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*Only for medical professionals to read for reference, 1 minute a day, to give you professional "talking information" in the tumor circle! (If you need the original text of the literature, you can add it to the editor's WeChat yxj_oncology to get it) Key points reminder JCO: Nivolumab + low-dose ipilimumab first-line treatment of MSI-H/dMMR metastatic colorectal cancer efficacy and safety Nat Commun : Phase II study of ipilimumab combined with ninavulumab in the treatment of meningeal carcinoma J Immunother Cancer: Efficacy and safety of immune checkpoint inhibitors in patients with psoriasis tumors New drug: sunitinib malate capsules Approved for marketing and deemed to have passed the consistency evaluation 01JCO: The efficacy and safety of nivolumab + low-dose ipilimumab in the first-line treatment of MSI-H/dMMR metastatic colorectal cancer, the Journal of Clinical Oncology recently published online A study presented the results of nivolumab + low-dose ipilimumab in the first-line treatment cohort of the Phase II CheckMate 142 study
.
Screenshot of research publication In this study, among patients with high microsatellite instability/deficient mismatch repair (MSI-H/dMMR) metastatic colorectal cancer, untreated patients received nivolumab every 2 weeks For treatment, receive a small dose of ipilimumab every 6 weeks until the disease progresses
.
The primary endpoint is the objective response rate (ORR) assessed by the investigator based on RECIST v1.
1
.
The results of the study showed that the median age of the treated patients was 66 years (N = 45)
.
The median follow-up time was 29.
0 months
.
ORR and disease control rate (DCR) were 69% (95% CI: 53-82) and 84% (95% CI: 70.
5-93.
5), respectively, and the complete remission rate was 13%
.
In the postmortem analysis, of 14 patients who stopped treatment and did not receive follow-up treatment, 10 remained progression-free
.
22% of patients had grade 3-4 treatment-related adverse events; 13% of patients discontinued the drug due to any grade of treatment-related adverse events
.
The study showed that nivolumab plus low-dose ipilimumab showed strong and long-lasting clinical benefits and was well tolerated as the first-line treatment for patients with MSI-H/dMMR metastatic colorectal cancer
.
02 Nat Commun: Phase II study of ipilimumab combined with nivolumab in the treatment of meningeal carcinoma.
Meningeal disease (LMD), also known as meningeal carcinoma or carcinogenic meningitis, is a metastatic spread of cancer cells to the meninges Characterized by the disease
.
Although there are many treatments for LMD patients, there are big differences in practice due to the lack of prospective clinical trial data
.
Traditional treatment methods are radiotherapy, including stereotactic radiosurgery (SRS), whole brain radiotherapy (WBRT), and craniospine irradiation (CSI)
.
At present, the possible toxic and side effects of traditional radiotherapy still trouble clinical practice
.
Recently, Nature Communications published a study online to explore the efficacy and safety of ipilimumab combined with ninavulumab in patients with LMD
.
Screenshot of study publication In this study, 18 LMD patients received a combination of ipilimumab and nivolumab until the disease progressed or unacceptable toxicity appeared
.
The primary endpoint of the study is the overall survival (OS) of 3 months
.
Secondary endpoints include toxicity, 3-month cumulative time to progression, and progression-free survival (PFS)
.
The results of the study showed that the 3-month OS was 44% (90% CI: 0.
24-0.
66), 8 of the 18 patients treated were alive within 3 months, and 1/3 of the patients experienced one or more grade 3 or For the above adverse events, two patients stopped treatment due to unacceptable toxicity (hepatitis and colitis respectively)
.
The most common adverse events included fatigue (N=7), nausea (N=6), fever (N=6), anorexia (N=6) and skin rash (N=6)
.
The study shows that the safety of ipilimumab combined with nivolumab is acceptable and shows certain anti-tumor activity in patients with LMD.
This result needs to be verified by a larger multi-center clinical trial
.
03J Immunother Cancer: Efficacy and safety of immune checkpoint inhibitors in patients with psoriasis tumors Immune checkpoint inhibitors (ICIs) are approved for the treatment of a variety of cancers
.
Relevant retrospective analysis showed that although the disease may worsen, the safety of ICIs for most patients with autoimmune diseases is acceptable
.
Recently, the Journal for Immuno Therapy of Cancer published a study online that evaluated the safety and effectiveness of ICIs in cancer patients with psoriasis
.
Screenshot of research publication In this retrospective cohort study, patients with psoriasis tumors treated with ICIs from 8 academic centers were included in the research evaluation
.
