Express first-line treatment of liver cancer, anti-CTLA-4/PD-L1 antibody combination entered priority review

▎WuXi AppTec Content Team Editor Today, AstraZeneca announced that its Biologics License Application (BLA) for the investigational CTLA-4 antibody tremelimumab has been accepted by the U.
S.
FDA and will be reviewed through the priority review channel , in combination with the anti-PD-L1 antibody Imfinzi (durvalumab) in patients with unresectable hepatocellular carcinoma
.

The innovative dosing regimen, called STRIDE, starts with a single dose of tremelimumab, and then patients continue to receive Imfinzi
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AstraZeneca submitted this BLA using a priority review voucher and expects a response from the FDA in the fourth quarter of this year
.

Liver cancer is the sixth most common cancer in the world, with approximately 900,000 patients diagnosed each year
.

It is also the third leading cause of cancer death, with only about 7% of advanced patients surviving more than 5 years
.

Imfinzi is an anti-PD-L1 monoclonal antibody that relieves tumor cells from suppressing immune responses by blocking the binding of PD-L1 to PD-1 and CD80 proteins
.

It has been approved in several countries and regions for the treatment of extensive-stage small cell lung cancer
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It is also FDA-approved for the treatment of non-small cell lung cancer and advanced bladder cancer
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Tremelimumab blocks the activity of CTLA-4, which promotes T cell activation and stimulates the immune system's immune response to cancer
.

It was used in combination with Imfinzi and chemotherapy to significantly improve patients' overall survival in a Phase 3 clinical trial in first-line treatment of stage IV non-small cell lung cancer
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Image source: 123RF This BLA is based on the final results of the Phase 3 clinical trial HIMALAYA
.

In this trial, patients treated with the STRIDE dosing 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)
.

Nearly one-third (31%) of patients survived for more than 3 years, compared with 20% in the active control group
.

Dr Susan Galbraith, Executive Vice President, Oncology R&D, said: "The Phase 3 HIMALAYA trial showed that the addition of a single dose of pre-treated tremelimumab to Imfinzi significantly improved three-year survival, underscoring the regimen's ability to improve long-term survival outcomes.
Potential
.

Patients with advanced liver cancer are in great need of new treatment options, and we are working closely with the FDA to bring this novel treatment option to patients as soon as possible
.

” Reference: [1] Tremelimumab accepted under Priority Review in the US for patients with unresectable liver cancer in combination with Imfinzi.
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.

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.

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.