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On January 1, 2022, China's self-innovated PD-1 monoclonal antibody-Baizean® (tislelizumab injection) combined with chemotherapy for advanced squamous and non-squamous non-small cell lung cancer (NSCLC) The indications for first-line treatment have entered the new version of the National Medical Insurance List
.
At the same time, based on the excellent efficacy data of the RATIONALE 303 study, a new indication of tislelizumab for the treatment of second- or third-line locally advanced or metastatic NSCLC patients with disease progression after platinum-based chemotherapy was recently approved by the national Approved by the National Medical Products Administration (NMPA)
.
Yimaitong specially invited one of the principal investigators of RATIONALE 304&303 research, Professor Wang Ziping of Peking University Cancer Hospital to interpret the research data of tislelizumab in the field of lung cancer, introduce the medical insurance indications of tislelizumab for lung cancer, and share the information about lung cancer.
Unique insights into immunotherapy
.
Expert Profile Professor Wang Ziping Director of the First Department of Thoracic Oncology, Peking University Cancer Hospital, Chief Physician/Professor China Medical Education Association, Chairman of the Cancer Chemotherapy Professional Committee Chinese Geriatrics and Geriatrics Society, Geriatric Oncology Professional Committee, Oncology and Microbiology Committee Chairman of the Chinese Society of Gerontology and Geriatrics, Deputy Chairman of the Geriatric Oncology Committee, and Deputy Chairman of the Lung Cancer Sub-Committee Member of the National Health Professional Technical Qualification Examination Expert Committee Secretary of the NCCN Chinese Edition Expert Group Secretary of Chinese Journal of Internal Medicine, Chinese Oncology The editorial board of the journal and other editorial boards for advanced NSCLC first-line indications/medical insurance is fully covered, and the benefits of tislelizumab are "expected.
" Professor Wang Ziping said that with the advancement of medical technology, new treatment methods and new drugs continue to emerge.
Bringing new hope to lung cancer patients
.
In recent years, immunotherapy has gradually come to the center of the tumor treatment arena, changing the treatment pattern of patients with advanced, locally advanced and early-stage operable NSCLC, and making it possible to gradually develop chronic lung cancer
.
However, the long-term treatment has significantly increased the economic burden of cancer patients, and the high cost of treatment has become the biggest obstacle for patients to regain a new life
.
Therefore, the National Medical Insurance Administration actively promotes the inclusion of innovative drugs and innovative therapies in medical insurance to benefit patients
.
Since January 1 this year, the new version of the medical insurance drug catalog has been officially implemented nationwide.
The update of the medical insurance catalog has aroused widespread concern across the country
.
We are pleased to see that tislelizumab combined with chemotherapy for the first-line treatment of unresectable locally advanced and advanced squamous and non-squamous NSCLC has been included in the new version of the National Medical Insurance List, which will greatly relieve the economic pressure of lung cancer patients in China
.
Tislelizumab is fully deployed in the field of lung cancer research, and timely meets the needs of Chinese lung cancer patients for immunotherapy.
Its indications for first-line treatment of NSCLC will be fully approved in 2021, and the first-line indications will be fully approved in 2022.
Medicare
.
The included indications for lung cancer cover unresectable locally advanced squamous and non-squamous NSCLC, making it the first immunotherapy drug in China that can simultaneously cover first-line treatment from locally advanced to advanced squamous and non-squamous NSCLC.
This provides clinicians with ample decision-making space
.
Especially in areas where there are currently few options for immunotherapy drugs, tislelizumab has a wide coverage and is cost-effective, providing more choices and opportunities for lung cancer patients
.
Structural optimization, full benefit, tislelizumab’s first-line treatment status highlights Prof.
Wang Ziping introduced that tislelizumab is a structure-optimized PD-1 mAb, which eliminates antibody dependence through Fc-segment modification Cell-mediated phagocytosis (ADCP effect), which can avoid the decrease in the number of T cells and affect the anti-tumor efficacy, making tislelizumab strong anti-tumor activity, and the incidence of adverse reactions is relatively low, that is, high efficiency and low poison
.
The results of the RATIONALE 304 study [1] showed that in patients with advanced and unresectable locally advanced non-squamous NSCLC, tislelizumab combined with pemetrexed and platinum-based chemotherapy was significantly more effective than first-line treatment with pemetrexed and platinum-based chemotherapy The median progression-free survival (PFS) was extended to 9.