The main safety results are exacerbation of psoriasis and immune-related adverse events (irAE)
.
The study also evaluated PFS and OS
.
Of the 76 patients included in this study, 50 (66%) were men, with a median age of 67 years
.
Melanoma is the most common cancer (N=62).
It also includes non-small cell lung cancer (N=5), head and neck tumors (N=2), esophageal adenocarcinoma (N=2) and other tumors (N= 2)
.
Fifty-one patients (67%) received PD-1/PD-L1 monoclonal antibody therapy, 8 patients (11%) received CTLA-4 monoclonal antibody therapy, and 17 patients (22%) received PD-1 and CTLA-4 combined therapy
.
Twenty-one patients (28%) were in stage III, of which 9 (12%) were treated with adjuvant or neoadjuvant therapy; 55 (72%) patients were in stage IV, of which 1 (1%) was treated with adjuvant therapy
.
The existing types of psoriasis include 46 cases of plaque psoriasis (61%) and the less common globular, pustular psoriasis or psoriatic arthritis
.
Forty-one patients (54%) had previously received psoriasis treatment, of which 24 patients (36%) had only received local treatment
.
Forty-three patients (57%) experienced exacerbation of psoriasis within a median of 44 days after ICIs treatment, 39 patients (51%) experienced skin deterioration, and 7 patients (9%) reported exacerbations of extracutaneous symptoms, including arthritis and iris
.
Most psoriasis worsened to grade 1 or 2, and only 7 cases (9%) were grade 3 or 4
.
Among all patients, only 5 patients (7%) discontinued ICI treatment because of worsening psoriasis
.
Among the patients who experienced deterioration, 23 (53%) received only local treatment; 16 (21%) required systemic treatment
.
Patients with melanoma (N=62) had a median PFS of 39 months and a median OS of 87 months
.
Ten patients received ICIs as neoadjuvant or adjuvant therapy
.
Among them, 52 patients were patients with advanced melanoma (that is, did not receive neoadjuvant therapy or adjuvant therapy), and the remission rate was 57.
7% (20 patients had complete remission, 10 patients had partial remission), and the other 4 patients were in stable condition
.
Among patients with advanced melanoma, the median PFS of patients with exacerbation of psoriasis was 43.
8 months, and that of patients with no exacerbation was 5.
0 months (p=0.
015); the median OS of patients with exacerbation of psoriasis did not reach, while in patients without exacerbation it was 29.
3 Month (p=0.
024)
.
The median PFS of patients with irAE was 43.
8 months, and that of patients without irAE was 2.
8 months (p<0.
001); the median OS of patients with irAE was 87.
3 months, and the median OS of patients without irAE was 17.
1 months (p=0.
0006)
.
The study showed that the safety of ICIs in the treatment of patients with psoriasis tumors is controllable and the curative effect is good, and the aggravation of psoriasis will not weaken the efficacy of ICIs
.
04New drug: Sunitinib malate capsules were approved for marketing and deemed to have passed the consistency evaluation.
Recently, Qilu Pharmaceutical's anti-tumor drug sunitinib malate capsules was approved for marketing by the National Medical Products Administration (NMPA) and deemed approved.
Consistency evaluation, 25mg, 37.
5mg, 50mg specifications are the first domestic evaluation
.
Sunitinib malate is the first multi-target tyrosine kinase inhibitor.
By preventing the phosphorylation of tyrosine in protein, inhibiting cell signal transduction, inducing tumor cell apoptosis and reducing tumor angiogenesis, Tumor cells lack the supply of nutrients, thus exerting anti-tumor effects
.
Clinically, it is mainly used to treat gastrointestinal stromal tumors, renal cell carcinoma and pancreatic neuroendocrine tumors
.
The sunitinib malate capsules approved by Qilu Pharmaceutical this time have four specifications.
Except for 12.
5mg, the other three specifications are the first in China to be reviewed
.
Abundant product specifications can better meet the needs of different clinical medications, and provide doctors and patients with differentiated medication options
.
References: [1] Lenz HJ, Cutsem EV, Limon ML, et al.
First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study.
J Clin Oncol.
October 12, 2021.
DOI: 10.
1200/JCO.
21.
01015.
[2]Brastianos, PK, Strickland, MR, Lee, EQ et al.
Phase II study of ipilimumab and nivolumab in leptomeningeal carcinomatosis.
