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PD1.01 (also presented as P2.46): LCSS as a Marker of Treatment Benefit With Nivolumab vs Docetaxel in Pts With Advanced Non-Squamous NSCLC From Checkmate 057
ABSTRACTS
POSTER DISCUSSION SESSION 1 SATURDAY, AUGUST 27, 2016 e 08:00 e 09:15 PD1.01 (also presented as P2.46) LCSS as a Marker of Treatment Benefit With Nivolumab vs Docetaxel in Pts With Advanced Non-Squamous NSCLC From Checkmate 057 Richard J. Gralla,1 David Spigel,2 Bryan Bennett,3 Fiona Taylor,3 John R. Penrod,4 Michael Derosa,3 Homa Dastani,4 Lucinda Orsini,4 Clarissa Mathias,5 Martin Reck6 1Albert Einstein College of Medicine, Bronx/NY/UNITED STATES OF AMERICA, 2Sarah Cannon Research Institute, Nashville/TN/UNITED STATES OF AMERICA, 3Adelphi Values, Boston/MA/UNITED STATES OF AMERICA, 4Bristol-Myers Squibb, Princeton/NJ/ UNITED STATES OF AMERICA, 5Núcleo de Oncologia da Bahia, Salvador/BRAZIL, 6Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf/ GERMANY Background: Nivolumab (nivo) is the first antie programmed death-1 agent to demonstrate a survival benefit vs docetaxel (doc) in patients (pts) with previously treated advanced (adv) non-squamous (NSQ) and SQ NSCLC. Here we report the impact of nivo vs doc on disease-related symptoms in pts with adv NSQ NSCLC from the CheckMate 057 study. Method: Lung Cancer Symptom Scale (LCSS) was assessed every other cycle (Q4W) for nivo and every cycle (Q3W) for doc for the first 6 mo on treatment (tx), then every 6 wks and at 2 post-tx follow-up visits. LCSS includes the average symptom burden index (ASBI; based on 6 symptoms: anorexia, fatigue, cough, dyspnea, hemoptysis, and pain) and the 3-item global index (3-IGI; symptom distress, interference with activities, and health-related quality of life [HRQoL]). LCSS changes from baseline (BL) and time to first deterioration (TTD) in symptoms were estimated. Results: Analyses of mean changes from BL in the LCSS ASBI and 3-IGI indicated numerical differences favoring nivo vs doc emerging at the first common assessment (wk 12) and persisting throughout the entire assessment period. At common assessments with >10 pts in each
arm (to wk 48), the differences were significant (CIs excluding no difference) for the ASBI at wks 12, 24, 30, and 42, and for the 3-IGI at wks 24 and 30. Five of 6 symptoms (including pain and fatigue) and 2 of 3 items of the 3-IGI (HRQoL and symptom distress) had significant differences favoring nivo at 1 common assessments. TTD (based on the minimally important difference [MID]) was longer with nivo vs doc for the ASBI (HR¼0.65; 95% CI: 0.49, 0.85) and 3-IGI (HR¼0.63; 95% CI: 0.48, 0.82), with Kaplan-Meier curves between tx arms separating at z2 months. TTD for individual symptoms within the ASBI and individual items of the 3IGI showed a similar pattern. The proportion of pts with improvement in the LCSS ASBI greater than the MID by wk 12 was similar for nivo (17.8%; 95% CI: 13.6, 22.7) and doc (19.7%; 95% CI: 15.2, 24.7). Conclusion: These results from this large, phase III study indicate that pts with previously treated adv NSQ NSCLC had significantly better symptom burden outcomes and HRQoL while on tx with nivo vs doc. TTD was significantly longer in nivo- vs doc-treated pts. Clinical Trial Registration: NCT01673867 Reused with permission from the American Society of Clinical Oncology (ASCO). This abstract was accepted and previously presented at the 2016 ASCO Annual Meeting. All rights reserved.