7 months, and the risk of disease progression was reduced by 35.
5%; the objective response rate (ORR) of tislelizumab combined with pemetrexed and platinum chemotherapy was 57.
4%
.
The research results of RATIONALE 304 have been published in full in the international authoritative journal "Journal of Thoracic Oncology"
.
For non-squamous NSCLC indications, tislelizumab can also be combined with carboplatin or cisplatin chemotherapy, so clinicians have more room for treatment options
.
After being included in the new version of the National Medical Insurance List, tislelizumab will bring a new choice of medical insurance reimbursement drugs for clinical non-squamous NSCLC immunotherapy
.
RATIONALE 304 study review The results of the RATIONALE 307 study [2] showed that for patients with advanced and unresectable locally advanced squamous NSCLC, tislelizumab combined with paclitaxel/carboplatin (group A) or nab-paclitaxel/carboplatin (B The median PFS of patients in group A and group B was 7.
6 months, which was significantly higher than that in the chemotherapy group alone, which was 5.
5 months; group A and group B treatment significantly reduced the risk of disease progression by 47.
6% and 52.
2%, respectively; group A and group B The ORR of the patients was 72.
5% and 74.
8%, respectively, even comparable to the efficacy of targeted therapy
.
The research results of RATIONALE 307 have been published in full in the international authoritative journal "JAMA Oncology"
.
Paclitaxel combined with platinum is one of the most commonly used first-line chemotherapy regimens for advanced squamous NSCLC.
After being included in the new version of the National Medical Insurance List, tislelizumab has become the only combination with taxane regimen for the treatment of squamous NSCLC and can be reimbursed by medical insurance.
PD-1 monoclonal antibody fully meets the actual needs of clinical diagnosis and treatment, and the drug is safe to use
.
RATIONALE 307 Study Review Follow the trend, another success, tislelizumab second-line/third-line new indications are approved In addition to the first-line treatment of advanced and unresectable locally advanced squamous, non-squamous NSCLC, tislelizumab Monoclonal antibodies are also deployed in the second/third-line treatment field of advanced NSCLC
.
The results of the RATIONALE 303 study [3] showed that in NSCLC patients with disease progression after prior chemotherapy, compared with docetaxel chemotherapy, tislelizumab single-agent second- or third-line treatment significantly prolonged the median overall The survival period was nearly half a year, up to 17.
2 months, significantly reducing the risk of death by 36%; compared with docetaxel chemotherapy, tislelizumab monotherapy increased the ORR of patients by nearly 3 times (21.
9% vs 7.
0%)
.
Recently, based on the excellent efficacy data of the RATIONALE 303 study, tislelizumab has also been approved by the NMPA for the new indication of tislelizumab for patients with second- or third-line locally advanced or metastatic NSCLC whose disease has progressed after previous platinum-based chemotherapy.
Such patients offer new options
.
The approval of the second/third-line NSCLC indication makes tislelizumab the only fully approved full-line indication for advanced NSCLC immunotherapy (from first-line to second/third-line, from locally advanced to advanced), and the first-line treatment indication for advanced NSCLC Medicare's PD-1 mAb
.
In addition, the RATIONALE 315 study of tislelizumab in perioperative neoadjuvant/adjuvant therapy for NSCLC and the RATIONALE 312 study in the field of small cell lung cancer are also in progress as planned, and it is expected that the results of these studies will be helpful for the immune practice of lung cancer patients.
Provide more evidence and give more options for treatment
.
RATIONALE 303 research review Prof.
Wang Ziping said that the success of PD-1/L1 drugs has established its status as the cornerstone drug in lung cancer immunotherapy
.
In the era of Immune 2.
0, the emergence of new immunotherapy targets TIGIT and LAG-3 have become the frontier areas for subsequent research and development.
, prolong survival, and lead lung cancer into the "chronic disease era"
.
As a local innovative pharmaceutical company, it is hoped that BeiGene will continue to innovate and continue to bring excellent products to the clinic, benefiting more Chinese and overseas patients
.
Reference: [1] 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.
[2] 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;7(5 ):709-717.
[3] Zhou C, et al.
Abstract CT039: Results from RATIONALE 303: A global phase 3 study of tislelizumab (TIS) vs docetaxel (TAX) as second- or third-line therapy for patients with locally advanced or metastatic NSCLC.
