CheckMate 057 : étude de phase III comparant en deuxième ligne nivolumab et docétaxel dans les cancers non épidermoïdes (1) Nivolumab 3 mg/kg toutes les.

Présentation au sujet: "CheckMate 057 : étude de phase III comparant en deuxième ligne nivolumab et docétaxel dans les cancers non épidermoïdes (1) Nivolumab 3 mg/kg toutes les."— Transcription de la présentation:

1 CheckMate 057 : étude de phase III comparant en deuxième ligne nivolumab et docétaxel dans les cancers non épidermoïdes (1) Nivolumab 3 mg/kg toutes les 2 semaines jusqu’à progression ou toxicité n = 292 cancers Non épidermoides Stades IIIB/IV ECOG PS 0-1 Prétraités par un doublet à base de platine ± ITK R 1:1 Docetaxel 75 mg/m2 toutes les 3 sem. 6 cycles jusqu’à progression ou toxicité Objectif principal : SG Objectifs secondaires RO RECIST 1.1 SSP Qualité de vie Tolérance Efficacité selon l’expression du PD-L1* n = 290 LBA109 - 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). 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). Sub-category: Lung Cancer—Non-Small Cell Metastatic Category: Lung Cancer—Non-Small Cell Metastatic Meeting: 2015 ASCO Annual Meeting Abstract No: LBA109 Citation: J Clin Oncol 33, 2015 (suppl; abstr LBA109) Author(s): Luis Paz-Ares, Leora Horn, Hossein Borghaei, David R. Spigel, Martin Steins, Neal Ready, Laura Quan Man Chow, Everett E. Vokes, Enriqueta Felip, Esther Holgado, Fabrice Barlesi, Martin Kohlhaeufl, Oscar Rodriguez, Marco Angelo Burgio, Jerome Fayette, Scott N. Gettinger, Christopher Harbison, Cécile Dorange, Friedrich Graf Finckenstein, Julie R. Brahmer; Hospital Universitario Virgen Del Rocio, Sevilla, Spain; Vanderbilt-Ingram Cancer Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Sarah Cannon Research Institute, Nashville, TN; Thoraxklinik-Heidelberg gGmbh, Heidelberg, Germany; Duke University Medical Center, Chapel Hill, NC; University of Washington, Seattle, WA; Department of Medicine, University of Chicago, Chicago, IL; Vall d'Hebron University Hospital, Barcelona, Spain; START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain; Aix Marseille University - Assistance Publique Hopitaux De Marseille, Marseille, France; Hospital Schillerhoehe Gerlingen, Gerlingen, Germany; Instituto Nacional de Cancerología, Mexico City, Mexico; IRST-IRCCS, Meldola (FC), Italy; Centre Leon Berard, Lyon, France; Yale School of Medicine, New Haven, CT; Bristol-Myers Squibb, Princeton, NJ; Bristol‐Myers Squibb, Princeton, NJ; Bristol-Myers Squibb Co, Princeton, NJ; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD Abstract Disclosures Abstract: 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= ) 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: NCT Efficacy measureNIVO (n=292)DOC (n=290)mOS, mo (95% CI)12.2 (9.7, 15.0)9.4 (8.0, 10.7)1-yr OS, % (95% CI)50.5 (44.6, 56.1)39.0 (33.3, 44.6)Median response duration, mo (95% CI)17.1 (8.4–not estimable)5.6 (4.4–7.0)mPFS, mo (95% CI)2.3 (2.2, 3.3)4.2 (3.4, 4.9)1-yr PFS, % (95% CI)18.5 (14.1, 23.4)8.1 (5.1, 12.0)m=medianPD-L1-quantifiable ptsPD-L1 expressionNIVO, n (N=231)DOC, n (N=224)OS HR (95% CI)<1% (0.66, 1.24)≥1% (0.43, 0.81)<5% (0.76, 1.33)≥5% (0.3, 0.63)<10% (0.76, 1.31)≥10% (0.27, 0.59) *IHC anti PD-L1 évaluée avec le systême IHC Dako ASCO® D’après Paz-Ares L et al., abstr. LBA109, actualisé

