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    Home > Medical News > Medical World News > ASCO China's innovative drug inventory: small molecules, antibody immunity, ADC drugs shine.

    ASCO China's innovative drug inventory: small molecules, antibody immunity, ADC drugs shine.

    • Last Update: 2020-08-03
    • Source: Internet
    • Author: User
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    affected by the COVID-19 outbreak, and ACSO will also hold an online conference this year. ASCO is the world's largest annual conference on clinical research on oncology, publishing clinical data on new and mature drugs, and clinical testing or markers. In recent years, domestic enterprises have increasingly participated in international conferences to increase their voice in the field of new drug research around the world. Today, we selected some of the data from the latest ASCO2010 summary to share with you.. Doafini is a xenon drug developed by Suzhou Zetseida for the multikine inhibitor solafenini and is currently undergoing clinical studies in liver cell cancer, colorectal cancer, thyroid cancer, nasopharyngeal cancer and other indications, and this meeting revealed a first-line liver cancer data from Donovani vs sorafenib. Although there are few drugs currently in the first-line field of liver cancer to defeat Soolafini, but Solafini Chinese compound patents will expire in 2020, the domestic generic sishaving enterprises have completed BE and declared listing, this move more or less make The future of Donafini is not so good, the success of the study, no doubt increased Donafini's "money path", Zei's stock first reacted.
    in this open-label, randomized, Phase II/III clinical trial (ZGDH3), in 37 centers in China, unremovable or metastatic HCC was recruited from 37 centers, and patients randomly grouped (1:1) to receive two oral doses of Doafini (0.2g) or sorafenib (0.4g) per day until intolerable toxicity or disease progression. The results showed that The median OS of Donafeni was significantly longer than that of Sorafeni (12.1vs 10.3 months, HR0.831), and the median progression-free life (3.7mvs 3.6 months, p-0.2824), Objective mitigation rate (4.6% vs 2.7%, p-0.2448), disease control rate (30.8% vs28.7%, p-0.5532) was slightly higher than Sorafenib, but there was no significant difference. Level 3 or more adverse reactions were quite even better than Donovani, with Donafini reporting a decrease in the number of patients with severe AE (55 s.16.5% ) vs67 ,20.2% , p .2307), Donafini Common adverse events include hand-foot skin reactions (50.5%), increased tintine transaminase (40.5%), increased blood bilirubin (39.0%), decreased platelet count (37.8%) and diarrhea (36.6%).
    Hengrui's meeting revealed a number of clinical studies of pyritinib and apatinib.
    is an irreversible pan-ErbB inhibitor developed by Hengrui Pharmaceuticals, and this meeting revealed a clinical phase 3 study of hertinib in or rapatinib with caperabin for patients with HER2-plus metastatic breast cancer (MBC).
    in the medium-term analysis, the median PFS of the pinotnosco-kapatabin vs. Capatini and Capatabin was 12.5 (95% CI9.7-notreached) vs 6.8m (95% CI55.4-8.1) to meet the statistical significance criteria. In patients with qurinazumab, an extension of PFS (12.5vs6.9 months; HR0.60, 95% CI0.29 to 1.21) was also observed. The penicitatonosiandi-capedabin also showed the objective mitigation rate and the benefit of the duration of the mitigation (table below). The most common level 3 adverse events were diarrhea (30.6 percent and 8.3 percent of the rapatinib group), hand and foot syndrome (16.4 percent and 15.2 percent)
    in addition, and the oxycodone also carried out data analysis studies on HER2-positive, qurtopzumab resistant metastatic breast cancer, as well as the activation of HER2 mutation NSCLC and other advanced solid tumors.
    Apatinib: Chinese patients account for more than 50% of the world's hepatocellular carcinoma (HCC) cases, and have special characteristics in terms of etiology, biological behavior, treatment strategies and prognosis. The randomized, controlled, double-blind Phase III study, published by ASCO2020, evaluated the efficacy and safety of apatinib as a second-line treatment in Chinese patients with advanced HCC.
