Merck & Co - MRK STOCK NEWS

AstraZeneca and Merck (NYSE: MRK) announced that the FDA will convene the Oncologic Drugs Advisory Committee (ODAC) on April 28, 2023, to discuss the supplemental new drug application (sNDA) for LYNPARZA, used in combination with abiraterone and prednisone for treating metastatic castration-resistant prostate cancer (mCRPC). The sNDA is based on results from the Phase 3 PROpel trial, showing improved radiographic progression-free survival. LYNPARZA is already approved in the EU for this combination. The meeting provides expert guidance but is advisory only, as the FDA makes the final decision.

Merck (NYSE: MRK) announced positive results from the Phase 3 KEYNOTE-671 trial, showing KEYTRUDA® (pembrolizumab) combined with chemotherapy significantly improved event-free survival (EFS) in patients with resectable stage II, IIIA, or IIIB non-small cell lung cancer (NSCLC). The trial also reported statistically significant enhancements in secondary endpoints, including pathological complete response (pCR) and major pathological response (mPR). The FDA has accepted Merck's supplemental Biologics License Application (sBLA), with a PDUFA date set for October 16, 2023. No new safety signals were noted, and results will be shared at an upcoming medical meeting.

Merck (NYSE: MRK) announced the discontinuation of the Phase 3 KEYNOTE-641 trial for KEYTRUDA® (pembrolizumab) in combination with enzalutamide and androgen deprivation therapy for metastatic castration-resistant prostate cancer (mCRPC). The decision follows an independent committee's recommendation due to lack of improvement in radiographic progression-free survival (rPFS) and overall survival (OS). Additionally, the KEYNOTE-789 trial for KEYTRUDA with pemetrexed and platinum-based chemotherapy also failed to meet its OS primary endpoint for patients with metastatic nonsquamous non-small cell lung cancer. Safety profiles remained consistent with earlier studies.

Merck (NYSE: MRK) and Ridgeback Biotherapeutics announced that the EMA's CHMP has recommended refusing marketing authorization for LAGEVRIO™ (molnupiravir) for certain COVID-19 patients in the EU. Merck plans to appeal this decision, believing it does not reflect data from the Phase 3 MOVe-OUT trial, which indicates LAGEVRIO can reduce hospitalization and death risks. Over 4 million patients have been treated globally, and LAGEVRIO is approved in over 25 countries. The EMA's scientific opinion supports availability based on the recommendations of 16 EU national authorities.

Moderna and Merck have received Breakthrough Therapy Designation from the FDA for their investigational personalized mRNA cancer vaccine mRNA-4157/V940. This designation is based on promising results from the Phase 2b KEYNOTE-942/mRNA-4157-P201 trial, showcasing efficacy in combination with Merck's KEYTRUDA for treating high-risk melanoma post-surgery. The designation expedites development for serious conditions with significant unmet needs. The companies plan to launch a Phase 3 study in adjuvant melanoma in 2023, with the potential to broaden to other cancers, including non-small cell lung cancer.

Merck (NYSE: MRK) announced the opening of enrollment for its new Phase 3 clinical program examining the investigational once-daily islatravir 0.25 mg combined with doravirine 100 mg for HIV-1 treatment. The studies aim to evaluate the efficacy and safety of this combination. Two studies, MK-8591A-051 and MK-8591A-052, have begun enrolling participants, while others are slated to start in March. Merck's commitment to HIV research continues as it develops antiviral options to combat the growing infection burden worldwide.

Merck (NYSE: MRK) has announced important clinical data to be presented at the American College of Cardiology's 72nd Annual Scientific Session and World Congress of Cardiology (ACC.23/WCC) in New Orleans, LA from March 4-6, 2023. Notably, the pivotal Phase 3 STELLAR trial results for sotatercept, an investigational therapy for pulmonary arterial hypertension (PAH), will be showcased alongside data from a Phase 2b trial of MK-0616, an oral PCSK9 inhibitor for hypercholesterolemia. Dr. Eliav Barr expressed enthusiasm for these updates, emphasizing Merck's commitment to advancing cardiovascular treatment options and improving patient outcomes.

Merck (NYSE: MRK) announced that its COVID-19 treatment, LAGEVRIO™ (molnupiravir), did not achieve a statistically significant reduction in COVID-19 risk in the Phase 3 MOVe-AHEAD trial. The trial involved individuals exposed to COVID-19 and assessed the treatment's efficacy over 14 days. The LAGEVRIO group was only 23.6% less likely to develop COVID-19 compared to the placebo, falling short of the primary endpoint. Despite this, Merck plans to submit the full study results for publication or presentation. LAGEVRIO remains approved in several countries for treating COVID-19 in adults, though not for prevention.

Merck (NYSE: MRK) announced that the FDA accepted two supplemental new drug applications (sNDA) for PREVYMIS™ (letermovir). The first application is for CMV prophylaxis in kidney transplant recipients at high risk, with a PDUFA target date of June 5, 2023. The second extends prophylaxis from 100 to 200 days for patients receiving allogeneic HSCT, target date Sept. 7, 2023. PREVYMIS demonstrated non-inferior efficacy and a superior safety profile to the current standard of care, valganciclovir, in clinical trials. This acceptance could present a significant advance in treatment options for high-risk transplant patients.