Boryung announced on December 12 that it presented the results of the Phase 1 clinical trial of its novel anti-cancer drug "BR101801" at the American Society of Hematology (ASH), the world's largest conference in the field of blood cancer, on December 9 (local time).
According to the company, BR101801, which is being developed for the treatment of Peripheral T-Cell Lymphoma (PTCL), confirmed two complete responses and one partial response in the recently completed Phase 1b trial, and confirmed efficacy in six of the 19 total Phase 1 efficacy patients, including results from the Phase 1a trial completed in 2021.
Duration of response, which is highly correlated with patient survival, has already exceeded two years with efficacy still ongoing in four of the six patients with confirmed efficacy. (31.8 months and 24,2 months, respectively).
In addition, the median progression-free survival (mPFS) of the 19 patients in the efficacy trial was 5.6 months, which is longer than that of prior therapies (less than 4 months).
Safety data also showed a low incidence of hematologic toxicity, a major side effect of blood cancer treatment, and no deaths across all patients treated with the drug.
PTCL is a type of non-Hodgkin's lymphoma characterized by rapid progression, high relapse rates, and high mortality. The prognosis is poor, with a median survival of 5.8 months and a 68% relapse/refractoriness rate for first-line CHOP chemotherapy, and there is currently no second-line standard of care for relapsed/refractory patients, making it a disease of significant unmet medical need.
Boryung began developing BR101801 as a treatment for non-Hodgkin lymphoma that simultaneously triple inhibits PI3K gamma (γ), PI3K delta (δ), and DNA-PK, the main growth regulators of cancer cells, and has been conducting Phase 1b clinical trials in PTCL since April last year after confirming efficacy in Phase 1a clinical trials.
BR101801 received orphan drug designation from the US FDA in October last year and developmental orphan drug designation from the Korean Ministry of Food and Drug Safety in August this year. This allows for an early launch depending on the results of the Phase 2 study. Boryung expects to complete the Phase 1 final results report in the first quarter of next year and plans to apply for Phase 2 in the middle of next year.
