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Foreword
, The incidence and mortality rate of mortality are at the forefront. The proportion of squamous cell lung cancer is low due to the low proportion of genetic mutations and fewer targeted treatment opportunities. Therefore, new treatment methods need to be developed for development.Improve patient prognosis.Patting April Mippling is an immune examination point inhibitor that activates patients self -immune cells to attack tumor cells.In order to further verify the efficacy and safety of the medicine and chemotherapy in patients with squamous squamous carcinoma, Professor Han Baohui, Shanghai Chest Hospital, and Professor Jiao Shunchang, General Hospital of the Peoples Liberation Army, led them together. The unit cooperated to complete the AK105-302 research. On February 1, 2024, the research results were published online in the top international medical journal of the International Medical Hospitals- "The Lancet Respiratory Medicine (IF: 76.2), Shanghai Chest DepartmentProfessor Zhong Hua, the hospital, is the first author of the article, and Professor Sun Shengjie of the General Hospital of the Peoples Liberation Army is the first author of the article.
Research Overview
Research background
Paidolyab is the only new type of differentiated programmatic receptor 1 (PD-1) monoclonal antibody in the worlds only new type of differentiated programmatic receptor 1 (PD-1) monoclonal in the world.AK105-302 Studies are designed to explore the efficacy and security of ANPlis Monument with the treatment of unreserved local advanced or metastatic SQ-NSCLC in the first-line treatment of paclitaxel plus carplatin.
Research method
AK105-302 StudyPhase III clinical trial (NCT03866993) in the control of the agent, which is incorporated into the inaccessible local advanced period (Phase III) or metastasis (phase IV) SQ-NSCLC patients with the initiative of the driving gene negative.It is allocated to Pai Andel Mippling combined chemotherapy group (test group) or placebo combined with chemotherapy group (control group) to receive corresponding first -line treatment and maintenance.
The main research ending includes the intentional treatment (ITT) population (ITT) and PD-L1 positive (TPS ≥ 1%) of the Independent Imaging Evaluation Committee (IRRC).PFS), all follow the RECIST V1.1 standard.Secondary end points include the total survival period (OS), the PFS evaluated by the researcher, the objective relief rate (ORR), the disease control rate (DCR) and the duration of duration (DOR) evaluated by IRRC and researchers.
Research Results
(1) Baseline information: Since 12 of 2018 12 From month to October 2020, a total of 350 patients with qualified patients in the 74 centers in my country were included in this study, and 175 cases were each in each group.ITT crowds and PD-L1-positive population two groups of population statistics and clinical pathological base lines are balanced to ensure comparability.
(2) Main endpoint: The final analysis data as of June 1, 2022, with a median follow -up for 24.7 months.Compared with the combined chemotherapy group, the median PFS of the combined chemotherapy group sent by the Apolidabi Anti-Anti-Anti-Anti-combined chemotherapy group is significantly extended. ITT people (7.6 months vs. 4.2 months) and PD-L1-positive people (8.1 months vs. 4.2The results are consistent, and the risk of disease progress or death is reduced by 57%.95%CI: 0.27 ~ 0.52, P & LT; 0.0001).
(3) Substance: As of the final analysis, the mid -bit OS in the test group has not yet reached, but 12 months (81.9% vs. 67.3%), 24 months (60.1%vs. 40.1%), 30 months (51.6%vs. 27.0%) OS rates were higher than the control group, and the risk of death was reduced by 45%(HR = 0.55,95%CI:0.40 ~ 0.75, P = 0.0002).In all preset sub-groups, including age, baseline ECOG PS score, clinical installment, smoking status, PD-L1 TPS levels, etc., the HR values of PFS and OS evaluated by IRRC are all inclined to send Andle Meticukethea combined chemotherapy groupBenefit.
In terms of tumor response, regardless of the IRRC or researcher evaluation results, they sent a comprehensive advantage in the combined chemotherapy group of Aprilumi.In the IRRC assessment, the ORR of the combined chemotherapy team sent by the Apoli Mipide reached 71%, which was significantly improved compared to the placebo combined with the placebo (44%).The median DOR is close to 3 times the combination of placebo combined chemotherapy (8.3 months vs. 3.0 months, P & LT; 0.0001).
(4) Safety: Paidianpulumab combined with chemotherapy is controllable, compared with placebo combined with chemotherapyPoisonous and sub -reactions have not observed new security signals, and the incidence of immune -related adverse events (Iraes) is low.