Cancer Res July 1 2021 (81) (13 Supplement) CT039.
.
At the same time, based on the excellent efficacy data of the RATIONALE 303 study, a new indication of tislelizumab for the treatment of second- or third-line locally advanced or metastatic NSCLC patients with disease progression after platinum-based chemotherapy was recently approved by the national Approved by the National Medical Products Administration (NMPA)
.
Yimaitong specially invited one of the principal investigators of RATIONALE 304&303 research, Professor Wang Ziping of Peking University Cancer Hospital to interpret the research data of tislelizumab in the field of lung cancer, introduce the medical insurance indications of tislelizumab for lung cancer, and share the information about lung cancer.
Unique insights into immunotherapy
.
Expert Profile Professor Wang Ziping Director of the First Department of Thoracic Oncology, Peking University Cancer Hospital, Chief Physician/Professor China Medical Education Association, Chairman of the Cancer Chemotherapy Professional Committee Chinese Geriatrics and Geriatrics Society, Geriatric Oncology Professional Committee, Oncology and Microbiology Committee Chairman of the Chinese Society of Gerontology and Geriatrics, Deputy Chairman of the Geriatric Oncology Committee, and Deputy Chairman of the Lung Cancer Sub-Committee Member of the National Health Professional Technical Qualification Examination Expert Committee Secretary of the NCCN Chinese Edition Expert Group Secretary of Chinese Journal of Internal Medicine, Chinese Oncology The editorial board of the journal and other editorial boards for advanced NSCLC first-line indications/medical insurance is fully covered, and the benefits of tislelizumab are "expected.
" Professor Wang Ziping said that with the advancement of medical technology, new treatment methods and new drugs continue to emerge.
Bringing new hope to lung cancer patients
.
In recent years, immunotherapy has gradually come to the center of the tumor treatment arena, changing the treatment pattern of patients with advanced, locally advanced and early-stage operable NSCLC, and making it possible to gradually develop chronic lung cancer
.
However, the long-term treatment has significantly increased the economic burden of cancer patients, and the high cost of treatment has become the biggest obstacle for patients to regain a new life
.
Therefore, the National Medical Insurance Administration actively promotes the inclusion of innovative drugs and innovative therapies in medical insurance to benefit patients
.
Since January 1 this year, the new version of the medical insurance drug catalog has been officially implemented nationwide.
The update of the medical insurance catalog has aroused widespread concern across the country
.
We are pleased to see that tislelizumab combined with chemotherapy for the first-line treatment of unresectable locally advanced and advanced squamous and non-squamous NSCLC has been included in the new version of the National Medical Insurance List, which will greatly relieve the economic pressure of lung cancer patients in China
.
Tislelizumab is fully deployed in the field of lung cancer research, and timely meets the needs of Chinese lung cancer patients for immunotherapy.
Its indications for first-line treatment of NSCLC will be fully approved in 2021, and the first-line indications will be fully approved in 2022.
Medicare
.
The included indications for lung cancer cover unresectable locally advanced squamous and non-squamous NSCLC, making it the first immunotherapy drug in China that can simultaneously cover first-line treatment from locally advanced to advanced squamous and non-squamous NSCLC.
This provides clinicians with ample decision-making space
.
Especially in areas where there are currently few options for immunotherapy drugs, tislelizumab has a wide coverage and is cost-effective, providing more choices and opportunities for lung cancer patients
.
Structural optimization, full benefit, tislelizumab’s first-line treatment status highlights Prof.
Wang Ziping introduced that tislelizumab is a structure-optimized PD-1 mAb, which eliminates antibody dependence through Fc-segment modification Cell-mediated phagocytosis (ADCP effect), which can avoid the decrease in the number of T cells and affect the anti-tumor efficacy, making tislelizumab strong anti-tumor activity, and the incidence of adverse reactions is relatively low, that is, high efficiency and low poison
.
The results of the RATIONALE 304 study [1] showed that in patients with advanced and unresectable locally advanced non-squamous NSCLC, tislelizumab combined with pemetrexed and platinum-based chemotherapy was significantly more effective than first-line treatment with pemetrexed and platinum-based chemotherapy The median progression-free survival (PFS) was extended to 9.
7 months, and the risk of disease progression was reduced by 35.
