Imjudo® (tremelimumab-actl – AstraZeneca) injection was approved by the U.S. Food and Drug Administration on Oct. 21, 2022. A cytotoxic T-lymphocyte–associated antigen 4(CTLA-4) inhibitor, it is indicated at the beginning of treatment for adult patients who have hepatocellular carcinoma (HCC) that cannot be removed by surgery. In a regimen called STRIDE (single tremelimumab, regular interval durvalumab), Imjudo is administered as a one-time intravenous (IV) infusion right before an IV dose of AstraZeneca’s programmed death ligand 1 (PD-L1) blocker, Imfinzi® (durvalumab). The recommended dose of Imjudo is 300mg for patients who weigh at least 30kg (66 pounds) followed by 1,500mg of Imfinzi. For those who weigh less, the dose of Imjudo is 4mg/kg and for Imfinzi 20mg/kg. Then, only Imfinzi continues to be administered once each month. Cost and distribution plans are not yet available for Imjudo, but its launch is expected by the middle of November. Although Imjudo presently has no other FDA approvals, Imfinzi additionally is approved for some lung and biliary tract cancers. Prescribing information for Imjudo is here and for Imfinzi, here.
At a Glance
- Brand (Generic) Name: Imjudo (tremelimumab-actl)
- Manufacturer: AstraZeneca
- Date Approved: Oct. 21, 2022
- Indication: the treatment of adult patients who have unresectable HCC
- Dosage Forms Available: single-dose vials containing 25mg/1.25mL or 300mg/15mL for dilution and IV infusion
- Launch Date: by mid-November
- Estimated Annual Cost: Not yet available
- According to information from the American Cancer Society (ACS), around 41,000 U.S. adults are diagnosed with HCC each year – about twice as many men as women.
- Symptoms of HCC tend to be nonspecific in the early stages. Since many cases of HCC are not discovered until they are advanced, the five-year survival rate for late-stage cases averages less than 5%.
- Imjudo is a CTLA-4 inhibitor that blocks the activity of a protein on the surface of T cells to increase the spread of T cells within tumors and decrease tumor growth.
- In the open-label, phase III HIMALAYA clinical trial, over 1,300 previously untreated patients were given either the STRIDE regimen or sorafenib, an oral multi-kinase inhibitor that is widely used to treat HCC. Deaths declined by 22% more in the combination drug group and about 10% more of the patients who received Imjudo/Imfinzi survived after three years, as compared with patients who got sorafenib.
- The most common side effects among study participants were decreased appetite, diarrhea, fever, and rash/itching. In the STRIDE group, 8.2% of patients stopped treatment due to a serious adverse event versus 11% of those taking sorafenib.
- Currently, several targeted drugs, such as sorafenib and Lenvima® (lenvatinib) capsules, and immunotherapies, including Keytruda® (pembrolizumab) and Yervoy® (ipilimumab); are FDA approved to treat HCC. Some systemic or localized chemotherapies also may be used, although they typically are not as effective as other treatments. Other therapies may include radiation and surgery for some patients.
- Imjudo’s HCC indication was granted under the FDA’s Priority Review process.