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Lung cancer is one of the most common malignant tumors in clinical practice.
New cases and deaths are increasing year by year.
It is currently the malignant tumor with the highest mortality rate in the world
.
There are about 800,000 new lung cancer patients in China each year, and the burden of disease is heavy
.
Immunotherapy has opened a new chapter in the treatment of lung cancer and brought hope to the majority of lung cancer patients
.
On January 1, 2022, China's independent innovation of PD-1 monoclonal antibody-Bezian® (Tilelizumab) combined with chemotherapy was used for the first-line treatment of advanced squamous and non-squamous non-small cell lung cancer (NSCLC) The indications of the disease will enter the 2022 national medical insurance, and the disease burden of patients will be greatly reduced
.
So far, tislelizumab has achieved "two comprehensives" for the first-line treatment of advanced NSCLC, that is, comprehensive coverage of advanced first-line indications and comprehensive coverage of advanced first-line medical insurance
.
In this regard, Yimaitong specially invited Professor Ma Zhiyong to interpret research data in the field of tislelizumab lung cancer, introduce the indications of tislelizumab lung cancer medical insurance, and share the latest insights on lung cancer immunotherapy
.
Expert ProfileProfessor Zhiyong Ma, Chief Physician, Henan Cancer Hospital, Zhengzhou University Affiliated Tumor Hospital, Director of Henan Lung Cancer Diagnosis and Treatment Center, Director of Henan Lung Cancer Clinic Member of the Standing Committee of the Lung Cancer Specialty Committee of the Medical Promotion Association.
Chairman of the Lung Cancer Specialty Committee of the Henan Anti-Cancer Association.
Member of the Lung Cancer Quality Control Committee of the National Cancer Center.
Yi Maitong: Hello, Professor Ma.
What is the significance of being included in the medical insurance for the first-line indication of NSCLC? Professor Ma Zhiyong: First of all, congratulations on the inclusion of tislelizumab combined with chemotherapy for the first-line treatment of unresectable locally advanced and advanced squamous and non-squamous NSCLC.
The indications are included in the National Medical Insurance List.
This is very exciting for lung cancer patients in China.
Exciting good news
.
After tislelizumab lung cancer indication is included in medical insurance, the patient will be reimbursed by medical insurance, and the out-of-pocket price will be greatly reduced
.
The indications for the first-line treatment of tislelizumab for NSCLC were fully approved in 2021, and comprehensive medical insurance for the first-line indications will be quickly achieved in 2022, giving new hope to many lung cancer patients who were unable to choose immunotherapy due to economic factors.
Let clinics have more medically insurable immunotherapy drugs
.
It is worth noting that the indications included in this tislelizumab lung cancer also cover unresectable locally advanced squamous and non-squamous NSCLC patients, making tislelizumab the first and only medical insurance available in China.
At the same time, immunotherapy drugs covering the first-line treatment of patients with squamous and non-squamous NSCLC from late stage to advanced stage will give more clinical decision-making space, so that immunotherapy can benefit China's lung cancer patients more widely
.
It is gratifying to see tislelizumab and BeiGene in the field of lung cancer step by step to meet the needs of immunotherapy for lung cancer patients in China
.
Yimaitong: Professor Ma, as one of the main researchers participating in the RATIONALE 307 and 304 studies of tislelizumab at the same time, the indications for the inclusion of tislelizumab in medical insurance are also derived from these two studies.
Could you please interpret the data of RATIONALE 307 and 304 research for us? Professor Ma Zhiyong: Tilelizumab is an independent and innovative PD-1 monoclonal antibody with "optimized structure and comprehensive benefits"
.
According to the data of RATIONALE 307 and 304 studies, tislelizumab can bring comprehensive benefits to patients in the treatment of squamous and non-squamous NSCLC, which is due to the modification of the Fc segment of tislelizumab With unique structural advantages, tislelizumab eliminates antibody-dependent cell-mediated phagocytosis (ADCP effect) through Fc segment modification, avoiding the impact of anti-tumor efficacy due to the decrease in the number of T cells, and the incidence of adverse reactions is relatively Lower, the anti-tumor activity is relatively stronger
.
For the first-line treatment of patients with advanced and unresectable locally advanced squamous NSCLC, tislelizumab RATIONALE 307 study 1 showed that tislelizumab combined with paclitaxel and carboplatin or albumin paclitaxel and carboplatin has an objective response rate (ORR) is nearly 75%, comparable to targeted therapy; the median progression-free survival (PFS) of patients is 7.
