NEW YORK (Reuters Health) – Adding veliparib to platinum-based chemotherapy for first-line treatment of current smokers with advanced squamous non-small-cell lung cancer (NSCLC) did not significantly improve overall survival in a phase-3 study.
However, the LP52 signature may identify a subgroup of patients “likely to derive benefit” from the addition of veliparib to chemotherapy, researchers report in the Journal of Clinical Oncology.
“Squamous NSCLC has limited therapeutic options. Veliparib is a potent, oral PARP1/2 inhibitor that enhances the activity of platinum-based chemotherapy regimens in solid tumors,” note Dr. Suresh S. Ramalingam, with Winship Cancer Institute, Atlanta, and colleagues.
For their study, they randomly allocated 970 patients (57% current smokers) with untreated, advanced squamous NSCLC to carboplatin and paclitaxel with veliparib 120 mg or placebo twice a day for up to six cycles.
There was no significant overall survival (OS) benefit with veliparib in current smokers (the primary outcome), with a median OS of 11.9 months with veliparib versus 11.1 months with placebo (hazard ratio, 0.905; 95% confidence interval, 0.744 to 1.101).
In the overall population, OS favored veliparib over placebo, with median OS of 12.2 versus 11.2 months (HR, 0.853; 95% CI, 0.747 to 0.974), with no difference in progression-free survival (median, 5.6 months per group).
Among the 360 patients with biomarker-evaluable tumor samples, veliparib had a favorable effect on OS in the LP52-positive population (median OS, 14.0 vs. 9.6 months; HR, 0.66; 95% CI, 0.49 to 0.89).
“Despite no benefit of adding veliparib to carboplatin and paclitxel in current smokers being observed, risk of death was decreased by 34% in the LP52-positive population with veliparib versus placebo,” the authors write in their paper.
“These findings indicate that this biomarker-defined subgroup may derive greater benefit from poly (ADP-ribose) polymerase inhibition and support the use of biomarkers to identify treatment-sensitive subgroups,” they conclude.
Funding for the study was provided by AbbVie, which makes veliparib. Several authors have disclosed financial relationships with the company.
SOURCE: https://bit.ly/3DQZQ6r Journal of Clinical Oncology, online August 26, 2021.
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