Merus Advances Petosemtamab and Zenocutuzumab in Phase III Trials for Head and Neck Cancer and NRG1+ Cancers
Key Insights
Merus is actively enrolling patients in Phase III trials for petosemtamab, both as a first-line treatment in combination with pembrolizumab and as a monotherapy for second and third-line treatment of head and neck squamous cell carcinoma (search) (HNSCC (search)).
Interim clinical data for petosemtamab in second-line or later HNSCC (search) treatment has been selected for rapid oral presentation at the ESMO® Asia 2024 Congress, highlighting its potential in this setting.
The FDA has accepted the Biologics License Application (BLA) for zenocutuzumab (Zeno) with priority review for the treatment of NRG1+ (search) non-small cell lung cancer (search) (NSCLC (search)) and pancreatic ductal adenocarcinoma (search) (PDAC (search)).
Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative full-length multi-specific antibodies Biclonics® and Triclonics®, has announced its third-quarter financial results and provided an update on its activities, highlighting the advancement of its key drug candidates, petosemtamab and zenocutuzumab, through critical clinical trials.
Petosemtamab: Targeting Head and Neck Cancer
Petosemtamab (MCLA-158), an EGFR (search) x LGR5 (search) Biclonics® antibody, is currently under evaluation in two Phase III trials, LiGeR-HN1 and LiGeR-HN2, for the treatment of recurrent or metastatic head and neck squamous cell carcinoma (search) (HNSCC (search)). The LiGeR-HN1 trial is assessing petosemtamab in combination with pembrolizumab as a first-line treatment for HNSCC patients with a PD-L1 (search) CPS score ≥1, while the LiGeR-HN2 trial is investigating petosemtamab as a second and third-line treatment for HNSCC.
In the third quarter, Merus announced the treatment of the first patient in the LiGeR-HN1 trial. Interim clinical data from the ongoing study of petosemtamab plus pembrolizumab as a first-line treatment for HNSCC (search) was presented at the 2024 American Society of Clinical Oncology® (ASCO®) annual meeting, demonstrating a 67% response rate in 24 evaluable patients.
Merus also plans to present updated efficacy, durability, and safety data from the monotherapy cohort, as well as clinical data from the dose optimization cohort evaluating petosemtamab monotherapy at dose levels of 1,500 or 1,100 mg as a 2nd line and later treatment for HNSCC (search) at the ESMO® Asia Congress in December 2024. The company believes that a registrational trial for HNSCC treatment based on overall response rate (ORR) as an endpoint could potentially support accelerated approval, with overall survival (OS) results from the same study potentially confirming clinical benefit for full approval.
Zenocutuzumab: Addressing NRG1+ Cancers
The FDA has accepted a Biologics License Application (BLA) with priority review for zenocutuzumab (Zeno), a bispecific antibody, for patients with NRG1+ (search) non-small cell lung cancer (search) (NSCLC (search)) and pancreatic ductal adenocarcinoma (search) (PDAC (search)). Merus is actively seeking a commercialization partnership to ensure Zeno is accessible to patients with NRG1+ cancer, pending approval.
MCLA-129: Advancing NSCLC Treatment
MCLA-129, an EGFR (search) x c-MET (search) Biclonics® antibody, is being studied in METex14 (search) skipping NSCLC (search). A Phase II trial evaluating MCLA-129 in combination with chemotherapy as a second-line and later treatment for EGFR-mutated NSCLC is underway. Merus is also open to partnering MCLA-129 to secure funding for its development, given its potential benefits for patients.
Financial Position
Merus reported having $782.9 million in cash, cash equivalents, and marketable securities as of September 30, 2024. The company anticipates that its current financial resources will be sufficient to fund operations into 2028.
Bill Lundberg, M.D., President and Chief Executive Officer of Merus, expressed enthusiasm for the company's operational efficiency and the potential of petosemtamab to provide a chemotherapy-free treatment option for patients with recurrent or metastatic head and neck cancers.