Findings of the IMMUTACE Trial in Hepatocellular Carcinoma

Arndt Vogel, MD, the managing senior consultant and professor in the department of Gastroenterology, Hepatology, and Endocrinology, at the Hannover Medical School, discusses the study results of the IMMUTACE (NCT03572582) study in hepatocellular carcinoma (HCC).

Within the single-arm, open-label phase 2 IMMUTACE study, investigators examined the efficacy of the combination of nivolumab (Opdivo) plus transarterial chemoembolization (TACE) as a first-line treatment option in 49 patients with multinodular, intermediate-stage HCC. Those enrolled were administered TACE along with 240 mg of nivolumab administered intravenously every 2 weeks after 2 to 3 days. TACE was then repeated after 8 weeks.

The primary end point of the trial was overall response rate (ORR) with secondary end points of progression-free survival (PFS), time to progression, overall survival (OS), duration of response, objective of response, time to failure of strategy, quality of life, and incidence of treatment-emergent adverse events.

At the early readout of the study, findings revealed that the primary end point of ORR was met with a rate of more than 50%. Results for PFS, OS, and the other secondary end points remain early. While secondary end point data has not yet been reached, Vogel explains that the signals look promising.

Transcription:

0:08 | I think this was an early readout. The study met its primary end point. We observed a very high overall response rate of more than 50%. PFS and overall survival is still early. Specifically, patients were allowed to continue nivolumab after the first progression.

0:30 | I think we have to wait for more major data in respect to the very important secondary end points like overall survival. Although I think the combination looks very promising in respect to maybe some synergistic, at least additive activity, I think it's a promising signal for the currently ongoing and phase 3 studies which compare TACE alone to TACE with various combinations.