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*Only for medical professionals to read for reference.
Sofatinib has a significant effect on advanced pancreatic neuroendocrine tumors with different Ki-67 indexes and different baseline CgA levels
.
In 2021, the American Society of Clinical Oncology (ASCO), a SANET-p study of Sofatinib in the treatment of pancreatic neuroendocrine tumors (p-NET) released the latest subgroup data, the results showed that regardless of Ki-67 expression level or baseline CgA Regardless of the level, Sofatinib has significant benefits in patients with advanced, progressive, and moderately well-differentiated p-NET
.
In addition, the interim analysis data of another Phase I study of Sofantinib in the treatment of NET patients in the United States also made a brilliant appearance
.
The "medical community" specially invited Professor Yu Xianjun from Fudan University Cancer Hospital to interpret relevant research results for readers
.
Figure 1.
2021ASCO Conference SANET-p Research Abstract (Abstract Number: 4111) SANET-p Research: Sofatinib is the world's first Chinese innovative drug with conclusive evidence for the treatment of p-NET.
The Phase III study of Sofantinib in the treatment of G1/G2 advanced pancreatic neuroendocrine tumors will be published at the 2020 European Society of Medical Oncology (ESMO) annual meeting and will be synchronized with the "Lancet Oncology" (The Lancet Oncology).
Published online by Lancet Oncology [1], the results showed that compared with placebo, the sofatinib group can significantly prolong the median progression-free survival (mPFS) of patients (13.
9 months vs 4.
6 months) (HR=0.
34; 95%CI 0.
21-0.
55; P<0.
0001) (assessed by the blinded independent reading committee), significantly reduce the risk of disease progression by 66%, and the safety is good, and the patient is well tolerated
.
Professor Yu emphasized that the p-NET G1/G2 level of malignancy is relatively low, and the patient's survival time is relatively long.
After Sofatinib treatment, the survival period can be improved to such a degree.
The research results are very exciting
.
Figure 2.
SANET-p study design (2021 ASCO abstract) At the same time, the ORR of Sofantinib was as high as 19.
2%, which was significantly better than placebo by 2%.
It is the previous p-NET treatment drug everolimus (ORR: 4.
8%), Sunitinib (ORR: 9.
3%) and octreotide (ORR: 2.
4%) benefited several times, and they are among the best in the history of p-NET treatment
.
The highly improved ORR has laid a solid foundation for the powerful tumor shrinkage effect of Sofantinib.
84% of patients achieved tumor shrinkage benefits, and 68% of patients had tumor shrinkage by more than 10% (compared to baseline)
.
Professor Yu said that the significant tumor regression effect of Sofatinib will create great application potential for neoadjuvant surgery and conversion therapy, and this is the only way for Sofatinib to succeed in the treatment of advanced p-NET, and It will have an important impact on the entire p-NET treatment pattern
.
SANET-p subgroup analysis tops ASCO: Sofantinib creates new highs in PFS and ORR benefits.
The 2021 ASCO conference announced the subgroup analysis results of the SANET-p study (abstract number: 4111) [2], the report will have different Ki -67 expression level (<3%, 3-10%,> 10%) and different baseline CgA levels [≤2 × upper limit of normal (ULN),> 2 × ULN] stratification, PFS, objective response rate (ORR) Perform post-mortem analysis
.
Professor Yu pointed out that Ki-67 is a cell proliferation index, and the increase in this index is related to the more aggressive clinical course and worse prognosis of NET patients
.
CgA is not as widely used as Ki-67, but as the best marker for neuroendocrine tumors (NENs), its level is closely related to the patient's tumor burden, prognosis and survival rate
.
The results of this subgroup analysis showed that compared with the placebo group, Sofatinib can significantly prolong the median PFS of Ki-67 3%-10% and Ki-67>10% subgroups, Ki-67<3% subgroups The PFS value of the group improved (Table 1)
.
The ORRs of the three subgroups in the sofatinib group were significantly better than those of the placebo group, which were 23.
1%, 20%, and 12.
5%, respectively.
It is particularly noteworthy that in the three different Ki-67 index subgroups, the The proportion of patients with tumor regression in the vantinib group was higher than that in the placebo group, and the effect was similar.
For p-NET patients with Ki-67<20%, the proportion of patients with tumor regression in the sofatinib group was in the Ki-67<3% subgroup Accounted for 69.
23%, the Ki-67 3%-10% subgroup accounted for 69.
33%, and the Ki-67 >10% subgroup accounted for 68.
