Ghassan K. Abou-Alfa, MD, on Integral Developments Leading to Phase 3 HIMALAYA Trial in Hepatocellular Carcinoma

Ghassan K. Abou-Alfa, MD, detailed the evolution of treatment options for unresectable hepatocellular carcinoma prior to the phase 3 HIMALAYA study and the reasons for launching the trial.

CancerNetwork® spoke with Ghassan K. Abou-Alfa, MD, a medical oncologist at Memorial Sloan Kettering Comprehensive Cancer Center, at the 2022 Gastrointestinal Cancer Symposium, about important developments leading to the examination of tremelimumab plus durvalumab (Imfinzi) compared with durvalumab alone for unresectable hepatocellular carcinoma in the phase 3 HIMALAYA study (NCT03298451).


Interestingly, it took a long while to get to this point [of presenting research at the 2022 Gastrointestinal Cancers Symposium]. If anything, I’m humbled to say that I started in the field before any therapy was available. We started with sorafenib [Nexavar], we evolved to [using another tyrosine kinase inhibitor] lenvatinib [Lenvima] in first-line therapy. There’s no question we all were interested in immunotherapy. We were looking forward to that because of the real effects that we anticipated in the setting of hepatocellular carcinoma [HCC] with the hyperimmune effects. Interestingly, the single-agent anti–PD-1 or anti–PD-L1 did not fare that well. If anything, it clearly started evolving the need for certain priming for that entity of the anti–PD-1, anti–PD-L1 effect. We have seen it with VGF or with FGF. HIMALAYA has completely evolved. The anti–CTLA-4 that comes into play as an important, powerful booster extract that comes all the way from the top of the chain in the lymph node itself to further enhance anti–PD-1, anti–PD-L1 activity. This led to the further evaluation of the HIMALAYA study.


Abou-Alfa G, Chan SL, Kudo M, et al. Phase 3 randomized, open-label, multicenter study of tremelimumab (T) and durvalumab (D) as first-line therapy in patients (pts) with unresectable hepatocellular carcinoma (uHCC): HIMALAYA. J Clin Oncol. 2022;40(suppl 4):379. doi: 10.1200/JCO.2022.40.4_suppl.379