R/R AML: binimetinib minimally effective in phase 2 trial

  • Maiti A, et al.
  • Clin Lymphoma Myeloma Leuk
  • 12 dic. 2018

  • de David Reilly
  • Univadis Clinical Summaries
El acceso al contenido completo es sólo para profesionales sanitarios registrados. El acceso al contenido completo es sólo para profesionales sanitarios registrados.

Takeaway

  • Monotherapy with the MEK 1/2 inhibitor binimetinib demonstrated acceptable tolerability but minimal efficacy in patients with relapsed or refractory acute myeloid leukemia (R/R AML).
  • Binimetinib may be better studied in combination with synergistic therapies in future studies.

Why this matters

  • Other MEK inhibitors, selumetinib and trametinib, have demonstrated modest monotherapy efficacy in this setting.

Study design

  • Phase 2 study to investigate binimetinib in 19 patients with R/R AML, 14 of whom had RAS mutations.
  • 64 (range, 31-85) years median patient age.
  • Patients had received a median of 3 (range, 1-6) prior lines of therapy.
  • Funding: National Cancer Institute.

Key results

  • 8% (1 of 13 evaluable patients) who had a NRAS G12A mutation achieved complete response with incomplete blood count recovery for a duration of 2.1 months.
  • 92% of patients did not respond to treatment.
  • 1.8 months median OS; 42% OS at 3 months, 12% OS at 6 months.
  • The most common grade 3/4 treatment-related adverse events (TRAEs) were hypokalemia (6%), hypotension (6%), lung infections (6%), and febrile neutropenia (6%).

Limitations

  • Open-label study.
  • Limited sample size.