(Liver Cancer) Opdivo + Yervoy After Sorafenib Resistance?
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This article is a summary of international medical information and is not medical advice; it cannot replace the diagnosis or treatment plan of your attending physician. The medical technologies, drug information and clinical data presented here are compiled from public literature and official statements of major Japanese medical institutions; the applicability and outcome of any therapy vary with each patient and must be assessed individually by a qualified physician.
At ASCO 2019 (American Society of Clinical Oncology Annual Meeting) held in Chicago from May 31 to June 4, 2019, results were presented from the CheckMate 040 Phase I/II clinical trial evaluating the efficacy and safety of combined anti-PD-1 antibody Opdivo (nivolumab) + anti-CTLA-4 antibody Yervoy (ipilimumab) in hepatocellular carcinoma (HCC) patients who developed resistance to or could not tolerate sorafenib (Nexavar).
The CheckMate 040 trial randomized HCC patients with sorafenib resistance or intolerance in a 1:1:1 ratio across three groups. Primary endpoints: safety, tolerability, ORR, and duration of response (DoR). Secondary endpoints: disease control rate (DCR), time to tumor progression (TTP), PFS, OS, and duration of response.
- Arm A: Opdivo 1 mg/kg + Yervoy 3 mg/kg every 3 weeks for 4 cycles, then Opdivo 240 mg every 2 weeks
- Arm B: Opdivo 3 mg/kg + Yervoy 1 mg/kg every 3 weeks for 4 cycles, then Opdivo 240 mg every 2 weeks
- Arm C: Opdivo 3 mg/kg every 2 weeks + Yervoy 1 mg/kg every 6 weeks
Results:
Primary endpoint ORR: Arm A 32% (CR 8%) / Arm B 31% (CR 6%) / Arm C 31% (CR 0%)
Duration of response: Arm A 17.5 months / Arm B 22.2 months / Arm C 16.6 months
Secondary endpoints:
- DCR: Arm A 54% / Arm B 43% / Arm C 49%
- TTP: Arm A 2.0 months / Arm B 2.6 months / Arm C 2.7 months
- Median OS: Arm A 22.8 months / Arm B 12.5 months / Arm C 12.7 months
Safety:
Overall adverse event rates: Arm A 94% / Arm B 71% / Arm C 79%. Rash, hepatitis, and adrenal insufficiency were confirmed as common adverse events across all groups.
Based on the CheckMate 040 results, Thomas Yau concluded: In HCC patients with sorafenib resistance or intolerance, combined anti-PD-1 antibody Opdivo + anti-CTLA-4 antibody Yervoy demonstrated high objective response rates.
Source: Nivolumab (NIVO) + ipilimumab (IPI) combination therapy in patients (pts) with advanced hepatocellular carcinoma (aHCC): Results from CheckMate 040. (2019 ASCO Annual Meeting, Abstract No: 4012)
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