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Borghaei H , Redman MW , Kelly K , Waqar SN , Robert F , Kiefer GJ , Stella PJ , Minichiello K , Gandara DR , Herbst RS , Papadimitrakopoulou VA
SWOG S1400A (NCT02154490): A Phase II Study of Durvalumab for Patients With Previously Treated Stage IV or Recurrent Squamous Cell Lung Cancer (Lung-MAP Sub-study)
Clinical Lung Cancer. 2021 May;22(3) :178-186
PMID: WOS:000660499500005   
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Abstract
The S1400A study was designed to evaluate the activity of durvalumab in patients with squamous cell carcinoma of lung. All eligible patients had to have evidence of disease progression after first line treatment with a platinum doublet regimen. This trial was originally designed as a randomized study; however, with the approval of other checkpoint inhibitors it was re-designed as a single-arm study. An overall response rate of 16% was observed in this study with a median overall survival of 11.6 months in unselected patients. Programmed death-ligand 1 data was available for 43 patients on durvalumab, with 14 (33%) patients who were programmed death-ligand 1-positive (>= 25%) and 2 responses (overall response rate, 14%; 95% confidence interval [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. Toxicity was in line with what has been reported for other drugs in this class. Durvalumab, therefore, has single-agent activity and toxicity comparable with other drugs in this class. 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- L1epositive (>= 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. (C) 2020 Elsevier Inc. All rights reserved.
Notes
Borghaei, Hossein Redman, Mary W. Kelly, Karen Waqar, Saima N. Robert, Francisco Kiefer, Gauri J. Stella, Philip J. Minichiello, Katherine Gandara, David R. Herbst, Roy S. Papadimitrakopoulou, Vassiliki A. 1938-0690