COPIKTRA, a Blockbuster of CSPC Pharma Group, Obtained Registration Approval

On September 22, 2022, the national launch conference of COPIKTRA® (duvelisib capsule) was grandly held in Shanghai in a combination of online and offline.

Professor Shen Zhixiang from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Professor Wang Jianxiang from Blood Diseases Hospital, Chinese Academy of Medical Sciences, Professor Ma Jun from Harbin Institute of Hematology & Oncology, Professor Wu Depei from the First Affiliated Hospital of Soochow University, Professor Huang Xiaojun from Peking University Institute of Hematology, Professor Hu Yu from Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Professor Zhao Weili from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Professor Qiu Lugui from Blood Diseases Hospital, Chinese Academy of Medical Sciences, Professor Li Jianyong from Jiangsu Provincial People 's Hospital, Professor Ji Chunyan from Qilu Hospital of Shandong University, Professor Liu Qifa from Nanfang Hospital of Southern Medical University, and Professor Huang He from the First Affiliated Hospital of Zhejiang University School of Medicine jointly served as the chairman of the conference. Mr. Zhang Cuilong, Vice Chairman and CEO of CSPC Pharma Group, participated in the event and witnessed this exciting moment together.

At the beginning of the meeting, Professors Shen Zhixiang, Wang Jianxiang, Ma Jun, Wu Depei, Huang Xiaojun, Yu Hu, Zhao Weili, Qiu Lugui, Li Jianyong, Ji Chunyan, Liu Qifa, and Huang He delivered speeches and recognized the efficacy of COPIKTRA® (duvelisib capsule). The launch of this product opens a new landscape for treating relapsed or refractory follicular lymphoma (r/rFL). They recognized the innovation level of CSPC Pharma Group, congratulated on the launch of COPIKTRA®, and looked forward to the subsequent clinical application of COPIKTRA® to benefit more patients.

Professor Zhao Weili of Ruijin Hospital, as the leading PI, pointed out that it was the honor as well as the responsibility of all PIs to make COPIKTRA® the first PI3K inhibitor marketed in China to serve more patients. During the clinical study of COPIKTRA®, there were concerns about whether the drug could truly serve the clinic and patients well. However, with the efforts of all PIs, the drug was not only found clinically safe, but also a resolution was developed to reduce its toxic side effects. The excellent efficacy of COPIKTRA® in Chinese patients may be related to the unique biological behavior of Chinese patients with follicular lymphoma, inspiring us to continuously carry out relevant translational medicine research and translate therapeutic targets into clinical treatment regimens truly.

Mr. Zhang Cuilong, Vice Chairman and CEO of CSPC Pharma Group, pointed out that COPIKTRA® (duvelisib capsule) is marketed as the first approved PI3K inhibitor in China and the only oral dual inhibitor of PI3K-δ and γ all around the world. Its launch gives new hope for the treatment of patients with relapsed or refractory follicular lymphoma (r/rFL). Moreover, COPIKTRA® is also laid out in solid tumors and other hematological oncology fields such as CLL/SL, PTCL, and DLBCL, which is expected to help and benefit more patients.

With the expectation of all parties, the presidium of the conference, leaders of CSPC Pharma Group, and the participating experts jointly witnessed the launch ceremony of the national marketing of COPIKTRA® in China. Working with experts, COPIKTRA® will open a new landscape of treatment for relapsed or refractory follicular lymphoma (r/rFL) – to "co-overcome the diseases with improved efficacy".

The conference then proceeded to the academic communication part.

Chapter I Trace the origin, Co-overcome the disease with the dual inhibitor

Professor Hou Ming from Qilu Hospital of Shandong University, Professor Feng Ru from Nanfang Hospital of Southern Medical University, Professor Hou Jian from Renji Hospital, Shanghai Jiao Tong University School of Medicine, Professor Niu Ting from West China Hospital, Sichuan University, and Professor Li Junmin from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine jointly presided over this section.

