#United States #Phoenix #Marengo Therapeutics #Invikafusp Alfa #Trodelvy

Interim Results from STARt-002 Study to be Presented at SITC 2026

In a major development in cancer treatment, Marengo Therapeutics, a leading biotechnology firm, has announced that interim results from the STARt-002 clinical study will be presented at the Society for Immunotherapy of Cancer (SITC) 41st Annual Meeting. This annual gathering, scheduled for November 4–8, 2026, in Phoenix, Arizona, will feature prominent figures in the field of immunotherapy, highlighting the latest innovations that can transform the landscape of cancer treatment.

The STARt-002 study is groundbreaking as it is the first clinical trial to combine a Vβ6-selective T-cell agonist with an antibody-drug conjugate (ADC). The study pairs Invikafusp alfa with TRODELVY®, focusing on metastatic breast cancer populations that have limited treatment options, specifically triple-negative and hormone receptor-positive/HER2-negative variants.

Significance of the Combination Therapy

Dr. Kevin Chin, Chief Medical Officer at Marengo Therapeutics, emphasizes that the Invikafusp alfa treatment is particularly effective on antigen-rich tumors. The role of TRODELVY in this combination enhances this approach by releasing tumor antigens and provoking an inflammatory response within the tumor microenvironment. This dual action aims to create a favorable condition for T-cell activation, particularly in tumors that are not usually immunogenic.

By utilizing this innovative approach, STARt-002 seeks to expand the therapeutic reach of invikafusp alfa to include not just tumors that are already abundant in antigens but also less responsive tumors, which could potentially revolutionize treatments available for breast cancer patients.

Key Study Details

The STARt-002 trial navigates through a pivotal Phase 1b/2 trial assessing the efficacy of invikafusp alfa in conjunction with TRODELVY® for patients battling metastatic breast cancer. The trial encompasses two distinct patient populations: those with metastatic triple-negative breast cancer (TNBC) and those suffering from HR-positive/HER2-negative metastatic breast cancer. Following a safety lead-in phase, the expansion cohorts are currently enrolling participants across multiple cancer centers in North America at the recommended Phase 2 dosage.

The SITC presentation will aim to unveil interim results from both cohorts, providing essential data that will contribute toward understanding the impact of this combination therapy on patient outcomes. Marengo Therapeutics anticipates that additional data will be unveiled in 2027, further solidifying the potential of invikafusp alfa as a backbone for immuno-oncology treatments.

Previous and Upcoming Presentations

The STARt-002 clinical trial builds upon Marengo’s earlier STARt-001 study, which looked into the use of invikafusp alfa alone in patients resistant to PD-1 blockade. Updated findings from the STARt-001 trial are set to be shared during an oral presentation at the European Society for Medical Oncology (ESMO) Congress from October 23–27 in Madrid.

The presentation at SITC will detail the initial clinical results of the combination therapy, and it is highly anticipated within the oncology community. With a focus on two specific sessions of the conference, notably titled Initial clinical results from STARt-002, the study reflects the progressive clinical research trends aimed at increasing patient survival rates and improving overall quality of life for women battling breast cancer.

About Marengo Therapeutics

Marengo Therapeutics is at the forefront of biotechnology innovation, engaged in developing cutting-edge TCR-targeting antibodies aimed at selectively modifying T-cell subsets implicated in various diseases such as cancer and autoimmune conditions. Their ambitious goal is to navigate the intricate human immune system and enable it to effectively combat cancer and autoimmune diseases.

For more details on ongoing studies and advancements from Marengo, interested parties can visit their official website at marengotx.com.

The advancements in therapeutic research and the collaborative efforts in presenting these results at forums like SITC emphasize the ongoing commitment to tackling the challenges posed by cancer, where continuous innovation is key to transforming clinical practices and enhancing patient outcomes.