Nat Commun 12, 5954 (2021 ).
https:// Halle BR, Betof Warner A, Zaman FY, et al Immune checkpoint inhibitors in patients with pre-existing psoriasis: safety and efficacy Journal for ImmunoTherapy of Cancer 2021;9:e003066.
doi: 10.
1136/jitc-2021-003066 https://jitc.
bmj.
com/content/9/10/e003066.
info[4] https://mp.
weixin.
qq .
com/s/QFqkOdd3qTaqOr-4Qu32eQ
.
Screenshot of research publication In this study, among patients with high microsatellite instability/deficient mismatch repair (MSI-H/dMMR) metastatic colorectal cancer, untreated patients received nivolumab every 2 weeks For treatment, receive a small dose of ipilimumab every 6 weeks until the disease progresses
.
The primary endpoint is the objective response rate (ORR) assessed by the investigator based on RECIST v1.
1
.
The results of the study showed that the median age of the treated patients was 66 years (N = 45)
.
The median follow-up time was 29.
0 months
.
ORR and disease control rate (DCR) were 69% (95% CI: 53-82) and 84% (95% CI: 70.
5-93.
5), respectively, and the complete remission rate was 13%
.
In the postmortem analysis, of 14 patients who stopped treatment and did not receive follow-up treatment, 10 remained progression-free
.
22% of patients had grade 3-4 treatment-related adverse events; 13% of patients discontinued the drug due to any grade of treatment-related adverse events
.
The study showed that nivolumab plus low-dose ipilimumab showed strong and long-lasting clinical benefits and was well tolerated as the first-line treatment for patients with MSI-H/dMMR metastatic colorectal cancer
.
02 Nat Commun: Phase II study of ipilimumab combined with nivolumab in the treatment of meningeal carcinoma.
Meningeal disease (LMD), also known as meningeal carcinoma or carcinogenic meningitis, is a metastatic spread of cancer cells to the meninges Characterized by the disease
.
Although there are many treatments for LMD patients, there are big differences in practice due to the lack of prospective clinical trial data
.
Traditional treatment methods are radiotherapy, including stereotactic radiosurgery (SRS), whole brain radiotherapy (WBRT), and craniospine irradiation (CSI)
.
At present, the possible toxic and side effects of traditional radiotherapy still trouble clinical practice
.
Recently, Nature Communications published a study online to explore the efficacy and safety of ipilimumab combined with ninavulumab in patients with LMD
.
Screenshot of study publication In this study, 18 LMD patients received a combination of ipilimumab and nivolumab until the disease progressed or unacceptable toxicity appeared
.
The primary endpoint of the study is the overall survival (OS) of 3 months
.
Secondary endpoints include toxicity, 3-month cumulative time to progression, and progression-free survival (PFS)
.
The results of the study showed that the 3-month OS was 44% (90% CI: 0.
24-0.
66), 8 of the 18 patients treated were alive within 3 months, and 1/3 of the patients experienced one or more grade 3 or For the above adverse events, two patients stopped treatment due to unacceptable toxicity (hepatitis and colitis respectively)
.
The most common adverse events included fatigue (N=7), nausea (N=6), fever (N=6), anorexia (N=6) and skin rash (N=6)
.
The study shows that the safety of ipilimumab combined with nivolumab is acceptable and shows certain anti-tumor activity in patients with LMD.
This result needs to be verified by a larger multi-center clinical trial
.
03J Immunother Cancer: Efficacy and safety of immune checkpoint inhibitors in patients with psoriasis tumors Immune checkpoint inhibitors (ICIs) are approved for the treatment of a variety of cancers
.
Relevant retrospective analysis showed that although the disease may worsen, the safety of ICIs for most patients with autoimmune diseases is acceptable
.
Recently, the Journal for Immuno Therapy of Cancer published a study online that evaluated the safety and effectiveness of ICIs in cancer patients with psoriasis
.
Screenshot of research publication In this retrospective cohort study, patients with psoriasis tumors treated with ICIs from 8 academic centers were included in the research evaluation
.
The main safety results are exacerbation of psoriasis and immune-related adverse events (irAE)
.
The study also evaluated PFS and OS
.
Of the 76 patients included in this study, 50 (66%) were men, with a median age of 67 years
.
Melanoma is the most common cancer (N=62).
It also includes non-small cell lung cancer (N=5), head and neck tumors (N=2), esophageal adenocarcinoma (N=2) and other tumors (N= 2)
.
Fifty-one patients (67%) received PD-1/PD-L1 monoclonal antibody therapy, 8 patients (11%) received CTLA-4 monoclonal antibody therapy, and 17 patients (22%) received PD-1 and CTLA-4 combined therapy
.
