High Activity for Nivolumab Alone and With Ipilimumab in Small-cell Lung Cancer

The following article features coverage from the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

Nivolumab alone or combined with ipilimumab provided durable responses in patients with advanced small-cell lung cancer (SCLC) whose disease progressed on prior platinum therapies, according to data from CheckMate 032 presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago.¹

CheckMate 032 (Clinicaltrials.gov Identifier: NCT01928394) is an ongoing phase 1/2 study evaluating multiple regimens of nivolumab with or without ipilimumab in solid tumors.

Matthew D. Hellman, MD, of the Memorial Sloan Kettering Cancer Center in New York, New York, presented data for 2 cohorts: the non-randomized cohort and the randomized cohort.

In the initial treatment arms, patients with advanced SCLC were randomly assigned to receive nivolumab 3 mg/kg every 2 weeks (98 patients) or nivolumab 1 mg/kg and ipilimumab 3 mg/kg every 3 weeks followed by nivolumab 3 mg/kg every 2 weeks (61 patients) until disease progression or toxicity.

In the expansion cohort, patients were randomly assigned 3:2 to receive nivolumab monotherapy (147 patients) or nivolumab plus ipilimumab (95 patients).

Updated results from the non-randomized cohort indicated that responses with combination therapy were better than those with nivolumab monotherapy across all clinical parameters. For nivolumab vs nivolumab plus ipilimumab, objective response rates (ORR) were 11% vs 23% for the combination.

Median overall survival (OS) (vs the combination) was 4.1 vs 7.8 months; 1-year OS: 27% vs 40%; 2-year OS was 14% vs 26%.

Data from the randomized cohort mirrored those reported for the non-randomized cohort. ORR (monotherapy vs combination): 12% vs 21%. Data for the nonrandomized cohort were not mature, but initial analyses into 3-month progression-free survival and OS rates showed similar benefits.

Any-grade treatment-related adverse events occurred in 73% in the combination vs 55% for nivolumab alone; grade 3 to 4 events occurred in 37% in the combination group vs 12% for nivolumab alone.

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Dr Hellman reported that CheckMate 451 (ClinicalTrials.gov Identifier: NCT02538666) is currently enrolling patients with extensive disease SCLC into a phase 3 study with 3 randomized arms: nivolumab, nivolumab plus ipilimumab, or placebo.

Read more of Cancer Therapy Advisor‘s coverage of the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting by visiting the conference page.

Reference

1. Hellmann MD, Ott PA, Zugazagoitia J, et al. Nivolumab (nivo) ± ipilimumab (ipi) in advanced small-cell lung cancer (SCLC): First report of a randomized expansion cohort from CheckMate 032. J Clin Oncol. 2017;35(suppl; abstr 8503).