Merus Faces Setback Following Interim Report for Lung Cancer Therapy

Merus, a biopharmaceutical company, confronted a significant setback following an interim report on the progress of MCLA-129, a bispecific therapy designed for lung cancer treatment. The report’s safety data uncovered treatment-related fatalities linked to grade 5 interstitial lung disease (ILD).

The ongoing phase 1/2 study involves 60 patients distributed across three expansion cohorts, with the primary objective of augmenting the overall response rate by strategically targeting EGFR and c-MET, identified as dysregulated factors in various tumors, particularly non-small cell lung cancer (NSCLC).

Within the subset of patients grappling with lung cancer, a cohort of 16 individuals subjected to MCLA-129 alongside AstraZeneca’s Tagrisso showcased good outcomes. Every patient in this group experienced a reduction in tumor size, culminating in nine confirmed partial responses and three provisional partial responses. The data underscored a robust 94% disease control rate, coupled with a median exposure duration of 5.1 months, with a commendable 81% of patients electing to persist with the treatment.

Transitioning to the second-line setting encompassing 44 patients, the data unveiled 11 verified partial responses and one unconfirmed partial response. This translated into a 74% disease control rate. However, the narrative shifted as the safety data took center stage, revealing a disconcerting triad of treatment-related fatalities attributed to grade 5 interstitial lung disease (ILD).

Each patient within the study cohort grappled with some form of treatment-related side effect, with infusion reactions and nausea reigning supreme in prevalence. Notably, 23 individuals confronted at least one grade 3 or higher adverse event, comprising seven instances of interstitial lung disease. 

Additional adverse events included acne, flushing, rash, and hypotension. Merus found the link between adverse events and the inhibition of EGFR and c-MET, prompting 14 discontinuations due to the emergence of treatment-related adverse events.

The specter of interstitial lung disease has pervaded recent cancer trials, mirroring challenges faced by industry counterparts such as Daiichi Sankyo and AstraZeneca. Merus brought attention to 14 cases of blood clots, with three deemed treatment-related, underscoring the intricate nature of managing adverse events associated with EGFR and c-MET inhibition.

Despite these setbacks, Merus’ CEO Bill Lundberg affirmed a commitment to fiscal prudence in navigating the program’s next steps. Lundberg unveiled plans to scrutinize MCLA-129 in conjunction with chemotherapy, poised to commence early in 2024. Armed with a robust financial standing, the company aspires to initiate a phase 3 trial of petosemtamab in second-line-plus head and neck squamous cell carcinoma (HNSCC) by mid-2024.

Merus previously unveiled its NRG-1 fusion tumor bispecific antibody, zenocutuzumab (Zeno), at a prior ESMO meeting. The outcomes in pancreatic cancer were commendable, with Zeno yielding a 42% response rate, including one instance of a complete response and 13 cases of partial responses. The safety profile was lauded as “extremely well tolerated.”

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