The data, reported by Dr Thomas Yau (University of Hong Kong, China) originated from the phase 3 CheckMate 459 study, which randomised 743 patients with advanced HCC to receive nivolumab every 2 weeks or oral sorafenib twice daily as first-line treatment. Median OS was 16.4 months for nivolumab and 14.7 months for sorafenib (HR 0.85; 95% CI 0.72-1.02; P=0.0752; see Table). This did not meet the predefined threshold of statistical significance. However, clinical benefit was observed across predefined subgroups of patients, including those with hepatitis infection and those with vascular invasion and/or extrahepatic spread. The overall response rate was 15% for nivolumab (including 14 patients with complete response) and 7% for sorafenib (5 patients with complete response). Grade 3/4 treatment-related adverse events were reported in 22% of patients in the nivolumab arm (81 patients) and in 49% of those given sorafenib (179 patients). Adverse events led to discontinuation in 4% (n=16) and 8% (n=29) of the patients, respectively.
Table. Results from 743 patients with advanced HCC were randomised to nivolumab (NIVO; n=371) or sorafenib (SOR; n=372) with minimum follow-up of 22.8 months at data cut-off.
OS, overall survival; PFS, progression-free survival; ORR, overall response rate.
Dr Yau said, “the primary analysis demonstrated a non-significant trend towards clinically meaningful OS benefit. Importantly, there was also a higher complete response rate with nivolumab compared with sorafenib.” He added that the patient-reported findings suggested that patients in the nivolumab arm experienced better quality of life and further supported clinical data that demonstrated a treatment benefit for nivolumab vs sorafenib in advanced HCC. Invited discussant Dr Arndt Vogel (Hannover Medical School, Germany) noted that regorafenib, lenvatinib, cabozantinib, and ramucirumab are other tyrosine kinase inhibitors in the second-line setting of advanced HCC that may account for some of the results.
Two possible limitations were mentioned, namely the unselected population and the predefined threshold of statistical significance. Results suggested patients with high PD-L1 had an increased response rate only in the nivolumab arm suggesting its potential role as a predictor biomarker, but preselection of patients based on PD-L1 will require another study.
- Yau T et al. ESMO Congress 2019. Abstract LBA38_PR.
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Table of Contents: ESMO 2019
Featured articles
Interview with ESMO President Prof. Josep Tabernero
Breast Cancer
Triple negative breast cancer gets positive news: KEYNOTE-522 interim results
CDK4/6 inhibitors change landscape of breast cancer treatment: 2 studies
Veliparib-chemo combo prolongs survival without disease progression in some advanced breast cancer patients
Lung Cancer
Improved response rates without survival benefit with pembrolizumab in pretreated mesothelioma
Frontline ipilimumab/nivolumab improves OS in advanced NCLSC
First-line osimertinib significantly lengthens OS in NSCLC
Liquid biopsy to decide the best treatment for NSCLC
Melanoma
Long-term data from CheckMate 067
Adjuvant nivolumab provides benefit
Nivolumab+ipilimumab superior to monotherapy for melanoma brain metastases
GI Cancers
Preoperative chemotherapy for colon cancer
Nivolumab improves OS in advanced oesophageal cancer
Liquid biopsy identifies relapse in patients with colorectal cancer after surgery
In hepatocellular carcinoma, CheckMate 459 misses OS endpoint, but some interesting trends emerge
Heavily pre-treated GIST: ripretinib improves PFS
FGFR2+ cholangiocarcinoma: pemigatinib active as second-line treatment
IDH1+ cholangiocarcinoma: phase 3 results show improved PFS
Advanced colorectal cancer and BRAF mutations: triplet combination improves survival
Genitourinary Cancers
25% reduction in the risk of death in patients with nmCRPC treated with apalutamide
Enfortumab vedotin and pembrolizumab in advanced bladder cancer: initial results
PARP inhibition in selected patients slows progression on advanced prostate cancer
PFS extension with immunotherapy + chemotherapy in urothelial cancer
Third-line in mCRPC: CARD trial
Prostate cancer: spare radiotherapy after surgery
Novel mode of action for kidney cancer treatment
Gynaecological Cancers
Ovarian cancer patients benefit from combined maintenance therapy
Combination of PARP inhibition plus chemotherapy in ovarian cancer
PFS benefit with niraparib as first-line maintenance in ovarian cancer
CNS Tumours
Ceritinib in ALK+ NSCLC brain metastases
Solid Tumours/Pan-Tumour Data
Mixed data: AMG 510 in tumours with KRASG12C
DNA profiling of carcinoma of unknown primary should inform treatment
Larotrectinib: safe and effective in TRK fusion-positive tumours
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Interview with ESMO President Prof. Josep Tabernero
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