone confirmed to have symptomatic COVID-19. Approximately 1,332 participants will receive molnupiravir or placebo for five days. The trial aims to reduce COVID-19 incidence and is part of ongoing evaluations of molnupiravir's efficacy. Results from a related study, MOVe-OUT, are expected in the latter half of 2021.

Merck (NYSE: MRK) announced the FDA's full approval of KEYTRUDA for treating patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for platinum-containing chemotherapy. The update shifts from accelerated approval and includes a revised indication. Despite the failure of the KEYNOTE-361 trial to meet dual primary endpoints, the FDA’s advisory committee voted to maintain accelerated approval. KEYTRUDA also holds indications for various stages of bladder cancer, highlighting Merck's commitment to advancing treatment options.

Merck (NYSE: MRK) announced that KEYTRUDA has received two approvals from Japan's Pharmaceuticals and Medical Devices Agency. The first approval allows its use in treating PD-L1-positive, hormone receptor-negative, and HER2-negative, inoperable or recurrent breast cancer, based on the KEYNOTE-355 trial results. The second approval is for unresectable, advanced, or recurrent high microsatellite instability colorectal cancer, based on KEYNOTE-177 results. KEYTRUDA now has 15 authorized uses in Japan, supporting the company's commitment to cancer care.