Whole-brain radiation therapy (WBRT) is the standard of care for patients with brain metastases that are surgically unresectable or have multiple lesions. These patients have a very poor prognosis (median survival between 3 and 4.9 months) and an impaired quality of life (QoL) with significant neurologic, cognitive, and emotional impairment. Approximately 7.4 % of patients with non-small cell lung cancer (NSCLC) will present with brain metastases at diagnosis an additional 25–30 % will develop brain metastases over the course of their disease. A significant unmet need for therapies that improve the outcomes of patients with brain metastases from NSCLC remains.īrain metastases are the most common intracranial malignancy affecting up to 30 % of patients diagnosed with cancer with an estimated annual incidence of more than 200,000 cases in the USA. No new safety signals were identified for veliparib. No differences were observed in adverse events (all grades) across treatment arms nausea, fatigue, alopecia, and headache were the most commonly reported. No statistically significant differences in OS, intracranial response rate, and time to clinical or radiographic progression between any of the treatment arms were noted.
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Median OS was 185 days for patients treated with WBRT plus placebo and 209 days for WBRT plus veliparib (50 or 200 mg).
Patient characteristics were well balanced between treatment arms. All randomized patients were included in the efficacy endpoint analyses. Patients who received ≥1 dose of treatment were included in the safety analysis.
Tumor response and safety were assessed the primary endpoint was overall survival (OS). Treatment began within 28 days of diagnosis. Three-hundred and seven patients with brain metastases from NSCLC were randomized 1:1:1 to WBRT (30 Gy in 10 fractions) plus 50 mg veliparib twice daily (BID n = 103), 200 mg veliparib BID ( n = 102), or placebo BID ( n = 102). This phase 2, randomized, global study evaluated the efficacy and safety of veliparib in combination with whole-brain radiation therapy (WBRT) in patients with brain metastases from non-small cell lung cancer (NSCLC). Veliparib is a potent, orally bioavailable, poly (adenosine diphosphate-ribose) polymerase (PARP) inhibitor that crosses the blood–brain barrier and has been shown to potentiate the effects of radiation in preclinical and early clinical studies.
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