2 CheckMate 057 : étude de phase III comparant en deuxième ligne nivolumab et docétaxel dans les cancers non épidermoïdes (2) Nivolumab (n = 292) Docétaxel (n = 290) Âge médian 61 64 Homme (%) 52 58 ECOG PS 0/1 (%) 29/71 33/67 Nombre de lignes antérieures 1/2 (%) 88/12 89/115,6 (4,4-7,0) ALK+/EGFR+ (%) 4/15 3/134,2 (3,4-4,9) LBA109 - 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). 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). Sub-category: Lung Cancer—Non-Small Cell Metastatic Category: Lung Cancer—Non-Small Cell Metastatic Meeting: 2015 ASCO Annual Meeting Abstract No: LBA109 Citation: J Clin Oncol 33, 2015 (suppl; abstr LBA109) Author(s): Luis Paz-Ares, Leora Horn, Hossein Borghaei, David R. Spigel, Martin Steins, Neal Ready, Laura Quan Man Chow, Everett E. Vokes, Enriqueta Felip, Esther Holgado, Fabrice Barlesi, Martin Kohlhaeufl, Oscar Rodriguez, Marco Angelo Burgio, Jerome Fayette, Scott N. Gettinger, Christopher Harbison, Cécile Dorange, Friedrich Graf Finckenstein, Julie R. Brahmer; Hospital Universitario Virgen Del Rocio, Sevilla, Spain; Vanderbilt-Ingram Cancer Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Sarah Cannon Research Institute, Nashville, TN; Thoraxklinik-Heidelberg gGmbh, Heidelberg, Germany; Duke University Medical Center, Chapel Hill, NC; University of Washington, Seattle, WA; Department of Medicine, University of Chicago, Chicago, IL; Vall d'Hebron University Hospital, Barcelona, Spain; START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain; Aix Marseille University - Assistance Publique Hopitaux De Marseille, Marseille, France; Hospital Schillerhoehe Gerlingen, Gerlingen, Germany; Instituto Nacional de Cancerología, Mexico City, Mexico; IRST-IRCCS, Meldola (FC), Italy; Centre Leon Berard, Lyon, France; Yale School of Medicine, New Haven, CT; Bristol-Myers Squibb, Princeton, NJ; Bristol‐Myers Squibb, Princeton, NJ; Bristol-Myers Squibb Co, Princeton, NJ; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD Abstract Disclosures Abstract: 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= ) 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: NCT Efficacy measureNIVO (n=292)DOC (n=290)mOS, mo (95% CI)12.2 (9.7, 15.0)9.4 (8.0, 10.7)1-yr OS, % (95% CI)50.5 (44.6, 56.1)39.0 (33.3, 44.6)Median response duration, mo (95% CI)17.1 (8.4–not estimable)5.6 (4.4–7.0)mPFS, mo (95% CI)2.3 (2.2, 3.3)4.2 (3.4, 4.9)1-yr PFS, % (95% CI)18.5 (14.1, 23.4)8.1 (5.1, 12.0)m=medianPD-L1-quantifiable ptsPD-L1 expressionNIVO, n (N=231)DOC, n (N=224)OS HR (95% CI)<1% (0.66, 1.24)≥1% (0.43, 0.81)<5% (0.76, 1.33)≥5% (0.3, 0.63)<10% (0.76, 1.31)≥10% (0.27, 0.59) ASCO® D’après Paz-Ares L et al., abstr. LBA109, actualisé

3 CheckMate 057 : étude de phase III comparant en deuxième ligne nivolumab et docétaxel dans les cancers non épidermoïdes (3) Résultats (1) Nivolumab (n = 292) Docétaxel (n = 290) RO (%) 19 12 Médiane de SG (IC95) 12,2 (9,7-15,0) 9,4 (8,0-10,7) SG à 1 an, % (IC95) 50,5 (44,6-56,1) 39,0 (33,3-44,6) Durée médiane de réponse 17,1 (8,4-non atteint) 5,6 (4,4-7,0) SSP médiane (IC95) 2,3 (2,2-3,3) 4,2 (3,4-4,9) SSP à 1 an, % (IC95) 18,5 (14,1-23,4) 8,1 (5,1-12,0) ASCO® D’après Paz-Ares L et al., abstr. LBA109, actualisé

