CLL: ofatumumab monotherapy effective in older patients with comorbidities

  • Vitale C & al.
  • J Geriatr Oncol
  • 17 Apr 2019

  • curated by David Reilly
  • Univadis Clinical Summaries
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Takeaway

  • In older patients with chronic lymphocytic leukemia (CLL) and comorbidities, treatment with ofatumumab monotherapy was well-tolerated and delivered response in more than 7 of 10 patients.  

Why this matters

  • Many patients receive initial therapy for CLL at approximately 75 years of age, at which time poor performance status and comorbidities may limit therapeutic options.

Study design

  • Phase 2 study to investigate ofatumumab monotherapy in older patients with poor performance status and comorbidities who would normally be ineligible for clinical trial enrollment.
  • All patients were aged ≥65 years (median patient age, 73 years; range, 65-87 years) and had an Eastern Cooperative Oncology Group performance status of 2/3 or Charlson comorbidity index ≥2.
  • Funding: National Comprehensive Cancer Network Oncology Research Program supported by Novartis.  

Key results

  • 72% overall response.
  • 19% of patients achieved complete response.
  • Median PFS, 21 (95% CI, 9-32) months.  
  • 87% estimated alive at last follow-up.
  • Infusion-related reactions comprised the most common treatment-related adverse events (AEs); only 3% were at grade 3.
  • Additional treatment-related grade 3 AEs included diarrhea, nausea, vomiting, hyperglycemia, pulmonary embolism, and allergic reaction.
  • No grade 4 AEs were observed.

Limitations

  • Open-label study.