JW Therapeutics Announces New Phase 2 Trial of Relma-Cel in Large B-cell Lymphoma
The investigator-initiated, single-arm, open-label trial will follow 20 patients with high-risk LBCL for 2 years, with a primary outcome measure of complete response rate per Lugano classification.
Yuqin Song, MD, PhD
An open-label, prospective, single-arm phase 2 clinical trial (NCT05590221) of relmacabtagene autoleucel injection (relma-cel; JW Therapeutics) has been initiated in China, according to an announcement by the therapy’s developer.1 The trial is aimed at assessing the autologous anti-CD19 CAR-T cell immunotherapy in a population of 20 individuals with high-risk large B-cell lymphoma (LBCL) as the first-line treatment and first patient infusion.
Those included in the treatment arm will receive intravenous (IV) cyclophosphamide 250 mg/m2 per day and IV fludarabine 25 mg/m2 per day conditioning chemotherapy for 3 days followed by a single IV infusion of relma-cel at a target dose of 1x108 cells on Day 1. The primary outcome measure is complete response rate per Lugano classification as determined by investigators at 2 years post infusion. The effort is being led by principal investigator Yuqin Song, MD, PhD, chief physician and deputy director of the Lymphoma Department at Peking University Cancer Hospital, in Beijing, China.
Some of the secondary end points planned are the objective response rate per Lugano classification, the duration of response per Lugano classification, event-free survival, progression-free survival, overall survival, adverse events, and a number of pharmacokinetic measures, among others. In its announcement, JW Therapeutics noted that individuals with high-risk LBCL often have a low response to standard first-line chemotherapy, with a complete response rate of 47.3%, 3-year overall survival rate of 58.9%, and progression-free survival rate of 40.7%.1
For inclusion in the study, high-risk LBCL is defined by the dynamic risk assessment of interim PET2+, in conjunction with either double- or triple-hit lymphomas or high-intermediate- and high-risk International Prognostic Index (IPI) scores, defined as scores of 3-5. Additionally, patients will need to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, expected survival greater than 12 weeks, and adequate organ function and vascular access for leukapheresis procedure.
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Relma-cel, though not yet FDA approved, was granted approval by China’s National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory LBCL.2 Previously known as JWCAR029, the therapy was then branded as Carteyva.
In October 2022, the NMPA approved it for the treatment of adult patients with follicular lymphoma (FL) that is refractory or that relapses within 24 months of second-line or above systemic treatment.3 Two months later, at the 64th American Society of Hematology (ASH) annual meeting, JW Therapeutics presented clinical data on the therapy in FL from the phase 2 RELIANCE study (NCT04089215), which showed that relma-cel demonstrated high rates of durable disease response and low rates of CAR-T associated toxicities.4
Similarly, data in patients with relapsed/refractory LBCL that were presented at the 2022 American Society of Clinical Oncology (ASCO) annual meeting by Song and colleagues, the therapy showed good efficacy.5 In a modified intent-to-treat population of patients (n = 58), the best 3-month objective response rate was 77.6% and best complete response rate was 53.5%.
“As the longest follow-up term of CD19+ CAR T cell study in heavily pretreated patients with [relapsed/refractory] LBCL in China, Carteyva demonstrated durable responses with a high 2-year [overall survival] rate, the median [overall survival] not yet reached for responding patients, and a manageable safety profile. These data continue supporting the compelling clinical benefit-risk profile of Carteyva for [relapsed/refractory] LBCL patients,” Song et al wrote.5
