Results of a randomized, global, multi-center study of whole-brain radiation therapy (WBRT) plus veliparib or placebo in patients (pts) with brain metastases (BM) from non-small cell lung cancer (NSCLC).

2021 Background: Veliparib (V) is a potent, orally bioavailable PARP inhibitor that crosses the blood brain barrier. Phase 2 trials in BRCA pts as monotherapy or in unselected pts in combination with platinum-based chemotherapy have demonstrated evidence of efficacy. V plus radiation has shown promising efficacy in preclinical models and clinically in combination with WBRT. Methods: Pts were randomized 1:1:1 to WBRT plus V 50 mg BID (V50), V 200 mg BID (V200), or P BID. Treatment began within 28 days (d) of diagnosis. Pts received 30 Gray WBRT in 10 fractions. V50, V200, or P BID was self-administered starting on d 1 of WBRT and continuing until 1 d after completion. The primary endpoint was overall survival (OS). Survival was assessed at 2 month (m) intervals for 6 m then every 3 m (≥36 m). Pts who received ≥1 dose were included in the safety analyses; AEs were compared across arms using Fisher’s exact test. Results: 307 pts were randomized. OS, intracranial response rate, and time to clinical or radiogr...