“Tivantinib for second-line treatment of MET-high, advanced hepatocellular carcinoma (METIV-HCC): a final analysis of a phase 3, randomized, placebo-controlled study”: this is the title of the study published in The Lancet Oncology, whose first author is Dr. Lorenza Rimassa, Deputy Head of the Medical Oncology Operational Unit in Humanitas.
The results of the multicenter international study, just published in the most prestigious journal of Oncology, were presented by Dr. Rimassa last June at the annual meeting of ASCO (American Society of Clinical Oncology), the leading international congress for oncology.
The Phase III study and the results
As Dr. Rimassa explains: “This is the publication of data from a phase III study involving a selected population of patients: 340 subjects with hepatocarcinoma with high expression of MET, the receptor for the growth factor of hepatocytes, involved in the progression and metastasis of this tumor. Patients were given tivantinib (or placebo with a 2:1 ratio) following failure of the standard sorafenib treatment.
The results of the previous phases (phase I and phase II studies) were positive, but phase III did not confirm the efficacy of the drug in patients with high expression hepatocarcinoma of MET, a biomarker for this type of tumor.
Advances in Research
“In the field of research, however, this study offers us some important ideas for the future. First of all, we collected more than 1,100 biopsies in patients with hepatic carcinoma, a very high number considering the type of tumor; this shows that it is feasible to conduct translational studies and therefore based on tissue biomarkers, even in the case of hepatocarcinoma. On a large number of biopsies we then had only 4 cases of bleeding, thus also demonstrating the safety of this approach.
It was also the first time in the case of hepatocarcinoma that a marker-based treatment was selected, an important step towards increasingly personalized medicine.
We also found that expression of MET is more frequent after standard treatment with sorafenib. We can therefore deduce that the tumor has its own plasticity and that it is good to make an assessment of the markers at several times. MET in fact varies over time and this could also apply to other markers.
Finally, the survival of placebo patients was much longer than we expected, another positive finding to take into account,” concluded Dr. Rimassa.