4 Résultats (2) : survie globale (critère principal)
CheckMate 057 : étude de phase III comparant en deuxième ligne nivolumab et docétaxel dans les cancers non épidermoïdes (4) Résultats (2) : survie globale (critère principal) (%) 100 Nivolumab (n = 292) Docétaxel (n = 290) Médiane (mois) 12,2 9,4 HR = 0,73 ; IC96 : 0,59-0,89 ; p = 0,0015 80 60 SG à 1 an : 51 % 40 SG à 1 an : 39 % NIVO 20 DOC 3 6 9 12 15 18 21 24 27 Mois Patients à risque (n) NIVO 292 232 194 169 146 123 62 32 9 DOC 290 244 194 150 111 88 34 10 5 ASCO® D’après Paz-Ares L et al., abstr. LBA109, actualisé

5 CheckMate 057 : étude de phase III comparant en deuxième ligne nivolumab et docétaxel dans les cancers non épidermoïdes (5) 100 80 Nivolumab (n = 292) Docétaxel (n = 290) SSP, mois 2,3 4,2 HR = 0,92 ; IC95 : 0,77, 1,11 ; p = 0,3932 60 SSP (%) 40 SSP à 1 an = 19 % 20 NIVO LBA109 - 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). 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). Sub-category: Lung Cancer—Non-Small Cell Metastatic Category: Lung Cancer—Non-Small Cell Metastatic Meeting: 2015 ASCO Annual Meeting Abstract No: LBA109 Citation: J Clin Oncol 33, 2015 (suppl; abstr LBA109) Author(s): Luis Paz-Ares, Leora Horn, Hossein Borghaei, David R. Spigel, Martin Steins, Neal Ready, Laura Quan Man Chow, Everett E. Vokes, Enriqueta Felip, Esther Holgado, Fabrice Barlesi, Martin Kohlhaeufl, Oscar Rodriguez, Marco Angelo Burgio, Jerome Fayette, Scott N. Gettinger, Christopher Harbison, Cécile Dorange, Friedrich Graf Finckenstein, Julie R. Brahmer; Hospital Universitario Virgen Del Rocio, Sevilla, Spain; Vanderbilt-Ingram Cancer Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Sarah Cannon Research Institute, Nashville, TN; Thoraxklinik-Heidelberg gGmbh, Heidelberg, Germany; Duke University Medical Center, Chapel Hill, NC; University of Washington, Seattle, WA; Department of Medicine, University of Chicago, Chicago, IL; Vall d'Hebron University Hospital, Barcelona, Spain; START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain; Aix Marseille University - Assistance Publique Hopitaux De Marseille, Marseille, France; Hospital Schillerhoehe Gerlingen, Gerlingen, Germany; Instituto Nacional de Cancerología, Mexico City, Mexico; IRST-IRCCS, Meldola (FC), Italy; Centre Leon Berard, Lyon, France; Yale School of Medicine, New Haven, CT; Bristol-Myers Squibb, Princeton, NJ; Bristol‐Myers Squibb, Princeton, NJ; Bristol-Myers Squibb Co, Princeton, NJ; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD Abstract Disclosures Abstract: 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= ) 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: NCT Efficacy measureNIVO (n=292)DOC (n=290)mOS, mo (95% CI)12.2 (9.7, 15.0)9.4 (8.0, 10.7)1-yr OS, % (95% CI)50.5 (44.6, 56.1)39.0 (33.3, 44.6)Median response duration, mo (95% CI)17.1 (8.4–not estimable)5.6 (4.4–7.0)mPFS, mo (95% CI)2.3 (2.2, 3.3)4.2 (3.4, 4.9)1-yr PFS, % (95% CI)18.5 (14.1, 23.4)8.1 (5.1, 12.0)m=medianPD-L1-quantifiable ptsPD-L1 expressionNIVO, n (N=231)DOC, n (N=224)OS HR (95% CI)<1% (0.66, 1.24)≥1% (0.43, 0.81)<5% (0.76, 1.33)≥5% (0.3, 0.63)<10% (0.76, 1.31)≥10% (0.27, 0.59) DOC SSP à 1 an = 8 % 27 21 18 15 12 9 6 3 24 Nombre de patients à risque Temps (mois) Nivolumab 292 128 82 58 46 35 17 7 2 290 156 87 38 18 6 1 Docétaxel ASCO® D’après Paz-Ares L et al., abstr. LBA109, actualisé

