What's Happening?
Marengo Therapeutics, a clinical-stage biotechnology company, has announced promising interim results from its Phase 2 clinical trial of Invikafusp Alfa, a novel immunotherapy drug. The data, presented at the Society for Immunotherapy of Cancer (SITC)
2025 Annual Meeting, highlights the drug's efficacy as a monotherapy in treating PD-1-resistant tumors across seven major solid tumor types, including colorectal, lung, and breast cancers. The trial showed a 20% overall response rate (ORR) and an 80% disease control rate (DCR) among patients with high tumor mutational burden (TMB-H) tumors. The drug demonstrated consistent clinical activity across various subgroups, regardless of prior PD-1 treatment, with 59% of patients experiencing tumor shrinkage. Invikafusp Alfa is designed to selectively activate and expand specific T-cell subsets to enhance anti-tumor immunity in patients who have progressed on or are insensitive to immune checkpoint blockade (ICB).
Why It's Important?
The results from Marengo Therapeutics' trial are significant as they offer a potential new treatment option for patients with PD-1-resistant cancers, a group that often has limited therapeutic options. The ability of Invikafusp Alfa to induce tumor shrinkage and control disease progression in a variety of solid tumors could lead to improved outcomes for patients who have not responded to existing immunotherapies. This development underscores the potential of precision immunotherapy in overcoming resistance to current treatments, which is a major challenge in oncology. The drug's promising safety profile and its ability to reprogram tumor-infiltrating lymphocytes (TILs) further highlight its potential as a next-generation immuno-oncology therapy.
What's Next?
Marengo Therapeutics plans to continue the Phase 2 monotherapy expansion of Invikafusp Alfa in TMB-H and MSI-H/dMMR solid tumors to further characterize the depth and durability of response across priority indications. Additionally, the company is conducting a Phase 2 combination study with Trodelvy® in triple-negative breast cancer to evaluate potential synergy in antibody-drug conjugate (ADC) and immuno-oncology (IO) combination settings. Marengo is also advancing regulatory interactions, having recently received U.S. FDA Fast Track designation for Invikafusp Alfa in TMB-H metastatic colorectal cancer. These steps indicate a strategic approach to broaden the drug's application and reach more patient populations.
Beyond the Headlines
The development of Invikafusp Alfa represents a shift towards more personalized cancer treatments that target specific immune pathways. This approach could lead to more effective therapies with fewer side effects compared to traditional chemotherapy. The trial's success also highlights the importance of biomarker-enriched strategies in drug development, which can help identify patients most likely to benefit from new treatments. As precision medicine continues to evolve, it may pave the way for more targeted and effective cancer therapies, potentially transforming the landscape of cancer treatment.
