RAHWAY, N.J. - Merck (NSE:PROR) & Co., Inc. (NYSE: MRK) has initiated a pivotal Phase 3 clinical trial, waveLINE-010, to evaluate the efficacy of its investigational drug zilovertamab vedotin in treating patients with previously untreated diffuse large B-cell lymphoma (DLBCL). The study compares zilovertamab vedotin combined with a regimen of rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) against the standard R-CHOP therapy.
The trial follows positive outcomes from the Phase 2 waveLINE-007 trial and aims to establish the potential benefits of the new combination regimen. Zilovertamab vedotin is an antibody-drug conjugate targeting the ROR1 protein, which is overexpressed in various hematologic malignancies. The global recruitment for the waveLINE-010 trial has started, aiming to enroll an estimated 1,046 patients.
Dr. Gregory Lubiniecki, vice president of oncology clinical research at Merck Research Laboratories, expressed optimism about the trial, citing antibody-drug conjugates as promising in cancer treatment. The primary endpoint of the trial is progression-free survival, with secondary endpoints including complete response rate, overall survival, event-free survival, duration of complete response, and safety.
DLBCL represents the most common form of non-Hodgkin lymphoma, accounting for about 25-30% of cases worldwide. In the United States, approximately 25,000 patients are diagnosed annually, with a five-year relative survival rate between 60-70%. This market opportunity aligns with Merck's strong financial position, evidenced by its $64.17 billion in revenue over the last twelve months. For deeper insights into Merck's market potential and financial metrics, InvestingPro subscribers can access the comprehensive Pro Research Report, one of 1,400+ available detailed company analyses.
Merck's commitment to oncology research is underscored by its broad clinical development program, which includes evaluating investigational medicines as monotherapy or in combination with other therapies across various hematologic neoplasms and malignancies. With the stock currently trading near its 52-week low and showing signs of being undervalued according to InvestingPro's Fair Value analysis, investors might find this an opportune time to evaluate the company's long-term potential in the oncology market.
The information in this article is based on a press release statement.
In other recent news, Merck & Co. has faced several significant developments. BMO Capital Markets has lowered Merck's stock target to $96, citing a decrease in confidence due to recent shifts in expectations for Merck's vaccine, Gardasil. Goldman Sachs also reduced its price target for Merck to $129, following Merck's recent 2025 guidance announcement which reflected challenging market conditions for Gardasil in China.
In addition, Merck has announced a halt in shipments of its Gardasil vaccine to China, leading to a significant drop in the company's sales forecast. The company now expects to generate between $64.1 billion and $65.6 billion in total sales for the year.
Merck has also received a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for its pneumococcal vaccine, CAPVAXIVE™. This endorsement moves the vaccine closer to potential marketing authorization within the European Union and additional countries.
Lastly, Merck is facing its first jury trial over allegations that the company improperly marketed its Gardasil cancer vaccine. The jury will examine whether Merck concealed reports of side effects and launched misleading marketing campaigns. These are recent developments that could significantly impact the company's future operations and reputation.
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