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CheckMate 032: Extended Follow-up of Nivolumab and Nivolumab/Ipilimumab Cohorts in Previously Treated Metastatic Urothelial Carcinoma

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Key Points

  • Objective response rates were 25.6%, 26.9%, and 38.0% in the NIVO3, NIVO3+IPI1, and NIVO1+IPI3 groups, respectively.
  • Median durations of response exceeded 22 months in all groups.

As reported in the Journal of Clinical Oncology by Sharma et al, follow-up of the cohort receiving nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg the phase I/II CheckMate 032 trial showed the regimen produced high levels of activity in platinum-treated, unresectable, locally advanced or metastatic urothelial carcinoma.

The report provided objective response data with nivolumab at 3 mg/kg every 2 weeks (NIVO3; n = 78); nivolumab at 3 mg/kg plus ipilimumab at 1 mg/kg every 3 weeks for four doses followed by nivolumab monotherapy at 3 mg/kg every 2 weeks (NIVO3+IPI1; n = 104); and nivolumab at 1 mg/kg plus ipilimumab at 3 mg/kg every 3 weeks for four doses followed by nivolumab monotherapy at 3 mg/kg every 2 weeks (NIVO1+IPI3; n = 92).

Response Rates

Minimum follow-up durations were 37.7 months in the NIVO3 group, 38.8 months in the NIVO3+IPI1 group, and 7.9 months in the NIVO1+IPI3 group. Objective response rates were 25.6%, 26.9%, and 38.0%, respectively.

Responses were observed regardless of programmed cell death ligand 1 (PD-L1) expression levels in all treatment groups. Median durations of response were 30.5 months in the NIVO3 group, 22.3 months in the NIVO3+IPI1 group, and 22.9 months in the NIVO1+IPI3 group, with response durations in each group being similar irrespective of PD-L1 expression.

Adverse Events

Grade 3 or 4 treatment-related adverse events occurred in 26.9%, 30.8%, and 39.1% of patients in the NIVO3, NIVO3+IPI1, and NIVO1+IPI3 groups, respectively. Treatment-related serious adverse events occurred in 11.5%, 25.0%, and 27.2% of patients, respectively. Treatment-related pneumonitis led to death in one patient in the NIVO3 group and one patient in the NIVO3+IPI1 group.

The investigators concluded, “With longer follow-up, NIVO3 demonstrated sustained antitumor activity alone and in combination with ipilimumab. NIVO1+IPI3 provided the greatest antitumor activity of all regimens, with a manageable safety profile. This result not only supports additional study of NIVO1+IPI3 in [metastatic urothelial carcinoma), but demonstrates the potential benefit of immunotherapy combinations in this disease.”

Padmanee Sharma, MD, PhD, of The University of Texas MD Anderson Cancer Center, is the corresponding author for the Journal of Clinical Oncology article.

Disclosure: The study was supported by Bristol-Myers Squibb and by a National Cancer Institute Cancer Center Support grant. For full disclosures of the study authors, visit jco.ascopubs.org.

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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