Dr Sunil Verma on Benefits, Safety Findings in HIMALAYA Trial

Sunil Verma, MD, senior vice president and global head of oncology, medical at AstraZeneca, summarizes the benefits and safety findings discovered in the HIMALAYA study.

Transcript

What are the benefits of a dual immunotherapy combination in treating HCC [hepatocellular carcinoma] compared with combining immunotherapy with another type of therapy?

So in this case, with the outline, the standard of care is TKIs [tyrosine kinase inhibitors]. So either lenvatinib or sorafenib. Now, sorafenib or lenvatinib, they are not easy drugs, and there are side effects that are associated with those therapies and with that standard of care. Combining it, we're really not getting rid of the side effects, because the patients potentially aren't suffering through those side effects. Our approach was really replacing the standard of care in this setting to see, can we have an immune therapy combo or immune therapy alone approach that will lead to a better outcome both from an efficacy as well as, much more critically, from a side effect profile.

Can you explain the safety findings?

Anytime when we look at a therapeutic index, we want to be able to improve the outcomes for patients both from efficacy, but also have a more tolerable regimen to offer them. So in the HIMALAYA study, not only was there an improvement in median overall survival with the combination of tremelimumab and durvalumab, as compared to standard of care. But as you noted, there were also fewer grade 3 and 4 adverse events noted with that combination compared to the standard of care. I think that, to me, is the most meaningful result and outcome that we want to be able to offer specifically in this patient population with other cellular cancers, which tend to be more frail, tend to be sicker, and can potentially be associated with significant other adverse events such as higher rates of bleeding risk. If we were to come up with a regimen, and this is what the data shows, that extends and improves survival including long term durable survival at 3 years without those side effects, I think that's a meaningful advance.