    randomly grouped 393 patients and received at least one dose of the drug between April 1, 2014 and May 03, 2017 (261 in the Appatinib group and 132 in the placebo group). Apatinib's median OS is significantly longer than the placebo (8.7m (95% CI7.5-9.8) vs6.8m (95% CI5.7-9.1), HR0.785 (95% CI0.617-0.998) ;p.0476). The median progression-free survival (PFS) in patients in the appabonic group was also extended (4.5m (95% CI3.9-4.7) vs1.9m (95% CI1.9-2.0) and HR0.471 (95% CI0.369-0.601) ;p˂0.0001). The objective mitigation rate of apatinib was 10.7% (95% CI7.2-15.1) and the placebo was 1.5% (95% CI0.2-5.4).
    treatment-related adverse events (TRAE) were 250 (97.3%) in the apatinib group and 92 (70.8%) in the placebo group. The most common TRAE at levels 3 and 4 were hypertension (71 cases in the Appatinib group, 3 cases in the placebo group , 3 cases in the placebo group , 3 cases of hand and foot syndrome ( 46 cases , 17.9% , vs0), decreased platelets (34 .13.2% ) vs1 , 0.8% ) , and neutrophils decreased ( 27 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Twenty-four cases (9.3 percent) in the appabonic group and 13 cases (10.0%) in the placebo group died from adverse events, none of which were found to be associated with treatment. In addition
    , Apatinib conducted a prospective, open, single-arm, multi-center post-chemotherapy post-chemotherapy late-stage soft tissue sarcoma (STS) patient efficacy study, overall, 27 out of 51 patients did not progress within six months, 6 months PFS rate of 53.32% (95% CI37.76%, 66.63%), to the end with ORR was 18.75% (9/48) and DCR was 87.5% (42/48), median PFS was 7.13 (95% CI3.84, 9.23) months, and median OS was not in fashion at 24.67 (9.30-NE) months.
    SHR6390 is a new inhibitor of cell cycle protein-dependent kinase 4/6 (CDK4/6). The study was designed to assess tolerance, pharmacokinetics, safety, and initial anti-tumor activity in patients with advanced breast cancer (ABC).
    recruited a total of 40 patients between 15 April 2016 and 21 December 2018. All patients were diagnosed with hormone receptor-positive and HER2-negative ABC, 45.0% received at least three chemotherapy and 55.0% received at least two endocrine therapy. The 100mg, 125 mg and 150mg queues of SHR6390 were expanded to 10 cases, respectively, with no dose-restricted toxicity observed and MTD not achieved. Level 3 adverse events (AEs), i.e. neutrophil deficiency (52.5%), leukocyte reduction (35.0%), platelet reduction (5.0%) and hypertension (2.5%), were observed in 55.0% of patients, with no serious adverse events reported. The disease control rate was 62.5% (25/40, 95% CI45.8%-77.3%), and 2 patients (5%, 125mg, 150mg group) achieved partial remission for 169 days and 356 plus days, respectively.
    Anrotini disclosed at least seven summaries at this meeting, limited to space, and we have only two. Other tumors covered at this meeting were recurrent advanced cervical cancer, recurrent platinum resistance or refractive ovarian cancer, thyroid myelin cancer, recurrent or metastatic primary malignant bone tumors, and advanced sarcoma.
    research in the joint ettinib first line treatment carrying EGFR mutation non-small cell lung cancer (NSCLC) recruited patients with previously untreated portable EGFR exon 19 deficiency and/or exon 21L858R mutation local lysyand and/or metastatic IIIB, IIIC or IV squamous NSCLC. Between July 2018 and December 2019, 35 patients were recruited at five centres, giving Anrotini (12mg, qd) and Ektinib (125mg, tid), mainly pfS, secondary endpoints OS, ORR, DCR and safety. As of January 7, 2020, patients were followed for a median of 6.01 months. THE ORR IS 59% (0CR, 19PR) AND THE DCR IS 88% (0CR, 19PR, 9SD). Twenty-six patients are still being treated, with the longest exposure time being 14 cycles. Of the 15 patients with 15 exceptions to the absence of the onser 19, 10 (67%) responded and 9 (53%) in 17 patients with L858R mutation. In 18 patients with distortion in other cancer-causing drivers (PIK3CA or AKT1) and/or tumor suppressorfactors (TP53, RB1 and PTEN), or 72% of the ORR. AE was observed in 97% (34/35) patients and no adverse events of level 5 were reported, with the most common level 3 adverse events being hypertension (6 s.17%), hyperglycerides (2 s.6%), diarrhea (1 s.3%), high Uric acid emis (1 s.3%), hand and foot skin reactions (1 s.3%), fatigue (1 s.3%), and acute coronary syndrome (1 s.3%), hypertriglyceride is the only level 4 adverse event (2 s.6%).
