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*For medical professionals to read for reference only, sugelimab brings new hope for the treatment of advanced lung cancer~ Recently, "The Lancet Oncology" (The Lancet Oncology) published online the first-line treatment of sugalimab in stage IV non-small cell lung cancer.
Results of a registrational clinical study (GEMSTONE-302) in cell lung cancer (NSCLC)
.
The findings were previously presented as an oral presentation at the 2021 World Conference on Lung Cancer
.
This publication in an international authoritative medical journal once again demonstrates the clinical value of sugelimab
.
Based on the results of this study, sugelimab has been approved in China for the treatment of naïve metastatic (stage IV) NSCLC patients in combination with chemotherapy, becoming the world's first approved combination chemotherapy for the first-line treatment of metastatic squamous and non-squamous PD-L1 antibody in patients with NSCLC
.
In this regard, the "Medical Tumor Channel" specially invited Professor Cao Lejie from the First Affiliated Hospital of the University of Science and Technology of China to interpret the research data of GEMSTONE-302 and look forward to the application prospects of sugelimab
.
The data are eye-catching, the GEMSTONE-302 study confirms the significant efficacy and benefit of sugalimumab cancer: carboplatin + pemetrexed; squamous cell carcinoma: carboplatin + paclitaxel), compared with placebo plus chemotherapy, in patients with stage IV NSCLC without first-line treatment
.
The study included both squamous cell carcinoma and non-squamous cell carcinoma patients.
Finally, 479 patients were enrolled and divided into the sugelimab group or the placebo group in a 2:1 ratio.
The primary endpoint of the study was the investigator-assessed progression-free survival.
(PFS), secondary endpoints include overall survival (OS), objective response rate (ORR), etc.
assessed by an independent blinded review committee
.
The data showed that among all patients, the median investigator-assessed PFS was 9.
0 months in the sugalimumab group, which was significantly better than the 4.
9 months in the placebo group, and sugelimumab reduced the risk of disease progression or death 52% (HR=0.
48, p<0.
0001)
.
"This is very eye-catching in this kind of research
.
" Professor Cao Lejie said
.
In addition, the 12-month PFS rate in the sugelimab combined chemotherapy group was 36.
4%, more than double the 14.
8% in the control group
.
Although OS data are immature, the current median OS was 22.
8 months vs.
17.
7 months in the sugalimab plus chemotherapy arm and placebo plus chemotherapy arm, with a 33% reduction in the risk of death (HR=0.
67, 95%CI: 0.
50 -0.
90, no formal statistical test); 24-month OS rate was 47.
1% vs.
38.
1%, and sugelimab has shown a trend of benefit
.
In addition, the ORR of the sugelimab group was 63.
4%, which was about 20% higher than that of the control group (40.
3%); the median duration of response (DoR) was 9.
8 months (vs.
4.
4 months), which was also significantly quite high
.
"So this study was very successful, it reached all the end points, and the data is very bright, I am very optimistic about the drug sugelimab
.
" Professor Cao Lejie said
.
Whole population coverage, sugelimab benefit is not affected by tissue type and PD-L1 expression level PFS benefited, and patients with squamous cell carcinoma benefited even more
.
The data showed that among patients with squamous cell carcinoma, median PFS was 8.
3 months vs.
4.
8 months in the sugelimab group and placebo group, and the risk of disease progression or death was reduced by 66% (HR=0.
34)
.
"As a double-blind study, it is very surprising to achieve such results
.
" Professor Cao Lejie said
.
In patients with non-squamous cell carcinoma, the median PFS was 9.
6 months vs.
5.
9 months, and the risk of disease progression or death was reduced by 41% (HR = 0.
59), also meeting the primary endpoint
.
"It can be seen that both squamous cell carcinoma and non-squamous cell carcinoma can benefit from sugelimab combined with chemotherapy
.
" In different PD-L1 expression subgroups, sugelimab combined with chemotherapy also Demonstrate significant benefits
.
The median PFS of the subgroup with PD-L1 TPS < 1% in the sugalimumab group and the placebo group was 7.
4 months vs.
4.
9 months (HR=0.
55).
It can be seen that patients with low PD-L1 expression can also recover from sugelimab.
benefit from Glimumab treatment
.