6 months, and the risk of disease progression is significantly reduced by 52%; the relevant research results have been published in full in the international authoritative journal JAMA Oncology
.
Taxus combined with platinum is one of the most commonly used first-line chemotherapy regimens for advanced squamous NSCLC.
After being included in the medical insurance, tislelizumab has become the only PD that can be insured by the combination of squamous NSCLC in immunotherapy options.
-1 monoclonal antibody, fully meets the actual needs of clinical diagnosis and treatment
.
Figure 1 RATIONALE 307 study review 1 For the first-line treatment of patients with advanced and unresectable locally advanced non-squamous NSCLC, tislelizumab RATIONALE 304 study 2 showed that tislelizumab combined with pemetrexed and platinum , ORR 57%; the median PFS of patients was 9.
7 months, and the risk of disease progression was significantly reduced by 36%; the relevant research results have been published in full in the international authoritative journal JTO
.
Both cisplatin and carboplatin are widely used in the treatment of non-squamous NSCLC, and the indications of tislelizumab for non-squamous NSCLC cover the combined carboplatin and cisplatin regimen
.
After being included in the medical insurance this time, tislelizumab will bring a new choice of medical insurable drugs for clinical non-squamous NSCLC immunotherapy
.
Figure 2 RATIONALE 304 research review 2 Yimaitong: After the implementation of this medical insurance, tislelizumab has achieved full coverage of first-line immunotherapy for patients with advanced & unresectable locally advanced squamous and non-squamous NSCLC in the field of lung cancer
.
At this moment, would you please share what else do you expect of tislelizumab and BeiGene? Professor Ma Zhiyong: Tilelizumab has a comprehensive deployment in the field of lung cancer.
RATIONALE 307 & 304 are respectively deployed as the first-line treatment for advanced & unresectable locally advanced squamous and non-squamous NSCLC; and RATIONALE 303 is deployed as the second/third-line treatment for advanced NSCLC.
, This indication has also been submitted to NMPA for review and approval is expected
.
In addition, the RATIONALE 315 study of tislelizumab in the perioperative period of NSCLC and the study of RATIONALE 312 in the field of SCLC are also underway.
We look forward to the subsequent disclosure of the results of these studies and provide more evidence and more options for immunotherapy for lung cancer patients.
.
In the era of immunization 1.
0, PD-1/L1 drugs have successfully established their status as the cornerstone drugs for immunotherapy.
The emergence of immunotherapy has completely changed our treatment of lung cancer, improved the prognosis of lung cancer patients, and how to further enhance the benefits of patients.
It is the focus of clinical follow-up attention
.
In the era of immunization 2.
0, new targets including TIGIT and LAG-3 have become the direction of follow-up research and development.
We look forward to using dual-target combined therapy to further expand the immunotherapy response population, improve efficacy, overcome drug resistance, and bring more patients , Longer benefits, bringing lung cancer into the "chronic disease era", I am very happy to see that Baekje has already made plans in this regard
.
BeiGene has brought a number of innovative anti-tumor drugs to patients in China and around the world.
Through cooperation with the global pharmaceutical giant Novartis, the PD-1 monoclonal antibody tislelizumab and the researching TIGIT monoclonal antibody have all been successful Going overseas fully proves BeiGene's research and development capabilities.
The excellent quality of innovative drugs independently developed by BeiGene has been repeatedly recognized internationally
.
It is hoped that BeiGene will continue to innovate and serve as a benchmark for local innovative pharmaceutical companies, and continue to bring excellent products to clinics, benefiting more Chinese and overseas patients
.
References: 1.
Wang J, et al.
Tislelizumab Plus Chemotherapy vs Chemotherapy Alone as First-line Treatment for Advanced Squamous Non-Small-Cell Lung Cancer: A Phase 3 Randomized Clinical Trial.
JAMA Oncol.
2021 May 1;7(5 ):709-717.
2.
Lu S, et al.
Tislelizumab Plus Chemotherapy as First-Line Treatment for Locally Advanced or Metastatic Nonsquamous NSCLC (RATIONALE 304): A Randomized Phase 3 Trial.
J Thorac Oncol.
2021 Sep;16(9): 1512-1522.