Twenty-one patients (28%) were in stage III, of which 9 (12%) were treated with adjuvant or neoadjuvant therapy; 55 (72%) patients were in stage IV, of which 1 (1%) was treated with adjuvant therapy
.
The existing types of psoriasis include 46 cases of plaque psoriasis (61%) and the less common globular, pustular psoriasis or psoriatic arthritis
.
Forty-one patients (54%) had previously received psoriasis treatment, of which 24 patients (36%) had only received local treatment
.
Forty-three patients (57%) experienced exacerbation of psoriasis within a median of 44 days after ICIs treatment, 39 patients (51%) experienced skin deterioration, and 7 patients (9%) reported exacerbations of extracutaneous symptoms, including arthritis and iris
.
Most psoriasis worsened to grade 1 or 2, and only 7 cases (9%) were grade 3 or 4
.
Among all patients, only 5 patients (7%) discontinued ICI treatment because of worsening psoriasis
.
Among the patients who experienced deterioration, 23 (53%) received only local treatment; 16 (21%) required systemic treatment
.
Patients with melanoma (N=62) had a median PFS of 39 months and a median OS of 87 months
.
Ten patients received ICIs as neoadjuvant or adjuvant therapy
.
Among them, 52 patients were patients with advanced melanoma (that is, did not receive neoadjuvant therapy or adjuvant therapy), and the remission rate was 57.
7% (20 patients had complete remission, 10 patients had partial remission), and the other 4 patients were in stable condition
.
Among patients with advanced melanoma, the median PFS of patients with exacerbation of psoriasis was 43.
8 months, and that of patients with no exacerbation was 5.
0 months (p=0.
015); the median OS of patients with exacerbation of psoriasis did not reach, while in patients without exacerbation it was 29.
3 Month (p=0.
024)
.
The median PFS of patients with irAE was 43.
8 months, and that of patients without irAE was 2.
8 months (p<0.
001); the median OS of patients with irAE was 87.
3 months, and the median OS of patients without irAE was 17.
1 months (p=0.
0006)
.
The study showed that the safety of ICIs in the treatment of patients with psoriasis tumors is controllable and the curative effect is good, and the aggravation of psoriasis will not weaken the efficacy of ICIs
.
04New drug: Sunitinib malate capsules were approved for marketing and deemed to have passed the consistency evaluation.
Recently, Qilu Pharmaceutical's anti-tumor drug sunitinib malate capsules was approved for marketing by the National Medical Products Administration (NMPA) and deemed approved.
Consistency evaluation, 25mg, 37.
5mg, 50mg specifications are the first domestic evaluation
.
Sunitinib malate is the first multi-target tyrosine kinase inhibitor.
By preventing the phosphorylation of tyrosine in protein, inhibiting cell signal transduction, inducing tumor cell apoptosis and reducing tumor angiogenesis, Tumor cells lack the supply of nutrients, thus exerting anti-tumor effects
.
Clinically, it is mainly used to treat gastrointestinal stromal tumors, renal cell carcinoma and pancreatic neuroendocrine tumors
.
The sunitinib malate capsules approved by Qilu Pharmaceutical this time have four specifications.
Except for 12.
5mg, the other three specifications are the first in China to be reviewed
.
Abundant product specifications can better meet the needs of different clinical medications, and provide doctors and patients with differentiated medication options
.
References: [1] Lenz HJ, Cutsem EV, Limon ML, et al.
First-Line Nivolumab Plus Low-Dose Ipilimumab for Microsatellite Instability-High/Mismatch Repair-Deficient Metastatic Colorectal Cancer: The Phase II CheckMate 142 Study.
J Clin Oncol.
October 12, 2021.
DOI: 10.
1200/JCO.
21.
01015.
[2]Brastianos, PK, Strickland, MR, Lee, EQ et al.
Phase II study of ipilimumab and nivolumab in leptomeningeal carcinomatosis.
Nat Commun 12, 5954 (2021 ).
https:// Halle BR, Betof Warner A, Zaman FY, et al Immune checkpoint inhibitors in patients with pre-existing psoriasis: safety and efficacy Journal for ImmunoTherapy of Cancer 2021;9:e003066.
doi: 10.
1136/jitc-2021-003066 https://jitc.
bmj.
com/content/9/10/e003066.
info[4] https://mp.
weixin.
qq .
com/s/QFqkOdd3qTaqOr-4Qu32eQ
