ifupinostat (BEBT-908) / BeBetter Med - LARVOL DELTA

Ifupinostat: First Approval. (PubMed, Drugs) - "Continued approval is dependent on the results of a confirmatory, randomized, controlled phase 3 trial. This article summarizes the milestones in the development of ifupinostat leading to this first approval as a monotherapy for adults with relapsed or refractory diffuse large B-cell lymphoma who have received at least two lines of systemic therapy."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • PIK3CA

China approves...new drugs, including a global first-in-class medicine (Fierce Pharma) - "Wednesday, Chinese regulators announced (Chinese) the conditional approval of ifupinostat (BEBT-908) for treating diffuse large B-cell lymphoma (DLBCL) patients who have tried at least two prior lines of therapy....The company is conducting a confirmatory phase 3 trial to turn ifupinostat’s conditional nod into a full approval. The study is combining ifupinostat with rituximab in second-line DLBCL."

China approval • Diffuse Large B Cell Lymphoma

BEBT-908 enters confirmatory Phase III clinical trial for the treatment of relapsed/refractory diffuse large B-cell lymphoma [Google translation] (bydrug.pharmcube.com) - "On November 21, 2024, Guangzhou Bibet Pharmaceutical Co., Ltd. (hereinafter referred to as 'Bibet Pharmaceutical') announced that the launch meeting of the multicenter, randomized, controlled, open Phase III clinical research project on the effectiveness and safety of the company's first-in-class innovative drug BEBT-908 combined with rituximab (R) versus rituximab-gemcitabine-oxaliplatin (R-GemOx) or combined with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) in the treatment of relapsed/refractory diffuse large B-cell lymphoma was successfully held at the Cancer Hospital, marking the official start of subject recruitment for the confirmatory Phase III clinical trial of BEBT-908."

New P3 trial • Diffuse Large B Cell Lymphoma

Efficacy and safety of ifupinostat (BEBT-908) in combination with rituximab for relapsed/refractory diffuse large B-cell lymphoma: Results from an exploratory phase Ib study. (ASCO 2025) - P1 | "The study results demonstrate promising efficacy and a manageable safety profile for Ifupinostat in combination with rituximab as a second-line treatment for r/r DLBCL. These findings support further investigation in confirmatory phase 3 trials, which are currently underway."

Clinical • Combination therapy • P1 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Leukopenia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Thrombocytopenia • PIK3CA

Study Comparing BEBT-908 Combined With R to SOC for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=416 | Recruiting | Sponsor: BeBetter Med Inc

New P3 trial • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Study of BEBT-908 Combined With Drugs in the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma (clinicaltrials.gov) - P1 | N=75 | Recruiting | Sponsor: BeBetter Med Inc

New P1 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Dual PI3K/HDAC Inhibitor BEBT-908 Exhibits Potent Efficacy as Monotherapy for Primary Central Nervous System Lymphoma. (PubMed, Target Oncol) - "Our study provides robust evidence for the dual PI3K/HDAC inhibitor BEBT-908 as an effective anti-cancer agent for PCNSL."

Journal • Monotherapy • CNS Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • MYC

Study of BEBT-908 in Subjects With Advanced Hematological Tumors (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: BeBetter Med Inc

Metastases • New P1 trial • Chronic Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Study of BEBT-908 in the Relapsed or Refractory Diffuse Large B-cell Lymphoma Subjects (clinicaltrials.gov) - P2 | N=128 | Active, not recruiting | Sponsor: BeBetter Med Inc

New P2 trial • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology