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*Only for medical professionals to read for reference 1 minute a day, give you professional "talking information" in the tumor circle! (If you need the original text of the literature, you can add to the editor WeChat yxj_oncology to obtain) Key points: JCO: Rucaparib maintenance treatment of platinum-sensitive advanced pancreatic cancer with pathogenic mutations is safe and effective JTO: Intrathecal injection of pemetrexed can effectively treat TKI failure New drug for patients with EGFR-mutant NSCLC-LM: "first in class" Pranabrin listing application is planned to be included in the priority review new drug: PD-L1+CTLA-4+ chemotherapy triple therapy first-line treatment of NSCLC Phase III POSEIDON study success 01JCO: Rucaparib maintenance The treatment of platinum-sensitive advanced pancreatic cancer with pathogenic mutations is safe and effective.
Recently, the Journal of Clinical Oncology published a phase II clinical study online showing that the PARP inhibitor Rucaparib maintains the treatment of BRCA1, BRCA2 or PALB2 gene pathogenic mutations (PV ) Platinum-sensitive advanced pancreatic cancer (PC) is safe and effective.
Article release screenshots The study included 46 patients with advanced PC who carried BRCA1, BRCA2, or PALB2 gene germ cells or somatic PVs and received platinum-containing chemotherapy for at least 16 weeks without drug resistance.
After the termination of chemotherapy, the patient received Rucaparib 600 mg orally, twice a day until progression.
The primary study endpoint was the progression-free survival (PFS) rate at 6 months.
A total of 42 patients are available for evaluation.
The PFS rate at 6 months was 59.
5%, the median PFS was 13.
1 months, and the median overall survival (OS) was 23.
5 months.
The PFS rate at 12 months was 54.
8%.The objective response rate (ORR) of 36 disease-evaluable patients was 41.
7% (3 cases of complete remission; 12 cases of partial remission), and the disease control rate (DCR) was 66.
7%.
The median duration of response (DoR) was 17.
3 months.
41%, 50%, and 50% of patients with gBRCA2, gPALB2, and sBRCA2 mutations had disease remission, respectively.
No new security events have been recorded.
The above results indicate that Rucaparib maintenance therapy is safe and effective for platinum-sensitive advanced PC patients carrying PVs of BRCA1, BRCA2 or PALB2 genes.
The discovery of the efficacy of patients with gPALB2 and sBRCA2 PVs broadens the potential benefit population of PARP inhibitor treatments other than gBRCA1/2 PV patients.
02JTO: Intrathecal injection of pemetrexed can effectively treat EGFR-mutant NSCLC-LM patients who have failed TKIs.
Recently, the Journal of Thoracic Oncology published an online phase I-II prospective study showing that intrathecal injection of pemetrexed (IP) Combined with dexamethasone can be effective in the treatment of EGFR-mutant NSCLC pial metastases (NSCLC-LM) that have failed the treatment of tyrosine kinase inhibitors (TKIs).
Screenshot of the article release.
In Phase I, the study used an accelerated titration design to increase the IP dose from 15 mg to 80 mg.
The recommended dose (RD) is used in the Phase II study.
The primary endpoint of the study was the clinical remission rate, and the secondary endpoints were OS and adverse events (AEs).
The RD of pemetrexed is 50mg.
A total of 30 NSCLC-LM patients were enrolled, including 14 males.
4 patients could not be evaluated because they did not survive for more than 4 weeks.
The clinical remission rate was 84.
6% (22/26).
The median OS was 9.
0 months (n=30). Most of the AEs were mild, and bone marrow suppression was the most common AE (n=9, 30%), and they returned to normal after systemic treatment.
The above results indicate that the recommended dose of 50 mg pemetrexed has fewer adverse effects and better curative effects.
Intrathecal injection of pemetrexed can effectively treat EGFR-mutant NSCLC-LM patients with TKI failure.
03 New drug: "first in class" prenabulin is planned to be included in the priority review.
May 12, the latest announcement from the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), prenabulinol for injection The solution has been included in the proposed priority review and publicity list, and its indication is-neutropenia (CIN) caused by chemotherapy in adult patients with non-myeloid malignant tumors.
In September 2020, the China National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) have respectively granted prinablin the "breakthrough therapy variety" and "breakthrough therapy designation" in the field of CIN treatment.
