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Paz-Ares, Luis; Horn, Leora; Borghaei, Hossein; Spigel, David R.; Steins, Martin; Ready, Neal; Chow, Laura Quan Man; Vokes, Everett E.; Felip, Enriqueta; Holgado, Esther; Barlesi, Fabrice; Kohlhaeufl, Martin; Rodriguez, Oscar; Burgio, Marco Angelo; Fayette, Jerome; Gettinger, Scott N.; Harbison, Christopher; Dorange, Cécile; Finckenstein, Friedrich Graf; Brahmer, Julie R.

Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-SQ) non-small cell lung cancer (NSCLC)

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  • Media type: E-Article
  • Title: Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-SQ) non-small cell lung cancer (NSCLC)
  • Contributor: Paz-Ares, Luis; Horn, Leora; Borghaei, Hossein; Spigel, David R.; Steins, Martin; Ready, Neal; Chow, Laura Quan Man; Vokes, Everett E.; Felip, Enriqueta; Holgado, Esther; Barlesi, Fabrice; Kohlhaeufl, Martin; Rodriguez, Oscar; Burgio, Marco Angelo; Fayette, Jerome; Gettinger, Scott N.; Harbison, Christopher; Dorange, Cécile; Finckenstein, Friedrich Graf; Brahmer, Julie R.
  • Published: American Society of Clinical Oncology (ASCO), 2015
  • Published in: Journal of Clinical Oncology, 33 (2015) 18_suppl, Seite LBA109-LBA109
  • Language: English
  • DOI: 10.1200/jco.2015.33.18_suppl.lba109
  • ISSN: 0732-183X; 1527-7755
  • Origination:
  • Footnote:
  • Description: <jats:p> LBA109 </jats:p><jats:p> Background: Options for advanced non-SQ NSCLC patients (pts) who progress after platinum-based doublet chemotherapy (PT-DC) are limited, with minimal improvement in overall survival (OS). We report results from a randomized, global phase III study of NIVO, a fully human IgG4 programmed death-1 (PD-1) immune checkpoint inhibitor antibody, vs DOC in pts with advanced non-SQ NSCLC after failure of PT-DC and tyrosine kinase inhibitor, if eligible. Methods: Pts were randomized to NIVO 3 mg/kg Q2W (n=292) or DOC 75 mg/m2 Q3W (n=290) until progression or discontinuation due to toxicity/other reasons. Primary objective was OS; Secondary objectives were investigator-assessed objective response rate (ORR; per RECIST v1.1), progression-free survival (PFS), efficacy by PD-L1 expression, quality of life, and safety. Results: NIVO demonstrated superior OS (HR=0.73; 96% CI: 0.59, 0.89; P=0.00155) and improved ORR (19.2% vs 12.4%; P=0.0235). HR for PFS was 0.92 (95% CI: 0.77, 1.11; P=0.393). PD-L1 expression was associated with benefit from NIVO (Table). In PD-L1+ pts, NIVO showed improved efficacy across all endpoints at predefined 1%, 5%, and 10% cut- points. Grade 3–5 drug-related AEs occurred in 10.5% (30/287) of NIVO and 53.7% (144/268) of DOC pts. No deaths were related to NIVO vs 1 DOC-related death. After discontinuation, 42.1% of NIVO and 49.7% of DOC pts received subsequent systemic therapy. Conclusions: NIVO demonstrated superior OS vs DOC in pts with advanced non-SQ NSCLC after failure of PT-DC. The safety profile of NIVO 3 mg/kg Q2W was favorable vs DOC. NIVO demonstrated survival benefit across histologies in two randomized phase III trials. Clinical trial information: NCT01673867. [Table: see text] </jats:p>
  • Access State: Open Access