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*For medical professionals to read for reference, the new PD-L1 inhibitor brings a light of cure to colon cancer patients with multiple liver metastases! The incidence and mortality of colorectal cancer (CRC) in China have maintained an upward trend in recent years
.
The 2018 China Cancer Statistical Report shows that the incidence and mortality of colorectal cancer in China ranked third and fifth among all malignant tumors, respectively, with 376,000 new cases, and most patients were in the middle and late stages at the time of diagnosis
.
High microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) is an important tumor prognostic indicator, and many studies have explored immunotherapy in the MSI-H/dMMR population
.
On November 24, 2021, based on the results of the pivotal Phase II clinical study of nvolimumab, nvolimumab was approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with unresectable or metastatic microsatellite height incompetence.
Treatment of adult patients with stable (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, including patients with advanced colorectal cancer who have progressed on prior fluorouracil, oxaliplatin, and irinotecan therapy and other advanced solid tumor patients with disease progression after previous treatment and no satisfactory alternative treatment options
.
This issue of "Shenzhen Shenghui" reports the treatment experience of a patient with MSI-H advanced colon cancer and multiple liver metastases shared by Professor Zhang Weijie of the First Affiliated Hospital of Zhengzhou University
.
The patient progressed rapidly after first-line treatment, and was subsequently enrolled in a pivotal phase II clinical study of nvolimumab.
Surprisingly, the patient's primary tumor and metastases completely disappeared after 1 year, and the efficacy evaluation was complete remission (CR)
.
Basic information of the patient A 39-year-old female patient presented to the doctor because of "upper abdominal pain for more than 1 month"
.
More than 1 month ago, there was no obvious incentive for epigastric pain, persistent sharp pain, paroxysmal aggravation, no fever, nausea, vomiting, abdominal pain, diarrhea and other discomforts.
After the onset, the body weight decreased by 3 kg
.
Past history, personal history, marital history, and family history were unremarkable
.
▎After admission, the electronic colonoscopy on February 19, 2019 showed: transverse colon occupying space
.
Biopsy pathology considered adenocarcinoma
.
On February 20, 2019, CT scan showed: colonic hepatic flexure occupying space, colon cancer was considered, with multiple surrounding enlarged lymph nodes metastasis
.
Multiple intrahepatic mass, consider metastasis
.
Figure 1 Electronic colonoscopy on February 19, 2019 2.
CT gene detection on February 20, 2019: MSI-H, KRAS (+), PIK3CA (+)
.
Diagnosis: Colon (right half) cancer with multiple liver metastases T4bN+M1a stage IVa ECOG: 0 points without success in the first battle, first-line anti-angiogenesis drugs + chemotherapy PFS The patient had multiple liver metastases, and the initial assessment was not feasible for surgical resection
.
The patient is young and in good physical condition.
It is recommended to undergo chemotherapy with the "bevacizumab + FOLFOXIRI" regimen.
A total of 9 cycles of chemotherapy were received from February 22, 2019 to June 15, 2019
.
On April 3, 2019, CT scan showed that the liver metastases and the primary tumor had shrunk, and the curative effect was evaluated as partial remission (PR)
.
On May 16, 2019, the CT scan showed that the liver metastases increased and the primary tumor continued to shrink
.
On June 29, 2019, the re-examination of CT showed that the liver metastases and the primary tumor were enlarged, and the efficacy was evaluated as disease progression (PD).
.
The patient's first-line "bevacizumab + FOLFOXIRI" regimen failed
.
Figure 3.
CT on April 3, 2019 Figure 4.
CT on May 16, 2019 Enrolled in the "Multicenter Phase II Clinical Study of Clinical Efficacy and Safety of Envolizumab Monotherapy in Patients with MSI-H/dMMR Advanced Colorectal Cancer and Other Advanced Solid Tumors".
Monoclonal antibody 150mg Qw was injected subcutaneously, and imaging examinations were performed every 8 weeks to evaluate the efficacy
.
On September 10, 2019, a CT scan was performed, and the results showed that the patient's liver metastases were stable (SD) and the primary tumor was PR
.
On October 9, 2019, CT scan was performed to determine liver metastases and PR of the primary tumor
.