According to the proposed priority review and public information, the indications applied for this time in China are: combined application with pegylated recombinant human granulocyte stimulating factor, which is suitable for adult patients with non-myeloid malignant tumors caused by chemotherapy CIN.
In an international multi-center Phase III PROTECTIVE-2 study of punabrine and pegfilgrastim in the treatment of breast cancer, pranablin reached the primary endpoint and all secondary endpoints.
The ROTECTIVE-2 study showed that the combination of prinabulin and pefigras increased the prevention rate of grade 4 CIN in the first cycle by more than 100%: the percentage of patients in the combined treatment group who did not develop grade 4 CIN was 31.
5%, which is much higher 13.
6% of the pefigrastim single-drug group. 04New drug: PD-L1+CTLA-4+ chemotherapy triple therapy for the first-line treatment of NSCLC Phase III POSEIDON study was successful May 7, AstraZeneca announced the positive results of the Phase III clinical study code-named POSEIDON, the study evaluated PD- L1 monoclonal antibody duvalizumab combined with platinum-containing chemotherapy or duvalizumab combined with anti-CTLA-4 monoclonal antibody tremelimumab and chemotherapy composed of triple therapy compared with the efficacy of chemotherapy alone in the first-line treatment of stage IV (metastatic) NSCLC patients.
The high-level positive results of the final analysis of POSEIDON showed that compared with chemotherapy alone, patients who received the triple therapy of duvalizumab, tremelimumab and chemotherapy showed statistically and clinically significant OS benefits and PFS improvements.
References: [1] Kim A.
Reiss, Rosemarie Mick, Mark H.
O'Hara, et al.
Phase II Study of Maintenance Rucaparib in Patients With Platinum-Sensitive Advanced Pancreatic Cancer and a Pathogenic Germline or Somatic Variant in BRCA1, BRCA2 ,or PALB2.
published on May 10,2021.
doi:10.
1200/JCO.
21.
00003.
[2]Chengjuan Fan,Qiuyu Zhao,Li Li,et al.
Efficacy and Safety of Intrathecal Pemetrexed Combined with Dexamethasone for Treating TKI-failed Leptomeningeal Metastases from EGFR-mutant NSCLC—A Prospective Open-label Single-arm Phase I/II Clinical Trial(unique identifier:ChiCTR1800016615).
published on May 10,2021.
doi:https://doi.
org/10.
1016/j.
jtho.
2021.
04.
018.
[3] Drug Evaluation Center of China National Medical Products Administration.
Retrieved May 12 2021, from #[4] https://mp.
weixin.
qq.
com/s/ABDYncIgDqOFDYck9YdIUA
Recently, the Journal of Clinical Oncology published a phase II clinical study online showing that the PARP inhibitor Rucaparib maintains the treatment of BRCA1, BRCA2 or PALB2 gene pathogenic mutations (PV ) Platinum-sensitive advanced pancreatic cancer (PC) is safe and effective.
Article release screenshots The study included 46 patients with advanced PC who carried BRCA1, BRCA2, or PALB2 gene germ cells or somatic PVs and received platinum-containing chemotherapy for at least 16 weeks without drug resistance.
After the termination of chemotherapy, the patient received Rucaparib 600 mg orally, twice a day until progression.
The primary study endpoint was the progression-free survival (PFS) rate at 6 months.
A total of 42 patients are available for evaluation.
The PFS rate at 6 months was 59.
5%, the median PFS was 13.
1 months, and the median overall survival (OS) was 23.
5 months.
The PFS rate at 12 months was 54.
8%.The objective response rate (ORR) of 36 disease-evaluable patients was 41.
7% (3 cases of complete remission; 12 cases of partial remission), and the disease control rate (DCR) was 66.
7%.
The median duration of response (DoR) was 17.
3 months.
41%, 50%, and 50% of patients with gBRCA2, gPALB2, and sBRCA2 mutations had disease remission, respectively.
No new security events have been recorded.
The above results indicate that Rucaparib maintenance therapy is safe and effective for platinum-sensitive advanced PC patients carrying PVs of BRCA1, BRCA2 or PALB2 genes.
The discovery of the efficacy of patients with gPALB2 and sBRCA2 PVs broadens the potential benefit population of PARP inhibitor treatments other than gBRCA1/2 PV patients.
02JTO: Intrathecal injection of pemetrexed can effectively treat EGFR-mutant NSCLC-LM patients who have failed TKIs.
