TY - JOUR
T1 - SWOG S1400A (NCT02154490)
T2 - A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study)
AU - Borghaei, Hossein
AU - Redman, Mary W.
AU - Kelly, Karen
AU - Waqar, Saima N.
AU - Robert, Francisco
AU - Kiefer, Gauri J.
AU - Stella, Philip J.
AU - Minichiello, Katherine
AU - Gandara, David R.
AU - Herbst, Roy S.
AU - Papadimitrakopoulou, Vassiliki A.
N1 - Funding Information:
This research supported in part by National Institutes of Health / National Cancer Institute grants CA180888, CA180819, CA180820, CA180821, CA180868, CA189971, CA189821, CA189830, CA189858, CA189953, CA189860, CA189804, CA180801, CA180835, CA189808, CA180826, CA180858, CA180846, CA189873, CA189822, CA189954, CA189854, CA189972, CA189952, CA13612, CA46368, CA11083 and by Amgen , AstraZeneca , Bristol-Myers Squibb Company , Genentech , and Pfizer through the Foundation for the National Institutes of Health, in partnership with Friends of Cancer Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Funding Information:
Dr Borghaei reports grants from Millennium , Merck / Celgene , and BMS/Lilly; personal fees from BMS, Lilly, Genentech, Celgene, Pfizer, Merck, EMD-Serono, Boehringer Ingelheim, Astra Zeneca, Novartis, Genmab, Regeneron, BioNTech, Cantargia AB, Amgen, Abbvie, Axiom, PharmaMar, and Takeda; personal fees from DSMB outside the submitted work; and scientific advisory board with stock options for Sonnetbio and Rgenix. Dr Gandara reports grants from BMS , Roche-Genentech , Novartis , and Merck ; and other from AstraZeneca , Celgene , CellMax , FujiFilm , Roche-Genentech , Guardant Health , Inivata , IO Biotech , Lilly , Liquid Genomics , Merck , Samsung Bioepis , and Pfizer , outside the submitted work. Dr Herbst reports personal fees from Abbvie Pharmaceuticals, ARMO Biosciences, Biodesix, Bristol-Myers Squibb, EMD Serrano, Genentech/Roche, Genmab, Heat Biologics, Halozyme, Loxo Oncology, Nektar, Novartis, Pfizer, Sanofi, Seattle Genetics, Shire PLC, Spectrum Pharmaceuticals, Symphogen, Tocagen, and Tesaro, outside the submitted work; grants and personal fees from AstraZeneca , Eli Lilly and Company , and Merck and Company ; personal fees and other from Infinity Pharmaceuticals, Junshi Pharmaceuticals, Neon Therapeutics, and NextCure. Dr Kelly reports personal fees and other from AstraZeneca, outside the submitted work. Dr Papadimitrakopoulou reports personal fees from Astra Zeneca, during the conduct of the study; and advisory board for Nektar Therapeutics, Arrys Therapeutics, Merck&Co, LOXO Oncology, Araxes Pharma, F. Hoffman-LaRoche Ltd, Janssen Research Foundation, Bristol-Myers Squibb, Clovis Oncology, Eli Lilly & Co, Novartis Pharmaceuticals Corp, Takeda Pharmaceuticals, Abbvie, TRM Oncology, Tesaro, Exelixis, Gritstone, Leeds Biolabs, Ideaya, Bolt Therapeutics, and G2 Innovation; research/grant from Eli Lilly & Co , Novartis , Merck , Astra Zeneca Pharmaceuticals , F Hoffman-La Roche , Nektar Therapeutics , Janssen , Bristol-Myers Squibb , Checkmate , and Incyte ; and speaker/preceptorship with F Hoffman-La Roche. Dr Papadimitrakopoulou is currently an employee of Pfizer, Inc. Dr Waqar reports grants from 1 UM1 CA186704-01; and other from F. Hoffmann-La Roche Ltd, Ariad, Pfizer Pharmaceuticals, Inc, Hengrui Therapeutics, Xcovery, EMD Serono Research & Development Institute, Inc, Checkpoint Therapeutics, Inc, Genentech, Inc, Lilly, Stemcentrx, Inc, Ignyta, Inc, Bristol-Myers Squibb Pharmaceuticals, Synermore Biologics Co, Ltd, Novartis Pharmaceuticals Corporation, Merck & Company, Inc, NewLink Genetics Corporation, and Celegene, outside the submitted work. The remaining authors have stated that they have no conflicts of interest.
