Long-term follow-up results from the Phase I clinical trial of zevorcabtagene autoleucel (zevor-cel, an autologous CAR T-cell product targeting BCMA) were recently presented as a poster at the 22nd International Myeloma Society (IMS) Annual Meeting.
The poster, titled “Long term Follow-up of Zevor-cel in Patients with Relapsed/Refractory Multiple Myeloma” (Abstract: PA-029), featured data with a median follow-up of 53.3 months (over 4.4 years), demonstrating durable efficacy and a manageable long-term safety profile in patients with relapsed or refractory multiple myeloma (R/R MM).
Key Efficacy Data (as of February 22, 2025):
- Overall Response Rate (ORR): 100% (14/14 patients; 95% CI: 76.8, 100.0).
- Complete Response Rate (CR/sCR): 78.6% (11/14 patients) achieved a complete response (CR) or stringent complete response (sCR).
- Minimal Residual Disease (MRD): All patients achieving CR/sCR were MRD-negative at the 10^−5 sensitivity threshold.
- Durability of Response: One patient remained in sCR at 59.3 months post-infusion.
- Survival Outcomes:
- Median Progression-Free Survival (mPFS) in CR/sCR patients: 44.1 months
- Median Duration of Response (mDoR) in CR/sCR patients: 43.2 months
- Median Overall Survival (OS) was not reached.
- OS Rates: The 24, 36, 48, and 60-month overall survival rates were 100%, 92.3%, 84.6%, and 76.9%, respectively.
Key Safety Data:
Throughout the long-term follow-up period, no patients experienced:
- Grade 3 or higher Cytokine Release Syndrome (CRS)
- Grade 3 or higher Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
- Delayed neurotoxic events
- Second primary malignancies
- Other delayed adverse events related to treatment
Conclusion:
With follow-up extending to approximately five years, zevor-cel continues to demonstrate a highly favorable and manageable safety profile while inducing deep and durable responses in patients with relapsed or refractory multiple myeloma.
