On April 23, 2026, the results of the Phase III registration clinical study (DEB Study) of Chipscreen Biosciences' self-developed original new drug Chidamide (trade name: Epidaza^®) in Chinese patients with previously untreated double-expressor diffuse large B-cell lymphoma (DE-DLBCL) were published online in full in the international top-tier medical journal *JAMA* (The Journal of the American Medical Association, IF=55).

Professor Zhao Weili from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, and Professor Zhu Jun from Peking University Cancer Hospital are the co-corresponding authors of this article. The publication of this research result contributes high-quality evidence from China to the international diagnosis and treatment of lymphoma, demonstrating the leadership of Chinese scholars in clinical research on original anti-tumor drugs.

Click the link: https://jamanetwork.com/journals/jama/article-abstract/2848060

Chidamide is the world's first subtype-selective histone deacetylase (HDAC) inhibitor and China's first original anti-tumor chemical new drug. It has been included in the National Reimbursement Drug List under Category B routine management. Based on the positive results of the DEB Study, the combination of Chidamide and the R-CHOP regimen has been included as a Grade I recommendation with Class 1A evidence in the Guidelines of Chinese Society of Clinical Oncology (CSCO) Guidelines for Lymphoid Malignancies for patients with previously untreated DE-DLBCL, thereby establishing a new standard of care for their first-line treatment in China.

The world's first Phase III registration study for previously untreated DE-DLBCL

The DEB Study is the world's first randomized, double-blind, controlled Phase III registration clinical study for previously untreated double-expressor diffuse large B-cell lymphoma (DE-DLBCL), enrolling a total of 423 patients with previously untreated DE-DLBCL and an IPI score ≥2, who were randomized 1:1 to receive either Chidamide combined with R-CHOP (Chidamide group, n=211) or placebo combined with R-CHOP (control group, n=212).The primary endpoint of the study was event-free survival (EFS), and secondary endpoints included complete response (CR) rate, progression-free survival (PFS), and overall survival (OS).

The DEB Study design was both innovative and rigorous; patients who achieved a complete response (CR) after the combination treatment phase continued to receive Chidamide monotherapy as sequential maintenance therapy for 24 weeks to reduce the high risk of early relapse in DE-DLBCL.The study utilized a central laboratory for uniform pathological review (MYC≥40%, BCL2≥50%), achieving a high concordance rate and ensuring robust and reliable data.

Efficacy Leap: 28% Reduction in EFS Risk, 11.1% Increase in CR Rate

Study results showed:

Primary Endpoint: The Chidamide group demonstrated a significant 28% reduction in the risk of an EFS event compared to the control group (HR=0.72, P=0.02); the 2-year EFS rate was significantly superior to the control group (60.3% vs 50.5%), clearly improving the cure metric EFS rate at 24 months (EFS24).

• CR Rate: At the end of combination therapy, the CR rate in the Chidamide group was significantly higher than in the control group, with an adjusted CR rate increase of 11.1% (73.0% vs 61.8%). This represents the only Phase III clinical trial in the past 20 years in the first-line DLBCL treatment setting to achieve a statistically significant improvement in CR rate.

• Long-Term Survival: The Chidamide group showed a 23% reduction in the risk of death for OS (HR=0.77), with a 7.8% absolute improvement in the 2-year OS rate, and the advantage widened during follow-up, suggesting that the combination regimen can provide clinically meaningful long-term survival benefits.

Manageable Safety Profile, Adverse Events Were Manageable

In the DEB Study, the types of adverse events (AEs) were consistent with the known safety profiles of Chidamide monotherapy and the R-CHOP regimen.While there was some overlapping hematological toxicity, the majority of patients were able to continue treatment with symptomatic management, dose holds, or dose reductions. No unexpected safety signals were observed, and no significant cardiac, hepatic, or renal toxicity was noted.

Professor Zhao Weili from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, the lead principal investigator of the study, stated: "The positive results of the DEB Study hold significant clinical importance.For the high-risk subgroup of DE-DLBCL, the regimen of Chidamide combined with R-CHOP followed by Chidamide maintenance therapy offers a novel treatment option that combines efficacy, safety, and accessibility, filling a previous treatment gap where effective regimens were lacking."

Professor Zhu Jun from Peking University Cancer Hospital, the principal investigator of the study, stated: "As a pivotal trial fully designed, conducted, and yielding positive results by Chinese researchers, this study marks an advancement in China's innovative research capabilities in the lymphoma field, demonstrating the scientific strength to evolve from following international research to leading the development of treatment regimens in specific areas."

Dr. Lu Xianping, Chairman of Chipscreen Biosciences, stated: "Chidamide is one of the representative innovative drugs developed in China. The publication of the DEB Study results in JAMA represents international recognition of both Chinese clinical researchers and Chipscreen's capabilities in original innovation. Chipscreen and its partners will continue to advance global clinical studies exploring chidamide in combination with tumor immunotherapy, covering first-line PTCL, colorectal cancer, melanoma, and other indications. We are also developing next-generation HDACi+IO drugs, committed to providing better treatment options for patients worldwide."