Moreover, the median PFS of the PD-L1 TPS 1%-49% subgroup was significantly improved, 8.
8 months vs.
4.
8 months (HR=0.
53); the median PFS of the PD-L1 TPS ≥ 50% subgroup was Further improvement was 12.
9 months vs.
5.
1 months (HR = 0.
41), and the sugelimab group was superior to the placebo group
.
Unique mechanism creates excellent efficacy and safety of sugelimab, Prof.
Lejie believes that the reason why sugelimab can achieve such good efficacy is closely related to its unique structural characteristics and mechanism of action
.
First, sugalimab is a fully human, full-length IgG4 anti-PD-L1 monoclonal antibody.
Preclinical studies have shown that it has high affinity for PD-L1, can selectively bind PD-L1, block The PD-1/L1 pathway enhances the anti-tumor immune response of T cells and exerts a tumor suppressor effect
.
Second, in addition to blocking the PD-1/L1 pathway, sugalimab also retains the Fc segment of the antibody, which enables it to bind to FcγR on the surface of macrophages and activate antibody-dependent cell-mediated phagocytosis (ADCP).
It induces macrophages to further kill tumors, and is the first PD-1/L1 monoclonal antibody that can activate ADCP
.
In addition, preclinical studies have shown that sugalimab does not induce antibody-dependent cellular cytotoxicity (ADCC); at the same time, as a fully humanized IgG4 antibody, sugalimab is less immunogenic and induces anti-drug antibodies (ADA).
) is also less likely, thus ensuring the safety of the drug
.
Professor Cao Lejie said that "Healthy China 2030" proposes that the overall 5-year survival rate of cancer in 2030 should not be lower than 46.
6% [3], while the current 5-year survival rate of lung cancer in China is only 19.
7% [4]
.
To achieve this goal, it is not only necessary to strengthen the early screening, early diagnosis and early treatment of lung cancer, but also to improve the treatment effect of advanced lung cancer
.
And immunotherapy has a long tail effect, which is expected to make some patients survive for more than 5 years, turning lung cancer into a "chronic disease"
.
Sugelimab can fully cover the advanced lung cancer population, regardless of the level of squamous cell carcinoma, non-squamous cell carcinoma and PD-L1 expression levels, all can benefit from it; at the same time, the price of sugelimab is moderate, and most patients can afford it
.
In addition, with the continuous enrichment of immunotherapy options for advanced lung cancer, in addition to efficacy, safety is also an important consideration when choosing a suitable drug.
Sugelimab has both efficacy and safety, and may emerge in the future clinically , has broad application prospects
.
Expert Profile Prof.
Cao Lejie Chief Physician, Professor, and Master Supervisor of the Department of Respiratory and Critical Care Department of the First Affiliated Hospital of China University of Science and Technology of China Member of the Standing Committee of the Special Committee of Tumor Immunity and Respiratory Rehabilitation of the Education Association, Member of the Standing Committee of the Chinese Lung Cancer Early Diagnosis and Treatment Cooperation Group, Chairman of the Anhui Anti-Cancer Association Lung Cancer Early Diagnosis and Cooperation Group Member of the Standing Committee of the Provincial Respiratory Branch, Deputy Director of the Lung Cancer Special Committee of Anhui Anti-Cancer Association, National Member of the Tuberculosis Branch of the Chinese Medical Association Reference materials: [1] GEMSTONE-302: Randomized, Double-Blind, Phase 3 Study of Sugemalimab or Placebo Plus Platinum-Based Chemotherapy as First-Line Treatment for Metastatic NSCLC.
WCLC 2021.
MA13.
07.
[2]Zhou C, Wang Z, Sun Y, et al.
Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial.
Lancet Oncol.
2022 Jan 14:S1470-2045(21)00650-1.
doi: 10.
1016/S1470-2045(21)00650-1.
[3] Opinions of the State Council on Implementing the Healthy China Action.
http:// Zeng H, Chen W, Zheng R, et al.
Changing cancer survival in China during 2003-15: a pooled analysis of 17 population-based cancer registries.
Lancet Glob Health.
2018;6(5):e555-e567.
Approval number: PP-CEJ-CHN-0086*This article is only It is used to provide scientific information to medical professionals and does not represent the views of this platform
Results of a registrational clinical study (GEMSTONE-302) in cell lung cancer (NSCLC)
.
