Five-Year Overall Survival for Patients With Advanced Non‒Small-Cell Lung Cancer Treated With Pembrolizumab: Results From the Phase I KEYNOTE-001 Study

Author:

Garon Edward B.1,Hellmann Matthew D.2,Rizvi Naiyer A.3,Carcereny Enric4,Leighl Natasha B.5,Ahn Myung-Ju6,Eder Joseph Paul7,Balmanoukian Ani S.8,Aggarwal Charu9,Horn Leora10,Patnaik Amita11,Gubens Matthew12,Ramalingam Suresh S.13,Felip Enriqueta14,Goldman Jonathan W.1,Scalzo Cathie15,Jensen Erin15,Kush Debra A.15,Hui Rina16

Affiliation:

1. University of California, Los Angeles, Los Angeles, CA

2. Memorial Sloan Kettering Cancer Center, New York, NY

3. Columbia University Medical Center, New York, NY

4. Catalan Institute of Oncology Badalona, Badalona, Spain

5. Princess Margaret Cancer Centre, Toronto, Ontario, Canada

6. Samsung Medical Center, Seoul, South Korea

7. Yale University, New Haven, CT

8. The Angeles Clinic and Research Institute, Los Angeles, CA

9. University of Pennsylvania, Philadelphia, PA

10. Vanderbilt-Ingram Cancer Center, Nashville, TN

11. South Texas Accelerated Research Therapeutics, San Antonio, TX

12. University of California, San Francisco, San Francisco, CA

13. Emory University, Atlanta, GA

14. Vall d’Hebron University Hospital, Vall d’Hebron Institute of Oncology, Barcelona, Spain

15. Merck & Co., Inc., Kenilworth, NJ

16. Westmead Hospital, University of Sydney, Sydney, NSW, Australia

Abstract

PURPOSE Pembrolizumab monotherapy has demonstrated durable antitumor activity in advanced programmed death ligand 1 (PD-L1)–expressing non‒small-cell lung cancer (NSCLC). We report 5-year outcomes from the phase Ib KEYNOTE-001 study. These data provide the longest efficacy and safety follow-up for patients with NSCLC treated with pembrolizumab monotherapy. PATIENTS AND METHODS Eligible patients had confirmed locally advanced/metastatic NSCLC and provided a contemporaneous tumor sample for PD-L1 evaluation by immunohistochemistry using the 22C3 antibody. Patients received intravenous pembrolizumab 2 mg/kg every 3 weeks or 10 mg/kg every 2 or 3 weeks. Investigators assessed response per immune-related response criteria. The primary efficacy end point was objective response rate. Overall survival (OS) and duration of response were secondary end points. RESULTS We enrolled 101 treatment-naive and 449 previously treated patients. Median follow-up was 60.6 months (range, 51.8 to 77.9 months). At data cutoff—November 5, 2018—450 patients (82%) had died. Median OS was 22.3 months (95% CI, 17.1 to 32.3 months) in treatment-naive patients and 10.5 months (95% CI, 8.6 to 13.2 months) in previously treated patients. Estimated 5-year OS was 23.2% for treatment-naive patients and 15.5% for previously treated patients. In patients with a PD-L1 tumor proportion score of 50% or greater, 5-year OS was 29.6% and 25.0% in treatment-naive and previously treated patients, respectively. Compared with analysis at 3 years, only three new-onset treatment-related grade 3 adverse events occurred (hypertension, glucose intolerance, and hypersensitivity reaction, all resolved). No late-onset grade 4 or 5 treatment-related adverse events occurred. CONCLUSION Pembrolizumab monotherapy provided durable antitumor activity and high 5-year OS rates in patients with treatment-naive or previously treated advanced NSCLC. Of note, the 5-year OS rate exceeded 25% among patients with a PD-L1 tumor proportion score of 50% or greater. Pembrolizumab had a tolerable long-term safety profile with little evidence of late-onset or new toxicity.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3