2019 ASCO Annual Meeting!
Session: Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
Type: Oral Abstract Session
Time: Saturday June 1, 1:15 PM to 4:15 PM
Location: Hall D2
Neoadjuvant atezolizumab in resectable non-small cell lung cancer (NSCLC): Interim analysis and biomarker data from a multicenter study (LCMC3).
Local-Regional Non-Small Cell Lung Cancer
Lung Cancer—Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 8503)
Author(s): David J. Kwiatkowski, Valerie W. Rusch, Jamie E. Chaft, Bruce E. Johnson, Alan Nicholas, Ignacio Ivan Wistuba, Robert Merritt, Jay M. Lee, Paul A. Bunn, Yan Tang, See-Chun Phan, Saiama Naheed Waqar, Alexander Patterson, Eric B. Haura, Eric M. Toloza, Karen L. Reckamp, Dan Raz, Katja Schulze, Ann Johnson, David Paul Carbone; Dana-Farber Cancer Institute, Boston, MA; Memorial Sloan Kettering Cancer Center, New York, NY; Thoracic Oncology Service, Department of Medicine, Memorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New York, NY; Genentech, Inc., South San Francisco, CA; Department of Translational Molecular Pathology, The University of Texas MD Anderson Cancer Center, Houston, TX; The Ohio State University Comprehensive Cancer Center, James Cancer Hospital, Solove Research Institute, Columbus, OH; David Geffen School of Medicine at UCLA, Los Angeles, CA; University of Colorado Denver, Aurora, CO; Brigham and Women’s Hospital, Boston, MA; Genentech, Inc., San Francisco, CA; Washington University School of Medicine, St. Louis, MO; Department of Thoracic Oncology, Moffitt Cancer Center and Research Institute, Tampa, FL; Moffitt Cancer Center, Tampa, FL; City of Hope Comprehensive Cancer Center, Duarte, CA; The Ohio State University Comprehensive Cancer Center, Columbus, OH
Background: Small pilot studies (e.g., N Engl J Med. 2018;378:1976) have shown that preoperative immune checkpoint inhibitor therapy may be of benefit in early-stage NSCLC. This large multicenter trial assesses the benefit of neoadjuvant treatment with atezolizumab (atezo; NCT02927301). Methods: Patients (pts) with stages IB to selected IIIB resectable NSCLC receive 2 cycles of atezo 1200 mg (days 1, 22) then undergo resection (day 40 ± 10). Primary tumor +/- node biopsies and blood samples are obtained before atezo and at surgery for biomarker studies. The primary endpoint is major pathological response (MPR), defined as ≤ 10% viable tumor cells in the resection specimen. Secondary endpoints include safety and correlation of response with PD-L1 expression, tumor mutation burden (TMB) and gene expression signatures. Results: For this interim efficacy analysis (5 Sep 2018 data cut), we report on the first 101 of 180 planned pts: 47 males, median age, 64 y; all ECOG PS 0-1; 23 current and 68 former smokers; 66 non-squamous NSCLC; clinical stages IB/IIA/IIB/IIIA/IIIB n = 11/16/28/39/7. There were 2 treatment-unrelated Gr 5 AEs (cardiac death post surgical resection; death due to disease progression), 29 Gr 3-4 AEs (6 [6%] treatment related). 90 pts had surgery. Excluding 8 pts who had driver mutations (7 EGFR, 1 ALK, no MPR), MPR rate was 15/82 (18%, 95% CI 11%-28%), 4 pts had pathological complete response (pCR). By RECIST, 6/82 pts had PR, 72 had SD and 4 had PD. Two of 26 (8%) PD-L1− (TC0 and IC0, clone SP142) and 10 of 35 (29%) PD-L1+ had MPR (P= 0.055). Five of 44 (11%) TPS < 50 (PD-L1 clone 22C3) and 7 of 20 (35%) TPS > 50 had MPR (P= 0.040). Exome sequencing data was available for 47/101 pts. Median TMB was 10.4 (range, 1.5-46.5) mutations per Mb and was not different in those with MPR compared with those without MPR. Further analysis of TMB, mutation signatures, and gene expression profiling is ongoing. Conclusions: Atezo in the neoadjuvant setting was well tolerated, and pCR and MPR rates are encouraging in this large multicenter trial. Efficacy interim analysis passed its futility boundary, and study enrollment continues. Safety, efficacy results and ongoing correlative analyses will be presented. Clinical trial information: NCT02927301
Meeting: 2019 ASCO Annual Meeting Abstract No: 8502 First Author: Theodoros Tsakiridis
Meeting: 2019 ASCO Annual Meeting Abstract No: 8504 First Author: Tina Cascone
3. Neoadjuvant chemo-immunotherapy for the treatment of stage IIIA resectable non-small-cell lung cancer (NSCLC): A phase II multicenter exploratory study—Final data of patients who underwent surgical assessment.
Meeting: 2019 ASCO Annual Meeting Abstract No: 8509 First Author: Mariano Provencio