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J Thorac Oncol. 2019 Feb;14(2):237-244. doi: 10.1016/j.jtho.2018.10.003. Epub 2018 Oct 10.

Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032.

Author information

1
Duke University Medical Center, Durham, North Carolina. Electronic address: neal.ready@duke.edu.
2
Massachusetts General Hospital, Boston, Massachusetts.
3
Fondazione IRCCS Istituto Nazionale dei Tumori Milano and University of Milan, Milan, Italy.
4
Krankenhaus Nordwest-Institut für Klinisch-Onkologische Forschung, UCT-University Cancer Center, Frankfurt am Main, Germany.
5
Memorial Sloan Kettering Cancer Center Hospital, New York, New York.
6
New York Uuniversity Winthrop University Hospital, Mineola, New York.
7
Sarah Cannon Research Institute/Tennessee Oncology, Nashville, Tennessee.
8
START Madrid-FJD. Hospital Fundación Jiménez Díaz, Madrid, Spain.
9
Royal Marsden National Health Service Foundation Trust, Surrey, United Kingdom.
10
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland.
11
Yale Cancer Center, New Haven, Connecticut.
12
Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom.
13
Bristol-Myers Squibb, Princeton, New Jersey.
14
H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.

Abstract

INTRODUCTION:

For patients with recurrent SCLC, topotecan remains the only approved second-line treatment, and the outcomes are poor. CheckMate 032 is a phase 1/2, multicenter, open-label study of nivolumab or nivolumab plus ipilimumab in SCLC or other advanced/metastatic solid tumors previously treated with one or more platinum-based chemotherapies. We report results of third- or later-line nivolumab monotherapy treatment in SCLC.

METHODS:

In this analysis, patients with limited-stage or extensive-stage SCLC and disease progression after two or more chemotherapy regimens received nivolumab monotherapy, 3 mg/kg every 2 weeks, until disease progression or unacceptable toxicity. The primary end point was objective response rate. Secondary end points included duration of response, progression-free survival, overall survival, and safety.

RESULTS:

Between December 4, 2013, and November 30, 2016, 109 patients began receiving third- or later-line nivolumab monotherapy. At a median follow-up of 28.3 months (from first dose to database lock), the objective response rate was 11.9% (95% confidence interval: 6.5-19.5) with a median duration of response of 17.9 months (range 3.0-42.1). At 6 months, 17.2% of patients were progression-free. The 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively. Grade 3 to 4 treatment-related adverse events occurred in 11.9% of patients. Three patients (2.8%) discontinued because of treatment-related adverse events.

CONCLUSIONS:

Nivolumab monotherapy provided durable responses and was well tolerated as a third- or later-line treatment for recurrent SCLC. These results suggest that nivolumab monotherapy is an effective third- or later-line treatment for this patient population.

KEYWORDS:

Immunotherapy; Nivolumab; PD-1 inhibitor; SCLC; Third-line

PMID:
30316010
DOI:
10.1016/j.jtho.2018.10.003
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