Merck & Co Stock Price, News & Analysis

Exelixis (EXEL) and Merck (MRK) have announced a clinical development collaboration to evaluate combinations of Exelixis' investigational tyrosine kinase inhibitor zanzalintinib with Merck's therapies in head and neck cancer and renal cell carcinoma (RCC). The collaboration includes:

1. A phase 3 trial combining zanzalintinib with KEYTRUDA (pembrolizumab) for head and neck squamous cell carcinoma (HNSCC).

2. A phase 1/2 trial and two phase 3 trials combining zanzalintinib with WELIREG (belzutifan) for RCC.

Merck will supply KEYTRUDA for the ongoing STELLAR-305 trial in HNSCC and sponsor the RCC trials. Exelixis will co-fund some studies and supply zanzalintinib and cabozantinib. Exelixis retains global commercial rights to zanzalintinib.

Merck (NYSE: MRK) announced plans to present new research findings at IDWeek 2024 in Los Angeles, showcasing its diverse vaccines and infectious disease portfolio. Key presentations include:

1. Detailed results from the Phase 2b/3 trial of clesrovimab (MK-1654), an investigational monoclonal antibody for RSV prevention in infants.

2. Data from the Phase 3 STRIDE-8 trial evaluating CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) in adults 18-64 years at increased risk of pneumococcal disease.

3. Week 48 data from a Phase 2 study on a once-weekly oral combination of islatravir and lenacapavir for HIV-1 treatment.

The company will present over 40 data presentations across vaccines, antibacterials, and antivirals, demonstrating its commitment to addressing global health needs in infectious diseases.

Merck's KEYTRUDA® (pembrolizumab) has met its primary endpoint of event-free survival (EFS) in the Phase 3 KEYNOTE-689 trial for patients with resected, locally advanced head and neck squamous cell carcinoma (LA-HNSCC). The study evaluated KEYTRUDA as a perioperative treatment, including neoadjuvant therapy, post-surgery treatment with standard-of-care radiotherapy, and maintenance therapy.

Key findings include:

• Statistically significant and clinically meaningful improvement in EFS
• Significant improvement in major pathological response (mPR)
• Trend toward improvement in overall survival (OS)
• Consistent safety profile with no new safety signals

This marks the first positive trial in two decades for this patient population and could potentially change clinical practice. Results will be presented at an upcoming medical meeting and submitted to regulatory authorities.

Merck has launched a new podcast series called 'Career On Purpose', with the first episode focusing on their 'Skills-First' program. This initiative aims to attract, develop, advance, and retain talented individuals without four-year degrees. The episode features insights from Ngozi Motilewa, enterprise HR lead for the Skills-First Diversity Talent Initiative, who discusses the program's origins and impact. Robert Roberson, an enterprise shared service manager at Merck, shares his personal journey and highlights the importance of mentoring in his career progression within the program.

Merck, known as MSD outside the US and Canada, is a research-intensive biopharmaceutical company with a 130-year history of developing medicines and vaccines. The company emphasizes its commitment to diversity, inclusion, and responsible operations to create a sustainable and healthy future for communities worldwide.

Merck (NYSE: MRK) has completed the acquisition of CN201, a novel investigational clinical-stage bispecific antibody, from Curon Biopharmaceutical. CN201 is designed for B-cell depletion therapy with potential applications in B-cell malignancies and autoimmune diseases.

CN201 is currently in Phase 1 and Phase 1b/2 clinical trials for treating relapsed or refractory non-Hodgkin's lymphoma (NHL) and B-cell acute lymphocytic leukemia (ALL). Preliminary data suggest it has activity in patients with relapsed or refractory B-cell hematologic malignancies and is well-tolerated.

Merck has acquired full global rights to CN201. The transaction is being accounted for as an asset acquisition, with Merck recording a pre-tax charge of approximately $750 million, or about $0.28 per share, to be included in third-quarter non-GAAP results.

Merck (NYSE: MRK) has announced its upcoming third-quarter 2024 sales and earnings conference call, scheduled for Thursday, October 31 at 9:00 a.m. ET. The call will provide institutional investors and analysts with an overview of the company's performance for the quarter. A live audio webcast will be accessible to investors, journalists, and the general public through a provided weblink. Following the call, a replay of the webcast, along with the sales and earnings news release, supplemental financial disclosures, and result highlights, will be available on www.merck.com. Participants can also join the call by dialing (800) 369-3351 (U.S. and Canada Toll-Free) or (517) 308-9448 using the access code 9818590.

Merck (NYSE: MRK) announced new long-term data for tulisokibart (MK-7240), an investigational anti-TL1A monoclonal antibody, in inflammatory bowel disease to be presented at UEG Week 2024. The data from Phase 2 ARTEMIS-UC and APOLLO-CD studies show maintenance of treatment efficacy at week 50 in 12-week induction responders for both ulcerative colitis and Crohn's disease.

Merck has initiated two Phase 3 studies (ATLAS-UC and ARES-CD) to evaluate tulisokibart's efficacy and safety. Recent results from the ARTEMIS-UC study, published in the New England Journal of Medicine, demonstrated tulisokibart's superiority over placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis after 12 weeks.

Merck (NYSE: MRK) announced that the Phase 3 KEYFORM-007 trial evaluating the investigational fixed-dose combination of favezelimab and pembrolizumab (KEYTRUDA®) did not meet its primary endpoint of overall survival (OS) for treating patients with previously treated PD-L1 positive microsatellite stable (MSS) metastatic colorectal cancer (mCRC). The combination did not demonstrate an improvement in OS compared to standard of care. The safety profile was consistent with previous studies, with no new safety signals observed.

Dr. M. Catherine Pietanza, VP of global clinical development at Merck Research Laboratories, acknowledged the challenges in treating MSS metastatic colorectal cancer. Merck will continue to advance its clinical development program for KEYTRUDA-based combinations and novel candidates for colorectal cancer patients. The favezelimab and pembrolizumab combination is also being evaluated in other malignancies, including the ongoing KEYFORM-008 Phase 3 study for relapsed or refractory classical Hodgkin lymphoma.

Merck (NYSE: MRK) announced new approvals for KEYTRUDA (pembrolizumab) in Japan for certain lung and urothelial cancers. The approvals include:

1. KEYTRUDA with chemotherapy as neoadjuvant treatment, then as monotherapy for adjuvant treatment in non-small cell lung carcinoma (NSCLC) patients.

2. KEYTRUDA with Padcev for first-line treatment of radically unresectable urothelial carcinoma.

3. KEYTRUDA monotherapy for radically unresectable urothelial carcinoma patients ineligible for platinum-containing chemotherapy.

These approvals are based on positive results from clinical trials KEYNOTE-671, KEYNOTE-A39, and KEYNOTE-052, respectively, showing significant improvements in overall survival and progression-free survival compared to standard treatments.