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Last week, AstraZeneca announced that its PD-L1 monoclonal antibody Imfinzi + tremelimumab (a CTLA4 antibody) + chemotherapy triple therapy as the first-line therapy for stage IV non-small cell lung cancer (NSCLC) showed for the first time an improvement in overall survival--POSEIDON .
Note: Imfinzi is a human monoclonal antibody that can bind to PD-L1 and block the interaction of PD-L1 with PD-1 and CD80, thereby resisting the immune evasion strategy of tumors and releasing the inhibitory effect on the immune response.
Imfinzi is currently approved for stage III non-small cell lung cancer (NSCLC), extensive stage small cell lung cancer (SCLC) and second-line bladder cancer (withdrawn from the US).
Tremelimumab is a therapeutic antibody targeting the IgG2 subtype of CTLA-4.
Tremelimumab was originally bought by Pfizer for commercial development, and then sold to AstraZeneca.
OS Improves POSEIDON is a randomized, open-label, global multicenter phase III clinical study designed to evaluate the safety and effectiveness of Imfinzi combination therapy in patients with stage IV NSCLC.
The primary endpoints were progression-free survival (PFS) and overall survival (OS) in the Imfinzi+tremelimumab group, and the secondary endpoints were PFS and OS in the Imfinzi+tremelimumab+ chemotherapy group.
On October 28, 2019, AstraZeneca announced that the POSEIDON clinical trial had reached the primary endpoint.
Compared with chemotherapy, the two combinations of Imfinzi+chemotherapy and Imfinzi+Tremelimumab+chemotherapy showed significant improvement in PFS.The updated clinical data showed that in terms of OS, the Imfinzi+tremelimumab+ chemotherapy combination also showed a significant improvement compared to chemotherapy.
In terms of safety, the Imfinzi+tremelimumab+ chemotherapy group was roughly similar to the Imfinzi+ chemotherapy group, and no new safety was found.
signal.
The entire clinical development path of Imfinzi and Tremelimumab combination therapy is very difficult.
There are basically repeated failures in lung cancer, head and neck cancer, bladder cancer and other cancers.
News about the failure of clinical trials is endless.
Lung Cancer On April 26, 2018, AstraZeneca announced that Imfinzi single-agent/Imfinzi combined with tremelimumab had failed in the treatment of stage IV non-small cell lung cancer with stage III clinical ARCTIC.
ARCTIC mainly evaluated the safety and effectiveness of Imfinzi monotherapy/ Imfinzi combined with tremelimumab, compared with standard therapies, in the third-line treatment of locally advanced or metastatic non-small cell lung cancer.
The primary endpoint of the trial is overall survival (OS).
The results showed that in PD-L1 low/negative patients, the combination therapy failed to prolong PFS and OS compared with standard chemotherapy.
After the termination of the ARCTIC trial, another Imfinzi single-agent/Imfinzi combined with tremelimumab was used for the treatment of stage IV non-small cell lung cancer phase III clinical trial-MYSTIC failed.
In November 2018, AstraZeneca announced MYSTIC, which ultimately did not reach To improve the test endpoint of OS, the test failed.
Mystic is a randomized, open, multi-center phase III clinical study designed to evaluate the safety of Imfinzi monotherapy/ Imfinzi combined with tremelimumab, compared with platinum-containing chemotherapy, in the treatment of untreated metastatic (stage IV) non-small cell lung cancer Sex and effectiveness.
The primary endpoints were PFS and OS of durvalumab + tremelimumab (compared to standard chemotherapy) and OS of durvalumab (compared to standard chemotherapy).
On August 21, 2019, the Imfinzi+tremelimumab combination was used as the first-line treatment of stage IV non-small cell lung cancer patients in the Phase III clinical trial--NEPTUNE failed.
OS in patients with small cell lung cancer.
On March 17, 2020, Imfinzi+chemotherapy/Imfinzi+Tremelimumab+chemotherapy as the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) Phase III clinical-CASPIAN failed.
CASPIAN is a randomized, open-label, multicenter, global phase III study that compares Imfinzi+platinum-containing chemotherapy (etoposide+cisplatin or carboplatin), Imfinzi+Tremelimumab+platinum-containing chemotherapy, and platinum-containing chemotherapy as ES-SCLC For the efficacy and safety of first-line treatment, the primary endpoint of the trial is OS.
The results showed that: Imfinzi+platinum-containing chemotherapy can provide patients with long-lasting and clinically significant OS benefits, but the OS of patients in the Imfinzi+Tremelimumab+platinum-containing chemotherapy group did not show a statistically significant improvement.
