Shenzhen Chipscreen Biosciences Co., Ltd. (“Chipscreen Biosciences,” stock code: 688321.SH) recently completed the final topline analysis of its pivotal Phase III clinical trial (DEB study) evaluating Chidamide, a first-in-class, globally innovative therapy, both in combination with standard first-line treatment and as monotherapy maintenance for diffuse large B-cell lymphoma (DLBCL). The results showed that the experimental arm achieved significantly improved event-free survival (EFS) compared to the control arm, meeting the study’s primary endpoint. Notably, the Chidamide plus R-CHOP (CR-CHOP) regimen represents the world’s first frontline DLBCL therapy to demonstrate significantly higher complete response (CR) rates than R-CHOP in a Phase III trial. The topline analysis also confirmed that the Chidamide combination regimen delivers substantial and durable EFS benefits for treatment-naïve patients with MYC and BCL2 double-expressor DLBCL, while maintaining a favorable safety profile. Chipscreen Biosciences is now advancing regulatory submissions for full approval of this indication. Complete final data will be shared at upcoming academic conferences and published in peer-reviewed journals.

The World’s Most Accessible First-Line DLBCL Treatment Now Covered by National Reimbursement

The final topline analysis confirms that Chidamide, when combined with standard first-line therapy followed by monotherapy maintenance, delivers clinically meaningful benefits for patients with double-expressor DLBCL. Based on its impressive interim results, the National Medical Products Administration (NMPA) granted conditional approval for this indication in April 2024. By the end of 2024, the National Healthcare Security Administration included it in the National Reimbursement Drug List (NRDL), making Chidamide the only approved and reimbursed first-line oral innovative therapy for DLBCL in China. This therapy’s clinical study was selected as a Late-Breaking Abstract (LBA) and presented orally at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. It has also been incorporated into the Chinese Society of Clinical Oncology (CSCO) guidelines as a Category 1A recommendation for DLBCL, providing authoritative clinical guidance for practitioners.

About the DEB Study

Diffuse large B-cell lymphoma (DLBCL) is the most common type of malignant lymphoma, with approximately 30,000 new cases and 20,000 deaths annually in China. Current domestic and international clinical guidelines recommend R-CHOP as the standard first-line therapy for DLBCL. However, roughly 30–50% of patients either fail to respond or relapse after a temporary remission. A significant subset of patients exhibits co-expression of MYC and BCL2 proteins, known clinically as double-expressor lymphoma (DEL). DEL is typically associated with aggressive features, including older age at onset, widespread metastasis, frequent extranodal involvement, and poor response to R-CHOP therapy. These patients have a significantly worse prognosis than non-DEL DLBCL patients, representing a substantial unmet clinical need. The DEB study was jointly led by Ruijin Hospital, affiliated with Shanghai Jiao Tong University School of Medicine, and Peking University Cancer Hospital, encompassing 45 clinical centers across China. This randomized, double-blind, placebo-controlled, multicenter Phase III trial evaluated the efficacy and safety of Chidamide combined with R-CHOP (Anti-CD20 rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) versus R-CHOP alone in previously untreated MYC/BCL2 double-expressor DLBCL patients. A total of 423 patients were enrolled, with 211 randomized to the Chidamide group and 212 to the placebo group. Participants received six cycles of either Chidamide or placebo in combination with R-CHOP (three weeks per cycle). Patients who achieved a complete response then continued with 24 weeks of oral Chidamide or placebo as maintenance therapy.