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Introduction Neuroendocrine tumors originate from neuroendocrine cells and can occur in different organs of the human body.
They are highly heterogeneous and belong to a class of rare diseases
.
In the past ten years, with the improvement of clinical diagnosis and treatment awareness and the advancement of diagnosis technology, the incidence of neuroendocrine tumors has been increasing year by year, which puts forward a higher demand for clinical diagnosis and treatment
.
The recent 2021 North American Society of Neuroendocrine Oncology (NANETS) annual meeting announced the latest data from the Phase II clinical study of sofatinib combined with teriprizumab in the treatment of advanced neuroendocrine cancer that failed first-line chemotherapy
.
In this regard, Yimaitong specially invited one of the main researchers of this research, Professor Lu Ming from Peking University Cancer Hospital to share the progress and future development prospects of sofantinib combined with triplimumab
.
[Encountered difficulties, urgently need to "break through"] Traditional drugs have limited efficacy, and the bottleneck of neuroendocrine cancer treatment needs to be broken.
Neuroendocrine tumors are relatively rare, and their incidence has been increasing year by year in recent years
.
Neuroendocrine carcinoma (NEC) is a poorly differentiated neuroendocrine tumor, accounting for about 10-20% of all neuroendocrine tumors
.
Regarding the pain points and difficulties of the clinical treatment of NEC, Professor Lu Ming pointed out that due to the relatively slow progress in the field of disease research, the drugs for the treatment of NEC are still very limited.
The first-line treatment mainly includes etoposide combined with cisplatin (EP) or irinotecan.
Cisplatin (IP) program
.
In addition, compared with neuroendocrine tumors (NET), NEC has a higher degree of malignancy.
Most patients have lost the opportunity of surgery when they are diagnosed, or the disease relapses soon after surgery.
Chemotherapy alone cannot meet clinical needs, and new treatment options (such as target Treatment, immunotherapy, etc.
) appear to improve the prognosis of patients
.
[Continuous search, finally welcome the light] Sofantinib + Teriplizumab combination therapy "breaks" NEC second-line treatment In the immunotherapy era, the treatment of tumors has undergone a breakthrough change
.
Many patients have obtained better results after using immunotherapy
.
Therefore, researchers all over the world have gradually begun to try to apply immunotherapy in the field of NEC
.
However, studies have found that the efficacy of immune monotherapy is not ideal, and the patient's objective response rate (ORR) is less than 10%, and the combination of immune and anti-angiogenesis targeted drugs shows a better therapeutic prospect
.
Professor Lu Ming introduced that Sofantinib is an anti-angiogenic small molecule targeted drug.
In addition to its anti-angiogenic effect, it can also inhibit colony stimulating factor 1 receptor (CSF-1R) to promote the body’s The immune response of tumor cells, combined with immunotherapy, can play an anti-tumor synergistic effect
.
Therefore, the team began to try to treat NEC with sofantinib combined with teriprizumab
.
Sofatinib is a drug that the team is very familiar with.
It has participated in the phase I trial to the phase III trial, so the efficacy and safety of Sofatinib have a good grasp
.
Teriplizumab is a PD-1 monoclonal antibody that can block the combination of PD-L1 and PD-1 and activate T cells to kill tumors
.
Therefore, the mechanism of sofatinib combined with teriprizumab in the treatment of NEC is very "solid"
.
Pre-clinical basic research and animal experiments also show the synergistic effect of the two
.
In view of the clear mechanism of action of sofantinib combined with teriprizumab and good preclinical research results, the neuroendocrine tumor team of Peking University Cancer Hospital where Professor Lu works led the development of a "sofantinib combined with tere A phase II clinical study of prilimumab in the treatment of advanced solid tumors-NEC cohort study"
.
The latest data of this research has been logged into NANETS, showing China's wisdom and achievements
.
As one of the main investigators of this study, Professor Lu Ming introduced that in the phase I climbing trial, the ORR of the enrolled patients exceeded 30%; in the phase II study, in addition to the NET cohort, the NEC cohort was also included.
