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Merck & Co., Inc. reports news across a global pharmaceutical business known as MSD outside the United States and Canada. Company updates center on human health products for areas such as oncology, cardiometabolic disease and infections; vaccines including Gardasil; and Merck Animal Health medicines, devices and customer-support systems.
Recurring developments include FDA approvals, clinical and regulatory disclosures, research publications, pipeline additions, business development transactions, material agreements, capital-structure updates, governance matters, and operating and financial results. Recent themes include the approved HIV-1 regimen IDVYNSO, investigational programs such as enlicitide decanoate and TERN-701, technology partnerships for research, manufacturing and commercial functions, and animal health digital engagement initiatives.
Merck (NYSE: MRK) and Eisai announced significant results from the Phase 3 KEYNOTE-581/CLEAR trial, demonstrating that KEYTRUDA® (pembrolizumab) combined with LENVIMA® (lenvatinib) provides superior progression-free survival (PFS), overall survival (OS), and objective response rate (ORR) compared to sunitinib in first-line treatment of advanced renal cell carcinoma (RCC). The study also showed LENVIMA plus everolimus met PFS and ORR endpoints versus sunitinib. Both combinations exhibited safety profiles consistent with prior studies, with plans for regulatory submissions based on these findings.
Pappas Capital announced the acquisition of its portfolio company VelosBio Inc. by Merck (NYSE: MRK) for $2.75 billion in cash. VelosBio, a clinical-stage biopharmaceutical firm, develops innovative cancer therapies targeting ROR1. Pappas Capital has invested in VelosBio since 2018, including a $137 million Series B financing in July 2020. The acquisition aims to advance VelosBio's investigational drug, VLS-101, currently in clinical trials for treating hematologic malignancies and solid tumors. This strategic move marks a significant milestone for both Pappas Capital and VelosBio.
AstraZeneca and Merck announced that LYNPARZA has been approved in the EU for treating adult patients with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations. This approval is based on the PROfound trial, which demonstrated significant improvement in radiographic progression-free survival (9.8 months vs. 3.0 months) and overall survival (20.1 months vs. 14.4 months) compared to enzalutamide or abiraterone. The approval highlights the importance of BRCA testing in treatment decisions for advanced prostate cancer.
AstraZeneca and Merck announced EU approval for LYNPARZA combined with bevacizumab for maintenance treatment of advanced ovarian cancer patients with HRD-positive status. This decision is based on the PAOLA-1 Phase 3 trial, showing a 67% reduction in disease progression risk when compared to bevacizumab alone, with median progression-free survival rising to 37.2 months. Despite serious adverse reactions reported, including fatigue and anemia, the approval underscores the importance of HRD testing in treatment selection. AstraZeneca will receive $25 million from Merck following this collaboration.
Merck (NYSE: MRK) announced its acquisition of VelosBio Inc. for $2.75 billion in cash, aiming to enhance its oncology portfolio. VelosBio specializes in first-in-class cancer therapies, focusing on VLS-101, an antibody-drug conjugate targeting ROR1. This acquisition aligns with Merck's strategy to expand its cancer treatment options, as VLS-101 shows promising clinical results in treating hematologic malignancies. The transaction is expected to close by the end of 2020, pending regulatory approvals.
Merck (MRK) reported third-quarter 2020 sales of $12.6 billion, a 1% increase from the previous year. GAAP net income rose 55% to $2.9 billion, with GAAP EPS at $1.16. Non-GAAP net income increased 14% to $4.4 billion, and Non-GAAP EPS rose 16% to $1.74. Despite a COVID-19 impact estimated at $475 million on revenues, product demand remains strong. Keytruda sales surged 21% to $3.7 billion. The company announced advancements in its COVID-19 research programs and oncology pipeline, including multiple Phase 2/3 trials for Molnupiravir and achievements with Keytruda.
Merck (NYSE: MRK) announced today details of new clinical and epidemiological data set to be presented at IDWeek 2020, taking place from Oct. 21 to 25, 2020. Highlights include Phase 3 RESTORE-IMI 2 trial results for RECARBRIO™ in treating hospital-acquired or ventilator-associated bacterial pneumonia and safety assessments of PIFELTRO™ and DELSTRIGO™ for HIV-1 patients aged 50 and older. Additionally, Merck will share insights from studies on antimicrobial resistance and vaccination strategies, emphasizing its commitment to advancing research against infectious diseases.
Merck (NYSE: MRK) announced results from two Phase 3 studies on V114, its 15-valent pneumococcal conjugate vaccine. In the PNEU-PATH study, V114 produced comparable immune responses to PCV13 in healthy adults 50+, with higher responses for serotypes 22F and 33F. The PNEU-DAY study showed similar findings in immunocompetent adults 18-49 with risk factors. V114 was well tolerated with a safety profile consistent with earlier studies. Plans for regulatory applications, starting with the FDA, are set for this year.
Merck (MRK) reported positive outcomes from two studies in its lung cancer treatment program, evaluating KEYTRUDA, an anti-PD-1 therapy. In the KEYNOTE-021 study, KEYTRUDA combined with chemotherapy showed improved objective response rates (58% vs. 33%), progression-free survival (PFS) of 24.5 months, and a median overall survival (OS) of 34.5 months compared to chemotherapy alone. Additionally, quavonlimab combined with KEYTRUDA demonstrated encouraging anti-tumor activity. The findings emphasize Merck's commitment to advancing lung cancer therapies and further trials, including a Phase 3 study, are planned.
Merck (NYSE:MRK) announced the FDA's approval of an expanded label for KEYTRUDA, its anti-PD-1 therapy, for adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL). This approval is based on the KEYNOTE-204 trial, showing a 35% reduction in disease progression risk (HR=0.65) compared to brentuximab vedotin, with a median progression-free survival of 13.2 months for KEYTRUDA versus 8.3 months for BV. An updated pediatric indication was also approved. The treatment offers a critical option for the estimated 8,500 annual U.S. cHL diagnoses, especially for younger patients.