Sorrento Therapeutics' ENGINE Global Phase III Trial Gains Prominent Recognition at CSCO 2019

From September 18 to 22, the 22nd National Clinical Oncology Conference and the 2019 CSCO Annual Academic Meeting were held as scheduled in Xiamen, drawing more than 35,000 attendees to this academic feast. The international and domestic special sessions on leukemia and lymphoma, hosted by the Expert Committees of the CSCO Anti-Leukemia Alliance and the CSCO Anti-Lymphoma Alliance from the afternoon of September 19 to September 20, attracted significant attention, with all three sessions fully packed. Notably, during their respective thematic oral presentations, Professor Zhu Jun from Peking University Cancer Hospital and Dr. Grzegorz S. Nowakowski from the Mayo Clinic College of Medicine and Science at Mayo Clinic both highlighted Suoyuan Biomedicine’s global multicenter ENGINE study as a major ongoing trial.

The ENGINE study is a randomized, double-blind, placebo-controlled, multicenter, pivotal Phase III clinical trial conducted simultaneously in China and the United States. Guided by DGM1, a unique biomarker discovered by Suoyuan Biomedicine, the study represents a practical application of precision medicine. The study population consists of adult patients with newly diagnosed, CD20-positive diffuse large B-cell lymphoma (DLBCL) at high risk (International Prognostic Index [IPI] > 3). These patients are randomized in a 1:1 ratio to receive either R-CHOP plus DB102 (enzastaurin) or R-CHOP plus placebo. During the combination therapy phase, all patients receive up to six cycles of treatment. Upon completion of the combination therapy phase, tumor response is assessed and the study is unblinded. Patients in the DB102 arm who achieve complete or partial response are eligible to enter the monotherapy phase, receiving up to two years of DB102 monotherapy. The ENGINE study is progressing smoothly, with more than half of the target enrollment completed. It holds promise for providing safer and more effective first-line therapeutic options to extend survival in patients with high-risk DLBCL. Since its initiation, the ENGINE study has attracted significant attention from academic communities, with findings presented at international conferences including ASH, ASCO, and ICML.

Professor Jun Zhu serves as the Secretary of the Party Committee, Director of the Department of Internal Medicine, and Director of the Lymphoma Department at Peking University Cancer Hospital. He is the Chairman of the China Anti-Lymphoma Alliance and was recently elected as Vice Supervisor of the Third Council of the Chinese Society of Clinical Oncology (CSCO). As the lead investigator for the Chinese region in the ENGINE study, Professor Zhu spearheaded the successful conduct of the trial.

Dr. Nowakowski is a Professor, Program Director, and Senior Hematology Researcher at the Mayo Clinic College of Medicine and Science, Mayo Clinic. His primary research interests include lymphoma, chronic lymphocytic leukemia (CLL), and multiple myeloma. He serves as a lead investigator in large-scale global clinical trials initiated by researchers and conducted through collaborative research groups such as ECOG and the Alliance. Additionally, he is a voting member of the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC). Dr. Nowakowski leads the Mayo Clinic team participating in the ENGINE study and has repeatedly affirmed the study’s innovative approach to precision medicine. With the involvement of these globally renowned experts in the field of lymphoma, the ENGINE study is poised to bring new hope to patients.