Clinical Trials
(MCLA-158)
Petosemtamab is being developed as a first line therapy for patients with recurrent/metastatic PD-L1+ head and neck squamous cell carcinoma (HNSCC). The LiGeR-HN1 trial is a phase 3, open-label, randomized trial comparing the efficacy and safety of petosemtamab plus pembrolizumab vs pembrolizumab.
More information is available at the clinicaltrials.gov website.
(MCLA-158)
Petosemtamab (MCLA-158) is being developed for the treatment of patients with incurable recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) who progressed on prior PD-1/PD-L1 and platinum chemotherapy. The LiGeR-HN2 trial is a phase 3 open-label, randomized trial comparing the efficacy and safety of petosemtamab vs. investigator’s choice of monotherapy treatment including cetuximab, methotrexate, or docetaxel.
More information is available at the clinicaltrials.gov website.
(MCLA-158)
Petosemtamab (MCLA-158) is being developed for the potential treatment of HNSCC and other solid tumors. The evaluation of petosemtamab monotherapy in 2L+ HNSCC, as well as petosemtamab in combination with pembrolizumab in 1L HNSCC continues. The phase 2 trial of petosemtamab in combination with standard chemotherapy in 2L metastatic colorectal cancer is enrolling.
More information is available at the clinicaltrials.gov website.
Zeno (zenocutuzumab, or MCLA-128) is being developed for the potential treatment of NRG1 fusion (NRG1+) lung, pancreas and other cancers. Our eNRGy trial, a phase 1/2 clinical trial is an ongoing open-label, multicenter trial enrolling patients with NRG1+ solid tumors. The FDA has accepted for review a Biologics License Application for Zeno for the treatment of NRG1+ non-small cell lung and pancreatic cancer (PDUFA date Feb. 4, 2025).
Further details about the eNRGy clinical trial for Zeno, including current trial sites, can be found at Merus™ trial website at http://www.nrg1.com or by calling 1-833-NRG-1234.
More information is available at the clinicaltrials.gov website.
Patients with NRG1+ cancer that are otherwise unable to participate in an applicable clinical trial may be eligible to participate in the Early Access Program for Zeno (MCLA-128). Further details about the Zeno Early Access Program can be found at Merus™ trial website www.nrg1.com or by calling 1-833-NRG-1234. Details on Merus™ Early Access Policy are available here. Information is also available at the clinicaltrials.gov website: Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor
MCLA-129 is currently being developed for the potential treatment of advanced non-small cell lung cancer (NSCLC) and other solid tumors. Our phase 1/2 trial is ongoing in the dose expansion phase of the open-label, multicenter trial. The evaluation of MCLA-129 monotherapy in METex14 NSCLC continues and the phase 2 trial of MCLA-129 in combination with chemotherapy in 2L+ EGFRm NSCLC is enrolling.
More information is available at the clinicaltrials.gov website.
MCLA-145 is currently being developed for the potential treatment of solid tumors in a phase 1 open-label, multicenter trial. The trial is in the dose expansion phase evaluating the combination of MCLA-145 with pembrolizumab.
More information is available at the clinicaltrials.gov website.
Unless otherwise noted, we are providing this information as of October 31, 2024. This description contains forward-looking statements that involve significant risks and uncertainties, including those discussed in Merus’ most recent Quarterly Report on Form 10-Q and in Merus’ other periodic reports on Form 10-Q and Form 8-K filed with the SEC, and actual results may vary materially. Merus provides this information as of the date above and does not undertake any obligation to update any forward-looking statements contained on these tables as a result of new information, future events or otherwise.
All Company therapeutic candidates described or mentioned herein are investigational and have not yet been approved for marketing by any regulatory authority.