75% (Table 2)
.
Table 1.
The PFS results of the Ki-67 subgroup of the SANET-p study Table 2.
The tumor regression data of the Ki-67 subgroup of the SANET-p study The results of the subgroup analysis based on CgA stratification showed that Sofatinib significantly prolonged CgA> The median PFS of the 2 × ULN subgroup, CgA ≤ 2 × ULN subgroup, was improved (Table 3)
.
Table 3.
The PFS results of the SANET-p study baseline CgA level subgroup.
After treatment with Sofatinib, the ORRs of patients in the CgA≤2 × ULN and> 2 × ULN groups were as high as 18.
9% and 21.
4%, respectively, compared with evermo Si, sunitinib, and octreotide also have multiple benefits
.
In the two subgroups based on CgA stratification, the proportion of patients with tumor regression in the sofatinib group was higher than that in the placebo group, and the proportion of patients who achieved a tumor shrinkage of more than 10% was also higher than that in the placebo group (Table 4)
.
Professor Yu emphasized that on the whole, sofatinib can obtain better efficacy data in p-NET, which has relatively mild biological behavior, which also reflects its potent characteristics, which is of far-reaching clinical significance, especially when used in surgery.
Pre-conversion therapy has important value
.
Table 4.
SANET-p study baseline CgA level subgroup tumor regression data.
The post-analysis results show that Sofatinib has a significant effect on advanced pancreatic neuroendocrine tumors with different Ki-67 indexes and baseline CgA levels
.
And the results of the post-mortem analysis were consistent with the results of the initial analysis of SANET-p, and the improvement effect brought by sofatinib was observed in the main subgroups
.
SANET-p research: Sofatinib has excellent curative effect and has great application prospects.
Professor Yu further added that the research and development of Sofatinib has gone through 14 years.
It can be described as step by step and step by step.
People's livelihood is indeed the pride of domestically developed original drugs
.
The SANET-p study evaluated the application of sofatinib in patients with advanced p-NET.
Most patients (more than 85%) had a pathological grade of G2, (more than 95%) metastasized to the liver, and involved multiple organs, three points The second patient had received advanced anti-tumor therapy
.
Although the enrolled population is at an advanced stage and the tumor burden is obvious, sofatinib still achieves a surprising effect, suggesting that sofatinib may be a favorable choice for patients with aggressive p-NET
.
In addition, SANET-p terminated the study early based on the interim analysis that reached the pre-determined primary efficacy endpoint of PFS, and based on its heavy achievements, it has submitted a new drug marketing application and will be approved soon
.
The ASCO conference announced the study based on Ki-67 index and baseline CgA level stratified PFS, ORR and tumor regression subgroup analysis data, not only obtained mPFS (16.
6 months) better than previous p-NET treatment drugs The benefit of ORR (23.
1%) is once again a new height in the history of p-NET treatment, and all subgroups have significant tumor regression effects, which can effectively reduce the tumor burden of patients with p-NET, which is extremely neoadjuvant and conversion therapy Potential
.
Going abroad, the performance of sofatinib in NET patients in the United States is still bright.
Figure 3.
Phase I study design of sofatinib in NET patients in the United States (2021ASCO abstract) This ASCO meeting also announced a sofatinib Interim analysis data used in the Phase I study of NET patients in the United States (Abstract No.
4114) [3] A total of 32 NET patients were enrolled (ep-NET and p-NET each accounted for 16 cases), and the ORR of the total population was 12.
5% , The DCR is as high as 90.
6%, the median PFS is up to 11.
5 months, and the 11-month PFS rate is 55.
6%, that is, more than half of the patients will not have disease progression and death within 11 months
.
In short, this study once again verified that Sofatinib has strong anti-tumor activity and controllable safety for patients with advanced neuroendocrine tumors, which is consistent with the results of SANET-p and SANET-ep
.
Based on this study and two successful phase III studies in China, Sofatinib also submitted a new drug application in the United States
.
This means that Sofatinib can not only bring new treatment opportunities for Chinese patients based on its locality, but also rely on its unique anti-angiogenesis and immune regulation unique mechanism to advance in the field of NET therapy, go abroad, and enter the United States.
The gradual implementation of the strategic deployment of the globalization journey is expected to become an internationally innovative therapeutic drug
.
Figure 4.
Expert profile on the efficacy data of Sofantinib Professor Yu Xianjun, Chief Physician, Ph.
D.