The findings were previously presented as an oral presentation at the 2021 World Conference on Lung Cancer
.
This publication in an international authoritative medical journal once again demonstrates the clinical value of sugelimab
.
Based on the results of this study, sugelimab has been approved in China for the treatment of naïve metastatic (stage IV) NSCLC patients in combination with chemotherapy, becoming the world's first approved combination chemotherapy for the first-line treatment of metastatic squamous and non-squamous PD-L1 antibody in patients with NSCLC
.
In this regard, the "Medical Tumor Channel" specially invited Professor Cao Lejie from the First Affiliated Hospital of the University of Science and Technology of China to interpret the research data of GEMSTONE-302 and look forward to the application prospects of sugelimab
.
The data are eye-catching, the GEMSTONE-302 study confirms the significant efficacy and benefit of sugalimumab cancer: carboplatin + pemetrexed; squamous cell carcinoma: carboplatin + paclitaxel), compared with placebo plus chemotherapy, in patients with stage IV NSCLC without first-line treatment
.
The study included both squamous cell carcinoma and non-squamous cell carcinoma patients.
Finally, 479 patients were enrolled and divided into the sugelimab group or the placebo group in a 2:1 ratio.
The primary endpoint of the study was the investigator-assessed progression-free survival.
(PFS), secondary endpoints include overall survival (OS), objective response rate (ORR), etc.
assessed by an independent blinded review committee
.
The data showed that among all patients, the median investigator-assessed PFS was 9.
0 months in the sugalimumab group, which was significantly better than the 4.
9 months in the placebo group, and sugelimumab reduced the risk of disease progression or death 52% (HR=0.
48, p<0.
0001)
.
"This is very eye-catching in this kind of research
.
" Professor Cao Lejie said
.
In addition, the 12-month PFS rate in the sugelimab combined chemotherapy group was 36.
4%, more than double the 14.
8% in the control group
.
Although OS data are immature, the current median OS was 22.
8 months vs.
17.
7 months in the sugalimab plus chemotherapy arm and placebo plus chemotherapy arm, with a 33% reduction in the risk of death (HR=0.
67, 95%CI: 0.
50 -0.
90, no formal statistical test); 24-month OS rate was 47.
1% vs.
38.
1%, and sugelimab has shown a trend of benefit
.
In addition, the ORR of the sugelimab group was 63.
4%, which was about 20% higher than that of the control group (40.
3%); the median duration of response (DoR) was 9.
8 months (vs.
4.
4 months), which was also significantly quite high
.
"So this study was very successful, it reached all the end points, and the data is very bright, I am very optimistic about the drug sugelimab
.
" Professor Cao Lejie said
.
Whole population coverage, sugelimab benefit is not affected by tissue type and PD-L1 expression level PFS benefited, and patients with squamous cell carcinoma benefited even more
.
The data showed that among patients with squamous cell carcinoma, median PFS was 8.
3 months vs.
4.
8 months in the sugelimab group and placebo group, and the risk of disease progression or death was reduced by 66% (HR=0.
34)
.
"As a double-blind study, it is very surprising to achieve such results
.
" Professor Cao Lejie said
.
In patients with non-squamous cell carcinoma, the median PFS was 9.
6 months vs.
5.
9 months, and the risk of disease progression or death was reduced by 41% (HR = 0.
59), also meeting the primary endpoint
.
"It can be seen that both squamous cell carcinoma and non-squamous cell carcinoma can benefit from sugelimab combined with chemotherapy
.
" In different PD-L1 expression subgroups, sugelimab combined with chemotherapy also Demonstrate significant benefits
.
The median PFS of the subgroup with PD-L1 TPS < 1% in the sugalimumab group and the placebo group was 7.
4 months vs.
4.
9 months (HR=0.
55).
It can be seen that patients with low PD-L1 expression can also recover from sugelimab.
benefit from Glimumab treatment
.
Moreover, the median PFS of the PD-L1 TPS 1%-49% subgroup was significantly improved, 8.
8 months vs.
4.
8 months (HR=0.
53); the median PFS of the PD-L1 TPS ≥ 50% subgroup was Further improvement was 12.
