Efficacy and safety of first-line avelumab in patients with advanced non-small cell lung cancer: results from a phase Ib cohort of the JAVELIN Solid Tumor study.INTRODUCTION
 Avelumab, an antiprogrammed death ligand-1 antibody, is approved as a monotherapy for treatment of metastatic Merkel cell carcinoma and advanced urothelial carcinoma, and in combination with axitinib for advanced renal cell carcinoma.  We report the efficacy and safety of first-line avelumab in advanced non-small cell lung cancer (NSCLC).


 In a phase I expansion cohort of the JAVELIN Solid Tumor trial, patients with treatment-naive, metastatic, or recurrent NSCLC received 10 mg/kg avelumab intravenously every 2 weeks.  Endpoints included best overall response, duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety.


 The objective response rate was 19.9% (95% CI, 13.9 to 27.0), including complete response in 3 (1.9%) and partial response in 28 (17.9%).  Median DOR was 12.0 months (95% CI, 6.9 to not estimable).  Median PFS was 4.0 months (95% CI, 2.7 to 5.4) and the 6-month PFS rate was 38.5% (95% CI, 30.7 to 46.3).  Median OS was 14.1 months (95% CI, 11.3 to 16.9) and the 12-month OS rate was 56.6% (95% CI, 48.2 to 64.1).  Treatment-related adverse events (TRAEs) occurred in 107 patients (68.6%), including grade ≥3 TRAEs in 19 (12.2%).  Immune-related adverse events and infusion-related reactions occurred in 31 (19.9%) and 40 patients (25.6%), respectively.  No treatment-related deaths occurred.


 CONCLUSION
 Avelumab showed antitumor activity with a tolerable safety profile as a first-line treatment in patients with advanced NSCLC.  ClinicalTrials.gov NCT01772004; registered January 21, 2013.
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