Funding Information:
Dr Borghaei reports grants from Millennium, Merck/Celgene, and BMS/Lilly; personal fees from BMS, Lilly, Genentech, Celgene, Pfizer, Merck, EMD-Serono, Boehringer Ingelheim, Astra Zeneca, Novartis, Genmab, Regeneron, BioNTech, Cantargia AB, Amgen, Abbvie, Axiom, PharmaMar, and Takeda; personal fees from DSMB outside the submitted work; and scientific advisory board with stock options for Sonnetbio and Rgenix. Dr Gandara reports grants from BMS, Roche-Genentech, Novartis, and Merck; and other from AstraZeneca, Celgene, CellMax, FujiFilm, Roche-Genentech, Guardant Health, Inivata, IO Biotech, Lilly, Liquid Genomics, Merck, Samsung Bioepis, and Pfizer, outside the submitted work. Dr Herbst reports personal fees from Abbvie Pharmaceuticals, ARMO Biosciences, Biodesix, Bristol-Myers Squibb, EMD Serrano, Genentech/Roche, Genmab, Heat Biologics, Halozyme, Loxo Oncology, Nektar, Novartis, Pfizer, Sanofi, Seattle Genetics, Shire PLC, Spectrum Pharmaceuticals, Symphogen, Tocagen, and Tesaro, outside the submitted work; grants and personal fees from AstraZeneca, Eli Lilly and Company, and Merck and Company; personal fees and other from Infinity Pharmaceuticals, Junshi Pharmaceuticals, Neon Therapeutics, and NextCure. Dr Kelly reports personal fees and other from AstraZeneca, outside the submitted work. Dr Papadimitrakopoulou reports personal fees from Astra Zeneca, during the conduct of the study; and advisory board for Nektar Therapeutics, Arrys Therapeutics, Merck&Co, LOXO Oncology, Araxes Pharma, F. Hoffman-LaRoche Ltd, Janssen Research Foundation, Bristol-Myers Squibb, Clovis Oncology, Eli Lilly & Co, Novartis Pharmaceuticals Corp, Takeda Pharmaceuticals, Abbvie, TRM Oncology, Tesaro, Exelixis, Gritstone, Leeds Biolabs, Ideaya, Bolt Therapeutics, and G2 Innovation; research/grant from Eli Lilly & Co, Novartis, Merck, Astra Zeneca Pharmaceuticals, F Hoffman-La Roche, Nektar Therapeutics, Janssen, Bristol-Myers Squibb, Checkmate, and Incyte; and speaker/preceptorship with F Hoffman-La Roche. Dr Papadimitrakopoulou is currently an employee of Pfizer, Inc. Dr Waqar reports grants from 1 UM1 CA186704-01; and other from F. Hoffmann-La Roche Ltd, Ariad, Pfizer Pharmaceuticals, Inc, Hengrui Therapeutics, Xcovery, EMD Serono Research & Development Institute, Inc, Checkpoint Therapeutics, Inc, Genentech, Inc, Lilly, Stemcentrx, Inc, Ignyta, Inc, Bristol-Myers Squibb Pharmaceuticals, Synermore Biologics Co, Ltd, Novartis Pharmaceuticals Corporation, Merck & Company, Inc, NewLink Genetics Corporation, and Celegene, outside the submitted work. The remaining authors have stated that they have no conflicts of interest.This research supported in part by National Institutes of Health/National Cancer Institute grants CA180888, CA180819, CA180820, CA180821, CA180868, CA189971, CA189821, CA189830, CA189858, CA189953, CA189860, CA189804, CA180801, CA180835, CA189808, CA180826, CA180858, CA180846, CA189873, CA189822, CA189954, CA189854, CA189972, CA189952, CA13612, CA46368, CA11083 and by Amgen, AstraZeneca, Bristol-Myers Squibb Company, Genentech, and Pfizer through the Foundation for the National Institutes of Health, in partnership with Friends of Cancer Research. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2021/5
Y1 - 2021/5