Recently, the Journal of Thoracic Oncology published an online phase I-II prospective study showing that intrathecal injection of pemetrexed (IP) Combined with dexamethasone can be effective in the treatment of EGFR-mutant NSCLC pial metastases (NSCLC-LM) that have failed the treatment of tyrosine kinase inhibitors (TKIs).
Screenshot of the article release.
In Phase I, the study used an accelerated titration design to increase the IP dose from 15 mg to 80 mg.
The recommended dose (RD) is used in the Phase II study.
The primary endpoint of the study was the clinical remission rate, and the secondary endpoints were OS and adverse events (AEs).
The RD of pemetrexed is 50mg.
A total of 30 NSCLC-LM patients were enrolled, including 14 males.
4 patients could not be evaluated because they did not survive for more than 4 weeks.
The clinical remission rate was 84.
6% (22/26).
The median OS was 9.
0 months (n=30). Most of the AEs were mild, and bone marrow suppression was the most common AE (n=9, 30%), and they returned to normal after systemic treatment.
The above results indicate that the recommended dose of 50 mg pemetrexed has fewer adverse effects and better curative effects.
Intrathecal injection of pemetrexed can effectively treat EGFR-mutant NSCLC-LM patients with TKI failure.
03 New drug: "first in class" prenabulin is planned to be included in the priority review.
May 12, the latest announcement from the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA), prenabulinol for injection The solution has been included in the proposed priority review and publicity list, and its indication is-neutropenia (CIN) caused by chemotherapy in adult patients with non-myeloid malignant tumors.
In September 2020, the China National Medical Products Administration (NMPA) and the U.
S.
Food and Drug Administration (FDA) have respectively granted prinablin the "breakthrough therapy variety" and "breakthrough therapy designation" in the field of CIN treatment.
According to the proposed priority review and public information, the indications applied for this time in China are: combined application with pegylated recombinant human granulocyte stimulating factor, which is suitable for adult patients with non-myeloid malignant tumors caused by chemotherapy CIN.
In an international multi-center Phase III PROTECTIVE-2 study of punabrine and pegfilgrastim in the treatment of breast cancer, pranablin reached the primary endpoint and all secondary endpoints.
The ROTECTIVE-2 study showed that the combination of prinabulin and pefigras increased the prevention rate of grade 4 CIN in the first cycle by more than 100%: the percentage of patients in the combined treatment group who did not develop grade 4 CIN was 31.
5%, which is much higher 13.
6% of the pefigrastim single-drug group. 04New drug: PD-L1+CTLA-4+ chemotherapy triple therapy for the first-line treatment of NSCLC Phase III POSEIDON study was successful May 7, AstraZeneca announced the positive results of the Phase III clinical study code-named POSEIDON, the study evaluated PD- L1 monoclonal antibody duvalizumab combined with platinum-containing chemotherapy or duvalizumab combined with anti-CTLA-4 monoclonal antibody tremelimumab and chemotherapy composed of triple therapy compared with the efficacy of chemotherapy alone in the first-line treatment of stage IV (metastatic) NSCLC patients.
The high-level positive results of the final analysis of POSEIDON showed that compared with chemotherapy alone, patients who received the triple therapy of duvalizumab, tremelimumab and chemotherapy showed statistically and clinically significant OS benefits and PFS improvements.
References: [1] Kim A.
Reiss, Rosemarie Mick, Mark H.
O'Hara, et al.
Phase II Study of Maintenance Rucaparib in Patients With Platinum-Sensitive Advanced Pancreatic Cancer and a Pathogenic Germline or Somatic Variant in BRCA1, BRCA2 ,or PALB2.
published on May 10,2021.
doi:10.
1200/JCO.
21.
00003.
[2]Chengjuan Fan,Qiuyu Zhao,Li Li,et al.
Efficacy and Safety of Intrathecal Pemetrexed Combined with Dexamethasone for Treating TKI-failed Leptomeningeal Metastases from EGFR-mutant NSCLC—A Prospective Open-label Single-arm Phase I/II Clinical Trial(unique identifier:ChiCTR1800016615).
published on May 10,2021.
doi:https://doi.
org/10.
1016/j.
jtho.
2021.
04.
018.
[3] Drug Evaluation Center of China National Medical Products Administration.
Retrieved May 12 2021, from #[4] https://mp.
weixin.
qq.
com/s/ABDYncIgDqOFDYck9YdIUA