Head and neck cancer At the end of 2018, Imfinzi monotherapy/ Imfinzi combined with tremelimumab was used to treat patients with recurrent or metastatic head and neck squamous cell carcinoma who had undergone chemotherapy with platinum-based drugs--HNSCC (regardless of PD-L1 expression level) ) Phase III clinical trial-EAGLE failed.
Neither Imfinzi single agent nor Imfinzi combined with Tremelimumab failed to reach the primary endpoint.
Compared with standard chemotherapy, it did not significantly improve the overall survival of patients; February 6, 2021, Imfinzi Single-agent/Imfinzi combined with tremelimumab for first-line treatment of HNSCC patients with tumors expressing high levels of PD-L1 in phase III clinical trials - KESTREL failed, and failed to achieve overall survival compared with the standard care EXTREME treatment plan (OS) the main end point.Bladder cancer In March 2020, Imfinzi monotherapy/ Imfinzi combined with tremelimumab was used for the first-line treatment of stage IV bladder cancer in Phase III clinical trial-Danube failed.
Danube is a randomized, open-label, multi-center, global phase III trial that mainly evaluates Imfinzi's monotherapy and combination therapy with anti-CTLA-4 therapy tremelimumab as the first-line therapy for patients with unresectable, stage IV UC The efficacy and safety.
Test data showed that Imfinzi's single drug and combination therapy with tremelimumab failed to beat standard chemotherapy and prolong the survival of patients.
Previously (February 23, 2021), AstraZeneca has announced the voluntary withdrawal of a second-line label for Imfinzi bladder cancer from the US market.
The editor concludes that by seizing the market segment of Phase III NSCLC, Imfinzi has found a foothold in the PD1/PD-L1 group.
However, after that, Imfinzi's other performances were far from satisfactory.
Imfinzi+Tremelimumab, the combination that AstraZeneca entrusted with high hopes, has little success.
It has been defeated repeatedly.
It can be seen that AstraZeneca is also determined to launch this combination.
Currently, it is counting on POSEIDON's final analysis.
It turned out.
Reference source 1.
os-win-is-tremelimumab-finally-ready-for-approval/copyright statement welcome personal forwarding and sharing.
Any other media or website that needs to reprint or quote the copyrighted content of this website must be authorized and marked "Reprinted from: Bai Aogu" in a prominent position.
Note: Imfinzi is a human monoclonal antibody that can bind to PD-L1 and block the interaction of PD-L1 with PD-1 and CD80, thereby resisting the immune evasion strategy of tumors and releasing the inhibitory effect on the immune response.
Imfinzi is currently approved for stage III non-small cell lung cancer (NSCLC), extensive stage small cell lung cancer (SCLC) and second-line bladder cancer (withdrawn from the US).
Tremelimumab is a therapeutic antibody targeting the IgG2 subtype of CTLA-4.
Tremelimumab was originally bought by Pfizer for commercial development, and then sold to AstraZeneca.
OS Improves POSEIDON is a randomized, open-label, global multicenter phase III clinical study designed to evaluate the safety and effectiveness of Imfinzi combination therapy in patients with stage IV NSCLC.
The primary endpoints were progression-free survival (PFS) and overall survival (OS) in the Imfinzi+tremelimumab group, and the secondary endpoints were PFS and OS in the Imfinzi+tremelimumab+ chemotherapy group.
On October 28, 2019, AstraZeneca announced that the POSEIDON clinical trial had reached the primary endpoint.
Compared with chemotherapy, the two combinations of Imfinzi+chemotherapy and Imfinzi+Tremelimumab+chemotherapy showed significant improvement in PFS.The updated clinical data showed that in terms of OS, the Imfinzi+tremelimumab+ chemotherapy combination also showed a significant improvement compared to chemotherapy.
In terms of safety, the Imfinzi+tremelimumab+ chemotherapy group was roughly similar to the Imfinzi+ chemotherapy group, and no new safety was found.
signal.
The entire clinical development path of Imfinzi and Tremelimumab combination therapy is very difficult.
There are basically repeated failures in lung cancer, head and neck cancer, bladder cancer and other cancers.
News about the failure of clinical trials is endless.
Lung Cancer On April 26, 2018, AstraZeneca announced that Imfinzi single-agent/Imfinzi combined with tremelimumab had failed in the treatment of stage IV non-small cell lung cancer with stage III clinical ARCTIC.