Five re-examinations were conducted in November 2019, January 2020, February 2020, April 2020, and June 2020: both liver metastases and primary lesions continued to PR
.
Until October 10, 2020, abdominal MR showed that the liver metastases and primary tumors had almost completely regressed, and the efficacy evaluation was CRu
.
Figure 6.
CT on September 10, 2019 Figure 7.
CT on October 9, 2019 Figure 8.
CT on November 5, 2019 Figure 9.
CT on January 2, 2020 Figure 10.
MRI on August 15, 2020 Figure 11.
MRI on October 10, 2020 MRI in January, January 2021, March 2021, and May 2021 all showed that the primary tumor was CRu.
On June 26, 2021, colonoscopy was performed and the primary tumor was CR
.
Figure 12.
CT on May 20, 2021 Figure 13.
Liver MRI on May 21, 2021 Chemotherapy PFS is only 4 months, the curative effect is not good, PD appears in a short time
.
Subsequent patients were enrolled in the "Multicenter Phase II Clinical Study of Clinical Efficacy and Safety of Envolizumab Monotherapy in Patients with MSI-H/dMMR Advanced Colorectal Cancer and Other Advanced Solid Tumors", and received envolizumab monotherapy.
The results of continuous PR within 1 year of anti-treatment and CR achieved after 1 year are very surprising
.
It also allows us to see that immunotherapy can bring definite benefits to MSI-H/dMMR patients
.
As a recently launched domestic innovative PD-L1 drug, nvolimab has demonstrated good efficacy in patients with MSI-H/dMMR colorectal cancer in phase II clinical studies [1]
.
In this study, the objective response rate (ORR) of envolizumab single agent (150mg QW administration) for 65 patients with MSI-H/dMMR colorectal cancer above second-line treatment was 43.
1%
.
The 12-month PFS rate was 43.
7% (95%CI 31.
2%-55.
4%), and the 12-month OS rate was 72.
9% (95%CI 60.
1%-82.
2%)
.
Envolizumab is a PD-L1 inhibitor, and its safety may have certain advantages compared to PD-1 inhibitors and CTLA-4 inhibitors
.
The patient in this case was younger and had a better physical performance score, and no serious immune-related adverse reactions occurred during the treatment with nvolimab
.
In Phase II clinical studies, the overall safety of nvolimab has also been confirmed
.
The incidences of all grades 3-4 drug-related treatment-period adverse events (TRAEs) were 85.
4% and 17.
5%, respectively, with no grade 5 TRAEs, and no immune pneumonitis and colitis
.
Envolizumab is administered by a unique subcutaneous injection, and the incidence of injection site reactions is 8.
7%, and all are grade 1-2
.
This shows that nvolimab has the dual advantages of safety and convenience
.
In addition, nvolimab also has its unique advantages.
Due to the high stability and high water solubility of the envolizumab protein molecule, it is possible to develop high-concentration formulations with a protein concentration of up to 200 mg/ml, so as to achieve its The subcutaneous injection mode of administration greatly reduces the pain and inconvenience of patients who need long-term frequent intravenous injections, and enhances the compliance of the treatment plan
.
This is more helpful for cancer patients who need long-term medication for chronic cancer management
.
This case shows the good efficacy and safety of nvolimumab.
As a brand-new immunotherapy drug that has just been launched, we also expect nvolimumab to bring greater surprises in the real world, and it can also be used in the future.
Carry out more large-scale clinical trials to benefit more patients! Expert Profile Prof.
Zhang Weijie, MD, Associate Professor, Deputy Chief Physician, Master Supervisor Member of the Standing Committee of the Esophageal Cancer Professional Committee of the Henan Anti-Cancer Association Member of the Standing Committee of the Sarcoma Professional Committee of the Henan Anti-Cancer Association Member of Research Professional Committee Member of Neuroendocrine Tumor Professional Committee of Henan Anti-Cancer Association Reference materials: [1].
Li J, Deng Y, Zhang W, et al.
Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors[J].
Journal of Hematology & Oncology, 2021, 14(1): 95.
*This article is only for providing scientific information to medical professionals and does not represent the views of this platform
.
