On April 11, Baiji Shenzhou announced that the final remission evaluation results of phase 3 global clinical trial Alpine study of baiyueze were released. It was confirmed by the Independent Review Committee (IRC) that in adult patients with recurrent or refractory (R / R) chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoblastoma (SLL), Btk inhibitor baiyueze (zebutinib) showed a better overall remission rate (ORR) than ibutinib, Once again confirmed its potential as the world's "best in class" Btk inhibitor.
It is reported that as early as the mid-term analysis of the test, Baiyue Ze has reached the main end point of the test, that is, it shows its superiority in the orr evaluated by the researchers. In this final mitigation assessment, Hyatt also reached the primary endpoint and showed better orr data than ibutinib in the IRC assessment. Compared with ibutinib, the orr results were 80.4% and 72.9% respectively (bilateral p value = 0.0264). Among them, Orr is defined as the sum of complete remission and partial remission data.
As one of the 35 clinical trials conducted by Hyatt worldwide, this alpine head-to-head trial has enrolled 652 patients worldwide, covering Europe, the United States, China, New Zealand, Australia and other countries and regions. The median follow-up time was 24.2 months.
"Head to head" research refers to the clinical trial carried out under the same test conditions with the therapeutic drugs or methods used clinically as the direct control, which can be regarded as the "direct single challenge" of the two drugs. The purpose of this kind of research is to conduct more direct and detailed research and comparison on the efficacy or safety of drugs. Through the direct control of head-to-head test, it can provide clear and accurate clinical evidence for doctors and patients. Usually, due to the difficulty, high investment and high risk of such tests, few enterprises directly initiated head-on research challenges in China in the past.
Dr. Wang Lai, global R & D director of Baiji Shenzhou, said, "We are pleased to announce the latest preliminary data from the phase 3 trial of Alpine. This trial shows that among CLL patients with disease recurrence or metastasis after previous treatment, the overall remission rate of Alpine is better than that of ibutinib. We are well aware that disease recurrence and treatment resistance are particularly difficult challenges for CLL patients and their families. Therefore, we are encouraged by the final remission evaluation results of this trial, which is further improved It has expanded our clinical evidence and once again confirmed the potential of Hyatt for the treatment of CLL. "
The company said that based on the support of the alpine test results, Baiji Shenzhou has submitted the listing license application of baiyueze for CLL in the United States, the European Union and other markets. In February 2022, Baekje announced that the US FDA and the European drug administration had accepted the listing application of new indications of Hyatt for the treatment of CLL. As a pioneer in the globalization of China's innovative drugs, baek Hyatt China was approved to be listed in the US FDA in November 2019, realizing the "zero breakthrough" of China's new anti-cancer drugs at sea. Subsequently, it has been approved in China, Canada, Australia, Russia, the European Union and other countries and regions. At present, it has successfully landed in 45 markets around the world. In addition, more than 40 drug administration declarations are still under review worldwide.
According to reports, in China, Hyatt has obtained conditional approval for three indications, including adult mantle cell lymphoma (MCL) patients who have received at least one treatment in the past, adult chronic lymphocytic leukemia (CLL) / small lymphocytic lymphoma (SLL) patients who have received at least one treatment in the past, and adult Fahrenheit macroglobulinemia (WM) patients who have received at least one treatment in the past. At present, the three approved indications of Hyatt Ze have been included in the latest version of China's national medical insurance catalogue, becoming the product with the lowest monthly treatment cost among similar Btk inhibitors, and benefiting Chinese patients with high standards of international quality.
Industry analysts said that as the first local R & D new drug to obtain the dual recommendation of the Sino US clinical guidelines, many indications of bayonet have been preferentially recommended by the guidelines. In the latest version of the national comprehensive cancer network (NCCN) guidelines of the United States, Hyatt Ze was included in the first-line or back-line priority recommended treatment scheme of CLL / SLL, marking a significant rise in its international guideline recommended position in this important indication of CLL. At the beginning of 2022, the drug audit center of the State Food and drug administration has also accepted the application for marketing license of new indications (SNDA) of Baiyue Ze for the treatment of newly treated adult CLL / SLL patients, and granted it the recognition of breakthrough therapy, which will accelerate its promotion as a first-line treatment scheme and bring treatment New Hope Liuhe Co.Ltd(000876) .
