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NEJM EvidenceVemurafenib and Obinutuzumab as Frontline Therapy for Hairy Cell Leukemia

More than 90% of Patients Achieve Complete Remission with No Signs of Disease Relapse

A recent study has shed light on the efficacy of combining vemurafenib and obinutuzumab in treating patients with previously untreated hairy cell leukemia (HCL). The study primarily focused on complete remission rates and safety profiles, revealing promising results.

HCN Medical Memo
This study indicates that a regimen of vemurafenib and obinutuzumab can achieve high rates of complete remission and minimal residual disease negativity. The treatment also showed a manageable safety profile, making it a promising option for previously untreated HCL patients.

Study Design
  • Single-arm, multicenter clinical study
  • 30 patients with previously untreated HCL enrolled
  • Vemurafenib 960 mg twice daily for four cycles
  • Obinutuzumab administered in cycles 2 to 4
  • Primary end point: Complete remission (CR)
  • Secondary end points: Safety, minimal residual disease (MRD), and BRAF allele burden

Hairy cell leukemia accounts for just 2% of all leukemias.

Key Findings
  • 27 out of 30 patients completed all four cycles and achieved CR (90%; 95% CI, 73 to 98)
  • 26 out of 27 patients who achieved CR also achieved MRD negativity (96%; 95% CI, 81 to 99)
  • BRAFV600E allele undetectable in all 21 evaluable patients
  • No disease relapse observed at a median follow-up of 34.9 months
  • Most common adverse events: rash and arthralgia
  • Febrile neutropenia in two patients; blood or platelet transfusions required in two patients

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