<Vadastuximab Talirine Monotherapy in Older Patients with Treatment Naive CD33-Positive Acute Myeloid Leukemia (Abstract #590, oral presentation on Monday, December 5, 2016 at 7:15 a.m. PT)>
Of the 26 patients evaluable for response, remission (CR or CRi) was observed in 15 patients (58 percent), with a median time to remission of 1.4 months.
Forty-three percent of patients who achieved remission were MRD negative.
Responses were observed in higher-risk patients, with remissions achieved in seven of 12 patients (58 percent) with underlying myelodysplasia and three of four patients (75 percent) who were positive for FLT3/ITD.
The 30- and 60-day mortality rates were zero and 15 percent, respectively. The median overall survival for all patients was seven months.
The most common Grade 3 or higher treatment-emergent adverse events occurring in 20 percent or more of patients were thrombocytopenia, febrile neutropenia and anemia.
The most common Grade 1 and 2 treatment-emergent adverse events occurring in 20 percent or more of patients were peripheral edema, decreased appetite, fatigue, diarrhea and dizziness.
Good data for mono-therapy (OS is not dramatic improvement), but AE are serious problem here.
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