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Abstract Details
Namodenoson in Advanced Hepatocellular Carcinoma and Child-Pugh B Cirrhosis: Randomized Placebo-Controlled Clinical Trial
Cancers (Basel). 2021 Jan 7;13(2):E187. doi: 10.3390/cancers13020187.
Salomon M Stemmer1, Nebojsa S Manojlovic2, Mihai Vasile Marinca3, Petar Petrov4, Nelly Cherciu5, Doina Ganea6, Tudor Eliade Ciuleanu7, Ioana Adriana Pusca8, Muhammad Shaalan Beg9, William T Purcell10, Adina-Emilia Croitoru11, Rumyana Nedyalkova Ilieva12, Sladjana Natoševic13, Amedeia Lavinir Nita14, Dimitar Nikolaev Kalev15, Zivit Harpaz16, Motti Farbstein16, Michael H Silverman16, David Bristol16, Inbal Itzhak16, Pnina Fishman16
Author information
1Davidoff Cancer Center, Rabin Medical Center-Beilinson Hospital, Petah Tikva and Sackler Faculty of Medicine, Tel Aviv 49100, Israel.
2Department of Gastroenterology and Hepatology, Military Medical Academy, 11000 Belgrade, Serbia.
3Department of Oncology, Iasi Regional Oncology Institute, Institutul Regional de Oncologie Iasi-Sectia Oncologie Medical, 700483 Iasi, Romania.
4Department of Medical Oncology and Oncological Diseases in Pneumology, Complex Oncology Center-Plovdiv, EOOD, 4000 Plovdiv, Bulgaria.
Namodenoson, an A3 adenosine-receptor agonist, showed promising results in advanced hepatocellular carcinoma (HCC) and moderate hepatic dysfunction (Child-Pugh B; CPB) in a phase I/II clinical study. This phase II study investigated namodenoson as second-line therapy in such patients. Patients were randomized 2:1 to twice a day (BID) namodenoson (25 mg; n = 50) or placebo (n = 28). The primary endpoint (overall survival [OS]) was not met. Median OS was 4.1/4.3 months for namodenoson/placebo (hazard ratio [HR], 0.82; 95% confidence interval [CI] 0.49-1.38; p = 0.46). Pre-planned subgroup analysis of CPB7 patients (34 namodenoson-treated, 22 placebo-treated) showed a nonsignificant improvement in OS/progression-free survival (PFS). OS: 6.9 versus 4.3 months; HR, 0.81; 95% CI: 0.45-1.43, p = 0.46. PFS: 3.5 versus 1.9 months; HR, 0.89; 95% CI: 0.51-1.55, p = 0.67 (log-rank test). The difference in 12-month OS was significant (44% versus 18%, p = 0.028). Response rates were determined in patients for whom ≥ 1 assessment post-baseline was available (34 namodenoson-treated, 21 placebo-treated). Partial response was achieved by 3/34 (8.8%) and 0/21 (0%) patients, respectively. Namodenoson was well-tolerated, with a safety profile comparable to that of the placebo group. No treatment-related deaths were reported; no patients withdrew due to toxicity. In conclusion, namodenoson demonstrated a favorable safety profile and a preliminary efficacy signal in HCC CPB.