Supervisor, Vice President, Fudan University Tumor Hospital, Vice President, Shanghai Pancreatic Tumor Institute Director, Fudan University Pancreatic Tumor Institute National Outstanding Youth Winner of National Science Fund, National Ministry of Science and Technology "Young and Middle-aged Science and Technology Innovation Leading Talents" National Ten Thousands of Talents Project "Outstanding Contribution Young and Middle-aged Experts" National May 1st Labor Medal Winner Shanghai Leading Talents, Shanghai Craftsmen, Shanghai May 1st Labor Medal Winner of the first "Famous Doctor Project" of Fudan University Selected member of the Pancreatic Cancer Professional Committee of China Anti-Cancer Association Chairman of the CSPAC Chinese Pancreatic Cancer Multidisciplinary Collaboration Group Member of the Pancreatic Surgery Group of the Chinese Medical Association Surgery Branch Member of the Chinese Medical Association Committee member Chinese Society of Clinical Oncology Pancreatic Cancer Expert Committee Standing Committee Member of the American College of Surgeons Fellow (FACS) presided over 1 National Natural Science Foundation Sino-German International Key Cooperation Project, 3 National Natural Science Foundation General Projects, and 12 Provincial and Ministerial Projects; A total of more than 30 million yuan in research funding has been obtained
.
The corresponding author has published more than 160 SCI papers in international authoritative journals such as J Clin Oncol, GUT, Ann Surg, Cell Res, Autophagy, Clin Cancer Res, Cancer Res, etc.
, with a total IF>650, and the highest IF for a single article: 32.
9
.
References: [1] Xu J, Shen L, Bai C, et al.
Surufatinib in advanced pancreatic neuroendocrinetumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3study.
Lancet Oncol.
2020 Nov; 21 (11):1489-1499.
[2] Yu XJ, Xu J, Shen L, et al.
Surufatinib demonstrated benefit irrespective of Ki-67expression levels or baseline CgA in patients with advanced, progressive,well-differentiated pancreatic NETs.
2021 ASCO .
Abstract 4111.
[3] Paulson S, Li D, Sung M, et al.
Interim Analysis Results of Surufatinib in USPatients with Neuroendocrine Tumors (NETs).
2021 ASCO.
Abstract 4114.
*This article is only used to provide science to medical professionals Information, does not represent the views of this platform
Sofatinib has a significant effect on advanced pancreatic neuroendocrine tumors with different Ki-67 indexes and different baseline CgA levels
.
In 2021, the American Society of Clinical Oncology (ASCO), a SANET-p study of Sofatinib in the treatment of pancreatic neuroendocrine tumors (p-NET) released the latest subgroup data, the results showed that regardless of Ki-67 expression level or baseline CgA Regardless of the level, Sofatinib has significant benefits in patients with advanced, progressive, and moderately well-differentiated p-NET
.
In addition, the interim analysis data of another Phase I study of Sofantinib in the treatment of NET patients in the United States also made a brilliant appearance
.
The "medical community" specially invited Professor Yu Xianjun from Fudan University Cancer Hospital to interpret relevant research results for readers
.
Figure 1.
2021ASCO Conference SANET-p Research Abstract (Abstract Number: 4111) SANET-p Research: Sofatinib is the world's first Chinese innovative drug with conclusive evidence for the treatment of p-NET.
The Phase III study of Sofantinib in the treatment of G1/G2 advanced pancreatic neuroendocrine tumors will be published at the 2020 European Society of Medical Oncology (ESMO) annual meeting and will be synchronized with the "Lancet Oncology" (The Lancet Oncology).
Published online by Lancet Oncology [1], the results showed that compared with placebo, the sofatinib group can significantly prolong the median progression-free survival (mPFS) of patients (13.
9 months vs 4.
6 months) (HR=0.
34; 95%CI 0.
21-0.
55; P<0.
0001) (assessed by the blinded independent reading committee), significantly reduce the risk of disease progression by 66%, and the safety is good, and the patient is well tolerated
.
Professor Yu emphasized that the p-NET G1/G2 level of malignancy is relatively low, and the patient's survival time is relatively long.
After Sofatinib treatment, the survival period can be improved to such a degree.
The research results are very exciting
.
Figure 2.
SANET-p study design (2021 ASCO abstract) At the same time, the ORR of Sofantinib was as high as 19.
2%, which was significantly better than placebo by 2%.
It is the previous p-NET treatment drug everolimus (ORR: 4.
8%), Sunitinib (ORR: 9.
3%) and octreotide (ORR: 2.
4%) benefited several times, and they are among the best in the history of p-NET treatment
.
