Contributions
Abstract: EP441
Type: E-Poster Presentation
Session title: Acute myeloid leukemia - Clinical
Background
Gilteritinib is an oral FLT3 inhibitor approved for patients with FLT3-mutated (FLT3mut+) relapsed or refractory (R/R) acute myeloid leukemia (AML) based on findings from the phase 3 ADMIRAL trial, which demonstrated the superiority of gilteritinib to salvage chemotherapy in this patient population.
Aims
To evaluate response and safety outcomes in patients with FLT3mut+ R/R AML treated with gilteritinib who underwent hematopoietic stem cell transplantation (HSCT) during the ADMIRAL trial.
Methods
Outcomes were evaluated for patients with FLT3mut+ R/R AML treated with gilteritinib who underwent HSCT during the phase 3 ADMIRAL trial and were without relapse for 60 days after HSCT.
Results
Of the 63 FLT3mut+ R/R AML patients treated with gilteritinib who underwent HSCT during the trial, 51 were without relapse for 60 days after transplantation. Of these 51 patients, 35 (69%) resumed gilteritinib therapy post-HSCT after a median of 1.9 months. Median gilteritinib exposures in patients who resumed gilteritinib were 3.0 months pre-HSCT and 6.4 months post-HSCT, respectively. With a median follow-up of 12.4 months, patients who resumed gilteritinib had longer median overall survival than patients who did not (16.2 vs 8.4 months; hazard ratio for death: 0.387; 95% CI: 0.164, 0.915). In patients who resumed gilteritinib, pre-HSCT rates of complete remission (CR), composite CR, and CR with full or partial hematologic recovery were 11%, 71%, and 31%, respectively. Common adverse events during the post-HSCT period in patients who resumed gilteritinib were increased alanine aminotransferase (46%) and pyrexia (37%); common grade ≥3 adverse events were thrombocytopenia and lung infection (both 14%). Fatal adverse events included cardiac arrest, acute graft-versus-host disease in the intestine, pneumothorax, and pulmonary embolism (all n=1).
Conclusion
Overall, patients with FLT3mut+ R/R AML who resumed gilteritinib post-HSCT had high response rates prior to HSCT and longer overall survival than patients who did not resume gilteritinib therapy. No new safety signals during the post-HSCT period were identified in patients who resumed gilteritinib therapy.
Keyword(s): Acute myeloid leukemia, Flt3 inhibitor, Hematopoietic cell transplantation
Abstract: EP441
Type: E-Poster Presentation
Session title: Acute myeloid leukemia - Clinical
Background
Gilteritinib is an oral FLT3 inhibitor approved for patients with FLT3-mutated (FLT3mut+) relapsed or refractory (R/R) acute myeloid leukemia (AML) based on findings from the phase 3 ADMIRAL trial, which demonstrated the superiority of gilteritinib to salvage chemotherapy in this patient population.
Aims
To evaluate response and safety outcomes in patients with FLT3mut+ R/R AML treated with gilteritinib who underwent hematopoietic stem cell transplantation (HSCT) during the ADMIRAL trial.
Methods
Outcomes were evaluated for patients with FLT3mut+ R/R AML treated with gilteritinib who underwent HSCT during the phase 3 ADMIRAL trial and were without relapse for 60 days after HSCT.
Results
Of the 63 FLT3mut+ R/R AML patients treated with gilteritinib who underwent HSCT during the trial, 51 were without relapse for 60 days after transplantation. Of these 51 patients, 35 (69%) resumed gilteritinib therapy post-HSCT after a median of 1.9 months. Median gilteritinib exposures in patients who resumed gilteritinib were 3.0 months pre-HSCT and 6.4 months post-HSCT, respectively. With a median follow-up of 12.4 months, patients who resumed gilteritinib had longer median overall survival than patients who did not (16.2 vs 8.4 months; hazard ratio for death: 0.387; 95% CI: 0.164, 0.915). In patients who resumed gilteritinib, pre-HSCT rates of complete remission (CR), composite CR, and CR with full or partial hematologic recovery were 11%, 71%, and 31%, respectively. Common adverse events during the post-HSCT period in patients who resumed gilteritinib were increased alanine aminotransferase (46%) and pyrexia (37%); common grade ≥3 adverse events were thrombocytopenia and lung infection (both 14%). Fatal adverse events included cardiac arrest, acute graft-versus-host disease in the intestine, pneumothorax, and pulmonary embolism (all n=1).
Conclusion
Overall, patients with FLT3mut+ R/R AML who resumed gilteritinib post-HSCT had high response rates prior to HSCT and longer overall survival than patients who did not resume gilteritinib therapy. No new safety signals during the post-HSCT period were identified in patients who resumed gilteritinib therapy.
Keyword(s): Acute myeloid leukemia, Flt3 inhibitor, Hematopoietic cell transplantation