    anrotinib and deprefensine combined cisplatin/karpin were conducted in a phase II single arm trial in patients with untreated large-period small cell lung cancer (SCLC). Between October 2018 and December 2019, 27 patients were included, with a median PFS of 9.61 months (95%Cl: 7.80-11.42), ANR of 77.78% (21/27) and a disease control rate of 96.30% (26/27). Toxicity above level 3 included neutrophil reduction 22%, leukocyte reduction 11%, hand and foot syndrome 15%, nausea 4%, mucositis 4%, edema 4%, anorexia 4%, oral dryness 4% and fatigue 4%, no level 5 toxicity.
    TQ-B3525 is a new type of selective oral PI3K alpha/gamma inhibitor, which is 41 times more active and 138 times higher than Buparlisib in preclinical studies. The Phase I study (NCT03510767) assessed the safety, tolerance, pharmacokinetics and antitumor activity of TQ-B3525 in patients with advanced malignancies in China.
    included patients with recurrent or refractive (R/R) lymphoma who have undergone at least two previous systemic anticancer treatments, as well as patients with advanced solid tumors who have failed standard anticancer treatments. TQ-B3525 is observed in the first cycle (28 days) of the dose increment phase from oral administration of 2 mg, 5 mg, 10 mg and 20 mg per day to 10 mg and 20 mg oral administration twice a day. Between June 2018 and December 2019, 40 patients were recruited, including 27 cases of R/R lymphoma and 13 patients with advanced solid tumors. Three types of DLT (all level 3 hyperglycemia) were observed, and the common adverse events at all levels were hyperglycemia (65.0%), increased glycogenic hemoglobin (35.0%) and diarrhea (32.5%). Treatment-related level 3 or 4 AE occurred in 11 patients (27.5%), the most common is also hyperglycemia (10.0%). THE ORR is 60.9% (95% CI, 38.5-80.2) and the ORR of 10mgqd is 70.0% (14/20, .95% CI, 49.9-90.1). For R/RFL, the ORR is 72.7% (8/11, 95% CI, 46.4-99.1). At the data cut-off (February 2, 2020), the median PFS for lymphoma was not reached.
    TQ-B3139 is a new TYPE OF ALK inhibitor that is 3-7 times higher than the active bikatinib for a wide range of ALK mutations, and this Phase I study (NCT030993330) aims to study the safety of TQ-B3139 in Patients with NSCLC in China and determine the recommended Phase II dose (RP2D) and pharmaceutical generation (PK Dynamics), and efficacy.
    patients with late-stage NSCLC and at least one systemic anti-cancer treatment failure, the design was designed in increments of 3 to 3 doses, from 50 to 100 mgqd and 200, 300, 400, 500, 600 and 800 mgbid. The overall ORR was 73.0% (2CR, 44PR) ;D CR was 85.7% (8SD). THE ORR AND DCR IN THE 200MGBID GROUP WERE 78.0% AND 89.8%, RESPECTIVELY, AND FOR PRIMARY AND DRUG-RESISTANT PATIENTS, ORR WAS 78.7% (37/47) AND 56.3% (9/16) RESPECTIVELY. For patients with measurable baseline brain metastasis, the ORR for cerebral lesions is 80.0% (8/10). As of January 23, 2020, the median PFS for all patients was 12.1 months (95% CI8.5-15.6) and the 200mg patients were 12.2 months. Primary patients did not reach the median PFS (6 months PFS rate 74.5%, 95% CI68.1-80.9), ALKTKI drug-resistant patients 5.6 months (95% CI1.6-9.5). In patients with high anti-tumor activity in Non-Small Cell Lung Cancer in China, TQ-B3139 had good tolerance, RP2D was 600mg, and TQ-B3139vs Crizotinib was in the process of a randomized Phase III trial in patients with advanced ALK-TKI primary treatment of NSCLC.
    ASCO2020 conference announced the Zebutinib vs Ibtinib treatment of Fahrenheit macroglobulinemia Phase III ASPEN study, 201 patients enrolled. Give Zebutini 160mg, bid or Ibtini 420mg, qd, respectively. The results showed that Zebutini was better than Zebutini in terms of effectiveness and safety:
    CR-VGPR: 28.4% vs 19.2%
    12 months PFS (all population): 89.7% vs 87.2% br.
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