Activity and safety of pembrolizumab in patients with metastatic non-small cell lung cancer with untreated brain metastases.

8035 Background: Brain metastases (BrMs) are common among patients (pts) with advanced non-small cell lung cancer (NSCLC) and local therapy such as surgery and radiation can add toxicity and delay systemic treatment. Pembrolizumab is a monoclonal anti-programmed death 1 (PD-1) antibody that relieves inhibition of anti-tumor immunity. In a Phase I trial of pembrolizumab, pts with advanced NSCLC showed a 21% response rate with good tolerability and durable responses, however pts were required to have local therapy to BrMs prior to enrollment. This trial aims to determine the activity and safety of pembrolizumab in patients with advanced NSCLC and untreated BrMs. Methods: This is a Phase II trial with 2 independent arms: one for pts with advanced NSCLC (reported here) and the other for pts with metastatic melanoma (NCT02085070). Pts are eligible if they have ≥ 1 BrM that is previously untreated or progressing after prior local therapy. BrMs must be between 5mm and 20mm, asymptomatic, and not requiring immedi...