On October 2, 2026 Marengo Therapeutics, Inc., a clinical-stage biotechnology company pioneering precision immunotherapies for oncology and inflammation and immunology (I&I), reported that interim results from the STARt-002 clinical study have been selected for an oral presentation at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting, taking place November 4–8, 2026, in Phoenix, Arizona.
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"Invikafusp alfa is designed for antigen-rich tumors. ADCs like TRODELVY help create that state by releasing tumor antigens and inflaming the tumor microenvironment, priming less immunogenic tumors for T-cell-mediated responses," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics. "STARt-002 is the first clinical study to test this hypothesis by pairing a selective T-cell agonist with an ADC, and this combination could extend invikafusp alfa’s reach beyond tumors that are antigen-rich on their own. Triple-negative and HRpositive/HER2-negative metastatic breast cancer are two settings where patients still have limited options after standard therapies. We look forward to presenting interim results from both cohorts at SITC (Free SITC Whitepaper)."
STARt-002 is the company’s Phase 1b/2 trial evaluating invikafusp alfa in combination with TRODELVY (sacituzumab govitecan-hziy) in patients with metastatic breast cancer. The Phase 2 portion is evaluating two distinct patient populations: metastatic triple-negative breast cancer (TNBC) and HR-positive/HER2-negative metastatic breast cancer. Following completion of the safety lead-in, both expansion cohorts are enrolling at the recommended Phase 2 dose at select cancer centers across North America. The SITC (Free SITC Whitepaper) presentation will feature interim results from both expansion cohorts, and Marengo expects to report additional data in 2027.
The STARt-002 combination strategy reflects invikafusp alfa’s long-term potential as an immuno-oncology backbone and builds on STARt-001, a Phase 1/2 trial evaluating invikafusp alfa monotherapy in patients with PD-1-resistant, biomarker-enriched solid tumors, including TNBC. Updated STARt-001 results will be presented during an oral presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2026 Congress, taking place October 23–27 in Madrid, Spain.
Presentation Details
● Title: Initial clinical results from START-002: A Phase 1b/2 study of invikafusp alfa, a first-in-class dual T-cell agonist, in combination with sacituzumab govitecan in triplenegative or HR+/HER2- mBC
● Abstract Number: 514
● Session: Oral Abstract Session 3
● Date/Time: Saturday, November 7, 2026 3:30PM MT
● Presenter: Steven Isakoff, MD, PhD, MMSc; Mass General Brigham
(Press release, Marengo Therapeutics, OCT 2, 2026, View Source [SID1234671241])