Oricell Publishes Data from POLARIS Clinical Study Evaluating OriCAR-017 in the Treatment of RRMM in The Lancet Haematology
Oricell Therapeutics, an innovative pharmaceutical company committed to the development of clinical-stage oncology cell therapies, today announced publication of data from a clinical study evaluating the efficacy of OriCAR-017, an autologous GPRC5D-directed CAR-T cell therapy, in the treatment of relapsed/refractory multiple myeloma (RRMM) in an article entitled “Phase 1 Open-Label Single-Centre Single Arm Study of GPRC5D CAR T Cells(OriCAR-017) in Patients with Relapsed/Refractory Multiple Myeloma (POLARIS)” in The Lancet Haematology.
The POLARIS study, the first-in-human study of OriCAR-017, explores the safety, tolerability and preliminary anti-tumor efficacy for a single intravenous infusion of OriCAR-017 in patients with RRMM (NCT05016778). As of June 30, 2022, the study had showed exciting clinical results for OriCAR-017 in the treatment of 10 patients with RRMM:
- Median follow-up time: 238 days (range: 99-345 days)
- Safety: Dose-limiting toxicities (DLTs), serious adverse events (SAEs), neurotoxicity and deaths were not observed. The common treatment-emergent AEs were Grade 3 or 4 hematologic toxicities, including neutropenia, leukopenia, thrombocytopenia and anemia. Cytokine release syndrome (CRS) was observed in all patients (9 patients in G1 and one patient in G2).
- Preliminary clinical efficacy: the study revealed an impressive 100% overall response rate, with 60% stringent complete response and 40% very good partial response. All patients (100%) achieved MRD negative (10-5/ml). Additionally, of the 5 patients who relapsed after BCMA CAR T-cell therapy, 2 achieved stringent complete response and 3 achieved very good partial response. At the date cut-off time, the mPFS (median progression-free survival) has not yet been reached; for the 2 patients who had disease progression, one with GPRC5D-positive while the other one with GPRC5D-negative.
“Advances in the treatment of R/RMM, including the introduction of immunomodulatory drugs, proteasome inhibitors and monoclonal antibodies as well as stem cell transplantation, have prolonged survival in R/RMM patients, the disease remains a clinically incurable plasma cell neoplasm,” said Prof. He Huang, Bone Marrow Transplantation Center, The First Affiliated Hospital, School of Medicine, Zhejiang University. “Nevertheless, almost all R/RMM patients eventually experience one or more relapses, with poorer survival outcomes for those with high-risk cytogenetic characteristics or refractory diseases. Data from our study showed that with extraordinary clinical efficacy, OriCAR-017 has been proved to be a novel, safe and effective therapy for patients with R/RMM, especially for those who experienced a relapse after receiving BCMA-targeted therapy. We are looking forward to continuously conducting follow-up clinical studies of OriCAR-017 in concert with Oricell.”
“OriCAR-017 has demonstrated 100% ORR and controllable safety in the POLARIS study, providing a solid foundation for Oricell’s subsequent registration of clinical studies,” stated Helen Yang, Chairman and CEO of Oricell. “The firm is in the process of submitting an application in the US and China for the registration of clinical studies of OriCAR-017 while advancing the therapy to critical phases of clinical research as soon as possible.”
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