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ORIENT-12 is the world's first randomized, double-blind, Phase III controlled clinical study for advanced squamous non-small cell lung cancer (sqNSCLC) first-line therapy.
study included 357 subjects in the group, and in-period analysis showed that Dabershu ® (Syndicate monoantigen injections) combined with exercise ® (injected with gisithamin) and platinum-type contrast placebo combined with placebo ® (injected with giesithamin) and platinum significantly extended progression-free survival (PFS).
latest analysis showed that the mid-PFS assessed by the Independent Imaging Commission (IRRC) in the Syndicant and Chemotherapy groups was 5.5 months and 4.9 months, respectively (HR=0.536, 95% CI: 0.422-0.681), The researchers assessed the mid-PFS at 6.7 months and 4.9 months (HR-0.532, 95% CI: 0.419-0.674, P.lt; 0.00001), respectively, to reach the preset main study endpoint.
the medium OS data analyzed in the second phase was premature, and there was a trend of benefit for the total survival of the single-anti-combination group (HR-0.567, 95%CI: 0.353-0.909, P-0.01701).
safety characteristics are consistent with previously reported ® of the Dabershu ® (Syndili monoantigen injection) and have no new safety signals.
"Lung cancer is the number one cause of death in all cancers (25.2%), with NSCLC accounting for about 80% to 85%, " said Professor Zhou Caissing, director of oncology at Shanghai Lung Hospital, the lead researcher in the ORIENT-12 study.
about 70% of NSCLC patients were unable to have surgical removal at the time of diagnosis, and 30-60% of NSCLC patients in phase I-III of genomic surgery eventually relapsed or metastasis.
the past two decades, NSCLC's drug research and development progress has been mainly concentrated in non-scaly NSCLC, which is relatively slow due to its unique epidemiological, hetological and molecular biology characteristics.
ORIENT-12 study is the world's first randomized double-blind control study to confirm that anti-PD-1 monoclonal antibodies combined with Gissythabin and platinum can significantly improve the benefits of progression-free survival in patients with first-line scaly NSCLC, which is of clinical significance.
Health ® (injection with gixiabin) / cisplatin (carpentine) is currently commonly used in Asia's advanced lung squamous cancer standard first-line program, the success of ORIENT-12 research, will benefit more patients with squamous cancer.
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