AFT-16: Phase II trial of neoadjuvant and adjuvant atezolizumab and chemoradiation (CRT) for stage III non-small cell lung cancer (NSCLC).

Authors

Helen Ross

Helen J. Ross

Thoracic Oncology, Phoenix, AZ

Helen J. Ross , David E. Kozono , James John Urbanic , Terence Marques Williams , Carter DuFrane , Ilze Bara , Katja Schulze , Jane Michelle Brockman , Xiaofei F. Wang , Junheng Gao , Everett E. Vokes , Tom Stinchcombe

Organizations

Thoracic Oncology, Phoenix, AZ, Dana-Farber Cancer Institute, Boston, MA, University of California, San Diego, Department of Radiation Medicine and Applied Sciences, San Diego, CA, City of Hope, Duarte, CA, Alliance Foundation Trials, Boston, MA, Genentech, Inc., South San Francisco, CA, Genentech, Inc, South San Francisco, CA, Duke Cancer Institute, Durham, NC, Duke University Health System, Durham, NC, University of Chicago Medicine, Chicago, IL

Research Funding

Other Foundation
Alliance for Clinical Trials in Oncology Foundation

Background: A minority of the approximately 40,000 US patients diagnosed annually with stage III NSCLC can be cured by concurrent CRT. Standard adjuvant immune checkpoint inhibitors (ICI) improve outcome for those patients who complete CRT with good performance status (PS) and without disease progression, but most patients diagnosed with unresectable stage III NSCLC will not meet the criteria for adjuvant ICI. AFT-16 investigated safety and efficacy of neoadjuvant and adjuvant atezolizumab as a strategy that may allow more patients to benefit from ICI. Methods: Eligible patients received 4 cycles (cy) of atezolizumab 1200 mg IV q 21 days followed by CRT with 60 Gy + weekly carboplatin and paclitaxel (CP), CP consolidation and adjuvant atezolizumab to complete 1 year of therapy (17 cy). The primary endpoint of disease control rate at 12 weeks (wks) has been reported. Secondary endpoints reported here include overall response rate, safety, and progression-free and overall survival (PFS, OS) measured from the start of induction therapy. Correlative science data and quality of life endpoints will be reported elsewhere. Results: 64 patients with unresectable stage III NSCLC, PS 0-1 and no active autoimmune disease or significant organ dysfunction were enrolled at 13 Alliance for Clinical Trials in Oncology sites from 11/2017 to 7/2019. 62 patients who received at least one dose of atezolizumab are included in this analysis. Median age was 63.9 years (range 38.1-86.5). Patients were 51.6% female, 77.4% white, 88.7% current & former smokers and 56.5% PS 0. All patients are off study treatment. Mean cycles of treatment received was 9 (1-17). 46 patients were alive at median follow up 24.1 mo (range 3 – 34.1 mo). PFS at 12 and 18 mo from start of induction atezolizumab was 66% (95%CI 55-79) and 57% (95%CI 45-71) respectively. Median PFS was 23.7 mo (95%CI 13.2-NE). OS at 18 mo was 84% (95%CI 75-94). Median OS is not yet estimable. Atezolizumab was well tolerated. One grade (gr) 4 Guillain-Barre syndrome and 1 each gr 3 pneumonia, pneumonitis and colitis were attributable to neoadjuvant atezolizumab. The remaining 9 severe adverse events were unrelated to ICI. Conclusions: Atezolizumab prior to and following CRT for stage III unresectable NSCLC was well tolerated with encouraging PFS and OS without unexpected safety signals. Analysis of correlative endpoints and quality of life are ongoing. Further study of induction atezolizumab is warranted in patients with unresectable stage III NSCLC. Support: https://acknowledgments.alliancefound.org; Clinical trial information: NCT03102242

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Abstract Details

Meeting

2021 ASCO Annual Meeting

Session Type

Poster Discussion Session

Session Title

Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers

Track

Lung Cancer

Sub Track

Local-Regional Non–Small Cell Lung Cancer

Clinical Trial Registration Number

NCT03102242

Citation

J Clin Oncol 39, 2021 (suppl 15; abstr 8513)

DOI

10.1200/JCO.2021.39.15_suppl.8513

Abstract #

8513

Abstract Disclosures