FDA Approves Promising Prostate Cancer Treatment
In a groundbreaking development in the field of prostate cancer treatment, the FDA has granted clearance to an investigational new drug (IND) application for 225Ac-J591, a prostate-specific membrane antigen-targeted monoclonal antibody. The drug, developed by Convergent Therapeutics, shows immense potential in the treatment of advanced prostate cancer.
The approval of the IND is considered a significant milestone for Convergent Therapeutics. According to Philip Kantoff, MD, the co-founder and CEO of the company, this clearance will pave the way for phase 3 studies and the further development of CONV01-α as a monotherapy and in combination with other prostate cancer therapies. With plans to start phase 2 clinical trials in 2024 and a registration program in 2025, Convergent Therapeutics is on track to revolutionize prostate cancer treatment.
The efficacy and safety of 225Ac-J591 were demonstrated in a phase 1 multi-dose, dose escalation study conducted on metastatic castration-resistant prostate cancer (mCRPC) patients. The study, presented at the American Association of Prostate Cancer Research Annual Meeting in 2023, showed promising results across all dose levels. Out of the 21 patients in the study who experienced a prostate-specific antigen (PSA) change, 95% saw a drop in PSA levels. Additionally, 67% of patients experienced a 50% decline, while 27% experienced a remarkable 90% decline.
Circulating tumor cell (CTC) samples were collected from a subset of patients at baseline and 12 weeks. The results were equally encouraging, with favorable or converted CTC counts observed in the majority of patients. Furthermore, no dose-limiting toxicity (DLT) was observed in any cohort, except for two instances in Cohort 3 where low-grade adverse events were reported, including fatigue, xerostomia, and nausea.
Neil Bander, MD, the Chief Scientific Officer of Convergent Therapeutics, highlighted the minimal adverse effects experienced by patients during the phase 1/2 trials. The drug’s design aims to target tumor-killing radiation to malignant cells while minimizing off-tumor effects and increasing treatment safety and efficacy. This innovative approach holds great promise for improving patient outcomes.
The study included 24 patients with predominantly 177Lu-naive mCRPC, with a median age of 73.5 years. Inclusion criteria required patients to have progressive mCRPC after treatment with an AR pathway inhibitor and chemotherapy, as well as an ECOG performance status of 0 to 2. The primary objective of the study was to identify the phase 2 dose for dose-limiting toxicities, while also exploring measures of efficacy such as PSA decline, radiographic response rate, progression-free survival, overall survival, CTC change, and patient-reported outcomes.
The FDA’s approval of the IND for 225Ac-J591 marks a significant step forward in the fight against prostate cancer. With its potential to revolutionize treatment options and improve patient outcomes, this groundbreaking drug offers hope to those battling advanced prostate cancer. As Convergent Therapeutics moves forward with phase 2 clinical trials and a registration program, the future of prostate cancer treatment looks brighter than ever.
In other medical news, recent studies suggest that patients with breast cancer may be able to skip chemotherapy in certain cases. This development could potentially spare many patients from the side effects associated with this aggressive treatment option. Further research and clinical trials are needed to fully determine the applicability and effectiveness of this alternative approach.