It has also been tried in other solid tumors
.
The study found that the ORR of multiple cohorts reached more than 20%
.
Therefore, sofantinib combined with teriprizumab also has great application prospects in solid tumors other than neuroendocrine tumors
.
At present, the data of the NEC cohort is relatively mature.
The confirmed ORR of Sofantinib combined with teriprizumab in the treatment of advanced NEC patients who have failed first-line chemotherapy is 23.
8%, and the median duration of response (DoR) is 4.
11 months; The median progression-free survival (PFS) was 4.
14 months, and the median overall survival (OS) was 10.
32 months
.
In terms of safety, the adverse events that occurred during the treatment of advanced NEC with sofantinib combined with teriprizumab are consistent with the reported safety of similar anti-vascular drugs combined with immunotherapy.
There is no "superimposition" of adverse reactions, and patient tolerance Good
.
Professor Lu Ming recalled that the first patient enrolled in the study was very lucky.
This was a 50-year-old patient with a metastatic neuroendocrine tumor of unknown primary focus (multiple metastases such as lung, mediastinum, bone, and liver).
The disease progressed rapidly about 3 months after chemotherapy, accompanied by obvious symptoms of coughing and suffocation
.
Subsequently, the patient joined the study to receive sofatinib combined with teriprizumab
.
One cycle after the first medication, the patient's above symptoms disappeared
.
Up to now, the patient has been on the drug for nearly 2 years, the tumor has basically disappeared, the efficacy evaluation is close to complete remission (CR), and the patient is in good condition
.
[Riding the wind and breaking the waves, moving forward on the “medicine” road] Sofantinib combined with teriprizumab is expected to bring hope to more cancer patients.
Professor Lu Ming pointed out that in the current treatment plan of NEC, the first-line treatment is chemotherapy, and the second-line treatment is not.
Standard plan
.
Sofatinib combined with teriprizumab has a good application prospect in the field of neuroendocrine tumors, and it is hoped that this therapy can become the standard second-line treatment of NEC
.
At present, a phase III multicenter study of sofatinib combined with teriprizumab in the second-line treatment of NEC is underway, and the first patient has achieved partial remission (PR) in the evaluation of efficacy
.
In addition, clinical research on the treatment of other advanced solid tumors with sofantinib combined with teriprizumab is in full swing, involving tumor types including gastric cancer, lung cancer, esophageal cancer, endometrial cancer, biliary tract cancer, soft tissue sarcoma, etc.
.
We look forward to more efficacy results and safety data in the follow-up of this study, so as to provide more tumor patients with new treatment options
.
Summary Neuroendocrine carcinoma is a rare and complex tumor.
Patients who fail the first-line treatment have a poor prognosis and limited treatment options
.
Single-agent immune checkpoint inhibitors have low efficiency and short disease control time
.
The combination of sofatinib and teriprizumab has a good application prospect, and we look forward to more gratifying clinical trial results, which will bring more options for the treatment of cancer patients! Expert profile: Professor Lu Ming, Chief Physician, Associate Professor, Department of Gastroenterology, Peking University Cancer Hospital, Master's Supervisor Professional direction: Drugs and comprehensive treatment of malignant tumors of the digestive system.
CSCO) Member of Neuroendocrine Tumor Committee Member of Chinese Society of Clinical Oncology (CSCO) Member of Biliary Tumor Committee Member of Neuroendocrine Oncology Group of Pancreatic Cancer Professional Committee of Chinese Anti-Cancer Association Chairperson Director of the Editorial Department of Frontier Chinese Journal of Medicine (Electronic Edition) Director of Beijing Medico Charity Foundation Chairman of Kanglin Tumor Technology Innovation Institute (Suzhou Industrial Park) NP-STD-21N97-Valid Until 2023 Nov This information is intended to promote Communication and exchange of medical information
.
This information is for academic reference only by medical and health professionals, not for the general public, nor for advertising
.
For prescriptions, please refer to the drug instructions approved by the State Drug Administration
.
