Efficacy, tolerability, and biologic activity of a novel regimen of tremelimumab (T) in combination with durvalumab (D) for patients (pts) with advanced hepatocellular carcinoma (aHCC)
Abstract No : 4508
Indication : Hepatocellular Carcinoma
Intervention : Tremelimumab + Durvalumab
Company : AstraZeneca
Technology : Monoclonal antibody
At data cut-off (09/02/2019), 332 pts were enrolled. Median followups were 11.7 months (mo) for T300+D, 14.6 (T75+D), 8.9 (D), and 15.8 (T). Treatmentrelated adverse event (trAE) incidences are shown (Table); no deaths were attributed to trAEs for T300+D or T. The T300+D arm had the highest confirmed ORR (DoR not reached [NR]) and longest OS (Table). A unique proliferative T cell profile was identified for pts in the T300+D arm, suggesting additive biologic activity for the combination, and showed pts with an OR exhibited high cytotoxic (CD8) counts
The encouraging clinical activity and tolerable safety profile suggest T300+D provides the best benefit-risk profile as opposed to T75+D or monotherapies. The unique pharmacodynamic activity of the T300+D regimen further supports its use in aHCC. T300+D and D are being evaluated in the ongoing phase III HIMALAYA study (NCT03298451) in first-line HCC vs sorafenib.
Good clinical response for dual immune checkpoint inhibitors (Tremelimumab + Durvalumab) in second line setting however, tough fight ahead in first line setting as it will unlikely give a fight to a new upcoming standard of treatment as per newly published results of the combination of atezolizumab and bevacizumab that has now moved solidly into the first-line setting. The biggest challenges ahead will likely need to focus on therapeutic strategies in the refractory setting following failure of atezolizumab/bevacizumab.