The Food and Drug Administration has approved AstraZeneca’s drug Imjudo for patients with liver cancer whose tumors can’t be surgically removed, the company said Monday. The clearance is the medicine’s first after a series of trial setbacks over several years.
Imjudo, known also as tremelimumab, has been approved for use as part of a combination regimen alongside Imfinzi, another immunotherapy developed by the U.K. drugmaker. The drug is administered as a single dose with Imfinzi, followed by regular Imfinzi infusions every four weeks. The medicine, which blocks a tumor-protecting protein called CTLA-4, is the second approved medicine of its kind, joining Bristol Myers Squibb’s Yervoy.
Imjudo has been in development for almost two decades, as early tests in patients date back as far as 2006. While Yervoy became the first so-called checkpoint inhibitor to win approval in 2011 and has since been cleared for multiple tumor types, AstraZeneca hit a number of challenges in developing Imjudo.
Among those setbacks was the drug’s failure in a closely watched trial in first-line lung cancer, which could’ve given AstraZeneca a chance to take on Merck & Co. in one of oncology’s largest and most competitive markets. AstraZeneca kept testing Imjudo despite those disappointments, however, and announced success last year in a Phase 3 study in liver cancer.
In that trial, called HIMALAYA, patients given Imjudo and Imfinzi combination were 22% less likely to die than patients given a standard treatment called Nexavar. After three years, 31% of patients given Imjudo and Imfinzi were alive, compared with 20% of the Nexavar patients.
Though comparing medicines across trials can be difficult, the Imjudo-Imfinzi combination also led to fewer study discontinuations due to intestinal side effects than Bristol Myers’ drugs. In the trial underlying Opdivo and Yervoy’s approval in liver cancer, 14% of patients dropped out due to incidences of intestinal inflammation, and doctors withheld treatment from 4% due to similar issues. Only 1% of Imjudo recipients had to stop testing because of intestinal problems.
“Patients with [inoperable] liver cancer are in need of well-tolerated treatments that can meaningfully extend overall survival,” said Ghassan Abou-Alfa, an oncologist at Memorial Sloan Kettering Cancer Center and a study investigator, in a statement from AstraZeneca.
Approved in seven different types of cancer, Yervoy had sales of $2 billion in 2021, up 20% from $1.7 billion in 2020. Yervoy’s dosing — up to four times in some settings, and until disease progression in others, like lung cancer — gives Bristol Myers Squibb more opportunities to charge insurers compared with AstraZeneca, which will only be able to charge once for Imjudo in liver cancer.
In an email, an AstraZeneca spokesperson said the company will disclose Imjudo’s price in a few days.
The company is currently running late-stage trials of the drug in bladder cancer. Academic institutions also are testing the drug ovarian, prostate, and head and neck cancers.