New hope in liver cancer as AstraZeneca Combo improves survival



Alliance Bodo Marks / photo via Getty Images

AstraZeneca announcement high-level positive data from the HIMALAYA phase 3 trial of a single, high initiation dose of tremelimumab plus Imfinzi (durvalumab) in patients with unresectable hepatocellular carcinoma (HCC) or cancer liver, who had not received previous systemic therapy and were not eligible for spot treatment.

Tremelimumab is a human monoclonal antibody that targets cytotoxic T cell associated protein 4 (CTLA-4). It is being developed in association with Imfinzi in non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC), bladder cancer and liver cancer. Imfinzi is a human monoclonal antibody checkpoint inhibitor that binds to the PD-L1 protein.

Imfinzi alone has demonstrated overall survival (OS) not inferior to Bayer’s sorafenib (Nexavar), showing a numerical trend in its favor and better tolerance. Imfinzi is approved for NSCLC, SCLC, bladder cancer and is in development for HCC, bile duct cancer, esophageal cancer, gastric and gastroesophageal cancer, cervical cancer uterine cancer, ovarian cancer, endometrial cancer and other solid tumors.

They call the combination of tremelimumab and Imfinzi the STRIDE regimen for a single Tremelimumab at regular interval Durvalumab.

HCC is the The most common type of liver cancer, accounting for about 75%. It is the third leading cause of cancer death and the sixth most commonly diagnosed cancer in the world. Around 900,000 people are diagnosed with HCC worldwide each year. About 7% of patients with advanced disease survive for five years.

“HIMALAYA is the first Phase III trial to add a new single priming dose of an anti-CTLA4 antibody to another checkpoint inhibitor, durvalumab,” said Ghassan Abou-Alfa, attending physician at Memorial Sloan Kettering Cancer Center and principal investigator of the HIMALAYA trial. “This serves to strengthen the patient’s immune system against their liver cancer, with the aim of maximizing long-term survival with minimal side effects. This is very exciting news for our patients.

In addition, the regulators of the European Union are initiate a real-time review of AstraZeneca’s COVID-19 antibody cocktail. The cocktail, AZD7442, is made up of two antibodies. It was also submitted to FDA for an Emergency Use Authorization (EUA) at the beginning of the month. AZD7442 is a long-acting antibody (LAAB) combination of tixagevimab and cilgavimab. Both antibodies were from B cells donated by patients who have recovered from COVID-19.

End of August, AstraZeneca reported high-level positive data from the PROVENT Phase III pre-exposure prophylaxis study of the cocktail. It showed a statistically significant drop in the incidence of symptomatic COVID-19, the primary endpoint of the study.

AZD7442 reduced the risk of developing COVID-19 by 77% compared to placebo. There were no cases of severe mortality from COVID-19 or COVID-19 in the cohort that received the cocktail. In the placebo cohort, however, there were three cases of severe COVID-19 with two deaths. The study involved 5,197 people.

Mene Pangalos, Executive Vice President of AstraZeneca, Biopharmaceutical R&D, noted at the time: “Vulnerable populations such as the immunocompromised are often unable to build a protective response after vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we take one more step towards providing an additional option to help protect against COVIDI-19 alongside vaccines. We look forward to sharing AZD7442 data for the treatment of COVID-19 later this year. “


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