The 2018 China Cancer Statistical Report shows that the incidence and mortality of colorectal cancer in China ranked third and fifth among all malignant tumors, respectively, with 376,000 new cases, and most patients were in the middle and late stages at the time of diagnosis
.
High microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR) is an important tumor prognostic indicator, and many studies have explored immunotherapy in the MSI-H/dMMR population
.
On November 24, 2021, based on the results of the pivotal Phase II clinical study of nvolimumab, nvolimumab was approved by the National Medical Products Administration (NMPA) of China for the treatment of patients with unresectable or metastatic microsatellite height incompetence.
Treatment of adult patients with stable (MSI-H) or mismatch repair deficient (dMMR) advanced solid tumors, including patients with advanced colorectal cancer who have progressed on prior fluorouracil, oxaliplatin, and irinotecan therapy and other advanced solid tumor patients with disease progression after previous treatment and no satisfactory alternative treatment options
.
This issue of "Shenzhen Shenghui" reports the treatment experience of a patient with MSI-H advanced colon cancer and multiple liver metastases shared by Professor Zhang Weijie of the First Affiliated Hospital of Zhengzhou University
.
The patient progressed rapidly after first-line treatment, and was subsequently enrolled in a pivotal phase II clinical study of nvolimumab.
Surprisingly, the patient's primary tumor and metastases completely disappeared after 1 year, and the efficacy evaluation was complete remission (CR)
.
Basic information of the patient A 39-year-old female patient presented to the doctor because of "upper abdominal pain for more than 1 month"
.
More than 1 month ago, there was no obvious incentive for epigastric pain, persistent sharp pain, paroxysmal aggravation, no fever, nausea, vomiting, abdominal pain, diarrhea and other discomforts.
After the onset, the body weight decreased by 3 kg
.
Past history, personal history, marital history, and family history were unremarkable
.
▎After admission, the electronic colonoscopy on February 19, 2019 showed: transverse colon occupying space
.
Biopsy pathology considered adenocarcinoma
.
On February 20, 2019, CT scan showed: colonic hepatic flexure occupying space, colon cancer was considered, with multiple surrounding enlarged lymph nodes metastasis
.
Multiple intrahepatic mass, consider metastasis
.
Figure 1 Electronic colonoscopy on February 19, 2019 2.
CT gene detection on February 20, 2019: MSI-H, KRAS (+), PIK3CA (+)
.
Diagnosis: Colon (right half) cancer with multiple liver metastases T4bN+M1a stage IVa ECOG: 0 points without success in the first battle, first-line anti-angiogenesis drugs + chemotherapy PFS The patient had multiple liver metastases, and the initial assessment was not feasible for surgical resection
.
The patient is young and in good physical condition.
It is recommended to undergo chemotherapy with the "bevacizumab + FOLFOXIRI" regimen.
A total of 9 cycles of chemotherapy were received from February 22, 2019 to June 15, 2019
.
On April 3, 2019, CT scan showed that the liver metastases and the primary tumor had shrunk, and the curative effect was evaluated as partial remission (PR)
.
On May 16, 2019, the CT scan showed that the liver metastases increased and the primary tumor continued to shrink
.
On June 29, 2019, the re-examination of CT showed that the liver metastases and the primary tumor were enlarged, and the efficacy was evaluated as disease progression (PD).
.
The patient's first-line "bevacizumab + FOLFOXIRI" regimen failed
.
Figure 3.
CT on April 3, 2019 Figure 4.
CT on May 16, 2019 Enrolled in the "Multicenter Phase II Clinical Study of Clinical Efficacy and Safety of Envolizumab Monotherapy in Patients with MSI-H/dMMR Advanced Colorectal Cancer and Other Advanced Solid Tumors".
Monoclonal antibody 150mg Qw was injected subcutaneously, and imaging examinations were performed every 8 weeks to evaluate the efficacy
.
On September 10, 2019, a CT scan was performed, and the results showed that the patient's liver metastases were stable (SD) and the primary tumor was PR
.
On October 9, 2019, CT scan was performed to determine liver metastases and PR of the primary tumor
.
