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Ziv-aflibercept failed to improve outcomes in NSCLC

Issue: October 25, 2012

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The novel protein ziv-aflibercept conferred similar survival outcomes as placebo in a cohort of patients with non–small-cell lung cancer, according to phase 3 results of the VITAL trial.

Ziv-aflibercept (Zaltrap, Sanofi-Aventis), a recombinant human fusion protein that targets the VEGF pathway, also was associated with more frequent adverse events, researchers said.

The researchers conducted the double blind, placebo-controlled, multination study to analyze the drug with or without docetaxel in 913 platinum-pretreated patients with advanced or metastatic nonsquamous NSCLC.

All patients received docetaxel 75 mg/m². The researchers assigned 456 patients to receive ziv-aflibercept 6 mg/kg intravenously, and the remaining 457 patients received IV placebo.

OS served as the primary outcome measure. Other efficacy outcomes, safety and immunogenicity served as secondary endpoints.

Baseline characteristics were similar across the two arms. Bevacizumab (Avastin, Genentech) had previously been administered to 12.3% of the study population.

The researchers did not observe improved OS among patients assigned to ziv-aflibercept (HR=1.01; 95% CI, 0.87-1.17). Median OS was 10.1 months (95% CI, 9.2-11.6) in the study drug group compared with 10.4 months in the placebo group (95% CI, 9.2-11.9).

“In common with every other superiority trial undertaken to compare a novel agent or regimen to standard therapy in second-line NSCLC, improvement of OS has proven to be an elusive goal, despite consistent response and PFS benefit,” the researchers wrote.

Exploratory analysis results indicated that median PFS was 5.2 months (95% CI, 4.4-5.6) for ziv-aflibercept and 4.1 months (95% CI, 3.5-4.3) for placebo (HR=0.82; 95% CI, 0.72-0.94).

The overall response rate for evaluable patients was 23.3% (95% CI, 19.1-27.4) in the ziv-aflibercept group and 8.9% (95% CI, 6.1-11.6) in the placebo group.

Several adverse events of at least grade 3 occurred more frequently in the ziv-aflibercept arm. They included neutropenia (28% vs. 21.1%), fatigue (11.1% vs. 4.2%), stomatitis (8.8% vs. 0.7%) and hypertension (7.3% vs. 0.9%).

Disclosure:

The researchers report financial relationships with AstraZeneca, Eli Lilly, Genentech, Pfizer, Roche and Sanofi-Aventis.