Please do not distribute or forward this information
.
They are highly heterogeneous and belong to a class of rare diseases
.
In the past ten years, with the improvement of clinical diagnosis and treatment awareness and the advancement of diagnosis technology, the incidence of neuroendocrine tumors has been increasing year by year, which puts forward a higher demand for clinical diagnosis and treatment
.
The recent 2021 North American Society of Neuroendocrine Oncology (NANETS) annual meeting announced the latest data from the Phase II clinical study of sofatinib combined with teriprizumab in the treatment of advanced neuroendocrine cancer that failed first-line chemotherapy
.
In this regard, Yimaitong specially invited one of the main researchers of this research, Professor Lu Ming from Peking University Cancer Hospital to share the progress and future development prospects of sofantinib combined with triplimumab
.
[Encountered difficulties, urgently need to "break through"] Traditional drugs have limited efficacy, and the bottleneck of neuroendocrine cancer treatment needs to be broken.
Neuroendocrine tumors are relatively rare, and their incidence has been increasing year by year in recent years
.
Neuroendocrine carcinoma (NEC) is a poorly differentiated neuroendocrine tumor, accounting for about 10-20% of all neuroendocrine tumors
.
Regarding the pain points and difficulties of the clinical treatment of NEC, Professor Lu Ming pointed out that due to the relatively slow progress in the field of disease research, the drugs for the treatment of NEC are still very limited.
The first-line treatment mainly includes etoposide combined with cisplatin (EP) or irinotecan.
Cisplatin (IP) program
.
In addition, compared with neuroendocrine tumors (NET), NEC has a higher degree of malignancy.
Most patients have lost the opportunity of surgery when they are diagnosed, or the disease relapses soon after surgery.
Chemotherapy alone cannot meet clinical needs, and new treatment options (such as target Treatment, immunotherapy, etc.
) appear to improve the prognosis of patients
.
[Continuous search, finally welcome the light] Sofantinib + Teriplizumab combination therapy "breaks" NEC second-line treatment In the immunotherapy era, the treatment of tumors has undergone a breakthrough change
.
Many patients have obtained better results after using immunotherapy
.
Therefore, researchers all over the world have gradually begun to try to apply immunotherapy in the field of NEC
.
However, studies have found that the efficacy of immune monotherapy is not ideal, and the patient's objective response rate (ORR) is less than 10%, and the combination of immune and anti-angiogenesis targeted drugs shows a better therapeutic prospect
.
Professor Lu Ming introduced that Sofantinib is an anti-angiogenic small molecule targeted drug.
In addition to its anti-angiogenic effect, it can also inhibit colony stimulating factor 1 receptor (CSF-1R) to promote the body’s The immune response of tumor cells, combined with immunotherapy, can play an anti-tumor synergistic effect
.
Therefore, the team began to try to treat NEC with sofantinib combined with teriprizumab
.
Sofatinib is a drug that the team is very familiar with.
It has participated in the phase I trial to the phase III trial, so the efficacy and safety of Sofatinib have a good grasp
.
Teriplizumab is a PD-1 monoclonal antibody that can block the combination of PD-L1 and PD-1 and activate T cells to kill tumors
.
Therefore, the mechanism of sofatinib combined with teriprizumab in the treatment of NEC is very "solid"
.
Pre-clinical basic research and animal experiments also show the synergistic effect of the two
.
In view of the clear mechanism of action of sofantinib combined with teriprizumab and good preclinical research results, the neuroendocrine tumor team of Peking University Cancer Hospital where Professor Lu works led the development of a "sofantinib combined with tere A phase II clinical study of prilimumab in the treatment of advanced solid tumors-NEC cohort study"
.
The latest data of this research has been logged into NANETS, showing China's wisdom and achievements
.
As one of the main investigators of this study, Professor Lu Ming introduced that in the phase I climbing trial, the ORR of the enrolled patients exceeded 30%; in the phase II study, in addition to the NET cohort, the NEC cohort was also included.
