Aurigene Oncology, a subsidiary of Dr Reddy’s Laboratories, has released the Phase 1 results for Ribrecabtagene autoleucel (DRL-1801), a BCMA-directed CAR-T cell therapy, from the SWASTH study. This trial marks India’s first use of novel autologous CAR-T cell therapy in patients with relapsed or refractory multiple myeloma.
The study presented data from the first eight patients enrolled. All participants had undergone extensive prior treatment, with a median of 5.5 previous treatment lines. Most had also received a transplant, and their disease had progressed after the procedure. The trial showed a clinical response in all eight patients. Of these, five (62.5 per cent) achieved stringent complete response. No high-grade cases of Cytokine Release Syndrome (CRS) or neurotoxicity were observed in any patients during the trial.
Following the review of this data, the Drugs Controller General of India (DCGI) has authorised the commencement of Phase 2 of the trial. The Phase 1 results were recently presented at the 21st annual meeting of the International Myeloma Society, held in Rio De Janeiro, Brazil.
“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,” said Dr Murali Ramachandra, CEO, Aurigene Oncology.
Ribrecabtagene autoleucel is an autologous anti-BCMA CAR-T therapy that uses a humanized single-domain antibody as its antigen binding domain and lentivirus as a vector. DRL-1801, used for the clinical trials, is manufactured at the CAR-T GMP manufacturing facility at Aurigene Oncology in Bangalore.
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