Research conclusion
Compared with simple chemotherapPatients with advanced or metastatic SQ-NSCLC survival and safe tolerance provides new first-line treatment options.
Researchers said
The need for immunotherapy
lung cancer is the most vicious incidence and mortality in my country. [2].NSCLC accounts for 80%to 85%in lung cancer [3], of which SQ-NSCLC accounts for about 25%[4-5].In lung adenocarcinoma, targeted therapy breaks through the survival level of the chemotherapy era.In this context, AK105-302 came into being, and eventually did not bear the mission.
High-quality clinical studies, Get internationally highly recognized
AK105-3022 The study was entered into 350 subjects from 74 research centers in my country. The sample volume was large, showing that this study has extensive representativeness and guiding significance.Although as many as 87%of patients are in phases IV and 19%of patients are metastasized, this study has still achieved excellent positive results.
1. Survival benefits, the 30 -month OS rate exceeds 50%
The published this timeData show that whether ITT people or PD-L1-positive people, the combination of Apeli monetta on the basis of platinum-containing dual pharmaceutical chemotherapy has significantly reduced the risk of disease progress or death (57%and 63%, respectively), benefits to benefitThe amplifier is encouraged.The median follow -up has been 24.7 months, and the medium OS data of the test group is not completely mature.The month (51.6%vs. 27.0%) was higher than the control group, of which the 30 -month OS rate exceeded 50%.In the combined chemotherapy group of the placebo, 58%of patients accepted the treatment of Andel Monopolysis after the disease progressed.0.55.
2. The benefits of the extensive crowd, in -depth and lasting
Asian group analysis further confirmed PaianPrimitabi has benefited from the extensive population including PD-L1 negative (TPS & LT; 1%) patients, and has benefited both in terms of PFS and OS, indicating that its combined chemotherapy can effectively break through clinical pathological heterogeneous heterogeneous qualitySexual restrictions on curative effect.
At the same time, Pattoo Apeli also shows good strength in improving ORR and DOR -ORR has increased by 27%, and 7%of patients have reached CR; medium mediumThe bit Dor is close to the control group three times, and the DCR is as high as 90%.These data show that Pai Andel Mutives can not only relieve deeply, but also have high efficiency and long -lasting efficiency.
Three, more optimization of the renovation, no increase in efficiency
In terms of safety, chemotherapy joint factionAt the same time, the side effects of Aplitab did not increase significantly, and the side effects did not increase significantly, and adverse events were controllable.The incidence of ≥ 3 Iraes is only 4%. The lower incidence of Iraes may be due to the effect function of the combination of FC γ receptor and FC mediatable (that is, antibody -dependent cytotoxicity and phagocytosis) [6] Increase specificity and affinity, while not affecting the effect of anti -tumor, reducing the incidence of related side effects.
Optimize the front-line pattern, broad prospects
Based on AK105-302 research data, sent AnptleyThe monoclonal anti-anti-anti-SQ-NSCLC first-line treatment was approved in January 2023.In the field of lung cancer, it was sent to show the extensive application prospects and layouts, covering all aspects such as comprehensive coverage of different types of pathological types of tissue pathology, expansion of different stages of diseases, and exploration of new joint plans.For example, in the first-line treatment of non-scale NSCLC, Patsopley Mipide has also emerged-AK105-301 Study preliminary data shows that Patti Anti Mippot and Arotinib ORR reached 57.1%, DCR up to 99.5% [7], it is expected to start a new era of "Chemo-Free"; in the Altn-AK105-II-01 study in the second line treatment field in small cell lung cancer (SCLC), sent APlitab and AnlotinibIt also shows the effectiveness and security worth looking forward to.It is expected that immunotherapy can further expand its application scope in future applications and achieve more innovative and breakthrough results, thereby making more outstanding contributions to the development of tumor treatment.
References:
[1] zhong h, et alian set respir med. January 31, 2024.
[2] xia cf, et al. Chin Med j (English), 2022,135 (5): 584-590.
p ID = "2gkroa2r"> [3] Novello S, et al. Ann Oncol, 2016, 27 (SUPPL 5): 1–27.[4] ETtinger DS, ETAl. J Natl Compr CANC Network, 2022, 20: 497–530.
[5] rivera mp, et al. Chest, 2013, SUPPL 5): E142–165.
[6] dhillon s. Drugs, 2021, 81: 2159–2166.
[7] han b, et al.J clin oncol, 2021, 39 (sub): e21072.
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