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Third-Line Nivolumab Monotherapy in Recurrent SCLC: CheckMate 032
Neal Ready1, Anna F Farago2, Filippo de Braud3
1Duke University Medical Center, Durham, North Carolina.
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.
Insights
For recurrent small cell lung cancer (SCLC), nivolumab monotherapy shows durable responses and good tolerability in third- or later-line treatment. This immunotherapy offers a promising option for patients with poor outcomes on existing therapies.
Area of Science:
- Oncology
- Immunotherapy
- Clinical Trials
Background:
- Recurrent small cell lung cancer (SCLC) has limited treatment options, with topotecan as the only approved second-line therapy yielding poor outcomes.
- The CheckMate 032 study investigated nivolumab (alone or with ipilimumab) in previously treated SCLC and other advanced solid tumors.
Purpose of the Study:
- To evaluate the efficacy and safety of third- or later-line nivolumab monotherapy in patients with recurrent SCLC.
- To determine objective response rate, duration of response, progression-free survival, and overall survival.
Main Methods:
- An open-label, multicenter, phase 1/2 study included 109 patients with SCLC progressing after two or more chemotherapy regimens.
- Patients received nivolumab monotherapy (3 mg/kg every 2 weeks) until disease progression or unacceptable toxicity.
Main Results:
- The objective response rate was 11.9% (95% CI: 6.5-19.5), with a median duration of response of 17.9 months.
- 12-month and 18-month overall survival rates were 28.3% and 20.0%, respectively.
- Grade 3-4 treatment-related adverse events occurred in 11.9% of patients, with 2.8% discontinuing treatment.
Conclusions:
- Nivolumab monotherapy demonstrated durable responses and was well-tolerated in the third- or later-line setting for recurrent SCLC.
- These findings suggest nivolumab monotherapy is an effective treatment option for this patient population with advanced SCLC.
