Eisai Co., Ltd. announced today that it has launched the anticancer agent “Remitoro® for Intravenous Drip Infusion 300μg” (Denileukin Diftitox (Genetical Recombination)) with the indications of relapsed or refractory Peripheral T-cell Lymphoma (PTCL) and relapsed or refractory Cutaneous T-cell Lymphoma (CTCL), in Japan. Eisai obtained the manufacturing and marketing approval of Remitoro on March 23, 2021. Remitoro was included to Japan’s National Health Insurance Drug Price List on May 19, 2021.
The agent is a fusion protein consisting of interleukin-2 (IL-2) and partial sequence of diphtheria toxin, and specifically binds to the IL-2 receptor on the surface of tumoral lymphocytes. The antitumor efficacy of denileukin diftitox is believed to depend on the intracellular delivery of diphtheria toxin fragment which inhibits protein synthesis and induce cell death.
The approval of Remitoro in Japan is based primarily on data from Study 205, which is a multicenter, open-label, single-arm Phase II clinical study, conducted in Japan to evaluate the efficacy and safety of the agent in patients with relapsed or refractory PTCL or CTCL.
Study 205 achieved the primary endpoint target and exceeded a prespecified tumor response threshold with statistical significance: the objective response rate (ORR) of PTCL and CTCL patients in total (n=36) was 36.1% (95% confidence interval (CI): 20.8-53.8). The ORRs of each subtype were 41.2% (95%CI: 18.4-67.1) for PTCL (n=17) and 31.6% (95% CI: 12.6-56.6) for CTCL (n=19).
The five most frequent treatment-emergent adverse events observed in this study were aspartate aminotransferase increased (AST) (89.2%), alanine aminotransferase increased (ALT) (86.5%), hypoalbuminaemia (70.3%), lymphopenia (70.3%), and pyrexia (51.4%).
Eisai will conduct a post-marketing special use results survey (all-case surveillance) in all patients who are administered the agent until a pre-determined number of patients has been reached in accordance with an approval condition imposed by the Ministry of Health, Labour and Welfare (MHLW).
According to a survey by the MHLW, it is estimated that, in Japan, the number of patients with PTCL is less than 6,000 and the number of patients with CTCL is less than 4000. These diseases may have a poor prognosis or be difficult to treat. Therefore, these are still diseases with extremely high-unmet medical need.
Remitoro was evaluated by the MHLW as a drug with high medical need at the “Study Group for Unapproved Drugs/Off-Label Drugs for High Medical Need”. Eisai retains exclusive development and marketing rights for the agent in Japan and Asia.
Eisai will deliver Remitoro as a new treatment option for relapsed or refractory PTCL and CTCL in Japan, and will appropriately conduct a post-marketing special use results survey (all-case surveillance) in accordance with an approval condition imposed by the MHLW and promote the proper use of this drug.
Eisai is committed to exploring the potential clinical benefits of Remitoro for cancer treatment, as it seeks to contribute to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families and healthcare professionals.
Topic: Press release summary