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AVEO says adding checkpoint inhibitor to renal cancer drug doesn’t improve survival

2024-07-18

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免疫疗法临床3期临床结果上市批准并购

Pairing its renal cell carcinoma (RCC) therapy with PD-1 inhibitor Opdivo (nivolumab) didn’t benefit patients any more than Fotivda (tivozanib) on its own, AVEO Oncology said on Thursday.

Monotherapy of Fotivda, an oral VEGFR tyrosine kinase inhibitor (TKI), was approved by the FDA in 2021 to treat adults with relapsed or refractory advanced RCC after at least two prior systemic therapies.

The Phase III TiNivo-2 study tested a combination of low-dose Fotivda plus Opdivo in patients whose tumours had progressed following immune checkpoint inhibitor (ICI) therapy, versus Fotivda alone as the control arm.

The drug combo did not meet the primary endpoint of improving progression-free survival.

AVEO pulled out a positive thread from the results, saying that the TiNivo-2 trial is “the second Phase III clinical trial to suggest that there is no clinical benefit derived from rechallenging RCC patients with immunotherapy after receiving ICI beyond progression on previous ICIs.”

The company added that the monotherapy data “further support the approved use of Fotivda.”

“We consider the control arm data an important, evidence-based and clinically meaningful contribution to the oncology community treating relapsed or refractory advanced RCC following front-line ICI combinations,” said CEO Michael Bailey.