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Association Between Pembrolizumab-related Adverse Events and Treatment Outcome in Advanced Melanoma: Results From the

Cornelis Bisschop1, Thijs T Wind1, Christian U Blank2

  • 1Department of Medical Oncology, University Medical Center Groningen, Groningen.

Journal of Immunotherapy (Hagerstown, Md. : 1997)
|May 31, 2019
PubMed

Insights

Immune checkpoint inhibitor toxicity, like that from pembrolizumab, correlates with better disease control and survival. High-grade adverse events (AEs) significantly improved outcomes, suggesting a link between toxicity and efficacy.

Area of Science:

  • Oncology
  • Immunology
  • Pharmacology

Background:

  • Immune checkpoint inhibitors (ICIs) like ipilimumab and nivolumab show toxicity linked to clinical efficacy.
  • Pembrolizumab is an ICI used in cancer treatment.

Purpose of the Study:

  • To evaluate the association between pembrolizumab-induced toxicity and clinical efficacy.
  • To determine if adverse events (AEs) predict treatment outcomes in patients receiving pembrolizumab.

Main Methods:

  • Prospective data collection from 147 patients in the Pembrolizumab Expanded Access Program.
  • Multivariate logistic regression and Cox regression analyses were used.
  • A pseudolandmark analysis at 6 months was performed to address time-dependent AEs.

Main Results:

  • Patients experiencing any AEs showed a higher chance of disease control compared to those without AEs (low-grade OR=12.8, high-grade OR=38.5).
  • High-grade AEs were associated with a reduced risk of death (HR=0.51) and disease progression (HR=0.54).
  • Prolonged survival was observed in patients who stopped therapy early due to AEs, suggesting a potential benefit.

Conclusions:

  • High-grade toxicity from pembrolizumab is associated with improved objective response rates, progression-free survival, and overall survival.
  • The occurrence of AEs during treatment may serve as a predictive marker for patient survival.
  • Further research is needed to validate the predictive value of early AEs on patient survival.

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