Oricell Therapeutics to Present Long-Term Phase 1 Data of OriCAR-017 in Relapsed/Refractory Multiple Myeloma at ASCO 2024

On May 24, 2024, Qrigincell Therapeutics announced that the abstract of the 2-year long-term follow-up results of its GPRC5D-targeted CAR-T drug (OriCAR-017) in the Phase I clinical trial for the treatment of relapsed/refractory multiple myeloma (RRMM) has been officially published on the website of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract ID: 7511).

Latest data shows that OriCAR-017 has demonstrated deep and durable efficacy responses in RRMM patients, including those refractory to anti-CD38, PIs, IMiDs, as well as those who failed BCMA CAR-T therapy, with a favorable safety profile. Long-term efficacy and safety follow-up results indicate that OriCAR-017 holds promise as an effective treatment option for RRMM patients. Currently, the registrational clinical trials of OriCAR-017 are ongoing in both China and the United States (China NCT05016778; USA NCT06271252).

OriCAR-017 Demonstrates Deep and Durable Efficacy

Data cut-off date: January 16, 2024. All (10) patients responded well to OriCAR-017 treatment, with the last patient completing a 24-month follow-up. The overall response rate (ORR) was 100.0%, the stringent complete response rate (sCR) was 80.0%, and the very good partial response rate (VGPR) was 20.0%. All patients achieved a 100% minimal residual disease-negative rate (MRD) by Day 28, which was further confirmed as 100% negative at Month 3. The median duration of response (mDoR) was 10.43 months (95% CI, 5.00-17.00); the median progression-free survival (mPFS) was 11.37 months (95% CI, 5.93-18.00); the median overall survival (mOS) has not yet been reached (7 patients are still in survival follow-up, 1 patient died from disease progression, and 2 patients died from COVID-19 infection). In the high-dose group (67% were BCMA CAR-T pretreated patients), the mDoR was 17.23 months (95% CI, 7.33-NR), and the mPFS was 19.10 months (95% CI, 8.30-NR).

OriCAR-017 Shows Good Safety and Tolerability

Grade 1 cytokine release syndrome (CRS) occurred in 9 patients (90%), with only 1 patient (10%) experiencing grade 2 CRS; no ≥grade 3 CRS was observed. The median onset time of CRS was 2 days (range, 1–9 days), and the median duration was 6 days (range, 3–9 days). No immune effector cell-associated neurotoxicity syndrome (ICANS) or dose-limiting toxicities (DLTs) were observed. There were no serious adverse events (SAEs) or treatment-related deaths, no cerebellar disorders, and no late-onset infections. No pharmacokinetic differences were observed between dose levels, with a Cmax of 7354.7 copies/μL and an AUC0–28 days of 68587 copies•day/μg. At higher doses, CAR-T cells were detectable at 9 months; after 21 months of follow-up, one patient still had CAR-T cell expansion above the lower limit of quantification (LLOQ). Patients with Tlast ≥9 months had longer progression-free survival compared to those with Tlast <9 months. No correlation was observed between antigen expression and efficacy. Baseline data from all patients showed positive GPRC5D expression in bone marrow CD138+ plasma cells (MMPC), with 50% of relapsed patients showing downregulated expression by flow cytometry.

OriCAR-017 Patients' Baseline Conditions Are More Challenging

40% of patients had extramedullary disease (EMD), 50% had received one or more CAR-T treatments targeting BCMA, 70% had high-risk cytogenetic abnormalities, 70% had an ECOG score of 2, and 80% were ISS stage II or III. These data further demonstrate the application potential of OriCAR-017 in very advanced patients.

Updated data will be presented in the oral presentation session at the ASCO Annual Meeting:
Abstract ID #7511
Title: OriCAR-017, a novel GPRC5D-targeting CAR-T, in patients with relapsed/refractory multiple myeloma: Long term follow-up results of phase 1 study (POLARIS).
Session Type: Rapid Oral Abstract Session
Session Title: Hematologic Malignancies—Plasma Cell Dyscrasia
Date/Time: June 4, 2024 at 9:57 AM Central Time
Location: S102
Link:https://meetings.asco.org/abstracts-presentations/239043

About OriCAR-017

OriCAR-017, a chimeric antigen receptor (CAR) T-cell therapy targeting GPRC5D, has brought new hope for patients with relapsed/refractory multiple myeloma. This therapy is based on QrigincellTherapeutics' self-developed technology platform and demonstrates excellent performance in terms of cell affinity, antigen-binding activity and persistence, anti-tumor efficacy, and safety. After receiving IND approval from the China National Medical Products Administration (NMPA), OriCAR-017 further obtained IND approval from the U.S. FDA in January 2024.

Currently, Qrigincell Therapeutics has established operational teams in both China and the United States, and is fully committed to advancing the global clinical development of its product pipeline.

Editor: Mu Mian

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