ARCTIC mainly evaluated the safety and effectiveness of Imfinzi monotherapy/ Imfinzi combined with tremelimumab, compared with standard therapies, in the third-line treatment of locally advanced or metastatic non-small cell lung cancer.
The primary endpoint of the trial is overall survival (OS).
The results showed that in PD-L1 low/negative patients, the combination therapy failed to prolong PFS and OS compared with standard chemotherapy.
After the termination of the ARCTIC trial, another Imfinzi single-agent/Imfinzi combined with tremelimumab was used for the treatment of stage IV non-small cell lung cancer phase III clinical trial-MYSTIC failed.
In November 2018, AstraZeneca announced MYSTIC, which ultimately did not reach To improve the test endpoint of OS, the test failed.
Mystic is a randomized, open, multi-center phase III clinical study designed to evaluate the safety of Imfinzi monotherapy/ Imfinzi combined with tremelimumab, compared with platinum-containing chemotherapy, in the treatment of untreated metastatic (stage IV) non-small cell lung cancer Sex and effectiveness.
The primary endpoints were PFS and OS of durvalumab + tremelimumab (compared to standard chemotherapy) and OS of durvalumab (compared to standard chemotherapy).
On August 21, 2019, the Imfinzi+tremelimumab combination was used as the first-line treatment of stage IV non-small cell lung cancer patients in the Phase III clinical trial--NEPTUNE failed.
OS in patients with small cell lung cancer.
On March 17, 2020, Imfinzi+chemotherapy/Imfinzi+Tremelimumab+chemotherapy as the first-line treatment of extensive-stage small cell lung cancer (ES-SCLC) Phase III clinical-CASPIAN failed.
CASPIAN is a randomized, open-label, multicenter, global phase III study that compares Imfinzi+platinum-containing chemotherapy (etoposide+cisplatin or carboplatin), Imfinzi+Tremelimumab+platinum-containing chemotherapy, and platinum-containing chemotherapy as ES-SCLC For the efficacy and safety of first-line treatment, the primary endpoint of the trial is OS.
The results showed that: Imfinzi+platinum-containing chemotherapy can provide patients with long-lasting and clinically significant OS benefits, but the OS of patients in the Imfinzi+Tremelimumab+platinum-containing chemotherapy group did not show a statistically significant improvement.
Head and neck cancer At the end of 2018, Imfinzi monotherapy/ Imfinzi combined with tremelimumab was used to treat patients with recurrent or metastatic head and neck squamous cell carcinoma who had undergone chemotherapy with platinum-based drugs--HNSCC (regardless of PD-L1 expression level) ) Phase III clinical trial-EAGLE failed.
Neither Imfinzi single agent nor Imfinzi combined with Tremelimumab failed to reach the primary endpoint.
Compared with standard chemotherapy, it did not significantly improve the overall survival of patients; February 6, 2021, Imfinzi Single-agent/Imfinzi combined with tremelimumab for first-line treatment of HNSCC patients with tumors expressing high levels of PD-L1 in phase III clinical trials - KESTREL failed, and failed to achieve overall survival compared with the standard care EXTREME treatment plan (OS) the main end point.Bladder cancer In March 2020, Imfinzi monotherapy/ Imfinzi combined with tremelimumab was used for the first-line treatment of stage IV bladder cancer in Phase III clinical trial-Danube failed.
Danube is a randomized, open-label, multi-center, global phase III trial that mainly evaluates Imfinzi's monotherapy and combination therapy with anti-CTLA-4 therapy tremelimumab as the first-line therapy for patients with unresectable, stage IV UC The efficacy and safety.
Test data showed that Imfinzi's single drug and combination therapy with tremelimumab failed to beat standard chemotherapy and prolong the survival of patients.
Previously (February 23, 2021), AstraZeneca has announced the voluntary withdrawal of a second-line label for Imfinzi bladder cancer from the US market.
The editor concludes that by seizing the market segment of Phase III NSCLC, Imfinzi has found a foothold in the PD1/PD-L1 group.
However, after that, Imfinzi's other performances were far from satisfactory.
Imfinzi+Tremelimumab, the combination that AstraZeneca entrusted with high hopes, has little success.
It has been defeated repeatedly.
It can be seen that AstraZeneca is also determined to launch this combination.
Currently, it is counting on POSEIDON's final analysis.
It turned out.
Reference source 1.
os-win-is-tremelimumab-finally-ready-for-approval/copyright statement welcome personal forwarding and sharing.
Any other media or website that needs to reprint or quote the copyrighted content of this website must be authorized and marked "Reprinted from: Bai Aogu" in a prominent position.