Five re-examinations were conducted in November 2019, January 2020, February 2020, April 2020, and June 2020: both liver metastases and primary lesions continued to PR
.
Until October 10, 2020, abdominal MR showed that the liver metastases and primary tumors had almost completely regressed, and the efficacy evaluation was CRu
.
Figure 6.
CT on September 10, 2019 Figure 7.
CT on October 9, 2019 Figure 8.
CT on November 5, 2019 Figure 9.
CT on January 2, 2020 Figure 10.
MRI on August 15, 2020 Figure 11.
MRI on October 10, 2020 MRI in January, January 2021, March 2021, and May 2021 all showed that the primary tumor was CRu.
On June 26, 2021, colonoscopy was performed and the primary tumor was CR
.
Figure 12.
CT on May 20, 2021 Figure 13.
Liver MRI on May 21, 2021 Chemotherapy PFS is only 4 months, the curative effect is not good, PD appears in a short time
.
Subsequent patients were enrolled in the "Multicenter Phase II Clinical Study of Clinical Efficacy and Safety of Envolizumab Monotherapy in Patients with MSI-H/dMMR Advanced Colorectal Cancer and Other Advanced Solid Tumors", and received envolizumab monotherapy.
The results of continuous PR within 1 year of anti-treatment and CR achieved after 1 year are very surprising
.
It also allows us to see that immunotherapy can bring definite benefits to MSI-H/dMMR patients
.
As a recently launched domestic innovative PD-L1 drug, nvolimab has demonstrated good efficacy in patients with MSI-H/dMMR colorectal cancer in phase II clinical studies [1]
.
In this study, the objective response rate (ORR) of envolizumab single agent (150mg QW administration) for 65 patients with MSI-H/dMMR colorectal cancer above second-line treatment was 43.
1%
.
The 12-month PFS rate was 43.
7% (95%CI 31.
2%-55.
4%), and the 12-month OS rate was 72.
9% (95%CI 60.
1%-82.
2%)
.
Envolizumab is a PD-L1 inhibitor, and its safety may have certain advantages compared to PD-1 inhibitors and CTLA-4 inhibitors
.
The patient in this case was younger and had a better physical performance score, and no serious immune-related adverse reactions occurred during the treatment with nvolimab
.
In Phase II clinical studies, the overall safety of nvolimab has also been confirmed
.
The incidences of all grades 3-4 drug-related treatment-period adverse events (TRAEs) were 85.
4% and 17.
5%, respectively, with no grade 5 TRAEs, and no immune pneumonitis and colitis
.
Envolizumab is administered by a unique subcutaneous injection, and the incidence of injection site reactions is 8.
7%, and all are grade 1-2
.
This shows that nvolimab has the dual advantages of safety and convenience
.
In addition, nvolimab also has its unique advantages.
Due to the high stability and high water solubility of the envolizumab protein molecule, it is possible to develop high-concentration formulations with a protein concentration of up to 200 mg/ml, so as to achieve its The subcutaneous injection mode of administration greatly reduces the pain and inconvenience of patients who need long-term frequent intravenous injections, and enhances the compliance of the treatment plan
.
This is more helpful for cancer patients who need long-term medication for chronic cancer management
.
This case shows the good efficacy and safety of nvolimumab.
As a brand-new immunotherapy drug that has just been launched, we also expect nvolimumab to bring greater surprises in the real world, and it can also be used in the future.
Carry out more large-scale clinical trials to benefit more patients! Expert Profile Prof.
Zhang Weijie, MD, Associate Professor, Deputy Chief Physician, Master Supervisor Member of the Standing Committee of the Esophageal Cancer Professional Committee of the Henan Anti-Cancer Association Member of the Standing Committee of the Sarcoma Professional Committee of the Henan Anti-Cancer Association Member of Research Professional Committee Member of Neuroendocrine Tumor Professional Committee of Henan Anti-Cancer Association Reference materials: [1].
Li J, Deng Y, Zhang W, et al.
Subcutaneous envafolimab monotherapy in patients with advanced defective mismatch repair/microsatellite instability high solid tumors[J].
Journal of Hematology & Oncology, 2021, 14(1): 95.
*This article is only for providing scientific information to medical professionals and does not represent the views of this platform