9 months vs.
5.
1 months (HR = 0.
41), and the sugelimab group was superior to the placebo group
.
Unique mechanism creates excellent efficacy and safety of sugelimab, Prof.
Lejie believes that the reason why sugelimab can achieve such good efficacy is closely related to its unique structural characteristics and mechanism of action
.
First, sugalimab is a fully human, full-length IgG4 anti-PD-L1 monoclonal antibody.
Preclinical studies have shown that it has high affinity for PD-L1, can selectively bind PD-L1, block The PD-1/L1 pathway enhances the anti-tumor immune response of T cells and exerts a tumor suppressor effect
.
Second, in addition to blocking the PD-1/L1 pathway, sugalimab also retains the Fc segment of the antibody, which enables it to bind to FcγR on the surface of macrophages and activate antibody-dependent cell-mediated phagocytosis (ADCP).
It induces macrophages to further kill tumors, and is the first PD-1/L1 monoclonal antibody that can activate ADCP
.
In addition, preclinical studies have shown that sugalimab does not induce antibody-dependent cellular cytotoxicity (ADCC); at the same time, as a fully humanized IgG4 antibody, sugalimab is less immunogenic and induces anti-drug antibodies (ADA).
) is also less likely, thus ensuring the safety of the drug
.
Professor Cao Lejie said that "Healthy China 2030" proposes that the overall 5-year survival rate of cancer in 2030 should not be lower than 46.
6% [3], while the current 5-year survival rate of lung cancer in China is only 19.
7% [4]
.
To achieve this goal, it is not only necessary to strengthen the early screening, early diagnosis and early treatment of lung cancer, but also to improve the treatment effect of advanced lung cancer
.
And immunotherapy has a long tail effect, which is expected to make some patients survive for more than 5 years, turning lung cancer into a "chronic disease"
.
Sugelimab can fully cover the advanced lung cancer population, regardless of the level of squamous cell carcinoma, non-squamous cell carcinoma and PD-L1 expression levels, all can benefit from it; at the same time, the price of sugelimab is moderate, and most patients can afford it
.
In addition, with the continuous enrichment of immunotherapy options for advanced lung cancer, in addition to efficacy, safety is also an important consideration when choosing a suitable drug.
Sugelimab has both efficacy and safety, and may emerge in the future clinically , has broad application prospects
.
Expert Profile Prof.
Cao Lejie Chief Physician, Professor, and Master Supervisor of the Department of Respiratory and Critical Care Department of the First Affiliated Hospital of China University of Science and Technology of China Member of the Standing Committee of the Special Committee of Tumor Immunity and Respiratory Rehabilitation of the Education Association, Member of the Standing Committee of the Chinese Lung Cancer Early Diagnosis and Treatment Cooperation Group, Chairman of the Anhui Anti-Cancer Association Lung Cancer Early Diagnosis and Cooperation Group Member of the Standing Committee of the Provincial Respiratory Branch, Deputy Director of the Lung Cancer Special Committee of Anhui Anti-Cancer Association, National Member of the Tuberculosis Branch of the Chinese Medical Association Reference materials: [1] GEMSTONE-302: Randomized, Double-Blind, Phase 3 Study of Sugemalimab or Placebo Plus Platinum-Based Chemotherapy as First-Line Treatment for Metastatic NSCLC.
WCLC 2021.
MA13.
07.
[2]Zhou C, Wang Z, Sun Y, et al.
Sugemalimab versus placebo, in combination with platinum-based chemotherapy, as first-line treatment of metastatic non-small-cell lung cancer (GEMSTONE-302): interim and final analyses of a double-blind, randomised, phase 3 clinical trial.
Lancet Oncol.
2022 Jan 14:S1470-2045(21)00650-1.
doi: 10.
1016/S1470-2045(21)00650-1.
[3] Opinions of the State Council on Implementing the Healthy China Action.
http:// Zeng H, Chen W, Zheng R, et al.
Changing cancer survival in China during 2003-15: a pooled analysis of 17 population-based cancer registries.
Lancet Glob Health.
2018;6(5):e555-e567.
Approval number: PP-CEJ-CHN-0086*This article is only It is used to provide scientific information to medical professionals and does not represent the views of this platform
