On September 3, Carteyva (Relmacabtagene Autoleucel Injection), a CD19 CAR-T cell therapy product was approved by the China National Medical Products Administration (NMPA). It is indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy.
What makes Carteyva a promising treatment for relapsed or refractory large B-cell lymphoma (LBCL), and how does it compare to existing therapies?
Professor Huang Huiqiang stated:
“Patients with newly diagnosed or treatment-resistant advanced lymphoma actually have the opportunity for disease-free survival or even a cure. The key to treatment lies in selecting the right drug for personalized therapy based on each individual patient. I’m very pleased to see the launch of Carteyva, a Class 1 innovative CAR-T therapy developed in China. The RELIANCE study shows a best overall response rate of 51.7%, with more than half of patients achieving complete remission (CR) with Carteyva. More importantly, it has a relatively long progression-free survival (PFS), and the 6-month overall survival (OS) rate reached 90.8%—this is indeed a very promising result. I believe Carteyva will achieve excellent outcomes in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), especially when combined with other immunotherapies or targeted treatments. I look forward to its wide clinical adoption and the accumulation of more experience to benefit patients across China.”
How does the efficacy of Carteyva compare to standard salvage treatments for relapsed/refractory LBCL, particularly in terms of complete remission and long-term outcomes?
Professor Zhou Jianfeng commented:
“In fact, under current standard treatment regimens, only about half of relapsed/refractory LBCL patients are able to complete the standard salvage therapy, and even after hematopoietic stem cell transplantation, only about half of those achieve complete remission (CR). This means that the probability of achieving long-term CR with today’s best salvage treatments is only around 25%. By comparison, the pivotal clinical study of Carteyva® in relapsed/refractory LBCL showed a best CR rate of 51.7%, indicating that Carteyva outperforms the current best therapies. With just one treatment, patients have a real chance at complete remission or even a cure. International studies have also confirmed that CAR-T therapy significantly outperforms existing standard treatments in both achieving durable remission and improving quality of life. As follow-up data from pivotal trials continue to mature, we expect more patients in China to achieve deep remission and curative outcomes. Therefore, the approval of Carteyva marks an unprecedented and milestone-level transformation in hematologic oncology, offering a fundamentally new therapeutic option.”
How does Carteyva perform in terms of safety, and why is it considered a reliable treatment for large B-cell lymphoma?
Professor Song Yongping added:
“CAR-T cell therapy is currently the most effective approach for treating large B-cell lymphoma. The safety of new therapies is always a primary concern. The safety of JW Therapeutics’ Carteyva® is well recognized. Its safety profile is trustworthy and provides a solid foundation for achieving deep remission and long-term survival. Carteyva® offers a safe and effective treatment option for adult patients in China with relapsed/refractory LBCL.”
What does the clinical trial data reveal about the safety and tolerability of Carteyva in treating relapsed/refractory DLBCL?
Professor Li Wenyu remarked:
“Carteyva has proven its safety in clinical trials while effectively serving patients. During its Phase I clinical trial, dose escalation studies helped determine the optimal infusion dose for adults, verifying its safety in the human body and establishing a safe dosage range. In the Phase II trial, 59 patients with relapsed/refractory DLBCL were enrolled. Prior to infusion, no prophylactic interventions were administered to prevent adverse events, allowing for a more objective evaluation of safety and efficacy. According to independent review committee (IRC) assessments, the incidence of Grade ≥3 cytokine release syndrome (CRS) and neurotoxicity (NT) were 5.1% and 3.4%, respectively. Carteyva demonstrates overall safety, reliability, and controllability, with a safety profile comparable to that of the world-class CAR-T product liso-cel (Grade ≥3 CRS and NT rates of 2% and 10%, respectively). Carteyva’s excellent safety brings a new option to clinical CAR-T applications and benefits a broader patient population.”
How does Carteyva’s safety profile compare to other CAR-T therapies currently available, and is it safe for patient use?
Professor Jin Jie concluded:
“The Phase II trial of Carteyva enrolled 59 patients, and the results indicate that its safety profile is at least comparable, if not superior, to similar products. The rates of Grade ≥3 CRS and NT events were 5.1% and 3.4%, respectively, which are on par with international CAR-T brands and potentially even better. Carteyva is a safe treatment that patients can rely on.”
