AVEO Oncology has introduced a Part III flop of its superior metastatic renal cell carcinoma (RCC) mixture remedy however has scored one other win for its lead drug Fotivda as a monotherapy.
The corporate, which is a part of the LG Chem group, mentioned the TiNivo-2 trial (NCT04987203) had not met the first endpoint of progression-free survival (PFS).
The trial was evaluating a mixture of Opdivo (nivolumab) and low-dose Fotivda (tivozanib) in sufferers with superior metastatic renal cell carcinoma (RCC) whose tumours had progressed following prior immune checkpoint inhibitor (ICI) remedy.
Regardless of the failure within the mixture arm, the management arm utilizing Fotivda alone at commonplace dose demonstrated a clinically significant end result in median PFS within the second line following ICI mixture remedy.
Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor whereas the chemotherapy routine comprised mFOLFOX-6 or FOLFIRI with or with out bevacizumab or cetuximab.
Fotivda is an oral, once-daily, vascular endothelial development issue (VEGF) tyrosine kinase inhibitor (TKI).
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AVEO Oncology says this new knowledge helps knowledge from the TIVO-3 trial (NCT02627963), FOTIVDA’s pivotal examine, which met the first endpoint of PFS.
This additional helps using Fotivda in relapsed or refractory superior RCC as a third-line remedy.
AVEO Oncology chief government officer and president Michael Bailey mentioned: “The PFS and security of the FOTIVDA management arm within the second-line following ICI combos provides to the rising physique of proof of the significance of a extremely selective anti-VEGFR TKI remedy as an efficient, well-tolerated remedy choice for relapsed or refractory RCC sufferers handled with prior ICI mixture remedy.
“Whereas the addition of an ICI to low dose Fotivda didn’t enhance PFS outcomes after prior ICI, we take into account the management arm knowledge an essential, evidence-based and clinically significant contribution to the oncology neighborhood treating relapsed or refractory superior RCC following front-line ICI combos.”
Extra knowledge, together with the analysis of secondary endpoints, together with total survival, shall be introduced at a later date.
LG Chem acquired AVEO Oncology in 2022 for $566m, one 12 months after the corporate gained approval for Fotivda. EUSA Pharma licensed Fotivda from AVEO Oncology in 2015 through the improvement course of.