6 CheckMate 057 : étude de phase III comparant en deuxième ligne nivolumab et docétaxel dans les cancers non épidermoïdes (6) Nivolumab (n = 237) Docétaxel (n = 268) EI grade 3-4 (%) 10 54 EIG grade 3-4 (%) 5 18 EIG avec arrêt du traitement (%) 15 Poumon interstitiel (%) 3 < 1 Hépatite (%) 6 2 Diarrhées (%) 8 23 Hypothyroidie (%) 7 LBA109 - 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). 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). Sub-category: Lung Cancer—Non-Small Cell Metastatic Category: Lung Cancer—Non-Small Cell Metastatic Meeting: 2015 ASCO Annual Meeting Abstract No: LBA109 Citation: J Clin Oncol 33, 2015 (suppl; abstr LBA109) Author(s): Luis Paz-Ares, Leora Horn, Hossein Borghaei, David R. Spigel, Martin Steins, Neal Ready, Laura Quan Man Chow, Everett E. Vokes, Enriqueta Felip, Esther Holgado, Fabrice Barlesi, Martin Kohlhaeufl, Oscar Rodriguez, Marco Angelo Burgio, Jerome Fayette, Scott N. Gettinger, Christopher Harbison, Cécile Dorange, Friedrich Graf Finckenstein, Julie R. Brahmer; Hospital Universitario Virgen Del Rocio, Sevilla, Spain; Vanderbilt-Ingram Cancer Center, Nashville, TN; Fox Chase Cancer Center, Philadelphia, PA; Sarah Cannon Research Institute, Nashville, TN; Thoraxklinik-Heidelberg gGmbh, Heidelberg, Germany; Duke University Medical Center, Chapel Hill, NC; University of Washington, Seattle, WA; Department of Medicine, University of Chicago, Chicago, IL; Vall d'Hebron University Hospital, Barcelona, Spain; START Madrid, Centro Integral Oncológico Clara Campal, Madrid, Spain; Aix Marseille University - Assistance Publique Hopitaux De Marseille, Marseille, France; Hospital Schillerhoehe Gerlingen, Gerlingen, Germany; Instituto Nacional de Cancerología, Mexico City, Mexico; IRST-IRCCS, Meldola (FC), Italy; Centre Leon Berard, Lyon, France; Yale School of Medicine, New Haven, CT; Bristol-Myers Squibb, Princeton, NJ; Bristol‐Myers Squibb, Princeton, NJ; Bristol-Myers Squibb Co, Princeton, NJ; The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD Abstract Disclosures Abstract: 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= ) 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: NCT Efficacy measureNIVO (n=292)DOC (n=290)mOS, mo (95% CI)12.2 (9.7, 15.0)9.4 (8.0, 10.7)1-yr OS, % (95% CI)50.5 (44.6, 56.1)39.0 (33.3, 44.6)Median response duration, mo (95% CI)17.1 (8.4–not estimable)5.6 (4.4–7.0)mPFS, mo (95% CI)2.3 (2.2, 3.3)4.2 (3.4, 4.9)1-yr PFS, % (95% CI)18.5 (14.1, 23.4)8.1 (5.1, 12.0)m=medianPD-L1-quantifiable ptsPD-L1 expressionNIVO, n (N=231)DOC, n (N=224)OS HR (95% CI)<1% (0.66, 1.24)≥1% (0.43, 0.81)<5% (0.76, 1.33)≥5% (0.3, 0.63)<10% (0.76, 1.31)≥10% (0.27, 0.59) ASCO® D’après Paz-Ares L et al., abstr. LBA109, actualisé