Exelixis, Inc. announced phase 1/2 clinical trial results from the combination of cabozantinib (CABOMETYX®) and nivolumab (Opdivo®) with or without ipilimumab (Yervoy®) in advanced hepatocellular carcinoma (HCC). Data from the cabozantinib combination cohort of the CheckMate 040 trial will be presented on January 24 during Rapid Abstract Session B from 7:00 – 7:45 a.m. PT at the 2020 American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (ASCO GI), which is being held in San Francisco, California, January 23-25, 2020. The data will also be included in Poster Session B from 12:00 – 1:30 p.m. PT and 4:30 – 5:30 p.m. PT on January 24. CheckMate 040 is a phase 1/2 study that includes an exploratory cohort of patients with advanced HCC who were either treatment naïve (41%) or who were intolerant to or had progressed on prior sorafenib therapy (59%). For the 36 patients treated with the combination of cabozantinib and nivolumab (17 treatment naïve [47%] and 19 with prior sorafenib therapy [53%]), the investigator-assessed objective response rate (ORR) was 19%, and disease control rate (DCR) was 75%. Median progression-free survival (PFS) was 5.4 months, and median overall survival was 21.5 months. For the 35 patients treated with the combination of cabozantinib, nivolumab and ipilimumab (12 treatment naïve [34%] and 23 with prior sorafenib therapy [66%]), the investigator-assessed ORR was 29%, and DCR was 83%. Median PFS was 6.8 months, and median overall survival had not yet been reached. No new safety signals were identified in this combination cohort. Treatment-related grade 3 or 4 adverse events were observed in 47% of the cabozantinib and nivolumab group; events occurring in more than 5% of patients were hypertension (11%), diarrhea (11%), aspartate aminotransferase (AST) increase (8%) and lipase increase (6%). Treatment-related grade 3 or 4 adverse events were observed in 71% of the cabozantinib, nivolumab and ipilimumab group; events occurring in more than 5% of patients were AST increase (23%), lipase increase (17%), ALT increase (17%), hypertension (17%) and palmar-plantar erythrodysaesthesia (9%). Discontinuation rates due to treatment-related adverse events were 11% for the cabozantinib and nivolumab group and 20% for the cabozantinib, nivolumab and ipilimumab group.