Oricell Showcases Long-term OriCAR-017 Data in RRMM at 2024 ASCO, Highlighting GPRC5D CAR-T Therapy Efficacy

Oricell Therapeutics, a leading clinical-stage biopharmaceutical company, has unveiled the two-year follow-up results for OriCAR-017, their GPRC5D-targeted CAR-T therapy designed for patients with relapsed/refractory multiple myeloma (RRMM). The findings were shared during an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting.

Efficacy and Durability

The data highlights the deep and sustained responses that OriCAR-017 delivers to RRMM patients, including those who are refractory to other treatments such as anti-CD38 therapies, proteasome inhibitors (PIs), immunomodulatory drugs (IMIDs), and BCMA-targeting CAR-T therapies. These long-term results reinforce the promise of OriCAR-017 as a potent treatment for RRMM. The clinical development of OriCAR-017 is advancing well in both China (NCT06182696) and the United States (NCT06271252).

As of January 16, 2024, all ten enrolled patients responded positively to OriCAR-017, with the last patient completing a 24-month follow-up. The overall response rate (ORR) was 100%, with 80% of the patients achieving a stringent complete response (sCR) and 20% achieving a very good partial response (VGPR). Additionally, all patients achieved 100% minimal residual disease (MRD) negativity at day 28, confirmed at the three-month follow-up. The median duration of response (mDoR) was 10.43 months, the median progression-free survival (mPFS) was 11.37 months, and the median overall survival (mOS) has not yet been reached. In the high-dose group, where 67% had previously received BCMA CAR-T treatment, the mDoR was 17.23 months and the mPFS was 19.10 months. Notably, one BCMA CAR-T-treated patient remains in remission for over 24 months.

Safety Profile

The treatment was generally well-tolerated among patients. Nine out of ten patients (90%) experienced only Grade 1 cytokine release syndrome (CRS), while one patient (10%) experienced Grade 2 CRS. No cases of Grade 3 CRS or higher were observed. The median onset of CRS was two days, with a median duration of six days. There were no instances of immune effector cell-associated neurotoxicity syndrome (ICANS) or dose-limiting toxicities (DLTs). Additionally, no severe adverse events (SAEs) or treatment-related deaths occurred.

Pharmacokinetics

OriCAR-017 showed no pharmacokinetic differences between dose levels, with a peak concentration (Cmax) of 7354.7 copies/μL and an area under the curve (AUC0-28) of 68587 copies•day/μg. At higher doses, CAR-T cells remained detectable for up to nine months, with one patient showing CAR-T cell expansion above the lower limit of quantitation (LLOQ) after 21 months. Patients with a lasting response (Tlast) of nine months or more had a longer progression-free survival compared to those with a Tlast of less than nine months.

Expression of GPRC5D

The study did not find a correlation between antigen expression and therapeutic efficacy. Baseline data indicated positive GPRC5D expression in bone marrow CD138+ plasma cells (MMPC) for all patients, while 50% of relapsed patients showed downregulated expression detected by flow cytometry.

Potential in Advanced RRMM

The study group included patients with complex and advanced disease. Among the ten patients, 40% had extramedullary disease (EMD), 50% had undergone BCMA-directed CAR-T treatments, 70% had high-risk cytogenetics, 70% were classified with an ECOG 2 score, and 80% were at International Staging System (ISS) stages II & III. OriCAR-017 has shown considerable potential as a safe and effective treatment for RRMM, representing a significant step forward in the fight against multiple myeloma and offering hope for those with challenging health conditions.

About OriCAR-017

OriCAR-017 is a chimeric antigen receptor (CAR) T cell therapy targeting GPRC5D, representing a novel approach in treating RRMM. Utilizing Oricell Therapeutics' advanced proprietary technology platforms, OriCAR-017 stands out for its unique binding avidity, persistence, anti-tumor efficacy, and safety profile. The therapy received IND approval from the FDA in January 2024, following its approval by the NMPA in 2023. Oricell Therapeutics continues to release impressive clinical results and is working with a highly skilled team to develop this therapy globally.

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