Marengo Therapeutics Reports Confirmed Complete Responses in Phase 2 Trial of Invikafusp Alfa Plus TRODELVY for Metastatic Breast Cancer
核心洞察
Marengo Therapeutics (搜索) announced late-breaking Phase 2a results from the STARt-002 trial showing confirmed complete responses with invikafusp alfa plus TRODELVY in heavily pretreated metastatic breast cancer patients.
The combination demonstrated encouraging clinical activity across both triple-negative breast cancer (TNBC) and HR+/HER2- breast cancer subtypes, including patients who had not responded to any prior therapy.
The safety profile remained consistent with the known profiles of individual agents, while pharmacodynamic analyses confirmed invikafusp alfa maintained its mechanism of action in the combination regimen.
Marengo Therapeutics (搜索) reported encouraging Phase 2a clinical results from its STARt-002 trial evaluating invikafusp alfa in combination with TRODELVY® (sacituzumab govitecan-hziy) for heavily pretreated metastatic breast cancer patients. The late-breaking data, presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting, demonstrated confirmed complete responses across both triple-negative breast cancer (TNBC) and HR+/HER2- breast cancer subtypes.
Clinical Activity in Heavily Pretreated Population
The Phase 2a results build on data previously presented at the 2025 San Antonio Breast Cancer Symposium, showing clinical activity in a challenging patient population. According to CEO Zhen Su, the trial has now reported "confirmed partial and complete responses across both HR+/HER2− and triple-negative breast cancer cohorts" in heavily pretreated patients, including those with no response to prior therapy.
"The observation of confirmed complete responses in heavily pretreated breast cancer patients that did not respond to any prior therapy further reinforces our confidence in this novel combination," said Kevin Chin, M.D., Chief Medical Officer of Marengo Therapeutics (搜索).
Safety and Mechanism of Action
The combination has demonstrated a safety profile consistent with the known profiles of the individual agents. Pharmacodynamic analyses confirmed that invikafusp alfa maintains its mechanism of action when used in combination, driving robust and selective expansion of Vβ6 (搜索)/Vβ10 (搜索) T cells.
"In a heavily pretreated metastatic breast cancer population, the observation of confirmed complete responses is notable and warrants attention," said Erika Hamilton, M.D., Chief Development Officer, Late Phase and Director of Breast Cancer Research. "While these are early data, the activity observed across both TNBC and HR+/HER2− subtypes, along with a safety profile consistent with the individual agents, supports further clinical evaluation of this combination."
Trial Design and Enrollment
The STARt-002 Phase 1b/2a trial is an open-label, multicenter study investigating the combination in patients with unresectable, locally advanced, or metastatic breast cancer. The trial consists of a safety lead-in phase followed by two dose expansion cohorts: one in triple-negative breast cancer and one in HR+/HER2− metastatic breast cancer. The study is actively enrolling patients at select cancer centers across North America, with enrollment expected to be completed later this year.
STAR Platform Advancement
Marengo also announced the first public disclosure of its second precision T cell activator from the STAR program, IPN01203 (搜索)/STAR0501, being developed in partnership with Ipsen. The candidate was selected for presentation during the prestigious New Drugs on the Horizon session at AACR 2026.
"Together with Marengo, we are advancing a novel precision T cell activation approach with the potential to transform treatment paradigms in solid tumors," said David Jenkins, Senior Vice President, Head of Research and External Innovation at Ipsen. "The rapid progression of this program into the clinic underscores the strength of our collaboration and the quality of scientific execution."
Platform Technology
Invikafusp alfa (STAR0602) is the lead candidate from Marengo's STAR™ platform, designed to selectively activate a common Vβ T cell subset found in all cancers by combining a non-clonal mode of TCR (搜索) activation with a T cell co-stimulatory signal in a single molecule. This approach promotes the expansion of clonally diverse, effector memory Vβ T cells, enhancing anti-tumor immunity.
The STAR™ Platform is a multi-specific antibody-fusion platform derived from Marengo's proprietary library of antibodies targeting germline-encoded variable Vβ regions of the TCR (搜索) fused to different T cell co-stimulatory moieties. IPN01203 (搜索) is a first-in-class T cell activator that selectively activates Vβ6 (搜索) T cells through the TCR and IL-15R (搜索) pathways, with a Phase I/II dose escalation and expansion trial ongoing under Ipsen sponsorship.