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Exposure-response evaluations of venetoclax efficacy and safety in patients with non-Hodgkin lymphoma.

Apurvasena ParikhSathej GopalakrishnanKevin J FreiseMaria E VerdugoRajeev M MenonSven MensingAhmed Hamed Salem
Published in: Leukemia & lymphoma (2017)
Exposure-response analyses were performed for a venetoclax monotherapy study in 106 patients with varying subtypes of non-Hodgkin lymphoma (NHL) (NCT01328626). Logistic regression, time-to-event, and progression-free survival (PFS) analyses were used to evaluate the relationship between venetoclax exposure, NHL subtype and response, PFS, or occurrence of serious adverse events. Trends for small increases in the probability of response with increasing venetoclax exposures were identified, and became more evident when assessed by NHL subtype. Trends in exposure-PFS were shown for the mantle cell lymphoma (MCL) subtype, but not other subtypes. There was no increase in the probability of experiencing a serious adverse event with increasing exposure. Overall, the results indicate that venetoclax doses of 800-1200 mg as a single agent may be appropriate to maximize efficacy in MCL, follicular lymphoma, and diffuse large B-cell lymphoma subtypes with no expected negative impact on safety.
Keyphrases
  • diffuse large b cell lymphoma
  • free survival
  • risk assessment
  • epstein barr virus
  • emergency department
  • clinical trial
  • air pollution
  • study protocol
  • electronic health record