Convergent Therapeutics Inc., a clinical-stage biotechnology company developing next-generation alpha radiopharmaceuticals for cancer, today announced the abstract release for its oral presentation on June 1, at the American Society of Clinical Oncology (ASCO) 2026 Annual Meeting. The abstract describes interim results from Part 3 of the CONVERGE-01 Phase 2 trial of Ac-225 rosopatamab tetraxetan (CONV01-α) in patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received Lu-177-PSMA radioligand therapy (Lu-PSMA).
The CONVERGE-01 Part 3 dataset represents the largest prospective Phase 2 evidence for an alpha-emitting radiopharmaceutical in Lu-PSMA exposed patients. This population has grown substantially with the establishment of Lu-PSMA therapy in mCRPC care, for which no subsequent standard of care exists.
The full data, including antitumor activity, emerging durability, and tolerability — notably clinically- manageable hematopoietic toxicity without renal toxicity or high-grade xerostomia — will be presented by Michael J. Morris, MD, Prostate Cancer Section Head at Memorial Sloan Kettering Cancer Center.
“What will be presented at ASCO represents a meaningful step forward for patients navigating prostate cancer after Lu-PSMA therapy,” said Phil Kantoff, MD, co-founder and CEO of Convergent Therapeutics. “CONVERGE-01 is a rigorous, prospective Phase 2 study evaluating CONV01-α in this growing Lu-PSMA-exposed population. We believe these data establish important benchmarks in this setting, and we look forward to its presentation at ASCO.”
Based on the totality of the CONVERGE-01 data, Convergent is planning a pivotal Phase 3 study of CONV01-α in Lu-PSMA-exposed mCRPC patients beginning in mid 2027.
Demonstrated Tolerability Profile in a Heavily Pretreated Population
Patients enrolled in CONVERGE-01 Part 3 following extensive prior treatment exposure: all had received prior androgen deprivation therapy, androgen receptor pathway inhibitor therapy, and multiple cycles of Lu-PSMA therapy. Eighty percent of patients had also received prior taxane chemotherapy for mCRPC. Following treatment with CONV01-α, patients experienced a favorable safety and tolerability profile with clinically manageable hematopoietic toxicity, no renal toxicity, and no high-grade xerostomia.
Supply of Reliable, High-Quality Actinium-225
Actinium-225 supply has been a recognized constraint in the development of alpha radiopharmaceuticals, and reliable access to these radioisotopes is a prerequisite for late-stage development. Convergent has established a flexible, networked CMC process that allows for integration of multiple sources of Ac-225 from redundant suppliers and has secured Phase 3 supply via a recently expanded agreement with NorthStar Medical Radioisotopes for domestically supplied Ac-225 and co-located drug product manufacturing.
ASCO Presentation: Abstract Title: CONVERGE-01 Part 3: Ac-225 Rosopatamab Tetraxetan (CONV01-α) In Lu-PSMA Pretreated Metastatic Castration-Resistant Prostate Cancer (mCRPC).
Abstract Number: 5011
Format: Oral Presentation
Session Type/Title: Clinical Science Symposium – Radiation Re-Imagined: Radioligand Innovation in Prostate Cancer
Date and Time: June 1, 3:00 PM-4:30 PM CDT
Presenter: Michael J. Morris, MD, Prostate Cancer Section Head, Memorial Sloan Kettering Cancer Center
About the CONVERGE-01 Trial
The CONVERGE-01 trial is a Phase 2, randomized, open-label, multicenter three-part study designed to assess the safety and efficacy of CONV01-α in patients with mCRPC. In Part 1, patients received radiolabelled rosopatamab tetraxetan to characterize the biodistribution of the radioantibody to target organs and prostate cancer lesions. Participants were then enrolled in either Part 2 (dose optimization) or Part 3 (dose escalation) depending on their prior treatment history. Part 2 enrolled participants naïve to Lu-PSMA and Part 3 enrolled participants who were previously exposed to Lu-PSMA-radioligand therapy. Participants received CONV01-α in a two-dose regimen administered on Days 1 and 15. Further details of the trial can be found at www.clinicaltrials.gov under NCT identifier: NCT06549465.
About CONV01-α
CONV01-α is a PSMA-targeted Ac-225 radioantibody that pairs antibody precision with the localized potency of alpha radiation. CONV01-α, which is being developed to improve the treatment of mCRPC, uses a humanized monoclonal antibody directed against prostate-specific membrane antigen (PSMA), a well-established and highly expressed antigen in prostate cancer. CONV01-α is differentiated by its ability to precisely deliver actinium-225 (Ac-225) through this PSMA-targeting antibody, enabling short-range, high-energy alpha particle radiation that creates focused DNA damage within tumor cells while limiting exposure to surrounding tissues. Initial studies in more than 120 patients have established clinical proof-of-concept for CONV01-α, showing consistent antitumor activity and a differentiated safety profile. This selectivity, combined with strong tumor retention and minimal salivary and renal uptake, supports the potential of CONV01-α to be a clinically impactful therapy for PSMA-positive cancers.
About Convergent Therapeutics, Inc.
Convergent Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radioantibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development, and cancer biology, and Convergent’s proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent’s radioantibodies precisely target cancer cells with potent, localized radiation. Visit: www.convergentrx.com
View source version on businesswire.com: https://www.businesswire.com/news/home/20260521939719/en/
Media gallery
