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FDA Grants Fast Trask Designation to Invikafusp Alfa for Advanced Colorectal Cancer
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Key Takeaways
- Invikafusp alfa targets specific T cell subsets, enhancing anti-tumor activity in PD-1 resistant tumors, particularly colorectal cancer.
- Phase 1 trials showed a 63% disease control rate and 50% tumor shrinkage in TMB-H patients, with a favorable safety profile.
Invikafusp alfa (STAR0602; Marengo Therapeutics Inc) is being investigated as a treatment for advanced colorectal cancer with high tumor mutational burden.
The FDA granted fast track designation for invikafusp alfa (STAR0602; Marengo Therapeutics Inc) as a potential treatment for advanced colorectal cancer with high tumor mutational burden (TMB-H).1
FDA, Fast Track Designation, Colorectal Cancer, Oncology | Image Credit: © Grandbrothers | stock.adobe.com
"Marengo's selective Vβ T cell activation approach targeting specific T cell subsets enriched in tumor-infiltrating lymphocytes to enhance anti-tumor activity is unique and highly promising," Bruce Chabner, MD, clinical director emeritus for the Massachusetts General Hospital Cancer Center and professor of Medicine at Harvard Medical School, said in a news release. "The phase 2 clinical investigation of invikafusp alfa is ongoing and this novel treatment could lead to a new class of therapeutics for tumor types that are PD-1 insensitive or resistant, especially in colorectal cancer where current treatment options remain limited."1
The designation was based on a phase 1 clinical study of the drug in heavily pretreated cancer patients, with results supporting the anti-tumor activity and favorable safety profile of the medication. The phase 1 clinical data were first presented as a late-breaking oral presentation at the Society for Immunotherapy of Cancer 36th Annual Meeting in Houston, Texas. The results demonstrated early anti-tumor activity and sustained and selective in vivo expansion of TCRVβ6/Vβ10 T cells up to 6 dose levels. The disease control rate was approximately 50% for 28 patients in all dose escalation cohorts, and 32% experienced tumor shrinkage across 6 tumor types.1,2
Investigators also reported that invikafusp alfa, at the optimal biological dose range of 0.08 mg/kg and 0.12 mg/kg, showed single agent clinical activity with a disease control rate of 63%, tumor shrinkage of 50%, and an overall response of 25% for patients with TMB-H and anti-PD-1 resistance. The safety was consistent with T cell activation and expansion mechanism of action without corticosteroid or tocilizumab pre-treatment. The most common treatment-related adverse events (AEs) were mainly grade 1 and 2 during the first and second infusion. There were no grade 4 AEs or immune effector cell-associated neurotoxicity syndrome, according to the news release. The data was also presented at the European Society for Medical Oncology Immuno-Oncology Congress 2024 in Geneva, Switzerland.2
Due to the data presented as part of the phase 1 trial, the company launched a phase 2 clinical trial, including patients treated with the recommended phase 2 dose of 0.08mg/kg. The trial will build upon the results from the phase 1 trial, with patients being enrolled from sites in France and Spain.3
“We are thrilled to advance invikafusp alfa into phase 2 with the addition of premier European oncology centers,” Ke Liu, MD, PhD, chief development officer of Marengo Therapeutics, said in a news release. “The single-agent anti-tumor activity observed in phase 1, particularly in PD-1-resistant ‘cold’ tumors like colorectal cancer, gives us confidence in our approach and fuels our hope to reach as many patients as possible. The addition of renowned European institutions expands our geographical footprint and enhances our ability to enroll more PD-1 resistant patient populations. Through our phase 2 study, we aim to deepen our understanding of invikafusp alfa’s mechanism of action across diverse tumor types.”3
The company expects to report additional efficacy data later in 2025.1
