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A few days ago, the official website of the US FDA showed that the anti-CTLA-4 antibody Imjudo (tremelimumab) developed by AstraZeneca has been approved, in combination with the anti-PD-L1 antibody Imfinzi (durvalumab), to treat patients with unresectable hepatocellular carcinoma, providing liver cancer patients with a new immune combination therapy
composed of dual immune checkpoint inhibitors.
Liver cancer is the sixth most common cancer in the world, with approximately 900,000 patients diagnosed
each year.
At the same time, liver cancer is also the third leading cause of tumor death in the world, and only about 7% of advanced patients can survive for more than 5 years, behind these data is the urgent need
for innovative therapies for thousands of liver cancer patients.
Tremelimumab is a humanized anti-CTLA-4 antibody developed by AstraZeneca that blocks CTLA-4, promotes T cell activation and strengthens the immune response
to cancer.
Imfinzi is an anti-PD-L1 monoclonal antibody that relieves the inhibition of tumor cells' immune response by blocking the binding of PD-L1 to PD-1 and CD80 proteins, and it has been approved in many countries and regions for the treatment of extensive-stage small cell lung cancer
.
It is also approved by the FDA for the treatment of non-small cell lung cancer and advanced bladder cancer
.
In April, the U.
S.
FDA accepted tremelimumab's Biologics License Application (BLA) and granted it priority
review.
to cancer.
The efficacy and safety of the combination regimen of Tremelimumab and Imfinzi for hepatocellular carcinoma is supported by positive clinical results, in a Phase 3 clinical trial in patients with unresectable hepatocellular carcinoma, the investigators first administered a combination of tremelimumab and imfinzi to the patient, followed by monotherapy with Imfinzi every 4 weeks, this dosing regimen is designed to stimulate T cell activation at the same time, Reduce the toxic side effects
of CTLA-4 antibodies.
The results of this trial showed that patients treated with this combination regimen had a 22% lower risk of death compared with the active control group (HR=0.
78, 96.
02% CI: 0.
65-0.
93, p=0.
0035), and overall survival, objective response rate, and survival rate after 3 years were significantly better than those
in the control group.
78, 96.
02% CI: 0.
65-0.
93, p=0.
0035), and overall survival, objective response rate, and survival rate after 3 years were significantly better than those in the control group
.
In 2019, Roche's PD-L1 inhibitor Tecentriq in combination with Avastin improved overall survival of liver cancer patients for the first time, bringing a new standard of care
to first-line treatment.
Since then, several companies have explored the effects of
immune checkpoint inhibitors as a first-line treatment for liver cancer as monotherapy or combination therapy.
In addition to AstraZeneca's immunotherapy portfolio, Hengrui Pharma and BeiGene also released the latest results
of their respective liver cancer combination therapies at this year's ESMO conference.
Looking forward to the smooth development of more innovative therapies and new treatment options
for patients.
Resources:
Resources:
[1] Novel Drug Approvals for 2022.
Retrieved October 23, 2022, from
Retrieved October 23, 2022, from
