10 most anticipated clinical studies in China at esmo2019
Last Update: 2020-06-19
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Autumn, harvestFor pharmaceutical and chemical workers, September and October are bound to be busy, exciting and rewarding timesJust after the end of wclc2019, CSCO will come one after anotherIn the new week, CSCO will return to Barcelona to open the ESMO eventIn October, Nobel prizes will be announced< br / > what domestic products and new data will be disclosed for the upcoming esmo2019 meeting? Of course, some enterprises have participated in wclc2019 and / or CSCO in the whole processThen, what is the gold content of data on esmo2019, we will see< br / > 1Baiji Shenzhou < br / > Baiji Shenzhou has just participated in the 22nd China Society of Clinical Oncology (CSCO) and published 7 clinical trials of tislilizumab, but it will not be absent from ESMO, and will continue to publish the latest progress of tislilizumab and PARP inhibitor pamiparibi< br / > pamiparib (bgb-290) is a small molecule inhibitor of PARP1 and PARP2 under research in Baiji, ChinaAt present, pamiparib is a key clinical trial in the treatment of platinum sensitive ovarian cancer maintenance therapy and BRCA germline mutant ovarian cancer in ChinaBefore that, the preliminary data of the combination of tislilizumab and pamiparib have been released in Baiji, and the latest research data of pamiparib single drug and temozolomide combination will be brought to this conference< br / > 1Updated results of the PARP1 / 2 initiator pamiparib incorporation with low-dose (LD) temozolomide (TMZ) in patients (PTS) with locally advanced or metallic solid tumors < br / > target: PARP1 / 2 < br / > time: 2019 / 9 / 28 < br / > 2Safety, antiator activity, and pharmacokinesics (PK) of pamiparb (bgb-290), a PARP1 / 2 initiator, In patients (PTS) with advanced solid tutorials: updated phase 1 dose escalation / expansion results < br / > target: PARP1 / 2 < br / > time: 2019 / 9 / 28 < br / > 2Hengrui medicine < br / > as a domestic R & D leader, Hengrui medicine participated in wclc2019 and CSCO two conferences, and published a number of research data for carrizumabThis time, Hengrui carried the PARP inhibitor fluzoparib (shr3162) and landed in ESMO At present, fluzoparib has been advanced to stage III in China and used for recurrent ovarian cancer At this conference, Hengrui will publish the results of two studies on the increasing dose of fluzopali and the efficacy and safety of ovarian cancer 1 Phase-I dose-escalation and expansion study of the PARP inhibitor, fluzoparib(SHR3162), Efficacy and safety of oral poly (ADP ribose) polymer inhibitor fluzoparib in patients with BRCA1 / 2 mutations and platinum sensitive recurrent ovarian cancer < br / > as a benchmark enterprise for new drug development in China, niraparib of zaiding pharmaceutical will also announce the results of the mid-term study based on the prospective assessment of dose tolerance based on the baseline body weight (BW) and platelet (PLT) count at the ESMO conference < br / > in 2017, the US Food and Drug Administration (FDA) and the European Drug Administration (EMA) approved the use of nilaparil in the maintenance treatment of women with recurrent platinum sensitive ovarian cancer In October 2018, nilaparil was approved in Hong Kong, China for the treatment of platinum sensitive recurrent high-grade serous epithelial ovarian cancer patients with complete or partial remission (PR) of chemotherapy containing platinum, without BRCA test At the end of 2018, niraparib submitted its listing application in China and was included in the priority review by CDE, which is still in the stage of listing review In addition, at this conference, niraparib will also have a number of foreign research data published < br / > a prospective evaluation of tolerance of niraparib doing based on baseline body weight (BW) and plate (PLT) count: blinded pooled interior safety data from the NORA study < br / > target: PARP < br / > time: 2019 / 9 / 29 < br / > published by Fudan University Shanghai Cancer Center < br / > 4 < br / > fcn-159 is a new and efficient mitogen activated protein kinase (MEK) inhibitor independently developed by Shanghai Fosun Pharmaceutical Industry Development Co., Ltd., a subsidiary of Fosun Pharmaceutical Holding Co., Ltd and Chongqing Fosun Pharmaceutical Research Co., Ltd MEK is a key member of Ras / Raf / MEK / ERK signaling pathway, regulating several key cell biological activities, including proliferation, differentiation, migration, survival and angiogenesis Disorders of this pathway are usually found in many types of cancer (especially those with BRAF, KRAS, and NRAS mutations) < br / > compared with the listed MEK inhibitor, trametinib (gsd1120212), fcn-159 has enhanced in vitro and in vivo activity, excellent physical, pharmacokinetic and safety characteristics, and is suitable for combination therapy At the meeting, the safety, pharmacokinetics (PK) and preliminary antitumor activity of fcn-159 in patients with NRAS abnormal or mutant advanced melanoma will be announced < br / > a phase IA / IB clinical study to evaluate the safety, phamacokinetics (PK) and preliminary anti tumor activity of fcn-159 in patients with advanced melanoma harboring NRAS aberrant (IA) and NRAS mutation (IB) < br / > disease field: melanoma (abnormal or mutated NRAS) < br / > time: 2019 / 9 / 30 < br / > published by Beijing University Cancer Hospital < br / > 5 Lilly < br / > in 2015, FDA granted Lilly CDK4 / 6 inhibitor abemaciclib