OLIE, ITCC-082: a Phase II trial of lenvatinib plus ifosfamide and etoposide in relapsed/refractory osteosarcoma.

ABSTRACT

While survival rates for patients with relapsed/refractory osteosarcoma are low, kinase inhibitors have shown efficacy in its treatment. The multikinase inhibitor lenvatinib, plus ifosfamide and etoposide, showed antitumor activity in a Phase II study in patients with relapsed/refractory osteosarcoma. This Phase II randomized controlled trial (OLIE) will assess whether the combination of lenvatinib + ifosfamide + etoposide is superior to ifosfamide + etoposide alone in children, adolescents and young adults with relapsed/refractory osteosarcoma. The primary end point is progression-free survival; secondary and exploratory end points include, but are not limited to, overall survival, objective response rate, safety and tolerability, pharmacokinetic characterization of lenvatinib in the combination treatment, quality of life and quantification of baseline unresectable lesions that are converted to resectable.

Lay abstract Traditional treatment for osteosarcoma (bone cancer) includes drugs that cause cell damage, such as ifosfamide and etoposide. The study in this article looked at adding lenvatinib, a drug that works to block development of blood vessels, to traditional chemotherapy to see whether it worked better. 'OLIE' is a Phase II clinical study comparing lenvatinib + chemotherapy (ifosfamide + etoposide) to the chemotherapy alone (ifosfamide + etoposide). An earlier study indicated that this drug combination may be successful. The study includes children, adolescents and young adults with osteosarcoma that has come back after, or did not respond to, previous treatment. OLIE will look at the antitumor activity and the side effects of this drug combination. The OLIE study is currently enrolling patients worldwide. Clinical trial registration number NCT04154189 (ClinicalTrials.gov).