It has also been tried in other solid tumors
.
The study found that the ORR of multiple cohorts reached more than 20%
.
Therefore, sofantinib combined with teriprizumab also has great application prospects in solid tumors other than neuroendocrine tumors
.
At present, the data of the NEC cohort is relatively mature.
The confirmed ORR of Sofantinib combined with teriprizumab in the treatment of advanced NEC patients who have failed first-line chemotherapy is 23.
8%, and the median duration of response (DoR) is 4.
11 months; The median progression-free survival (PFS) was 4.
14 months, and the median overall survival (OS) was 10.
32 months
.
In terms of safety, the adverse events that occurred during the treatment of advanced NEC with sofantinib combined with teriprizumab are consistent with the reported safety of similar anti-vascular drugs combined with immunotherapy.
There is no "superimposition" of adverse reactions, and patient tolerance Good
.
Professor Lu Ming recalled that the first patient enrolled in the study was very lucky.
This was a 50-year-old patient with a metastatic neuroendocrine tumor of unknown primary focus (multiple metastases such as lung, mediastinum, bone, and liver).
The disease progressed rapidly about 3 months after chemotherapy, accompanied by obvious symptoms of coughing and suffocation
.
Subsequently, the patient joined the study to receive sofatinib combined with teriprizumab
.
One cycle after the first medication, the patient's above symptoms disappeared
.
Up to now, the patient has been on the drug for nearly 2 years, the tumor has basically disappeared, the efficacy evaluation is close to complete remission (CR), and the patient is in good condition
.
[Riding the wind and breaking the waves, moving forward on the “medicine” road] Sofantinib combined with teriprizumab is expected to bring hope to more cancer patients.
Professor Lu Ming pointed out that in the current treatment plan of NEC, the first-line treatment is chemotherapy, and the second-line treatment is not.
Standard plan
.
Sofatinib combined with teriprizumab has a good application prospect in the field of neuroendocrine tumors, and it is hoped that this therapy can become the standard second-line treatment of NEC
.
At present, a phase III multicenter study of sofatinib combined with teriprizumab in the second-line treatment of NEC is underway, and the first patient has achieved partial remission (PR) in the evaluation of efficacy
.
In addition, clinical research on the treatment of other advanced solid tumors with sofantinib combined with teriprizumab is in full swing, involving tumor types including gastric cancer, lung cancer, esophageal cancer, endometrial cancer, biliary tract cancer, soft tissue sarcoma, etc.
.
We look forward to more efficacy results and safety data in the follow-up of this study, so as to provide more tumor patients with new treatment options
.
Summary Neuroendocrine carcinoma is a rare and complex tumor.
Patients who fail the first-line treatment have a poor prognosis and limited treatment options
.
Single-agent immune checkpoint inhibitors have low efficiency and short disease control time
.
The combination of sofatinib and teriprizumab has a good application prospect, and we look forward to more gratifying clinical trial results, which will bring more options for the treatment of cancer patients! Expert profile: Professor Lu Ming, Chief Physician, Associate Professor, Department of Gastroenterology, Peking University Cancer Hospital, Master's Supervisor Professional direction: Drugs and comprehensive treatment of malignant tumors of the digestive system.
CSCO) Member of Neuroendocrine Tumor Committee Member of Chinese Society of Clinical Oncology (CSCO) Member of Biliary Tumor Committee Member of Neuroendocrine Oncology Group of Pancreatic Cancer Professional Committee of Chinese Anti-Cancer Association Chairperson Director of the Editorial Department of Frontier Chinese Journal of Medicine (Electronic Edition) Director of Beijing Medico Charity Foundation Chairman of Kanglin Tumor Technology Innovation Institute (Suzhou Industrial Park) NP-STD-21N97-Valid Until 2023 Nov This information is intended to promote Communication and exchange of medical information
.
This information is for academic reference only by medical and health professionals, not for the general public, nor for advertising
.
For prescriptions, please refer to the drug instructions approved by the State Drug Administration
.
Please do not distribute or forward this information
.
