On September 26, 2021 JW Therapeutics (HKEx: 2126), an innovative biotechnology company focused on developing, manufacturing and commercializing cell immunotherapy products, reported updated 1-year follow-up result of relmacabtagene autoleucel injection (relma-cel) for the treatment of relapsed or refractory large B-cell lymphoma (r/r LBCL) at the 24th Annual Meeting of the Chinese Society of Clinical Oncology (CSCO) (Press release, JW Therapeutics, SEP 26, 2021, View Source [SID1234590275]).

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RELIANCE Study was a phase II, open-label, single-arm, multi-center clinical study in China, which included 59 adult patients with r/r LBCL who had failed at least 2 lines of previous treatment. As of the December 31st, 2020 data cut-off, in 58 evaluable patients, results include:

Relma-cel showed durable responses and long-term survival benefit; the Best Overall Response Rate was 77.6%, the Best Complete Response Rate was 51.7% and 1-year Overall Survival (OS) was 76.8% with a median follow-up of 17.9 months;
Relma-cel was generally well-tolerated with a safety profile including a low severe Cytokine Release Syndrome (≥grade 3) of 5.1% and a low severe neurotoxicity rate (≥grade 3) of 3.4%, and no new safety signals with a median of 17.9 months of follow up;
Long-term follow-up of the RELIANCE study have confirmed the durability of response and long-term OS with relma-cel treatment, which also was associated with low rates of CAR-T-associated toxicities.
"Large B-cell lymphoma (LBCL) is the most common and aggressive type of non-Hodgkin lymphoma and most patients relapse after initial therapies with limited treatment options with standard therapies and a median survival of approximately 6 months," said Mark J. Gilbert, Chief Medical Officer of JW Therapeutics, "These long-term follow-up data reported from the RELIANCE study have confirmed the durability of responses after relma-cel treatment, representing a potentially important treatment option for these patients that appears to offer clear hope of longer survival in these patients."

Reference:

Crump M, Neelapu SS, Farooq U, Van Den Neste E, Kuruvilla J, Westin J, Link BK, Hay A, Cerhan JR, Zhu L, Boussetta S, Feng L, Maurer MJ, Navale L, Wiezorek J, Go WY, Gisselbrecht C. Outcomes in refractory diffuse large B-cell lymphoma: results from the international SCHOLAR-1 study. Blood. 2017 Oct 19;130(16):1800-1808. doi: 10.1182/blood-2017-03-769620. Epub 2017 Aug 3. Erratum in: Blood. 2018 Feb 1;131(5):587-588. PMID: 28774879; PMCID: PMC5649550.

About Relmacabtagene Autoleucel Injection (trade name: Carteyva)

Relmacabtagene autoleucel injection (trade name: Carteyva) is an autologous anti-CD19 CAR-T cell immunotherapy products that was independently developed by JW Therapeutics based on a CAR T cell process platform of Juno Therapeutics (a Bristol Myers Squibb company). The first product of JW Therapeutics, relma-cel was approved by the China National Medical Products Administration (NMPA) in September 2021 for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, making it the first CAR-T product approved as a Category 1 biologics product in China. Currently, it is the only CAR-T product in China that has been simultaneously included in the National Significant New Drug Development Program, granted priority review and breakthrough therapy designations.

About RELIANCE Study (NCT04089215)

RELIANCE study was a single-arm, multi-center, pivotal study to evaluate the efficacy and safety of relmacabtagene autoleucel injection (relma-cel) in patients with relapsed or refractory large B-cell lymphoma (r/r LBCL) in China. At the time it was conducted, this study was the largest clinical study of CAR-T cell therapy in China under the Investigational New Drug (IND) pathway.

RELIANCE study enrolled 59 patients with r/r LBCL who had failed at least two lines of therapy, including a CD20 agent and anthracycline, and patients continue to be monitored for up to 2 years and beyond for long term outcomes. As of the December 31st, 2020 data cut-off, the Best Overall Response Rate was 77.6% with a Best Complete Response Rate of 51.7%, and 12-month Overall Survival (OS) was 76.8% in 58 evaluable patients; With a median follow-up of 17.9 months, of 59 treated patients, 5.1% and 3.4% of the patients experienced Cytokine Release Syndrome (CRS) and Neurotoxicity (NT) of Grade 3 or above, respectively. Rates for any severity grade CRS and NT were 47.5% and 20.3%, respectively. Long term follow up of the RELIANCE study have confirmed the durability of response and long-term OS with relma-cel treatment, which also was associated with low rates of CAR-T-associated toxicities.