They are calling the combination of tremelimumab and Imfinzi the STRIDE regimen for Single Tremelimumab Regular Interval Durvalumab.
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AstraZeneca announced positive high-level data from the HIMALAYA Phase III trial of a single, high priming dose of tremelimumab plus Imfinzi (durvalumab) in patients with unresectable hepatocellular carcinoma (HCC), or liver cancer, who had not had previous systemic therapy and weren’t eligible for localized treatment.
Tremelimumab is a human monoclonal antibody that targets cytotoxic T-lymphocyte-associated protein 4 (CTLA-4). It is being developed in combination 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 by itself demonstrated non-inferior overall survival (OS) to Bayer’s sorafenib (Nexavar), showing a numerical trend in its favor and improved tolerability. Imfinzi is approved for NSCLC, SCLC, bladder cancer and is being developed for HCC, biliary tract cancer, esophageal cancer, gastric and gastroesophageal cancer, cervical cancer, ovarian cancer, endometrial cancer, and other solid tumors.
They are calling the combination of tremelimumab and Imfinzi the STRIDE regimen for Single Tremelimumab Regular Interval Durvalumab.
HCC is 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 globally. About 900,000 people are diagnosed with HCC worldwide every year. About 7% of patients with the advanced disease survive five years.
“HIMALAYA is the first Phase III trial to add a novel 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 boost the patient’s own immune system against their liver cancer, aiming to maximize long-term survival with minimal side effects. This is very exciting news for our patients.”
In other news, European Union regulators are initiating 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 the 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 originated from B-cells donated by patients who recovered from COVID-19.
In late August, AstraZeneca reported positive high-level 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 study’s primary endpoint.
AZD7442 reduced the risk of developing COVID-19 by 77% compared to placebo. There were no cases of severe COVID-19 or COVID-19-related mortality 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 included 5,197 people.
Mene Pangalos, AstraZeneca’s executive vice president, Biopharmaceuticals R&D, noted at the time, “Vulnerable populations such as the immunocompromised often aren’t able to mount a protective response following vaccination and continue to be at risk of developing COVID-19. With this first global regulatory filing, we are one step closer to 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.”
