Merck & Co., Inc. - MRK STOCK NEWS

Moderna (NASDAQ:MRNA) and Merck (NYSE:MRK) announced that their investigational personalized mRNA cancer vaccine, mRNA-4157/V940, in combination with KEYTRUDA, has received PRIME scheme designation from the European Medicines Agency (EMA). This designation follows positive data from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial for treating high-risk stage III/IV melanoma after complete surgical resection. The first detailed results will be presented at the American Association for Cancer Research (AACR) from April 14-19. With a high unmet need for melanoma therapies, this designation aims to accelerate access to effective treatments for patients. Further, the FDA has granted Breakthrough Therapy Designation for the same combination, alongside plans for a Phase 3 study in 2023.

Merck's executive director of health equity, Josette Gbemudu, is prominently positioned to address health disparities and promote access to care for underserved populations. Drawing from her experiences in Nigeria, she emphasizes the importance of health equity within Merck's core strategies. Gbemudu is the first representative from Merck to join the Aspen Institute's First Movers Fellowship program, where she focuses on becoming a corporate social intrapreneur. This fellowship has enabled her to implement strategies to close care gaps while advocating for a health equity mindset. Gbemudu believes that addressing these significant challenges is essential for the company's long-term success and aligns with Merck's commitment to tackling pressing public health issues. Learn more about Merck's Environmental, Social & Governance (ESG) initiatives at merck.com/company-overview/esg.

Merck has been recognized for the third consecutive year as one of Barron's 100 Most Sustainable U.S. Companies, ranking No. 1 in the pharmaceutical sector and advancing from No. 67 to No. 29 overall. This accolade highlights Merck's commitment to social responsibility and sustainability, as expressed by Carmen Villar, vice president of Social Business Innovation. In addition to this, Merck has also received accolades from JUST Capital, CNBC, Newsweek, and Statista for its ethical operations. The evaluation was based on over 230 ESG performance indicators by Calvert Research and Management.

Merck (NYSE: MRK) announces FDA approval of KEYTRUDA in combination with Padcev for adult patients with locally advanced or metastatic urothelial carcinoma (la/mUC) who cannot receive cisplatin-containing chemotherapy. This groundbreaking approval represents the first combination of an anti-PD-1 therapy and an antibody-drug conjugate for this patient group, based on the KEYNOTE-869 trial data. The objective response rate was 68%, with a median duration of response of 22.1 months. The approval is granted under accelerated terms, which may depend on further verification of clinical benefit. The ongoing Phase 3 trial, EV-302/KEYNOTE-A39, will serve as the confirmatory trial.

Merck (NYSE: MRK) will host its first-quarter 2023 sales and earnings conference call on April 27, 2023, at 9:00 a.m. ET. During this call, company executives will discuss Merck's financial performance for the quarter, including key metrics and sales figures. Investors and the public can access the live audio webcast through the company's website. A replay of the call and additional financial disclosures will also be available.

Merck continues its commitment to innovative research and development in the biopharmaceutical sector, aiming to enhance health outcomes globally.

Merck (NYSE: MRK) has received full FDA approval for KEYTRUDA, its anti-PD-1 therapy, for treating adult and pediatric patients with unresectable or metastatic MSI-H or dMMR solid tumors. This approval, transitioning from an accelerated status, is founded on data from 504 patients across three significant trials (KEYNOTE-158, KEYNOTE-164, and KEYNOTE-051). The therapy showed an overall objective response rate (ORR) of 33.3% with a median duration of response (DOR) of 63.2 months. KEYTRUDA is notably the first immunotherapy to gain full approval based on a pan-tumor predictive biomarker, emphasizing the importance of biomarker testing in treatment eligibility.

Merck (NYSE: MRK) announced promising results from the Phase 3 NRG-GY018 trial of KEYTRUDA combined with chemotherapy for advanced endometrial cancer. The study showed a 46% reduction in disease progression or death for mismatch repair proficient (pMMR) patients and a remarkable 70% for mismatch repair deficient (dMMR) patients compared to chemotherapy alone. Median progression-free survival (PFS) was 13.1 months for pMMR and not reached for dMMR, compared to 8.7 months and 7.6 months respectively for chemotherapy alone. These results could present KEYTRUDA as a new first-line treatment option, pending regulatory discussions.

Merck & Co. highlights its commitment to empowering women in science through the WCC Merck Research Award. Co-founded by Dr. Rebecca Ruck in 2015, this award supports talented women graduate students in chemistry through mentorship and opportunities to present their research. Last year alone, approximately 120 applicants vied for the award, which fosters relationships between Merck and emerging scientists, ultimately leading to recruitment opportunities. The initiative showcases Merck's dedication to diversity, emphasizing the importance of early engagement in attracting diverse talent.

Merck (NYSE: MRK) announced updates on the Phase 2 KeyVibe-002 trial evaluating MK-7684A, a coformulation of vibostolimab and pembrolizumab, in metastatic non-small cell lung cancer. The open-label arm results revealed MK-7684A did not achieve statistical significance for progression-free survival compared to docetaxel, showing it was less effective. Patients in this arm are advised to switch to standard care unless they show benefits. The blinded arms continue to assess MK-7684A with docetaxel vs. docetaxel alone. The safety profile remains consistent with prior studies. Further results will be presented at a medical meeting as the trial progresses.