An expert from Memorial Sloan Kettering Cancer Center in New York discusses the promising findings from a study that analyzed tremelimumab plus Imfinzi for unresectable hepatocellular carcinoma, and outlines side effects patients should discuss with their doctor.
Adding tremelimumab to Imfinzi (durvalumab) was safe and effective for patients with unresectable hepatocellular carcinoma (HCC), according to findings from the phase 3 HIMALAYA trial that were presented at the 2022 ASCO Gastrointestinal Cancers Symposium.
Dr. Ghassan K. Abou-Alfa, the study’s primary investigator and a medical oncologist at Memorial Sloan Kettering Cancer Center in New York, said that the hope is that these study results lead to the Food and Drug Administration’s approval of the regimen. If that happens, it is important for patients to talk with their doctors to see if they would be a good fit for this therapy and understand the side effects that might come along with it.
“Patients really now have another option of therapy,” Abou-Alfa said during an interview with CURE®. “It’s very important to be sure that we look at the perspective of the long duration of survival in the study … by that time, hopefully, this will be an approved regimen. Patients should definitely ask their doctors about it.”
The HIMALAYA trial included 1,171 patients with unresectable HCC who did not previously undergo systemic therapy (treatments like chemotherapy that target the whole body). They were randomized to receive the STRIDE regimen (singular tremelimumab with Imfinzi given at regular intervals), Imfinzi alone or Nexavar (sorafenib).
The 24-month overall survival rate for patients on STRIDE was 40.5%; 39.6% for those on Imfinzi alone; and 32.6% for those on Nexavar. STRIDE’s tremelimumab/Imfinzi regimen proved to have a more superior benefit at 36 months, compared to other regimens, with a 30.7% overall survival rate, compared to 24.7 and 20.2%, respectively.
Overall, patient response (when the tumor shrinks as a result of treatment) was also better in the STRIDE group, with overall response rates of 20.1% for STRIDE, 17% for Imfinzi and 5.1% for Nexavar.
Like virtually all cancer treatments, the combination of tremelimumab and Imfinzi came with side effects, too, though there were no new side effects that researchers saw that they did not expect.
In the HIMALAYA study, the adverse events that were noted were exactly what was expected. Interestingly, the grade 3 and 4 treatment-related adverse events were more noticeable in the (Nexavar) arm with about 7%, compared to a lower number in the (tremelimumab) 300 (mg dose) plus (Imfinzi), among which was a concern because of the parameters with the anti-CTLA-4, there was concern about hepatic events … or at the same time for hemorrhage. And these were multiple, but maybe not necessarily of any pronounced impact compared to the other arms.
And more importantly, for the hemorrhage, not a single bleeding was related to esophageal varices in this study. Number three, in regard to the immune-related adverse events, yes, of course they were noticeable more in the combination of the (tremelimumab) plus (Imfinzi). And they were the classic ones, including the hepatitis, dermatitis and diarrhea.
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