CAMBRIDGE, Mass., June 2, 2026
Convergent Therapeutics announced positive interim Phase 2 data from its CONVERGE-01 study evaluating CONV01-α (Ac-225 rosopatamab tetraxetan) in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with Lu-177-PSMA (PLUVICTO). Presented at the ASCO 2026 Annual Meeting, the results demonstrated meaningful anti-tumor activity, encouraging durability, and a favorable safety profile in a patient population with limited treatment options after progression on radioligand therapy.
Phase 2 Data Demonstrate Durable Disease Control in Lu-PSMA-Exposed Patients
The CONVERGE-01 Part 3 study enrolled heavily pretreated mCRPC patients who had progressed following Lu-PSMA therapy. In the target dose range, median radiographic progression-free survival (rPFS) reached 8.4 months. Among 25 evaluable patients, 40% achieved a PSA reduction of at least 50%, including patients who were resistant to prior Lu-PSMA treatment. The findings suggest that CONV01-α may offer clinically meaningful benefit in a setting where no established standard of care currently exists.
Favorable Safety Profile Supports Further Development
CONV01-α continued to demonstrate a differentiated safety profile compared with other PSMA-targeted radiotherapies. No dose-limiting toxicities were observed, and no treatment-related adverse events led to discontinuation. Importantly, investigators reported no renal toxicity and no high-grade xerostomia (dry mouth), two common concerns associated with radioligand therapies. Most patients experienced only manageable hematologic toxicities, while 77% reported Grade 0 or Grade 1 xerostomia following treatment.
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Unique Radioantibody Design May Differentiate CONV01-α
CONV01-α combines a PSMA-targeted monoclonal antibody (rosopatamab) with the alpha-emitting isotope Actinium-225 (Ac-225). Unlike small-molecule radioligands, the antibody-based approach demonstrated strong tumor uptake and prolonged retention while minimizing exposure to salivary glands and kidneys. Researchers believe this biodistribution profile may improve therapeutic effectiveness while reducing off-target toxicity, supporting its potential as a next-generation radiopharmaceutical therapy.
Company Preparing for Pivotal Phase 3 Study
Based on the encouraging efficacy and safety findings, Convergent plans to advance CONV01-α into a pivotal Phase 3 clinical trial targeting patients previously treated with taxane chemotherapy and Lu-PSMA therapy. The company has also secured a reliable domestic Actinium-225 supply chain and manufacturing infrastructure to support late-stage development and potential commercialization. If future studies confirm these results, CONV01-α could become an important treatment option for patients with advanced prostate cancer who have exhausted current radioligand therapies
Source: Convergent Therapeutics press release
