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On 8 August, the 21st World Lung Cancer Congress (WCLC), organized by the International Association for Lung Cancer Research (IASLC), organized the Bureau's Seminar (Presidential) online.
, three phase 3 research data from Cinda Bio/Lilly Pharmaceuticals, Beida Pharmaceuticals, and BMS were released.
, BMS's first-line double immunotherapy has made significant progress in pleural mesothelioma, promising to break a 15-year new drug-free stalemate in the field.
Cinda Biology: A Phase 3 study of Dabersu Combined Chemotherapy First Line Treatment of Non-Squamoud Non-Small Cell Lung Cancer (NSCLC) This is a randomized, double-blind, phase 3 control clinical study called ORIENT-11, designed to evaluate the efficacy of innovative PD-1 inhibitor Dabersu (Sindili monoantinotic injection) and platinum chemotherapy line treatment for non-scale NCl.
Cindy Singli Singad was developed by Cinda Bio and Lilly Pharmaceuticals. The results of the
-phase analysis showed that Dabshu's combination chemotherapy significantly extended the patient's progression-free survival (PFS) and reached the preset efficiency standards.
as of the data deadline, the median PFS assessed by the Independent Imaging Review Board (IRRC) was 8.9 months (vs 5.0 months) and the confirmed objective mitigation rate (ORR) increased from 29.8% to 51.9% to 1.51 months (vs 2.63 months).
the total median lifetime (OS) in both groups had not yet been reached, but the test group improved compared to the control group OS.
study found no new safety signals.
orient-11 study (photo source: WCLC) according to Cinda Bio news release, which showed that The OS and PFS of dabersu combined traditional chemotherapy as a first-line therapy showed significant improvement compared to chemotherapy alone.
currently, the New Indications Application (sNDA) for the first-line treatment of non-squamous non-small cell lung cancer in Dabshu and Platinum chemotherapy has been submitted and accepted in China.
, more than 20 clinical studies are under way worldwide to assess the anti-tumor effects of Cindilla in a wide range of solid and blood tumors, more than 10 of which are registered clinical trials.
Beida Pharmaceuticals: Enshatinib's phase 3 randomized controlled study of ALK-positive NSCLC This is an international multicenter 3 clinical study called eXalt3, with a total of 290 ALK-positive NSCLC patients in the group, which were randomly assigned to the Enshatinib treatment group (143 cases) and the keratinib treatment group (147 cases).
data as of July 1, 64 patients treated with Ensatinib and 25 patients treated with krythinib were still being treated in the group for observation.
Enshatinib is a new generation of ALK tyrosine kinase inhibitors (TKI) developed by Beida Pharmaceuticals and its controlling subsidiary Xcovery. The results of the
mid-period analysis showed that in the ITT population, the median PFS was significantly prolonged (25.8 months vs 12.7 months) in al-Shatinib first-line treatment patients.
in the mITT population, the median PFS in the Enshatinib treatment group has not yet reached (vs 12.7 months).
in patients with measurable brain metastasis, the Independent Review Board (BIRC) assessed an intracranial ORR of 64% (vs 21%).
the rate of brain metastasis in ensatinib group therapy also decreased significantly in patients with baseline abrain transfer (4% vs 24% in 12 months).
survival analysis (K-M curve) showed that less than 40% of patients in the Enshatinib group progressed (vs 75%) at the 36-month time point of treatment.
eXalt3 part of the study results (photo: WCLC official website) In the Beda Pharmaceuticals press release, Beida Pharmaceuticals Senior Vice President and Chief Medical Officer, The United States Xcoveri CEO Professor Mao Li said: "This report of the Enshatinib first line BIRC initial assessment data mPFS is very good, for baseline brainless patients, Ensatinib is expected to greatly extend survival."
based on the results of the study, the company will actively prepare the U.S.-China first-line indications of the listing declaration.
believe that the future successful listing will be a full line of attack, in the ALK-positive NSCLC patients in the whole process of management to fully protect the patient's life.
" BMS: Navuliu monoto-anti-combination Ipimumonomonomonomonotherapy non-removable malignant pleural mesothelioma (MPM) This is a multi-centered, randomized, open-label 3-phase trial called MateCheck-743, designed to evaluate the therapeutic effect of Navuliu monosar in patients with previously untreated malignant pleural methomas compared to standard chemotherapy. A total of 605 subjects were randomly assigned to the trial group (receiving two years of nabumonobinal combination ipizumab therapy) or the control group (receiving 6 rounds of permeitus cisplatin or kaplatin treatment).
nvulumab, Opdivo is a PD-1 antibody, ipilimumab(Yervoy) is a CTLA-4 antibody.
mid-term analysis data show that, compared to platinum chemotherapy, navuliu monotomaamin combined ipimuse therapy extended the median OS by 4 months (18.1 months vs 14.1 months), reducing the risk of death by 26%.
at 24 months, 41% of the patients in the trial group survived (vs 27%).
in the trial group, the median OS in the epithelial and non-epithelial patients were 18.7 months (vs 16.5 months) and 18.1 months (vs 8.8 months) respectively.
study did not observe new safety signals. "Malignant pleural mesothelioma is a highly invasive cancer with a five-year survival rate of less than 10% in patients, compared with poor clinical outcomes," Dr. Paul Baas, of the Department of Chest Oncology at Leiden University and the Netherlands Cancer Institute, said in a BMS press release from the
CheckMate-743 (Photo: WCLC Website).
now for the first time, we have demonstrated that biimmune combination therapy can deliver significant and lasting total survival benefits for patients with all types of malignant pleural mesothelioma on the first line compared to chemotherapy.
based on CheckMate-743 data, Navuliu monoto-resistance is expected to be the new standard treatment.
" References: the results of the Phase III study of The First Phase OF Chemotherapy Phase III of Dabelshu (Cindilly Syngenta Injection) in combination with chemotherapy were published in oral reports at the 2020 WCLC Online Topic Forum. Retrieved Aug8, 2020, from the first line of data of nshatini global stunning debut of the entire line of guardian ALK-positive patients. Retrieved Aug9, 2020, from beida pharmaceutical officer micro 3. Retrieved Aug10, 2020, from . . .