|The following article features coverage from the 2021 Annual Meeting of the Society of Hematologic Oncology (SOHO). Click here to read more of Hematology Advisor‘s conference coverage.|
Outcomes for patients with relapsed/refractory (R/R) acute myeloid leukemia (AML) who received gilteritinib after treatment with midostaurin or sorafenib were evaluated in an analysis of 2 clinical trials presented at the Annual Meeting of the Society of Hematologic Oncology (SOHO) by Alexander E. Perl, MD, MS, of Abramson Cancer Center at the University of Pennsylvania in Philadelphia, PA, and colleagues.
The clinical trials were the phase 1/2 CHRYSALIS trial (ClinicalTrials.gov Identifier: NCT02014558) and the phase 3 ADMIRAL trial (ClinicalTrials.gov Identifier: NCT02421939), with both evaluated the use of gilteritinib in patients with R/R AML. The CHRYSALIS trial showed this agent to be safe and have antileukemic activity in an FLT3-mutation-enriched population, and ADMIRAL showed this agent to be superior to salvage chemotherapy in FLT3-mutated patients. The analysis presented by Dr Perl and colleagues focused on outcomes for patients in these trials who were previously treated with tyrosine kinase inhibitors (TKIs).
In patients from the CHRYSALIS trial who were evaluated in this analysis (145 patients), 23% had received prior therapy with the TKI sorafenib. In evaluated patients from the ADMIRAL trial (371 patients), 247 patients received gilteritinib, and 124 received salvage chemotherapy. Of the gilteritinib-treated patients in the ADMIRAL trial, 13% had received prior TKI therapy, including both midostaurin and sorafenib, and 11% of patients on salvage chemotherapy also received TKIs.
Both trials showed that patients treated with gilteritinib had composite complete remission rates above 40%, whether they had received a prior TKI or not. In the ADMIRAL trial, gilteritinib-treated patients showed higher composite complete remission rates regardless of prior TKI status, compared with those given salvage chemotherapy. Responses on the ADMIRAL trial also were reported to be high for patients receiving gilteritinib independent of FLT3 mutation type and with or without prior TKI therapy.
In a combined analysis of median overall survival (OS) in gilteritinib-treated patients (dosed at 120 or 200 mg) from both trials, the median OS was 7.0 months (95% CI, 4.7-8.7) for patients with a history of prior TKI therapy, and it was 8.7 months (95% CI, 7.5-10.2) for patients without a history of prior TKI therapy.
Dr Perl and colleagues concluded that in the ADMIRAL trial, gilteritinib was associated with longer survival, compared with salvage chemotherapy, in patients with prior receipt of midostaurin or sorafenib. They also concluded that the analysis demonstrated high remission rates with gilteritinib in patients with FLT3-mutated R/R AML who had previously been treated with midostaurin or sorafenib.
Disclosures: Some authors have declared affiliations with or received grant support from the pharmaceutical industry. Please refer to the original study for a full list of disclosures.
Read more of Hematology Advisor’s coverage of SOHO 2021 by visiting the conference page.
Perl AE, Altman JK, Hosono N, et al. Clinical outcomes in patients with relapsed/refractory acute myeloid leukemia treated with gilteritinib who received prior midostaurin or sorafenib. Paper presented at: Annual Meeting of the Society of Hematologic Oncology (SOHO); September 8-11, 2021. Abstract AML-091.