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Clinical Trial
. 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

Neal Ready  1 , Anna F Farago  2 , Filippo de Braud  3 , Akin Atmaca  4 , Matthew D Hellmann  5 , Jeffrey G Schneider  6 , David R Spigel  7 , Victor Moreno  8 , Ian Chau  9 , Christine L Hann  10 , Joseph Paul Eder  11 , Nicola L Steele  12 , Anne Pieters  13 , Justin Fairchild  13 , Scott J Antonia  14
Affiliations
Clinical Trial

Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032

Neal Ready et al. J Thorac Oncol. 2019 Feb.

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.

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Conflict of interest statement

Disclosure: Dr. Ready has received personal fees from AbbVie, AstraZeneca, Bristol-Myers Squibb, Celgene, Genentech, MedImmune, Merck, and Novartis. Dr. Farago has received grants from AbbVie, AstraZeneca, Ignyta, Loxo Oncology, Merck, and PharmaMar; personal fees from AbbVie, Foundation Medicine, Loxo Oncology, Merrimack Pharmaceuticals, PharmaMar, and Takeda; and research funding from Bristol-Myers Squibb to her institution. Dr. Atmaca has received personal fees and grants from Bristol-Myers Squibb. Dr. Hellmann has received personal fees from AstraZeneca, Bristol-Myers Squibb, Genentech, Janssen, Merck, Mirati, Novartis, and Shattuck Labs; he has received grants from Bristol-Myers Squibb; and he has a pending patent (PCT/US2015/062208) filed by Memorial Sloan Kettering and related to the use of tumor mutational burden to predict response to immunotherapy. Dr. Schneider has received personal fees from and has stock ownership in Bristol-Myers Squibb. Dr. Chau has received personal fees from Amgen, Bayer, Bristol-Myers Squibb, Eli Lilly, Five Prime Therapeutics, Merck Sharp and Dohme, Pfizer, Roche, Sanofi Oncology, and Taiho and research funding from Eli Lilly, Janssen-Cilag, Merck Serono, and Sanofi Oncology. Dr. Hann has received personal fees from AbbVie, Bristol-Myers Squibb, and Genentech and clinical research support from AbbVie and Bristol-Myers to her institution. Dr. Steele received personal fees from Bristol-Myers Squibb. Ms. Pieters and Mr. Fairchild are employees of Bristol-Myers Squibb. Dr. Antonia has received personal fees from AstraZeneca, Boehringer Ingelheim, Bristol-Myers Squibb, and Merck and has stock ownership in Cellular Biomedicine Group. The remaining authors declare no conflict of interest.

Figures

Figure 1.
Figure 1.
Duration of response (DOR) by blinded independent central review with third- or later-line (3L+) nivolumab monotherapy. CI, confidence interval.
Figure 2.
Figure 2.
Progression-free survival (PFS) by blinded independent central review with third- or later-line (3L+) nivolumab monotherapy. CI, confidence interval.
Figure 3.
Figure 3.
Overall survival (OS) with third- or later-line (3L+) nivolumab monotherapy. CI, confidence interval.
See this image and copyright information in PMC

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