Severe renal and pancreatic toxicities associated with ipilimumab and nivolumab combination therapy in non-small cell lung cancer: a pharmacovigilance analysis of the FDA adverse event reporting system - Scorecard - MDSpire

Severe renal and pancreatic toxicities associated with ipilimumab and nivolumab combination therapy in non-small cell lung cancer: a pharmacovigilance analysis of the FDA adverse event reporting system

  • By

  • Jiongrui Cao

  • Li Peng

  • Jin Yang

  • Gang Yin

  • Ping Ke

  • Jifa Zhang

  • Min Su

  • Yun Gao

  • Yuehui Zhang

  • June 17, 2026

  • 0 min

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Clinical Scorecard: Severe renal and pancreatic adverse effects linked to ipilimumab and nivolumab combination therapy in patients with non-small cell lung cancer: Insights from a pharmacovigilance study using the FDA adverse event reporting system

At a Glance

CategoryDetail
ConditionNon-small cell lung cancer (NSCLC)
Key MechanismsCTLA-4-dependent disruption of B-cell tolerance and PD-1-mediated release of T-cell cytotoxicity
Target PopulationPatients with advanced non-small cell lung cancer
Care SettingOncology clinics and hospitals

Key Highlights

  • Significant signals for glomerular-predominant renal injury and pancreatic toxicity associated with Ipi+Nivo therapy.
  • Median time-to-onset for renal events was 73 days and for pancreatic events was 84 days in the combination therapy group.
  • Co-reported renal and pancreatic events were infrequent in combination therapy reports.

Guideline-Based Recommendations

Diagnosis

  • Monitor for renal and pancreatic adverse events in patients receiving Ipi+Nivo therapy.

Management

  • Implement tailored monitoring strategies beyond conventional acute interstitial nephritis surveillance.

Monitoring & Follow-up

  • Enhanced clinical vigilance for immune-related adverse events.

Risks

  • Potential for serious clinical outcomes including death and hospitalization.

Patient & Prescribing Data

Patients receiving ipilimumab and nivolumab for advanced NSCLC.

Combination therapy is associated with a broader spectrum and greater severity of toxicity compared to nivolumab monotherapy.

Clinical Best Practices

  • Recognize and manage immune-related acute kidney injury promptly.
  • Be aware of the potential for immune-mediated pancreatic injury, including type 1 diabetes mellitus.

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