breakthrough drug qualification, and approved the combination of abemaciclib and aromatase inhibitor for postmenopausal hormone receptor (HR) positive, HER2 negative advanced or metastatic breast cancer on February 26, 2018 At this meeting, the results of phase III clinical studies of the drug in China will be announced < br / > monarchplus: a phase 3 trial of abemaciclib plus nonsteroidal array inhibitor (NSAI) or fulvestrant (f) for women with HR + / HER2 advanced breath cancer (ABC) < br / > time: 2019 / 9 / 29 < br / > published by: Affiliated Hospital of Academy of Military Medical Sciences < br / > alfetinib mesylate (ast2818) is an irreversible, third-generation EGFR inhibitor developed by Elis in Shanghai According to the information disclosed by the network, alfetinib has the same objective response rate as Teresa, and has good tolerance The adverse reactions of gastrointestinal tract and skin are significantly lower than Teresa Last month, Teresa was approved as a domestic first-line drug for adult patients with egfrt790m mutant advanced metastatic non-small cell lung cancer; in the just concluded wclc2019 meeting, the latest research data of ometinib showed that the same objective response rate and disease control rate as that of Teresa were achieved in terms of efficacy, and ometinib has applied for listing, which was also included in the priority review by CDE It remains to be seen whether the research data at this session will add to the score of efutinib < br / > safety and activity of alflutinib in patients with advanced EGFR T790M mutationnon small cell lung cancer who progressed after EGFR-TKI therapy < br / > target: EGFR T790M < br / > time: 2019 / 9 / 28 < br / > 8 Development pharmaceutical < br / > proxalutamine (gt0918) is based on the structure optimization of azalutamine, The new generation of androgen receptor (AR) antagonists developed independently are also in the first-line clinical trials of metastatic castration resistant prostate cancer (mcrpc) At this ESMO meeting, pioneer pharmaceutical will release the data of clinical phase II safety and tolerance of Prochloraz in patients with metastatic castrated resistant prostate cancer (mcrpc) who failed to receive abitron or azarulamine treatment < br / > the extended / phase II study of safety and tolerance of proxalutamide (gt0918) in subjects with metastatic cast resistant project cancer (mcrpc) who failed either absolute (ABI) or enzalutamide (Enza) < br / > target: AR < br / > time: 2019 / 9 / 30 < br / > in addition to the above several Chinese clinical studies, it is worth looking forward to, There are also a lot of research highlights that can be seen around the world For example: < br / > 1) under the guidance of recent amg510 clinical data, RAS target drug research, especially KRAS, must attract many followers to carry out similar research one after another However, there are still some uncertain factors in the future research of this target Even if the curative effect is significant, there is still a certain time limit to the wide application of patients As a drug on the market, If bevacizumab can perform well in the results disclosed in this meeting, it will bring more timely gospel for colorectal cancer patients with ras mutation < br / > bevacizumab plus chemotherapy versus chemotherapy alone as first treatment for patientswith Ras mutant unresponsive color Limited cancers - a single center randomized control trial < br / > 2) a few days ago, a small sample size (n = 94) single arm study conducted by FDA / TGA / Health Canada approved keytruda + lovatinib for endometrial cancer patients without hsi-h and without mismatch repair defect (dmmr) who were not suitable for surgery or radiotherapy after systematic treatment At present, PD-1 / PD-L1 single drug treatment of various types of cancer has very obvious limitations, combined with chemotherapy, anti angiogenic drugs is the general trend Therefore, there are a large number of PD-1 / PD-L1 joint data published on this ESMO We select two items as one of the concerns < br / > lenvatinib plus PD-1 blockade inadvanced bill track carcinoma < br / > time: 2019 / 9 / 30 < br / > publishing unit: Peking Union Medical College Hospital < br / > pembrolizumab vs chemotherapy in patients with advanced / metastatic adenocarcinoma (AC) or squad cell carcinoma (SCC) of the esophagus as second line therapy: analysis of the Chinese subgroup in keynote-181 < br / > time: 2019 / 9 / 29 < br / > published by Jiangsu cancer hospital < br / > 3) lung cancer is the most concerned cancer in the world At this ESMO meeting, there will be a number of research data disclosure for different ALK drugs, and there will also be "head to head" research, which is worth looking at In addition, the mechanism of EGFR T790M inhibitor oxitinib on brain metastasis of EGFR + NSCLC and the efficacy data were also included < br / > crizotinib vs platinum based chemotherapy as first line treatment for advanced non small cell lung cancer with different ros1 fusion variants < br / > time: 2019 / 9 / 28 < br / > published by: Cancer Hospital of Peking Union Medical College, Chinese Academy of Medical Sciences EGFR mutant lung cancer < br / > time: 2019 / 9 / 28 < br / > publishing unit: Henan cancer hospital < br / > action 1509: phase 3 study of bevacizumab with or without erlotinib in untreated Chinese patients with advanced EGFR mutated NSCLC < br / > time: 2019 / 9 / 30 < br / > public unit: Guangdong lung cancer research center
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