PD1.02 (also presented as P2.47) The Role of PD-L1 Expression as a Predictive Biomarker in Advanced NSCLC: An Update of a Network Meta-Analysis Pedro Aguiar Jr.,1 Gilberto Lopes,2 Ilka Santoro,3 Hakaru Tadokoro,3 Carmelia Barreto,3 Ramon De Mello4 1Clinical Oncology, Universidade Federal de São Paulo, São Paulo/BRAZIL, 2Oncoclinicas do Brasil, São Paulo/BRAZIL, 3Universidade Federal de São Paulo, São Paulo/BRAZIL, 4Universidade do Algarve, Faro/PORTUGAL Background: Advanced lung cancer still portends a poor prognosis. Programmed cell death 1 (PD-1) is a negative costimulatory factor expressed on the surface of T-cells. It binds to one of its ligands; PD-L1 or PD-L2 expressed on the surface of neoplastic cells and inhibits cytotoxic T-cell responses. Several antibodies were developed against PD-1 or PD-L1 achieving encouraging
Journal of Thoracic Oncology
Vol. 11 No. 10S: S171-S175
POSTER DISCUSSION SESSION 1 SATURDAY, AUGUST 27, 2016 e 08:00 e 09:15 PD1.01 (also presented as P2.46) LCSS as a Marker of Treatment Benefit With Nivolumab vs Docetaxel in Pts With Advanced Non-Squamous NSCLC From Checkmate 057 Richard J. Gralla,1 David Spigel,2 Bryan Bennett,3 Fiona Taylor,3 John R. Penrod,4 Michael Derosa,3 Homa Dastani,4 Lucinda Orsini,4 Clarissa Mathias,5 Martin Reck6 1Albert Einstein College of Medicine, Bronx/NY/UNITED STATES OF AMERICA, 2Sarah Cannon Research Institute, Nashville/TN/UNITED STATES OF AMERICA, 3Adelphi Values, Boston/MA/UNITED STATES OF AMERICA, 4Bristol-Myers Squibb, Princeton/NJ/ UNITED STATES OF AMERICA, 5Núcleo de Oncologia da Bahia, Salvador/BRAZIL, 6Lung Clinic Grosshansdorf, Airway Research Center North (ARCN), Member of the German Center for Lung Research (DZL), Grosshansdorf/ GERMANY Background: Nivolumab (nivo) is the first antie programmed death-1 agent to demonstrate a survival benefit vs docetaxel (doc) in patients (pts) with previously treated advanced (adv) non-squamous (NSQ) and SQ NSCLC. Here we report the impact of nivo vs doc on disease-related symptoms in pts with adv NSQ NSCLC from the CheckMate 057 study. Method: Lung Cancer Symptom Scale (LCSS) was assessed every other cycle (Q4W) for nivo and every cycle (Q3W) for doc for the first 6 mo on treatment (tx), then every 6 wks and at 2 post-tx follow-up visits. LCSS includes the average symptom burden index (ASBI; based on 6 symptoms: anorexia, fatigue, cough, dyspnea, hemoptysis, and pain) and the 3-item global index (3-IGI; symptom distress, interference with activities, and health-related quality of life [HRQoL]). LCSS changes from baseline (BL) and time to first deterioration (TTD) in symptoms were estimated. Results: Analyses of mean changes from BL in the LCSS ASBI and 3-IGI indicated numerical differences favoring nivo vs doc emerging at the first common assessment (wk 12) and persisting throughout the entire assessment period. At common assessments with >10 pts in each
arm (to wk 48), the differences were significant (CIs excluding no difference) for the ASBI at wks 12, 24, 30, and 42, and for the 3-IGI at wks 24 and 30. Five of 6 symptoms (including pain and fatigue) and 2 of 3 items of the 3-IGI (HRQoL and symptom distress) had significant differences favoring nivo at 1 common assessments. TTD (based on the minimally important difference [MID]) was longer with nivo vs doc for the ASBI (HR¼0.65; 95% CI: 0.49, 0.85) and 3-IGI (HR¼0.63; 95% CI: 0.48, 0.82), with Kaplan-Meier curves between tx arms separating at z2 months. TTD for individual symptoms within the ASBI and individual items of the 3IGI showed a similar pattern. The proportion of pts with improvement in the LCSS ASBI greater than the MID by wk 12 was similar for nivo (17.8%; 95% CI: 13.6, 22.7) and doc (19.7%; 95% CI: 15.2, 24.7). Conclusion: These results from this large, phase III study indicate that pts with previously treated adv NSQ NSCLC had significantly better symptom burden outcomes and HRQoL while on tx with nivo vs doc. TTD was significantly longer in nivo- vs doc-treated pts. Clinical Trial Registration: NCT01673867 Reused with permission from the American Society of Clinical Oncology (ASCO). This abstract was accepted and previously presented at the 2016 ASCO Annual Meeting. All rights reserved.
PD1.02 (also presented as P2.47) The Role of PD-L1 Expression as a Predictive Biomarker in Advanced NSCLC: An Update of a Network Meta-Analysis Pedro Aguiar Jr.,1 Gilberto Lopes,2 Ilka Santoro,3 Hakaru Tadokoro,3 Carmelia Barreto,3 Ramon De Mello4 1Clinical Oncology, Universidade Federal de São Paulo, São Paulo/BRAZIL, 2Oncoclinicas do Brasil, São Paulo/BRAZIL, 3Universidade Federal de São Paulo, São Paulo/BRAZIL, 4Universidade do Algarve, Faro/PORTUGAL Background: Advanced lung cancer still portends a poor prognosis. Programmed cell death 1 (PD-1) is a negative costimulatory factor expressed on the surface of T-cells. It binds to one of its ligands; PD-L1 or PD-L2 expressed on the surface of neoplastic cells and inhibits cytotoxic T-cell responses. Several antibodies were developed against PD-1 or PD-L1 achieving encouraging
Journal of Thoracic Oncology
Vol. 11 No. 10S: S171-S175