5%; the objective response rate (ORR) of tislelizumab combined with pemetrexed and platinum chemotherapy was 57.
4%
.
The research results of RATIONALE 304 have been published in full in the international authoritative journal "Journal of Thoracic Oncology"
.
For non-squamous NSCLC indications, tislelizumab can also be combined with carboplatin or cisplatin chemotherapy, so clinicians have more room for treatment options
.
After being included in the new version of the National Medical Insurance List, tislelizumab will bring a new choice of medical insurance reimbursement drugs for clinical non-squamous NSCLC immunotherapy
.
RATIONALE 304 study review The results of the RATIONALE 307 study [2] showed that for patients with advanced and unresectable locally advanced squamous NSCLC, tislelizumab combined with paclitaxel/carboplatin (group A) or nab-paclitaxel/carboplatin (B The median PFS of patients in group A and group B was 7.
6 months, which was significantly higher than that in the chemotherapy group alone, which was 5.
5 months; group A and group B treatment significantly reduced the risk of disease progression by 47.
6% and 52.
2%, respectively; group A and group B The ORR of the patients was 72.
5% and 74.
8%, respectively, even comparable to the efficacy of targeted therapy
.
The research results of RATIONALE 307 have been published in full in the international authoritative journal "JAMA Oncology"
.
Paclitaxel combined with platinum is one of the most commonly used first-line chemotherapy regimens for advanced squamous NSCLC.
After being included in the new version of the National Medical Insurance List, tislelizumab has become the only combination with taxane regimen for the treatment of squamous NSCLC and can be reimbursed by medical insurance.
PD-1 monoclonal antibody fully meets the actual needs of clinical diagnosis and treatment, and the drug is safe to use
.
RATIONALE 307 Study Review Follow the trend, another success, tislelizumab second-line/third-line new indications are approved In addition to the first-line treatment of advanced and unresectable locally advanced squamous, non-squamous NSCLC, tislelizumab Monoclonal antibodies are also deployed in the second/third-line treatment field of advanced NSCLC
.
The results of the RATIONALE 303 study [3] showed that in NSCLC patients with disease progression after prior chemotherapy, compared with docetaxel chemotherapy, tislelizumab single-agent second- or third-line treatment significantly prolonged the median overall The survival period was nearly half a year, up to 17.
2 months, significantly reducing the risk of death by 36%; compared with docetaxel chemotherapy, tislelizumab monotherapy increased the ORR of patients by nearly 3 times (21.
9% vs 7.
0%)
.
Recently, based on the excellent efficacy data of the RATIONALE 303 study, tislelizumab has also been approved by the NMPA for the new indication of tislelizumab for patients with second- or third-line locally advanced or metastatic NSCLC whose disease has progressed after previous platinum-based chemotherapy.
Such patients offer new options
.
The approval of the second/third-line NSCLC indication makes tislelizumab the only fully approved full-line indication for advanced NSCLC immunotherapy (from first-line to second/third-line, from locally advanced to advanced), and the first-line treatment indication for advanced NSCLC Medicare's PD-1 mAb
.
In addition, the RATIONALE 315 study of tislelizumab in perioperative neoadjuvant/adjuvant therapy for NSCLC and the RATIONALE 312 study in the field of small cell lung cancer are also in progress as planned, and it is expected that the results of these studies will be helpful for the immune practice of lung cancer patients.
Provide more evidence and give more options for treatment
.
RATIONALE 303 research review Prof.
Wang Ziping said that the success of PD-1/L1 drugs has established its status as the cornerstone drug in lung cancer immunotherapy
.
In the era of Immune 2.
0, the emergence of new immunotherapy targets TIGIT and LAG-3 have become the frontier areas for subsequent research and development.
, prolong survival, and lead lung cancer into the "chronic disease era"
.
As a local innovative pharmaceutical company, it is hoped that BeiGene will continue to innovate and continue to bring excellent products to the clinic, benefiting more Chinese and overseas patients
.
Reference: [1] 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.
[2] 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;7(5 ):709-717.
[3] Zhou C, et al.
Abstract CT039: Results from RATIONALE 303: A global phase 3 study of tislelizumab (TIS) vs docetaxel (TAX) as second- or third-line therapy for patients with locally advanced or metastatic NSCLC.
Cancer Res July 1 2021 (81) (13 Supplement) CT039.