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AstraZeneca: 18 years of difficult delivery, tremelimumab combined with duvalumab is approved for the treatment of patients with unresectable liver cancer

 Last Update: 2022-11-05
 Source: Internet
 Author: User

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AstraZeneca's Imjudo (generic name: tremelimumab) in combination with Infineon (generic name: duvolumab) has been approved in the United States for the treatment of liver cancer patients
with unresectable tumors 。 The combination, known as the STRIDE regimen (Single Tremelimumab Regular Interval Durvalumab, STRIDE), uses an innovative dosing and timing that includes only one dose of anti-CTLA-4 monoclonal antibody tremelimumab 300 mg plus anti-PD-L1 monoclonal antibody duvalumab 1500 mg, followed by duvalumab administered every four weeks
。
U.
S.
Food and Drug Administration (U.
S.
Food and Drug Administration (FDA) is based on the positive results
of the Phase III clinical study HIMALAYA.
In this study, patients treated with tremelimumab in combination with duvalumab had a 22%
lower risk of death compared with sorafenib monotherapy.
The results showed that about 31 percent of patients receiving the combination therapy were still alive after three years, compared with only 20 percent of patients treated with sorafenib monotherapy
.

Liver cancer is the third leading cause of cancer death worldwide and the sixth most common cancer
.
Liver cancer is the fastest-rising number of cancer-related deaths in the United States, with about 36,000 new cases
each year.
Ghassan Abou-Alfa, MD, MBA, attending physician at Memorial Sloan Kettering Cancer Center (MSK), and principal investigator of HIMALAYA, a Phase III clinical study, said: "Patients with unresectable liver cancer need well-tolerated treatment options
that can significantly prolong their overall survival 。 In addition to demonstrating good 3-year survival in the HIMALAYA study, safety data showed no increased risk of severe hepatotoxicity or bleeding from this combination regimen, which is an important factor
for liver cancer patients with advanced liver disease.

Dave Fredrickson, global executive vice president and head of the Oncology Business Unit at AstraZeneca, said: "With the first regulatory approval of tremelimumab, patients with unresectable liver cancer in the United States now have an approved dual immunotherapy option
.
This protocol leverages the unique combination potential of CTLA-4 inhibitors with PD-L1 inhibitors to enhance the immune response
against cancer.

Andrea Wilson Woods, president and founder of the Blue Faery: Adrienne Wilson Liver Cancer Foundation, said: "In the past, liver cancer patients had few treatment options and a poor
prognosis.
Based on this approval, we appreciate the new and innovative treatment options and remain optimistic
.
" These new treatment options could improve long-term survival
in patients with unresectable hepatocellular carcinoma.
We are grateful to the patients, their families and the wider liver cancer community
who continue to fight for and support each other in their new treatment options.
"
The safety profile of Tremelimumab in combination with duvalumab versus duvalumab monotherapy is consistent with the known profile of each drug, and no new safety signals
have been found.
The regulatory application for the combination of Tremelimumab and duvalumab in patients with advanced liver cancer is currently being reviewed
in Europe, Japan and several other countries based on the results of the HIMALAYA clinical study.

Tremelimumab's fate can be said to have twists and turns, after 18 years of development, between Pfizer and AstraZeneca, and tried a number of indications for different cancer types
.
Pfizer first put tremelimumab into clinical trials in 2004, and phase I and II clinical studies have shown that it induces a lasting tumor response
in patients with metastatic melanoma.
But in phase III trials, interim data showed that tremelimumab therapy was no better than standard chemotherapy
.
So in 2008 Pfizer stopped clinical trials of tremelimumab for the treatment of advanced melanoma, and soon after abandoned tremelimumab
.
At that time, there were limited research projects for the CTLA-4 target, and tremelimumab did not cause much splash
.

Until Bristol-Myers Squibb's research proved that blocking CTLA-4 can significantly prolong the lives of a subset of melanoma patients, and launched its own CTLA-4 monoclonal antibody Yervoy (ipilimumab).

Yervoy was approved by the FDA in 2013, and tremelimumab was far from seeing the light of day
.
AstraZeneca received authorization from Pfizer in 2011 to enter the still-nascent field of immuno-oncology, but Tremelimumab continued to fail in trials including lung cancer, urothelial carcinoma, and head and neck cancer until it showed positive efficacy
in combination with PD-L1 monoclonal antibody Imfinzi in patients with liver cancer who could not undergo surgery.
Written by| Qiao Weijun

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