UTRECHT, The Netherlands – Merus N.V. (NASDAQ:MRUS), a clinical-stage oncology company, announced the initiation of a phase 3 clinical trial for petosemtamab, a novel cancer treatment, in combination with pembrolizumab for patients with recurrent or metastatic head and neck squamous cell carcinoma (r/m HNSCC). The first patient has been dosed in the LiGeR-HN1 trial, which will compare the efficacy and safety of this combination therapy against pembrolizumab alone as a first-line treatment.
Petosemtamab is a full-length human antibody developed using Merus's proprietary Biclonics® platform. It targets the epidermal growth factor receptor (EGFR) and LGR5, aiming to inhibit cancer cell growth through multiple mechanisms. The U.S. Food and Drug Administration (FDA) has provided feedback affirming the selected dose of 1500 mg every two weeks for further development in combination with pembrolizumab, as well as a monotherapy.
The phase 3 LiGeR-HN1 trial plans to enroll approximately 500 patients, focusing on those eligible to receive pembrolizumab as a monotherapy with PD-L1+ tumors. Primary endpoints of the study include the overall response rate and overall survival, with secondary endpoints being the duration of response and progression-free survival.
Head and neck cancer encompasses a variety of malignancies that appear in the mucosal surfaces of the oral cavity, throat, and larynx, with HNSCC being the sixth most common type globally. It is often associated with tobacco use, alcohol consumption, and HPV infections. The incidence of HNSCC is on the rise, with projections suggesting a 30% increase to over 1 million new cases annually by 2030.
Merus's CEO, Dr. Bill Lundberg, expressed confidence in petosemtamab's potential to set a new standard of care for r/m HNSCC, citing strong phase 2 clinical data for the drug both as a monotherapy and in combination with pembrolizumab. The company aims to address the serious and life-threatening nature of HNSCC, which continues to have a poor prognosis despite current treatments.
This news article is based on a press release statement from Merus N.V., and it is intended to provide an overview of the trial's initiation and the potential implications for the treatment of head and neck cancer.
In other recent news, Merus N.V. has been the subject of several analyst reports following its recent earnings report and clinical updates. Needham adjusted its price target for Merus to $85.00 from $92.00, maintaining a Buy rating. The firm's outlook for Merus remains positive, with anticipation for upcoming clinical developments, including a Phase 2 study of peto monotherapy in second-line or later treatment for head and neck squamous cell carcinoma (HNSCC).
Concurrently, BMO Capital Markets raised its price target for Merus to $95, with an Outperform rating, highlighting the company's significant strides in its clinical programs. The company has launched the Phase 3 LiGeR-HN2 trial for petosemtamab, a treatment targeting HNSCC, and plans to commence the Phase 3 LiGeR-HN1 trial by the end of the year.
In other developments, Merus announced the appointment of Dr. Fabian Zohren as its new Chief Medical Officer. This move is part of a broader executive restructuring within the company. Dr. Zohren, with his extensive experience in the pharmaceutical industry, is expected to guide the company's ongoing strategy to develop innovative cancer therapies.
Other firms such as Stifel, BofA Securities, and Truist Securities also adjusted their price targets for Merus, reflecting the company's promising results from clinical trials and successful fundraising efforts. These recent developments underscore the company's progress and potential in the oncology field.
InvestingPro Insights
As Merus N.V. (NASDAQ:MRUS) advances its clinical trials for petosemtamab, investors may find value in examining the company's financial health and market performance. According to InvestingPro data, Merus has a market capitalization of $3.26 billion, reflecting investor confidence in its potential.
Despite the promising developments in its oncology pipeline, it's important to note that Merus is not currently profitable. An InvestingPro Tip highlights that analysts do not anticipate the company will be profitable this year. This is not uncommon for clinical-stage biotech companies investing heavily in research and development.
However, Merus's financial position appears stable. Another InvestingPro Tip indicates that the company holds more cash than debt on its balance sheet, which is crucial for funding ongoing clinical trials and operations. Additionally, liquid assets exceed short-term obligations, suggesting a solid near-term financial footing.
The stock has shown impressive performance, with a one-year price total return of 102.46% as of the latest data. This aligns with the InvestingPro Tip noting a high return over the last year, possibly reflecting investor optimism about the company's clinical progress.
For those interested in a deeper analysis, InvestingPro offers 12 additional tips for Merus, providing a more comprehensive view of the company's financial health and market position.
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