China-based JW Therapeutics (HKG: 2126) presented the latest clinical data on Carteyva (relmacabtagene autoleucel injection) in Chinese adults with relapsed/refractory follicular lymphoma (r/r FL) and relapsed/refractory mantle cell lymphoma (r/r MCL) at the 64th American Society of Hematology (ASH) annual meeting.
Efficacy and Safety in Relapsed/Refractory Follicular Lymphoma
In the pivotal phase II RELIANCE study, patients with histologically confirmed grade 1, 2, or 3a FL with r/r disease were included. Eligible patients were randomized to receive relma-cel at the dose level of 100×106 or 150×106 CAR+ T cells, following lymphodepletion chemotherapy. At the data cut-off (Dec 17, 2021), based on 28 patients with 11.7 months of median follow-up, relma-cel demonstrated remarkable clinical responses achieving high rates of complete response rate (CRR) and overall response rate (ORR) (6 months ORR and CRR were 100% and 83.33% respectively), and a manageable safety profile (only 1 patient experienced Gr ≥3 neurotoxicity (NT), no Gr ≥3 cytokine release syndrome (CRS)). Updated safety and efficacy data with a longer follow-up will be presented later.
Preliminary Safety and Efficacy in Relapsed/Refractory Mantle Cell Lymphoma
In this phase II single-arm open-label study in China, participants with MCL who underwent ≥2 lines of therapy including anti-CD20 antibody, anthracycline or bendamustine, and BTKis were included. After lymphodepleting chemotherapy, participants received relma-cel (100×106 CAR+ T cells). As of Nov 30, 2021, the preliminary data of relma-cel based on 11 patients provided promising clinical efficacy outcome (best ORR 81.8%, best CRR 54.5%) in high-risk patients with r/r MCL and a low incidence of grade ≥ 3 CRS (1 patient) and immune effector cell-associated neurotoxicity syndrome (ICANS, 1 patient). This study is ongoing and further results will be presented.
Relmacabtagene Autoleucel: Approved CAR-T Therapy
Relmacabtagene autoleucel, an autologous anti-CD19 CAR-T cell immunotherapy product independently developed by JW Therapeutics, has been approved to treat adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, and adult patients with follicular lymphoma that is refractory or that relapse within 24 months of second-line or above systemic treatment (r/r FL) in China.Fineline Info & Tech
