Convergent Therapeutics has reported promising clinical outcomes for its lead radiopharmaceutical CONV01-α in treating advanced prostate cancer, with data presented at the 2025 ASCO Genitourinary Cancers Symposium in San Francisco.
The Phase I dose-escalation trial, which evaluated CONV01-α (225Ac-J591) in combination with 177Lu-PSMA-I&T, demonstrated significant survival benefits in patients with metastatic castration-resistant prostate cancer (mCRPC). The study enrolled 18 patients, equally distributed across three dose levels of CONV01-α.
Clinical Efficacy and Safety Outcomes
The trial achieved a median overall survival of 29.8 months, with 10 patients still alive at data cutoff. Notably, five patients maintained PSA progression-free status at one year, including one patient showing no progression after 34 months without active therapy.
Treatment response metrics were particularly impressive:
- 94% of patients experienced PSA level decline
- 64% achieved PSA50 response
- 28% reached PSA90 response
- 80% of evaluable patients showed improvement from "unfavorable" to "favorable" circulating tumor cell counts
The combination therapy demonstrated a favorable safety profile, with high-grade adverse events occurring rarely.
Scientific Mechanism and Therapeutic Approach
CONV01-α combines a PSMA-targeted monoclonal antibody with actinium-225, delivering precise alpha particle radiation to cancer cells. Dr. Neil Bander, Convergent's Co-Founder and Chief Scientific Officer, explained the scientific rationale: "The antibody/ligand combination delivers a synergistic dose to tumor without additive toxicity, due to the non-overlapping normal organ biodistribution of the ligand and antibody."
Advancing Clinical Development
The company has initiated CONVERGE-01, a three-part Phase II trial investigating CONV01-α as monotherapy in PSMA-positive castration-resistant prostate cancer. Dr. Philip Kantoff, Co-Founder and CEO, emphasized the trial's strategic importance: "CONVERGE-01 is intended to confirm the high response rate and durability of CONV01-α monotherapy and solidify the path forward to our pivotal trial."
Treatment Innovation
CONV01-α represents an innovative approach to targeted cancer therapy, combining:
- Precise antibody-based targeting of PSMA-expressing prostate cancer cells
- High-energy alpha particle radiation delivered over short distances
- Minimal radiation exposure to healthy tissues
The treatment's demonstrated efficacy, particularly doubling the overall survival compared to the Phase III VISION trial of 177Lu PSMA-617, suggests significant potential for improving outcomes in advanced prostate cancer patients.
