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GU Cancers 2021 | Sitravatinib, nivolumab and ipilimumab for accRCC

Pavlos Msaouel, MD, PhD, University of Texas MD Anderson Cancer Center, Houston, TX, gives an update on an ongoing Phase I/Ib trial (NCT04518046) investigating the use of sitravatinib, nivolumab and ipilimumab (Sitra+Nivo+Ipi) for advanced clear cell renal cell carcinoma (accRCC) and other solid malignancies. The primary endpoint of this trial is the safety and tolerability of Sitra+Nivo+Ipi. The Phase I dose escalation portion will enrol apporximately 30 patients with intermediate- or poor-risk accRCC. This interview took place during the 2021 Genitourinary Cancers Symposium.

Transcript (edited for clarity)

In last year’s GU ASCO we presented data showing the efficacy of combining sitravatinib, which is a new TKI multi-receptor targeting at VEGF, c-MET and the TAB family of receptors, Tyro3, Axl and MerTK. And we presented last year data combining sitravatinib with the anti-PD1 inhibitor nivolumab in the setting of advanced clear cell renal cell carcinoma that had progressed already to previous anti-VEGF therapies...

In last year’s GU ASCO we presented data showing the efficacy of combining sitravatinib, which is a new TKI multi-receptor targeting at VEGF, c-MET and the TAB family of receptors, Tyro3, Axl and MerTK. And we presented last year data combining sitravatinib with the anti-PD1 inhibitor nivolumab in the setting of advanced clear cell renal cell carcinoma that had progressed already to previous anti-VEGF therapies.

And we have found evidence that the addition of sitravatinib may improve outcomes in patients treated in this setting, when you add sitravatinib to nivolumab. And our correlative data are supporting the notion that sitravatinib has distinct immunomodulatory properties that can enhance immune checkpoint therapy. But not just anti-PD1 immune checkpoint therapy, but potentially as well, anti-CTLA-4 immune checkpoint therapy with the ipilimumab.

So we’re very excited to open this trial of the triplet combining sitravatinib now with anti-PD1 nivolumab and anti-CTLA-4, ipilimumab in the same first-line setting that the combination of the backbone of nivolumab and ipilimumab has been FDA approved for clear cell renal cell carcinoma as the first-line therapy. So, in that exact same setting, we are now conducting this Phase I trial to determine the efficacy and safety of combining sitravatinib with this double with immune checkpoint therapy.

Another update that we will be presenting at GU ASCO this year connected to the sitravatinib story, are the results of administrating, preliminary results of administrating sitravatinib in combination with nivolumab in the neoadjuvant setting for clear cell renal cell carcinoma. I think that this is another interesting space to explore this combination.

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Disclosures

Pavlos Msaouel, MD, PhD, has received honoraria from Mirati Therapeutics, Exelixis, and Bristol-Myers Squibb; has received consulting fees from Axiom Healthcare Strategies; has participated in non-branded educational programs supported by Exelixis and Pfizer; and has received research funding from Takeda, Bristol-Myers Squibb, Mirati Therapeutics, Gateway for Cancer Research and the University of Texas MD Anderson Cancer Center.