In March of this year, CAR-T therapy LCAR-B38M cell autologous reinfusion preparation obtained the clinical trial approval of the former State Food and Drug Administration (CFDA), becoming the first clinically approved CAR-T therapy in China.
Recently, at the just-concluded 60th Annual Meeting of the American Society of Hematology (ASH), Kingsray's controlling subsidiary, Nanjing Legend Bio, published the latest safety and efficacy data for LCAR-B38M therapy. Clinical research data shows that As of June 25, 2018, 57 patients with advanced multiple myeloma who were 54 years old (range 27-72 years) underwent LCAR-B38M therapy with an overall response rate (ORR) of 88%, 74%. (42) patients achieved complete remission (CR), 4% (2 patients) achieved very good partial response (VGPR), and 11% (6 patients) achieved partial remission (PR), flow Cellular examination showed that of the 42 patients who achieved complete remission, 39 patients had a negative residual lesion (MRD) with a median duration of 1 month.
At the same time, the median duration of remission (DOR) was 16 months, and the median duration of response to complete remission was 22 months. By the data cut-off date, 18 patients who achieved partial or better outcome (36%) The disease progressed, with a median progression-free survival (PFS) of 15 months for all admitted patients and a median progression-free survival (PFS) of 24 months for patients achieving complete remission.
In addition, a peak of LCAR-B38M (≥1×104 copies/μg genomic DNA) was detected in blood samples of most patients (32 patients). At 4 months after treatment, LCAR-B38M CAR-T cells were not detected in the peripheral blood of 71% of patients, and 5 patients were still able to detect CAR-T cells after 10 months of treatment.
It is reported that the above results are also the first demonstration of the results of the CAR-T therapy LCAR-B38M study since the 2017 American Society of Clinical Oncology (ASCO) annual meeting. In addition, another LCAR-B38M treatment for relapsed/refractory multiple A phase 1/2 clinical study of sexual myeloma (Clinical Trial number NCT03548207) has been conducted in the United States.
In June last year, data published by Nanjing Legend at the annual meeting of the American Society of Clinical Oncology showed an objective response rate for LCAR-B38M therapy in a clinical trial involving 35 patients with relapsed or drug-resistant multiple myeloma. Up to 100%, of the 19 patients who received the first treatment, 14 achieved strict complete remission (sCR), and the remaining 5 had partial remission, 4 of whom were in very good condition, and 5 of them were Patients who have been treated for more than 1 year are still in the sCR phase. The above excellent data displayed by LCAR-B38M therapy in the treatment of multiple myeloma has brought great attention to Nanjing legendary creatures and is known as the black horse of ASCO in 2017. This sought-after thermal effect has nearly collapsed with a report released this year by the short-selling organization.
On September 27, 2018, an independent research institute launched by a group of senior stock investors, the bonfire research report released that the suspected Nanjing legendary CAR-T data was suspected of fraud, the final valuation is only 3.29 Hong Kong dollars per share, strongly recommended Selling, the news has caused strong concern in the industry.
Specifically, the bonfire research questioned Nanjing legendary creatures in seven aspects, including technical sources, process design and commercialization progress, clinical data published in ASCO in 2017, suspected fraud, and deaths from subjects in Shanghai Changzheng Hospital.
Subsequently, Kingsley issued a clarification report. In response to the alleged fraud on clinical trial data, the response stated that the 2017 ASCO meeting was held in June, but the deadline for the conference paper was February 2017, so the company submitted the traffic to Xi'an to the conference. The clinical data of the cooperation of the Second Affiliated Hospital of the University is also as of February 2017. The data was released at the ASCO conference in June 2017. The cooperation between Nanjing Legend and Shanghai Ruijin Hospital, Shanghai Changzheng Hospital and Jiangsu Provincial People's Hospital was submitted after the submission of the 2017 ASCO paper submission deadline (ie February 2017). Only then did the data unfold at the ASCO conference in June 2017.
For the death case, Kingsray said that on September 16, 2017, after the death, the company notified all the researchers in the form of a researcher's letter. The company disclosed this to the public on September 19, 2017. The information was not concealed as stated in the report. All professional medical information reports of the patient have also been reported to China CDE and the US FDA, and are evaluated and judged by professionals without any concealment. However, Kingsley did not mention the specific reasons for the death of the case.
As a result, the bonfire research did not buy for its announcement. On October 1, bonfire research released a second report, arguing that Kingsray responded with evasiveness and further misled investors. Kingsley denied all the allegations against the group in the second report and stated that he had taken the necessary legal action on the two reports.
Also because of the alleged data fraud, the Nanjing Legend announced the data at the annual meeting of ASH.
According to health reports, the clinical trial data released by Nanjing Legend, the question of its selective disclosure data has not been completely eliminated. The data on LCAR-B38M is “at least controversialâ€, and Leerink analyst Porges recently accepted The media said in an interview.
To date, there have been 74 subjects in the LCAR-B38M therapy, and the study was conducted in four pilots. The Clinical Center Xi'an Jiaotong University Second Affiliated Hospital is the main responsible party for the recruitment of patients (57 subjects were recruited), and only 57 patients were published. The other three pilots involved in the study, Shanghai Ruijin Hospital, Shanghai Changzheng Hospital and Jiangsu Provincial People's Hospital, also recruited a total of 17 patients, but the data of the three pilots were not announced. The information in these three places was only disclosed once at the ASH Annual Meeting in 2017. At that time, 11 patients who were treated at these three locations were detailed. Among them, 8 patients had sCR, 2 patients had VGPR, and 1 patient had PR. The total response rate was up to 100%.
Fan Xiaohu, the chief scientific officer of Nanjing Legendary Biology, recently told BioCentury (American biomedical industry consulting company) that the data set of 17 patients in the three pilots “is very consistent in terms of safety and efficacy†and may appear soon. In peer-reviewed journals.
The fat of squid contains a large amount of highly unsaturated fatty acids such as EPA and DHA, plus the high amount of taurine contained in the meat, which can effectively reduce the cholesterol accumulated in the blood vessel wall, which is effective in preventing vascular sclerosis and the formation of gallstones. Quite effective. At the same time, it can replenish brain power and prevent Alzheimer's disease. Therefore, squid is healthy food for middle-aged and elderly people who are prone to cardiovascular diseases.
Squid Fillets,Fish Fillet Squid,Fresh Frozen Squid Fillets,Filleting Whole Squid
Zhejiang Industrial Group Co., Ltd. , https://www.xingyeseafood.com