What question did this study set out to answer?

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the IDO1 inhibitor navoximod combined with the PD-L1 inhibitor atezolizumab in advanced solid tumors.

February 15, 2019Clinical Cancer ResearchOpen Access

Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors

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To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the IDO1 inhibitor navoximod combined with the PD-L1 inhibitor atezolizumab in advanced solid tumors.
Phase I dose-escalation and expansion study enrolling patients with advanced cancer (total N = 157; expansion cohort N = 92).
Navoximod was administered orally every 12 hours (50–1,000 mg across 6 dose levels) for 21-day cycles alongside intravenous atezolizumab at 1,200 mg every 3 weeks.
The maximum administered dose of navoximod was 1,000 mg twice daily, and the maximum tolerated dose was not reached.
Most frequent treatment-related adverse events were fatigue (22%), rash (22%), and chromaturia (20%).
Navoximod displayed linear pharmacokinetics and decreased plasma kynurenine, but objective responses occurred in only 6 of 65 dose-escalation patients (9% partial response) and 10 of 92 expansion patients (11% overall response rate), showing no clear benefit over atezolizumab monotherapy.

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Implication

Phase I trial reports acceptable safety but no clear added benefit for navoximod combined with atezolizumab in advanced solid tumors, highlighting limits of IDO1 inhibition.

Cite This Study

Jung et al. (2019) studied this question.

synapsesocial.com/papers/6a00d768e4618ba4162dc196 https://doi.org/10.1158/1078-0432.ccr-18-2740

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Implication

Phase I trial reports acceptable safety but no clear added benefit for navoximod combined with atezolizumab in advanced solid tumors, highlighting limits of IDO1 inhibition.

Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors

Key Points

Discussion

Implication

Cite This Study

Phase I Study of the Indoleamine 2,3-Dioxygenase 1 (IDO1) Inhibitor Navoximod (GDC-0919) Administered with PD-L1 Inhibitor (Atezolizumab) in Advanced Solid Tumors

Key Points

Discussion

Implication

Cite This Study