Aurigene Oncology Limited, a Dr. Reddy's Laboratories company, has announced encouraging results from its first clinical trial of Ribrecabtagene autoleucel (DRL-1801), a CAR-T cell therapy for multiple myeloma. The Phase 1 SWASTH study, the first of its kind in India, demonstrated promising efficacy and safety in heavily pre-treated patients.
Promising Clinical Response
The SWASTH trial involved eight patients with multiple myeloma who had undergone an average of 5.5 prior treatments, including transplants. All eight patients exhibited a clinical response to Ribrecabtagene autoleucel. A significant 62.5% of patients achieved a complete response, indicating a substantial reduction or disappearance of myeloma cells. These results, shared at the 21st annual meeting of the International Myeloma Society in Rio De Janeiro, Brazil, highlight the potential of this therapy for patients with relapsed or refractory disease.
Safety Profile
An important aspect of the trial was the safety profile of Ribrecabtagene autoleucel. The study reported no serious side effects such as Cytokine Release Syndrome (CRS) or neurotoxicity, common concerns with CAR-T cell therapies. This suggests that Ribrecabtagene autoleucel may offer a safer treatment option for patients with multiple myeloma.
Regulatory Approval for Phase 2
Based on the positive Phase 1 results, the Drugs Controller General of India (DCGI) has approved the advancement to Phase 2 of the clinical trial. This regulatory milestone allows for further investigation of Ribrecabtagene autoleucel's efficacy and safety in a larger patient population.
Expert Commentary
Murali Ramachandra, CEO of Aurigene Oncology, expressed enthusiasm about the trial results, stating, "The results from the trial in heavily pre-treated relapsed refractory myeloma patients are very exciting for us in India. We are thrilled with the data, as the drug could be transformative for Indian patients with myeloma."
About Ribrecabtagene autoleucel
Ribrecabtagene autoleucel is a CAR-T cell therapy that utilizes a specific antibody and lentivirus to target cancer cells. The therapy is manufactured at Aurigene’s facility in Bangalore. Aurigene Oncology, founded in 2002, is dedicated to developing novel cancer treatments and has a pipeline of 10 therapies, including those targeting immune checkpoint proteins.