The highly improved ORR has laid a solid foundation for the powerful tumor shrinkage effect of Sofantinib.
84% of patients achieved tumor shrinkage benefits, and 68% of patients had tumor shrinkage by more than 10% (compared to baseline)
.
Professor Yu said that the significant tumor regression effect of Sofatinib will create great application potential for neoadjuvant surgery and conversion therapy, and this is the only way for Sofatinib to succeed in the treatment of advanced p-NET, and It will have an important impact on the entire p-NET treatment pattern
.
SANET-p subgroup analysis tops ASCO: Sofantinib creates new highs in PFS and ORR benefits.
The 2021 ASCO conference announced the subgroup analysis results of the SANET-p study (abstract number: 4111) [2], the report will have different Ki -67 expression level (<3%, 3-10%,> 10%) and different baseline CgA levels [≤2 × upper limit of normal (ULN),> 2 × ULN] stratification, PFS, objective response rate (ORR) Perform post-mortem analysis
.
Professor Yu pointed out that Ki-67 is a cell proliferation index, and the increase in this index is related to the more aggressive clinical course and worse prognosis of NET patients
.
CgA is not as widely used as Ki-67, but as the best marker for neuroendocrine tumors (NENs), its level is closely related to the patient's tumor burden, prognosis and survival rate
.
The results of this subgroup analysis showed that compared with the placebo group, Sofatinib can significantly prolong the median PFS of Ki-67 3%-10% and Ki-67>10% subgroups, Ki-67<3% subgroups The PFS value of the group improved (Table 1)
.
The ORRs of the three subgroups in the sofatinib group were significantly better than those of the placebo group, which were 23.
1%, 20%, and 12.
5%, respectively.
It is particularly noteworthy that in the three different Ki-67 index subgroups, the The proportion of patients with tumor regression in the vantinib group was higher than that in the placebo group, and the effect was similar.
For p-NET patients with Ki-67<20%, the proportion of patients with tumor regression in the sofatinib group was in the Ki-67<3% subgroup Accounted for 69.
23%, the Ki-67 3%-10% subgroup accounted for 69.
33%, and the Ki-67 >10% subgroup accounted for 68.
75% (Table 2)
.
Table 1.
The PFS results of the Ki-67 subgroup of the SANET-p study Table 2.
The tumor regression data of the Ki-67 subgroup of the SANET-p study The results of the subgroup analysis based on CgA stratification showed that Sofatinib significantly prolonged CgA> The median PFS of the 2 × ULN subgroup, CgA ≤ 2 × ULN subgroup, was improved (Table 3)
.
Table 3.
The PFS results of the SANET-p study baseline CgA level subgroup.
After treatment with Sofatinib, the ORRs of patients in the CgA≤2 × ULN and> 2 × ULN groups were as high as 18.
9% and 21.
4%, respectively, compared with evermo Si, sunitinib, and octreotide also have multiple benefits
.
In the two subgroups based on CgA stratification, the proportion of patients with tumor regression in the sofatinib group was higher than that in the placebo group, and the proportion of patients who achieved a tumor shrinkage of more than 10% was also higher than that in the placebo group (Table 4)
.
Professor Yu emphasized that on the whole, sofatinib can obtain better efficacy data in p-NET, which has relatively mild biological behavior, which also reflects its potent characteristics, which is of far-reaching clinical significance, especially when used in surgery.
Pre-conversion therapy has important value
.
Table 4.
SANET-p study baseline CgA level subgroup tumor regression data.
The post-analysis results show that Sofatinib has a significant effect on advanced pancreatic neuroendocrine tumors with different Ki-67 indexes and baseline CgA levels
.
And the results of the post-mortem analysis were consistent with the results of the initial analysis of SANET-p, and the improvement effect brought by sofatinib was observed in the main subgroups
.
SANET-p research: Sofatinib has excellent curative effect and has great application prospects.
Professor Yu further added that the research and development of Sofatinib has gone through 14 years.
It can be described as step by step and step by step.
People's livelihood is indeed the pride of domestically developed original drugs
.
The SANET-p study evaluated the application of sofatinib in patients with advanced p-NET.
Most patients (more than 85%) had a pathological grade of G2, (more than 95%) metastasized to the liver, and involved multiple organs, three points The second patient had received advanced anti-tumor therapy
.
Although the enrolled population is at an advanced stage and the tumor burden is obvious, sofatinib still achieves a surprising effect, suggesting that sofatinib may be a favorable choice for patients with aggressive p-NET
.
