Convergent Therapeutics Announces Promising Clinical Trial Updates for CONV01-α at ASCO Genitourinary Cancers Symposium 2025

11 February 2025 | Tuesday | News

New data highlights significant survival benefits and safety in advanced prostate cancer, with potential for future trials based on impressive response rates and synergistic tumor targeting.
Picture Courtesy | Public Domain

Picture Courtesy | Public Domain

Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, announced clinical trial updates for its lead asset, CONV01-α (225Ac-J591), a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to actinium-225 (225Ac). Data will be presented at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium, which will take place February 13-15, 2025, in San Francisco, California.

The first presentation, titled "Mature phase 1 follow up of alpha emitter 225Ac-J591 with 177Lu-PSMA-I&T in advanced prostate cancer," reported clinical follow-up of a Phase I dose-escalation trial exploring the addition of CONV01-α to 177Lu-PSMA-I&T, a PSMA-targeted beta emitting small molecule for the treatment of advanced prostate cancer. The study population presented included 18 patients (six at each dose level of CONV01-α) with progressive metastatic castration-resistant prostate cancer (mCRPC). Relatively low doses of CONV01-α were used.

Data showed that the median overall survival was 29.8 months, with 10 patients still alive at the time of submission. Five patients were free from PSA progression at one year including one patient progression-free at 34 months on no active therapy. A decline in prostate-specific antigen (PSA) levels was seen in 94% of patients, 64% of patients achieved a PSA50 and 28% achieved a PSA90 response. Additionally, circulating tumor cell count changes were seen, with 80% of evaluable patients converting from "unfavorable" to "favorable." High grade adverse events were rare.

"The impressive clinical activity is consistent with our pre-clinical data demonstrating that the antibody/ligand combination delivers a synergistic dose to tumor. Importantly, the synergistic tumor dose is achieved in the absence of additive toxicity due to the non-overlapping normal organ biodistribution of the ligand and antibody. This was also confirmed by the benign safety profile in the trial. The dosimetry and safety profile suggest the potential for additional cycles beyond the two cycles used in this trial. That the overall survival in this trial was double that of the Phase III VISION trial of 177Lu PSMA-617 further increases our enthusiasm for future trials of this combination," said Neil Bander, MD, Convergent's Co-Founder and Chief Scientific Officer and Professor Emeritus of Urology at Weill Cornell Medicine.

The second presentation, titled "CONVERGE-01: Dosimetry, randomized dose optimization, dose escalation, and efficacy of Ac-225 rosopatamab tetraxetan in participants with PSMA-positive castration-resistant prostate cancer," is a "Trials in Progress" presentation of the three-part company sponsored Phase II trial evaluating the safety and efficacy of CONV01-α (225Ac-J591) monotherapy in patients with castration-resistant prostate cancer. Philip Kantoff, MD, Co-Founder and CEO said, "CONVERGE-01 is intended to confirm the high response rate and durability of CONV01-a monotherapy and solidify the path forward to our pivotal trial."

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