Sanofi Announces Latest Real-World Evidence from IsaFiRsT Study, Accelerating Access to Innovative Therapy for Relapsed or Refractory Multiple Myeloma in China

China Finance and Economics News, June 14 — The European Hematology Association (EHA) Annual Meeting, a major event in the field of global hematology, was recently held in Spain. At this annual meeting, Sanofi announced the latest progress of a real-world study (IsaFiRsT) conducted in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan, China.

IsaFiRsT study data show that the combination therapy of next-generation CD38 monoclonal antibody Isatuximab with Pomalidomide and Dexamethasone (Isa-Pd) achieved an Objective Response Rate (ORR) of 82.6% in Chinese patients with relapsed or refractory multiple myeloma (RRMM).

　　Real-world study in Chinese population: Primary endpoint of ORR achieved

The IsaFiRsT study, presented at this year's EHA conference, is the first real-world study to evaluate the efficacy and safety of Isatuximab in combination with Pd in Chinese patients, and serves as an innovative drug registration study. The primary endpoint of this study is the objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), overall survival (OS), duration of response (DoR), and safety.

The study enrolled a total of 24 patients with RRMM who had previously received ≥2 types of treatment (including lenalidomide and proteasome inhibitors). The median age was 62 years, 91.7% of the patients were resistant to PI, 95.8% were resistant to lenalidomide, 91.7% were double-resistant, and 91.7% were resistant to the last line of prior treatment. These patients received Isa-Pd treatment until disease progression or the occurrence of unacceptable toxicity. As of November 12, 2023, the investigator-assessed ORR was 82.6%, consistent with the results of the global Phase III ICARIA-MM study. The median time to first response was 1.18 months (range: 0.9-3.1 months). At a median follow-up of 8.41 months, the median PFS, OS, and DoR were not reached. Additionally, no new safety signals were identified, and overall adverse reactions were manageable.

Professor Weili Zhao from Ruijin Hospital, affiliated with the Shanghai Jiao Tong University School of Medicine, introduced that based on the research results of new drugs in the MM field and the unmet treatment needs of MM patients, the IsaFiRsT study analyzed the efficacy of the Isatuximab + Pomalidomide + Dexamethasone (Isa-Pd) regimen in the RRMM population in China using real-world research data. "Ruijin Hainan Hospital rapidly completed the real-world research project of Isatuximab injection in just 238 days. Isatuximab has also become the first hematological tumor treatment drug to utilize real-world data from Lecheng to receive an application for marketing authorization acceptance from the National Medical Products Administration."

　　Real-World Research "Accelerates" to Enhance Access to Innovative Drugs

To promote the entry of internationally advanced drugs and medical devices into the Chinese market for the benefit of patients, the National Medical Products Administration (NMPA) has actively explored the application of Real-World Evidence (RWE) in the review and approval of drug and device products in recent years. As China's only "medical special zone," Lecheng Pilot Zone leverages special policies such as "pioneering trials" to conduct cutting-edge research on the application of real-world data, accumulating experience and exploring methods for the reform of China’s drug and device review and approval systems.

Currently, with the Hainan Provincial People's Government as the construction entity, Ruijin Hospital Shanghai as the output hospital, and Hainan Provincial People's Hospital as the supporting unit, multiple real-world studies are being actively promoted. Isatuximab is one of the three pilot drugs conducting clinical real-world data research in the Lecheng International Medical Tourism Pilot Zone.

According to statistics, in China, there are approximately 1.6 patients with multiple myeloma per 100,000 people. The incidence rate is increasing annually and the age of onset is lower compared to the global average. Moreover, multiple myeloma remains an incurable malignant hematological tumor, and patients will eventually face the dilemma of recurrence.

Dr. Huang Junming, Head of Clinical Research and Development at Sanofi China, stated that real-world evidence is playing an increasingly important role in the field of drug development and regulation. It demonstrates innovative value in promoting registration, access, and other aspects, opening up an accelerated pathway for the availability of innovative products. This has drawn significant attention and emphasis from drug regulatory agencies, the pharmaceutical industry, and academia worldwide. "Sanofi is responding to China's reform of the drug approval and review system by leveraging the pilot policy in Boao Lecheng, Hainan, to conduct real-world studies and generate high-quality evidence. This marks the 'first step' in accelerating innovation in the field of multiple myeloma."

Moreover, at the recently concluded American Society of Clinical Oncology (ASCO) Annual Meeting, another Phase 3 clinical study on Isatuximab in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for the treatment of newly diagnosed multiple myeloma patients ineligible for transplant was also presented. Compared to the standard VRd treatment, the combination of Isatuximab with VRd reduced the risk of recurrence or death by 40%. The U.S. Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for Isatuximab based on the IMROZ Phase 3 clinical trial and granted it priority review. Currently, the NMPA has also accepted the marketing application for this indication, which is expected to bring more innovative options to multiple myeloma patients in China as soon as possible.