Merck & Co., Inc. - MRK STOCK NEWS

Merck (NYSE: MRK) and AstraZeneca announced that LYNPARZA has received approval in China as first-line maintenance treatment for patients with advanced ovarian cancer exhibiting homologous recombination deficiency (HRD)-positive status. The approval is based on the favorable outcomes of the Phase 3 PAOLA-1 trial showing significant progression-free survival (PFS) benefits. In China, ovarian cancer has a survival rate of ~39% among patients with advanced stages. This new treatment option is expected to enhance clinical outcomes for HRD-positive patients.

Merck (NYSE: MRK) achieved a significant legal victory as the U.S. District Court for the Northern District of West Virginia ruled in its favor in a patent infringement lawsuit against Viatris concerning sitagliptin, an active ingredient in JANUVIA and JANUMET. The court upheld the validity of two Merck patents, with expiration dates set for 2026 and 2029. Viatris aims to launch generic versions but faces challenges following this ruling. Merck has already settled agreements allowing generics to enter the market by May 2026. This decision is subject to appeal.

Merck (NYSE: MRK) announced the resumption of a Phase 2 study on an investigational weekly oral combination treatment of islatravir and lenacapavir for HIV-1, using a lower dose of islatravir. Merck will discontinue its monthly oral islatravir development for pre-exposure prophylaxis (PrEP) but plans to initiate a new Phase 3 clinical program for once-daily islatravir and doravirine. The FDA has approved this new approach, highlighting Merck's commitment to HIV treatment.

Merck (NYSE: MRK) has received a positive recommendation from the European Medicines Agency’s CHMP for its pneumococcal vaccine VAXNEUVANCE. The vaccine, which targets Streptococcus pneumoniae, is aimed at infants and children aged 6 weeks to under 18 years, complementing existing approvals for older populations. A final decision from the European Commission is anticipated by year-end 2023. Merck's commitment to combating pneumococcal disease continues, highlighting its focus on developing vaccines for various demographics against serious infections.

Seagen, Astellas, and Merck announced promising results from the phase 1b/2 EV-103 trial, showcasing a 64.5% confirmed objective response rate (ORR) in patients with unresectable locally advanced or metastatic urothelial cancer treated with enfortumab vedotin and pembrolizumab. The primary endpoint was met with significant responses including 10.5% complete responses. The median overall survival (OS) was 22.3 months. The trial highlights the potential of this combination therapy for patients ineligible for cisplatin chemotherapy. Discussions with regulatory authorities are planned.

Astellas, Seagen, and Merck announced significant findings from the phase 1b/2 EV-103 trial, highlighting a 64.5% confirmed objective response rate in unresectable advanced urothelial cancer patients treated with enfortumab vedotin and pembrolizumab. This combination demonstrated promising efficacy as a first-line treatment, with 10.5% achieving complete response. Additionally, median overall survival reached 22.3 months for the combination group. Adverse events mainly included skin reactions and neuropathy. The companies plan to discuss results with regulatory authorities and pursue further studies.

Merck (NYSE: MRK) announced promising five-year survival data for KEYTRUDA in treating metastatic non-small cell lung cancer (NSCLC). In KEYNOTE-189, KEYTRUDA plus chemotherapy achieved a five-year overall survival (OS) rate of 19.4%, significantly higher than 11.3% for chemotherapy alone. KEYNOTE-407 reported a five-year OS rate of 18.4% for KEYTRUDA plus chemotherapy versus 9.7% for chemotherapy alone. These results affirm KEYTRUDA's role as a first-line treatment, demonstrating improved overall survival and durable responses, significantly altering the treatment landscape for NSCLC.

Merck (MRK) and Eisai presented findings from the Phase 3 LEAP-002 trial at the ESMO Congress 2022. The study evaluated the combination of KEYTRUDA and LENVIMA against LENVIMA alone for unresectable hepatocellular carcinoma (uHCC). The final analysis showed a median overall survival (OS) of 21.2 months for the combination versus 19.0 months for monotherapy, but results did not reach statistical significance. The trial highlights the need for further research into this combination therapy.

AstraZeneca and Merck announced long-term results from the Phase 3 PAOLA-1 and SOLO-1 trials for LYNPARZA in advanced ovarian cancer. The PAOLA-1 trial showed that, in HRD-positive patients, overall survival was 65.5% for LYNPARZA plus bevacizumab versus 48.4% for bevacizumab alone. In the SOLO-1 trial, 67% of patients with BRCA mutations treated with LYNPARZA were alive at seven years compared to 47% on placebo. Both trials highlighted the importance of biomarker testing in treatment decisions. While the OS results were not statistically significant for the PAOLA-1 trial overall, HRD-positive subgroup showed a 38% reduced risk of death.