First, Dr. Svende Vos, an MD and PhD from DavideGeffen School of Medicine at UCLA, USA, introduced the mechanism of action of duvelisib: activation of the PI3K pathway leads to activation of the PI3K-AKT-mTOR pathway, resulting in the growth and survival of B cells, while PI3Kδ mainly inhibits this pathway, thus inhibits the growth and survival of malignant B cells. Meanwhile, PI3K-γ inhibition helps regulate the tumor microenvironment, a non-tumor cell network that is essential for the survival and proliferation of malignant B cells. In addition, the efficacy and safety data from IPI-145-02 (treatment for R/RiNHL) and DYNAMO studies were also shared. Given the promising efficacy and manageable safety data of duvelisib, the drug deserves further exploration in the future.

Professor Zhao Weili from Ruijin Hospital, Shanghai Jiao Tong University School of Medicine shared the data of duvelisib in China compared with the key registered clinical data in the United States, duvelisib showed superior efficacy in a representative population of r/rFL subjects in China, with a rapid onset of action (median time 1.8 months), an objective response rate (ORR) of up to 95.2%, a complete response rate (CR) of 52.4%, and a median progression-free survival (PFS) of up to 18.86 months. Similar to the safety profile from the pivotal clinical trials in the United States, no new safety signals were identified, most treatment-emergent adverse events were events with low grade (Grade 1-2), and no subjects had adverse events with a fatal outcome. Pneumonitis reaction, adverse events of special interest in the US clinical trials, can also be effectively prevented with safe and convenient pretreatment. Overall, it showed a superior benefit-risk ratio.

During the master dialogue, experts recognized the efficacy of COPIKTRA® (duvelisib capsule) in r/rFL.

Chapter 2: Think deeply and plan carefully, Focus on COPIKTRA®

Professor Luo Jianmin from the Second Hospital of Hebei Medical University, Professor Zhang Huilai from Tianjin Medical University Cancer Institute and Hospital, Professor Jiang Qian from Peking University People's Hospital, Professor Zhang Mingzhi from the First Affiliated Hospital of Zhengzhou University, and Professor Wei Xu from Jiangsu Provincial People's Hospital jointly presided over this section.

Professor Xu Bing from the First Affiliated Hospital of Xiamen University shared the current status of diagnosis and treatment of follicular lymphoma and the progress in diagnosing and treating r/rFL. Follicular lymphoma is incurable, and patients with POD24 have significantly shorter survival. At the 2022 EHA meeting, the interim data of the TEMPO study (exploratory research of the intermittent dosing paradigm of duvelisib) showed that DUV 25 mg BID intermittent dosing after continuous dosing (Group 1) and intermittent dosing (Group 2) were safe and effective in iNHL patients, with overall response and complete response rates similar to those observed in the DYNAMO study. A study of duvelisib combined with rituximab and bendamustine in iNHL patients showed an overall response rate of 71.8% and median progression-free survival of 13.7 months; the adverse event profile of the drug combination was consistent with that of monotherapy. In addition, Professor Xu Bing shared the exploration of CD20 × CD3 bispecific antibody, CAR-T, BTK inhibitor, SYK inhibitor, EZH2 inhibitor, HDAC inhibitor, and other new drugs in the FL field and looked forward to more new drug exploration benefiting patients with follicular lymphoma.

During the dialogue section, experts said there were still many unmet clinical needs for r/rFL. Oral duvelisib was more convenient for clinical use and had excellent efficacy. Experts in lymphoma need to explore the data of Chinese people to obtain better benefits for them. At the same time, it contains the application prospects in other hematological malignancies.

Summary

Finally, Professors Ji Chunyan, Li Jianyong, and Shen Zhixiang summarized the conference, praising its informativeness and smooth progression. They looked forward to COPIKTRA® exerting excellent efficacy in Chinese patients and opening a new chapter in the clinical treatment for follicular lymphoma.