Boryung announced on the 19th that it has completed patient enrollment for the Phase 2 clinical trial of its next-generation targeted cancer therapy candidate, bosmolisib (BR101801).
Bosmolisib is an investigational drug that simultaneously inhibits PI3K gamma, PI3K delta, and DNA-PK—three key proteins involved in cancer cell growth, survival signaling, and DNA damage repair. According to Boryung, it is the world's first candidate designed to inhibit all three targets at once. The drug is currently being developed to treat relapsed or refractory peripheral T-cell lymphoma (PTCL).
PTCL is an aggressive form of blood cancer that affects not only the lymph nodes but also organs such as the spleen, liver, bone marrow, skin, and gastrointestinal tract. While relapse or treatment failure is common after initial chemotherapy, no standard second-line therapy has been established.
The Phase 2 trial is a single-arm, multicenter, open-label study designed to evaluate the antitumor activity, safety, and tolerability of monotherapy bosmolisib in patients with relapsed or refractory PTCL. Following the first patient dosing in March, 44 patients were enrolled across 17 clinical sites in South Korea, reaching the enrollment target in approximately seven months. Boryung plans to conclude Phase 2 in 2028 following a one-year follow-up period, after which it intends to apply for marketing approval.
In the earlier Phase 1 trial, six of the 19 efficacy-evaluable patients achieved an objective response. At the latest follow-up assessment, four patients showed a complete response and two demonstrated a partial response. Notably, several patients who continued taking the medication after Phase 1 concluded maintained treatment for more than three years while remaining in complete response.
Bosmolisib has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for two PTCL subtypes: PTCL not otherwise specified (PTCL-NOS) and angioimmunoblastic T-cell lymphoma (AITL). It has also received orphan drug designation in South Korea, enabling Boryung to apply for conditional marketing approval upon successful completion of Phase 2.
“We will work to carry the potential demonstrated in Phase 1 through to our Phase 2 results so that bosmolisib can become a meaningful treatment option for patients with peripheral T-cell lymphoma,” said CEO Kim Jung-gyun. “We will focus our full capabilities on the remaining clinical work to bring this drug to patients as quickly as possible.”
