Marengo Secures ESMO 2026 Oral Presentation for Phase 2 Invikafusp Alfa Data in PD-1–Resistant Solid Tumors, Appoints KEYTRUDA Development Leader Eric Rubin to Scientific Advisory Board
Key Insights
Marengo Therapeutics (search)' Phase 2 data for invikafusp alfa, a first-in-class bispecific dual T-cell agonist, has been selected for an oral presentation at ESMO Congress 2026.
The STARt-001 trial evaluates invikafusp alfa monotherapy in biomarker-enriched cohorts of patients with TMB-H solid tumors (search) resistant to PD-1 (search)–directed therapy.
Eric Rubin, M.D., former Merck (search) SVP who led pembrolizumab (KEYTRUDA®) initial development, has joined Marengo's Scientific Advisory Board to guide the next development phase.
Marengo Therapeutics (search), Inc., a clinical-stage biotechnology company pioneering precision immunotherapies, today announced that key Phase 2 data from the ongoing STARt-001 study of invikafusp alfa have been selected for an oral presentation at the European Society for Medical Oncology (ESMO) Congress 2026. The presentation will evaluate the single-agent activity of invikafusp alfa, a first-in-class bispecific dual T-cell agonist, in patients whose cancers have progressed following PD-1 (search)–directed treatment. Concurrently, the company appointed Eric Rubin, M.D., the former Merck (search) Senior Vice President who led the initial development of pembrolizumab (KEYTRUDA®), to its Scientific Advisory Board.
The ESMO presentation, scheduled for Friday, October 23, 2026, from 1:30 to 3:00 PM CET in the "Proffered paper: Investigational immunotherapy" session, will feature updated clinical and translational data from tumor mutational burden-high (TMB-H) patients with advanced solid tumors that are refractory or resistant to PD-1 (search)–directed therapy. Dr. Elena Garralda will present the findings under presentation number #4703.
Building on Prior Data with a Biomarker-Enrichment Strategy
The STARt-001 results build on data previously reported at SITC 2025 and will further assess whether selective activation of Vβ6/Vβ10 T-cell subsets in vivo can generate single-agent activity across biomarker-enriched tumor types after PD-1 (search) resistance. The Phase 2 portion of the global Phase 1/2 trial employs biomarker-enriched cohorts, including TMB-H and MSI-H, to assess activity across multiple tumor types and help identify patients most likely to benefit.
"Selection of our Phase 2 data for an ESMO oral presentation reflects the encouraging clinical efficacy signal from the ongoing Phase 2 study of invikafusp alfa and its differentiated biology," said Zhen Su, M.D., M.B.A., Chief Executive Officer of Marengo Therapeutics (search). "STARt-001 is designed to test single-agent activity after PD-1 (search)–directed treatment has stopped working, using a biomarker-enriched strategy such as TMB-H. These studies will help us determine whether selective activation of Vβ6/Vβ10 T-cell subsets can support a broader pan-tumor development strategy."
Precision T-Cell Agonist Mechanism
Invikafusp alfa (STAR0602), the lead candidate from Marengo's STAR™ platform, is designed to selectively activate Vβ6/Vβ10 T-cell subsets found across cancers by combining non-clonal TCR activation with an IL-2 signal in a single molecule. This precision approach is intended to generate durable antitumor immunity while limiting broader systemic immune activation, distinguishing it from less selective immunotherapies.
The STARt-001 trial (NCT05592626) evaluates invikafusp alfa monotherapy in patients with advanced, antigen-rich solid tumors that are refractory or resistant to PD-1 (search)–directed therapy. Marengo is evaluating the candidate's single-agent activity in biomarker-selected, PD-1–resistant cancers and its longer-term potential as a combination backbone in larger and earlier-line settings.
Strategic Appointment of Dr. Eric Rubin
Dr. Rubin brings more than 35 years of cancer drug-development experience across academic and industry settings. Most recently, he served as Senior Vice President of Global Clinical Oncology at Merck (search), where he held several senior leadership roles during his 16-year tenure and led the initial development of pembrolizumab (KEYTRUDA®) through its global regulatory approvals. Earlier, he served on the faculty of Dana-Farber Cancer Institute and as Director of Investigational Therapeutics at Rutgers Cancer Institute of New Jersey.
"Invikafusp alfa is one of the more compelling novel immunotherapy approaches I have seen in recent years," said Dr. Rubin. "Its precision T-cell agonist mechanism provides a strong rationale for testing single-agent activity after PD-1 (search) resistance while avoiding broad activation of the entire T-cell compartment. The biomarker-enriched design of STARt-001 should help define the patients and tumor settings in which this approach may offer the greatest benefit and inform its potential role in future combination strategies."
Dr. Rubin has authored more than 100 peer-reviewed publications and served on national research and policy committees, including for the National Cancer Institute, American Cancer Society, American Association for Cancer Research, and American Society of Clinical Oncology. His appointment strengthens Marengo's scientific leadership as invikafusp alfa enters its next stage of development, with his experience informing the company's strategy for evaluating the candidate in biomarker-selected, heavily pretreated PD-1 (search)–resistant cancers and, over time, as a potential combination backbone.
Marengo's Platform and Pipeline
Marengo Therapeutics (search) is developing TCR-targeting antibodies that selectively modulate disease-relevant T-cell subsets for cancer and autoimmune diseases. The company's three proprietary platforms—Selective T Cell Activation Repertoire (STAR), Trispecific T Cell Engager (TriSTAR), and T Cell Depletor (MSTAR)—are designed to target the right T cells in the right patients, reflecting a precision medicine approach to immunotherapy development.