N2 - Introduction: The objective of the Lung-MAP sub-study S1400A was to evaluate the response rate to durvalumab, an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with squamous non–small-cell lung cancer (SqNSCLC). Patients and Methods: Patients who progressed on at least 1 prior platinum-based chemotherapy were eligible. The study was designed as a phase II/III trial comparing durvalumab with docetaxel but was modified to a single-arm, phase II trial with the primary endpoint of objective response when immunotherapy became an approved treatment. Results: A total of 116 patients were registered to this sub-study; 78 to durvalumab and 38 to docetaxel. Of the 78 patients, 9 were ineligible, and 1 was not evaluable for endpoints. Responses were achieved in 11 patients among the 68 eligible and evaluable patients on durvalumab (overall response rate, 16%; 95% confidence interval [CI], 7%-25%). The disease control rate was 54% (95% CI, 43%-66%), the median overall survival was 11.6 months (95% CI, 10.2-14.3 months), and the median progression-free survival was 2.9 months (95% CI, 2.0-4.0 months). PD-L1 data was available for 43 patients on durvalumab, with 14 (33%) patients who were PD-L1–positive (≥ 25%) and 2 responses (overall response rate, 14%; 95% CI, 0%-33%), the disease control rate was 57% (95% CI, 31%-83%), the median overall survival and progression-free survival were 10.7 months (95% CI, 9.2-14.3 months) and 2.3 months (95% CI, 1.4-4.2 months), respectively. Grade ≥ 3 treatment-related adverse events occurred in 22 (32%) patients on durvalumab, with 6 discontinuing owing to drug-related adverse events (9%; 95% CI, 2%-16%). Conclusions: Durvalumab shows single-agent activity and toxicities in this sub-group of patients that is comparable with other anti-programmed cell death protein 1/PD-L1 antibodies.
AB - Introduction: The objective of the Lung-MAP sub-study S1400A was to evaluate the response rate to durvalumab, an anti-programmed death-ligand 1 (PD-L1) antibody, in patients with squamous non–small-cell lung cancer (SqNSCLC). Patients and Methods: Patients who progressed on at least 1 prior platinum-based chemotherapy were eligible. The study was designed as a phase II/III trial comparing durvalumab with docetaxel but was modified to a single-arm, phase II trial with the primary endpoint of objective response when immunotherapy became an approved treatment. Results: A total of 116 patients were registered to this sub-study; 78 to durvalumab and 38 to docetaxel. Of the 78 patients, 9 were ineligible, and 1 was not evaluable for endpoints. Responses were achieved in 11 patients among the 68 eligible and evaluable patients on durvalumab (overall response rate, 16%; 95% confidence interval [CI], 7%-25%). The disease control rate was 54% (95% CI, 43%-66%), the median overall survival was 11.6 months (95% CI, 10.2-14.3 months), and the median progression-free survival was 2.9 months (95% CI, 2.0-4.0 months). PD-L1 data was available for 43 patients on durvalumab, with 14 (33%) patients who were PD-L1–positive (≥ 25%) and 2 responses (overall response rate, 14%; 95% CI, 0%-33%), the disease control rate was 57% (95% CI, 31%-83%), the median overall survival and progression-free survival were 10.7 months (95% CI, 9.2-14.3 months) and 2.3 months (95% CI, 1.4-4.2 months), respectively. Grade ≥ 3 treatment-related adverse events occurred in 22 (32%) patients on durvalumab, with 6 discontinuing owing to drug-related adverse events (9%; 95% CI, 2%-16%). Conclusions: Durvalumab shows single-agent activity and toxicities in this sub-group of patients that is comparable with other anti-programmed cell death protein 1/PD-L1 antibodies.
KW - Biomarkers
KW - Clinical trials
KW - Immunotherapy
KW - Non–small-cell lung cancer
UR - http://www.scopus.com/inward/record.url?scp=85098103416&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2020.10.015
DO - 10.1016/j.cllc.2020.10.015
M3 - Article
C2 - 33358401
AN - SCOPUS:85098103416
SN - 1525-7304
VL - 22
SP - 178
EP - 186
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
IS - 3
ER -