In addition, SANET-p terminated the study early based on the interim analysis that reached the pre-determined primary efficacy endpoint of PFS, and based on its heavy achievements, it has submitted a new drug marketing application and will be approved soon
.
The ASCO conference announced the study based on Ki-67 index and baseline CgA level stratified PFS, ORR and tumor regression subgroup analysis data, not only obtained mPFS (16.
6 months) better than previous p-NET treatment drugs The benefit of ORR (23.
1%) is once again a new height in the history of p-NET treatment, and all subgroups have significant tumor regression effects, which can effectively reduce the tumor burden of patients with p-NET, which is extremely neoadjuvant and conversion therapy Potential
.
Going abroad, the performance of sofatinib in NET patients in the United States is still bright.
Figure 3.
Phase I study design of sofatinib in NET patients in the United States (2021ASCO abstract) This ASCO meeting also announced a sofatinib Interim analysis data used in the Phase I study of NET patients in the United States (Abstract No.
4114) [3] A total of 32 NET patients were enrolled (ep-NET and p-NET each accounted for 16 cases), and the ORR of the total population was 12.
5% , The DCR is as high as 90.
6%, the median PFS is up to 11.
5 months, and the 11-month PFS rate is 55.
6%, that is, more than half of the patients will not have disease progression and death within 11 months
.
In short, this study once again verified that Sofatinib has strong anti-tumor activity and controllable safety for patients with advanced neuroendocrine tumors, which is consistent with the results of SANET-p and SANET-ep
.
Based on this study and two successful phase III studies in China, Sofatinib also submitted a new drug application in the United States
.
This means that Sofatinib can not only bring new treatment opportunities for Chinese patients based on its locality, but also rely on its unique anti-angiogenesis and immune regulation unique mechanism to advance in the field of NET therapy, go abroad, and enter the United States.
The gradual implementation of the strategic deployment of the globalization journey is expected to become an internationally innovative therapeutic drug
.
Figure 4.
Expert profile on the efficacy data of Sofantinib Professor Yu Xianjun, Chief Physician, Ph.
D.
Supervisor, Vice President, Fudan University Tumor Hospital, Vice President, Shanghai Pancreatic Tumor Institute Director, Fudan University Pancreatic Tumor Institute National Outstanding Youth Winner of National Science Fund, National Ministry of Science and Technology "Young and Middle-aged Science and Technology Innovation Leading Talents" National Ten Thousands of Talents Project "Outstanding Contribution Young and Middle-aged Experts" National May 1st Labor Medal Winner Shanghai Leading Talents, Shanghai Craftsmen, Shanghai May 1st Labor Medal Winner of the first "Famous Doctor Project" of Fudan University Selected member of the Pancreatic Cancer Professional Committee of China Anti-Cancer Association Chairman of the CSPAC Chinese Pancreatic Cancer Multidisciplinary Collaboration Group Member of the Pancreatic Surgery Group of the Chinese Medical Association Surgery Branch Member of the Chinese Medical Association Committee member Chinese Society of Clinical Oncology Pancreatic Cancer Expert Committee Standing Committee Member of the American College of Surgeons Fellow (FACS) presided over 1 National Natural Science Foundation Sino-German International Key Cooperation Project, 3 National Natural Science Foundation General Projects, and 12 Provincial and Ministerial Projects; A total of more than 30 million yuan in research funding has been obtained
.
The corresponding author has published more than 160 SCI papers in international authoritative journals such as J Clin Oncol, GUT, Ann Surg, Cell Res, Autophagy, Clin Cancer Res, Cancer Res, etc.
, with a total IF>650, and the highest IF for a single article: 32.
9
.
References: [1] Xu J, Shen L, Bai C, et al.
Surufatinib in advanced pancreatic neuroendocrinetumours (SANET-p): a randomised, double-blind, placebo-controlled, phase 3study.
Lancet Oncol.
2020 Nov; 21 (11):1489-1499.
[2] Yu XJ, Xu J, Shen L, et al.
Surufatinib demonstrated benefit irrespective of Ki-67expression levels or baseline CgA in patients with advanced, progressive,well-differentiated pancreatic NETs.
2021 ASCO .
Abstract 4111.
[3] Paulson S, Li D, Sung M, et al.
Interim Analysis Results of Surufatinib in USPatients with Neuroendocrine Tumors (NETs).
2021 ASCO.
Abstract 4114.
*This article is only used to provide science to medical professionals Information, does not represent the views of this platform
