Third-Line Nivolumab Monotherapy in Recurrent SCLC

CheckMate 032

Neal Ready, Anna F. Farago, Filippo de Braud, Akin Atmaca, Matthew D. Hellmann, Jeffrey G. Schneider, David R. Spigel, Victor Moreno, Ian Chau, Christine Hann, Joseph Paul Eder, Nicola L. Steele, Anne Pieters, Justin Fairchild, Scott J. Antonia

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
JournalJournal of Thoracic Oncology
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Disease Progression
Topotecan
Therapeutics
Drug Therapy
nivolumab
Platinum
Disease-Free Survival
Survival Rate
Databases
Confidence Intervals
Safety
Survival
Population
Neoplasms
ipilimumab

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine

Cite this

Ready, N., Farago, A. F., de Braud, F., Atmaca, A., Hellmann, M. D., Schneider, J. G., ... Antonia, S. J. (Accepted/In press). Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032. Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2018.10.003

Third-Line Nivolumab Monotherapy in Recurrent SCLC : CheckMate 032. / Ready, Neal; Farago, Anna F.; de Braud, Filippo; Atmaca, Akin; Hellmann, Matthew D.; Schneider, Jeffrey G.; Spigel, David R.; Moreno, Victor; Chau, Ian; Hann, Christine; Eder, Joseph Paul; Steele, Nicola L.; Pieters, Anne; Fairchild, Justin; Antonia, Scott J.

In: Journal of Thoracic Oncology, 01.01.2018.

Research output: Contribution to journalArticle

Ready, N, Farago, AF, de Braud, F, Atmaca, A, Hellmann, MD, Schneider, JG, Spigel, DR, Moreno, V, Chau, I, Hann, C, Eder, JP, Steele, NL, Pieters, A, Fairchild, J & Antonia, SJ 2018, 'Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032', Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2018.10.003
Ready N, Farago AF, de Braud F, Atmaca A, Hellmann MD, Schneider JG et al. Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032. Journal of Thoracic Oncology. 2018 Jan 1. https://doi.org/10.1016/j.jtho.2018.10.003
Ready, Neal ; Farago, Anna F. ; de Braud, Filippo ; Atmaca, Akin ; Hellmann, Matthew D. ; Schneider, Jeffrey G. ; Spigel, David R. ; Moreno, Victor ; Chau, Ian ; Hann, Christine ; Eder, Joseph Paul ; Steele, Nicola L. ; Pieters, Anne ; Fairchild, Justin ; Antonia, Scott J. / Third-Line Nivolumab Monotherapy in Recurrent SCLC : CheckMate 032. In: Journal of Thoracic Oncology. 2018.
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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.",
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T2 - CheckMate 032

AU - Ready, Neal

AU - Farago, Anna F.

AU - de Braud, Filippo

AU - Atmaca, Akin

AU - Hellmann, Matthew D.

AU - Schneider, Jeffrey G.

AU - Spigel, David R.

AU - Moreno, Victor

AU - Chau, Ian

AU - Hann, Christine

AU - Eder, Joseph Paul

AU - Steele, Nicola L.

AU - Pieters, Anne

AU - Fairchild, Justin

AU - Antonia, Scott J.

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Y1 - 2018/1/1

N2 - 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.

AB - 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.

KW - Immunotherapy

KW - Nivolumab

KW - PD-1 inhibitor

KW - SCLC

KW - Third-line

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