ASCO 2016: Nivolumab Alone or in Combination With Ipilimumab Active in Recurrent Small Cell Lung Cancer

Key Points

  • Ten percent of patients treated with single-agent nivolumab responded to therapy, whereas approximately 20% of patients treated with nivolumab combined with ipilimumab responded.
  • A total of 16 patients maintained their response for longer than 6 months.
  • The immunotherapeutic regimens are active in patients who are particularly difficult to treat, with responses observed in those who were resistant to initial standard chemotherapy and in patients who had two or more prior treatments.

A study presented by Antonia et al at the 2016 ASCO Annual Meeting (Abstract 100) showed that utilizing the immunotherapeutic agents nivolumab (Opdivo) and ipilimumab (Yervoy) could lead to more effective treatment options for patients with small cell lung cancer (SCLC) who have progressed after prior chemotherapy.

Studies have shown that nivolumab combined with ipilimumab results in improved antitumor activity when compared with either agent alone. The U.S. Food and Drug Administration recently approved this two-drug combination for the treatment of advanced melanoma.

Given the promising activity of the immunotherapy combination in melanoma, researchers wanted to assess whether this regimen could also be effective in other types of tumors with few to no therapeutic options.

Study Findings

A phase I/II international study (CheckMate 032) assessed the activity and safety of nivolumab and ipilimumab in 216 patients with SCLC who developed progressive disease after prior standard chemotherapy. Patients received either nivolumab as a single agent or two different combination regimens of nivolumab plus ipilimumab.

The researchers reported that nivolumab and the combination regimen were active in patients with SCLC and resulted in responses that lasted longer than many other investigational agents. Ten percent of patients treated with single-agent nivolumab responded to therapy, whereas approximately 20% of patients treated with nivolumab combined with ipilimumab responded. Furthermore, 16 patients maintained their response for longer than 6 months.

Preliminary results suggest that the immunotherapeutic regimens are active in patients who are particularly difficult to treat, with responses observed in those who were resistant to initial standard chemotherapy and in patients who had two or more prior treatments.

Patients tolerated the treatment well, with 13% to 30% percent treated with the nivolumab or the combination regimens having high-grade toxicities. The most common toxicities associated with treatment were altered pancreatic enzyme activity, diarrhea, difficulty breathing, and lung tissue inflammation.

“This is the first trial showing activity of nivolumab and nivolumab plus ipilimumab in SCLC, in a hard-to-treat population of patients with limited treatment options,” said Scott J. Antonia, MD, PhD, first author of the study and Chair of the Thoracic Oncology Department at Moffitt Cancer Center.

On the basis of these encouraging results, two phase III studies are ongoing to assess the therapeutic impact of nivolumab and nivolumab plus ipilimumab in patients with SCLC.

The study is sponsored by Bristol-Myers Squibb.

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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