- 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.
- 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.
- 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.
- Open-label study.