FDA Grants Fast Track Designation to Potential New Treatment for Advanced Colorectal Cancer
Initial data from Phase I clinical trial showed encouraging single agent activity in patients with different types of PD-1 resistant tumors.
The FDA has granted Fast Track designation to Marengo Therapeutics’ invikafusp alfa (STAR0602), a first-in-class selective dual T cell agonist being evaluated as a potential new treatment for advanced colorectal cancer with high tumor mutational burden (TMB-H).1
In a press release, Zhen Su, MD, MBA, chief executive officer of Marengo Therapeutics said, "The FDA's Fast Track designation is an important milestone for the STAR0602 program and further positions our unique selective dual T cell agonist platform as a promising solution to address key challenges that perpetuate significant unmet needs in oncology. This recognition specifically validates the promise of STAR0602 as a novel treatment option for patients with TMB-H metastatic colorectal cancer, which is insensitive to PD-1 treatment."
The designation is based on encouraging results from the first-in-human, open-label, multi-center Phase I STARt-001 study of invikafusp alfa in heavily pretreated cancer patients. Data from the trial reinforced the potential treatment’s anti-tumor activity and favorable safety profile.
STARt-001 is evaluating invikafusp alfa as a single agent in biomarker selected patients with advanced antigen-rich solid tumors including PD-1 refractory and rare tumors. The trial is comprised of two parts with a Phase I dose escalation followed by a Phase II dose expansion.
In the press release, Bruce Chabner, MD, clinical director emeritus for the Massachusetts General Hospital Cancer Center and professor of medicine at Harvard Medical School added, "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. The Phase II 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."
Prior to the new year, Marengo announced it had dosed the first patient for its Phase II portion of STARt-001. This Phase II trial builds on the previously mentioned portion in which invikafusp alfa was evaluated as a monotherapy. Additonally, the Phase II portion has expanded from North America to include sites in France and Spain.2
"We are thrilled to advance invikafusp alfa into Phase II with the addition of premier European oncology centers," Ke Liu, MD, PhD, chief development officer of Marengo Therapeutics, said in an earlier press release. "The single-agent anti-tumor activity observed in Phase I, 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 II study, we aim to deepen our understanding of invikafusp alfa's mechanism of action across diverse tumor types."
References
1. Marengo's First-in-Class Invikafusp Alfa (STAR0602) Receives U.S. FDA Fast Track Designation for Treatment of Unresectable, Locally Advanced, or Metastatic Colorectal Cancers with High Tumor Mutational Burden (TMB-H). News release. Marengo. January 8, 2025. Accessed January 8, 2025. https://www.prnewswire.com/news-releases/marengos-first-in-class-invikafusp-alfa-star0602-receives-us-fda-fast-track-designation-for-treatment-of-unresectable-locally-advanced-or-metastatic-colorectal-cancers-with-high-tumor-mutational-burden-tmb-h-302344827.html
2. Marengo Announces First Patient Dosed in Phase 2 Clinical Study for its Lead Program, Invikafusp Alfa (STAR0602) in PD-1 Resistant Tumors, Expands Study to Europe. News release. Marengo. December 20, 2024. Accessed January 8, 2025. https://www.prnewswire.com/news-releases/marengo-announces-first-patient-dosed-in-phase-2-clinical-study-for-its-lead-program-invikafusp-alfa-star0602-in-pd-1-resistant-tumors-expands-study-to-europe-302336691.html
Merck Launches Phase III Trials of Once-Monthly Oral HIV PrEP Candidate MK-8527
July 14th 2025In the new EXPrESSIVE clinical trial program, Merck will evaluate MK-8527, a once-monthly, oral PrEP therapy, in populations at high risk of HIV-1 infection, including adolescent girls and women in sub-Saharan Africa.
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Baxdrostat Shows Significant Blood Pressure Reduction in Phase III BaxHTN Trial
July 14th 2025In the BaxHTN Phase III study, AstraZeneca’s baxdrostat demonstrated statistically significant and clinically meaningful reductions in systolic blood pressure in patients with uncontrolled or treatment-resistant hypertension.
New FDA Initiative Reveals Common Reasons for Drug Application Rejection
July 11th 2025By publishing more than 200 complete response letters, the FDA is offering new visibility into the issues that most often delay drug approvals, including safety concerns, trial design flaws, and manufacturing gaps.
Arcus’ Quemliclustat Earns Orphan Drug Designation as Phase III Pancreatic Cancer Trial Advances
July 11th 2025The FDA has granted orphan status to Arcus Biosciences’ CD73 inhibitor quemliclustat for metastatic pancreatic cancer, as the global PRISM-1 Phase III trial nears full enrollment following promising survival data from ARC-8.
