- |||||||||| Review, Journal: Oral therapy for myelodysplastic syndromes/neoplasms and acute myeloid leukemia: a revolution in progress. (Pubmed Central) - Jul 20, 2023
The approvals of oral HMAs such as cedazuridine-decitabine (C-DEC) and oral azacitidine (CC-486) have kindled the hope that myeloid malignancies may soon be treated with total oral therapy...Oral HMAs have the potential to be a convenient and efficacy-equivalent treatment option for patients with HR-MDS or AML and improve their quality of life by reducing clinic visits for medication administration. Total-oral therapy combinations, largely including an oral HMA 'backbone,' are in the early phases of clinical development, and it is our hope that well-designed trials employing these agents may soon allow the identification of optimal regimens that deliver effective disease-directed therapy with good tolerability.
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Rezlidhia (olutasidenib) / Rigel
OLUTASIDENIB IN POST-VENETOCLAX PATIENTS WITH MUTANT IDH1 AML (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_2087; Olutasidenib induced durable remissions in patients with mIDH1 R/R AML, including those failing prior treatment with a venetoclax-based regimen. relapsed/refractory, Acute myeloid leukemia, Phase II
- |||||||||| Venclexta (venetoclax) / Roche, AbbVie, Walter and Eliza Hall Institute, Rezlidhia (olutasidenib) / Rigel
Olutasidenib in post-venetoclax patients with mIDH1 AML. () - Apr 26, 2023 - Abstract #ASCO2023ASCO_6141; P1/2 Olutasidenib induced durable remissions in patients with mIDH1 R/R AML, including those failing prior treatment with a venetoclax-based regimen. Clinical trial information: NCT02719574.
- |||||||||| Rezlidhia (olutasidenib) / Rigel
Journal: Olutasidenib. (Pubmed Central) - Mar 24, 2023 Correlative work is ongoing with a focus on differential effects on IDHm tumors and whether modulation of the immune microenvironment might support combinations with immunotherapy. No abstract available
- |||||||||| Rezlidhia (olutasidenib) / Rigel
Review, Journal: Olutasidenib: First Approval. (Pubmed Central) - Mar 24, 2023 Olutasidenib was recently approved in the USA for the treatment of adults with R/R AML with a susceptible IDH1 mutation as detected by a US Food and Drug Administration-approved test. This article summarizes the milestones in the development of olutasidenib leading to this first approval for R/R AML.
- |||||||||| BAY1436032 / Bayer, Idhifa (enasidenib) / BMS, Servier, olutasidenib (FT-2102) / Rigel
Efficacy and Safety of IDH Inhibitors in AML: A Systematic Review of Clinical Trials () - Nov 29, 2022 - Abstract #ASH2022ASH_7281; In two clinical trials (N=192) on ND mIDH-2 AML patients, ORR was 74%-89%, CR was 54%-55%, and MLFS was 4%-11% with enasidenib + chemotherapy/azacytidine as compared to ORR of 36%, CR of 12%, and MLFS of 0% with azacytidine alone...In two clinical trials, ORR with BAY1436032 (N=27) and olutasidenib (N=123) were 15% and 46% respectively...Olutasidenib was also effective in patients with R/R mIDH-1 AML. More randomized double-blind multicenter clinical trials are needed to confirm these results.
- |||||||||| Real-World Outcomes of IDH Mutant AML Patients Treated with or without IDH Inhibitors (Hall D (Ernest N. Morial Convention Center)) - Nov 4, 2022 - Abstract #ASH2022ASH_4185;
Surprisingly, the median survival for patients who didn't receive IDHi therapy seemed not different, underscoring the other therapies' effects, including the influence of the venetoclax-based regimen. More extensive randomized studies are needed to compare the efficacy of IDHi to other therapies in treating IDHMT AML.
- |||||||||| olutasidenib (FT-2102) / Forma Therap
Journal: Novel Radioiodinated and Radiofluorinated Analogues of FT-2102 for SPECT or PET Imaging of mIDH1 Mutant Tumours. (Pubmed Central) - Jul 1, 2022 Using a common organotin precursor, (S)-[I]2 and (S)-[F]3 were efficiently synthesised by radio-iododemetallation and copper-mediated radiofluorination, respectively. Both radiotracers were stable at room temperature in saline or DPBS solution and at 37 °C in mouse serum, allowing future planning of their in vitro and in vivo evaluations in glioma and chondrosarcoma models.
- |||||||||| olutasidenib (FT-2102) / Forma Therap
P1/2 data, Journal: Olutasidenib (FT-2102) in patients with relapsed or refractory IDH1-mutant glioma: a multicenter, open-label, phase 1b/2 trial. (Pubmed Central) - Jun 4, 2022 Both radiotracers were stable at room temperature in saline or DPBS solution and at 37 °C in mouse serum, allowing future planning of their in vitro and in vivo evaluations in glioma and chondrosarcoma models. Olutasidenib 150 mg BID was well tolerated in patients with relapsed/refractory gliomas harboring an IDH1 R132X mutation and demonstrated preliminary evidence of clinical activity in this heavily pretreated population.
- |||||||||| Rezlidhia (olutasidenib) / Rigel
Enrollment change, Metastases: A Study of FT-2102 in Patients With Advanced Solid Tumors and Gliomas With an IDH1 Mutation (clinicaltrials.gov) - May 26, 2022 P1b/2, N=93, Active, not recruiting, Olutasidenib 150 mg BID was well tolerated in patients with relapsed/refractory gliomas harboring an IDH1 R132X mutation and demonstrated preliminary evidence of clinical activity in this heavily pretreated population. N=200 --> 93
- |||||||||| Clinical guideline, Review, Journal: Infectious complications of targeted drugs and biotherapies in acute leukemia. Clinical practice guidelines by the European Conference on Infections in Leukemia (ECIL), a joint venture of the European Group for Blood and Marrow Transplantation (EBMT), the European Organization for Research and Treatment of Cancer (EORTC), the International Immunocompromised Host Society (ICHS) and the European Leukemia Net (ELN). (Pubmed Central) - May 6, 2022
The set of recommendations was posted on the ECIL website for a month for comments from members of EBMT, EORTC, ICHS and ELN before final approval by the panelists. While a majority of these agents are not associated with a significantly increased risk when used as monotherapy, caution is required with combination therapy such as venetoclax plus hypomethylating agents, gemtuzumab ozogamicin plus cytotoxic drugs or midostaurin added to conventional AML chemotherapy.
- |||||||||| Rezlidhia (olutasidenib) / Rigel
Enrollment closed, Enrollment change, Combination therapy: 2102-HEM-101: Open-label Study of FT-2102 With or Without Azacitidine or Cytarabine in Patients With AML or MDS With an IDH1 Mutation (clinicaltrials.gov) - Mar 3, 2022 P1/2, N=336, Active, not recruiting, While a majority of these agents are not associated with a significantly increased risk when used as monotherapy, caution is required with combination therapy such as venetoclax plus hypomethylating agents, gemtuzumab ozogamicin plus cytotoxic drugs or midostaurin added to conventional AML chemotherapy. Recruiting --> Active, not recruiting | N=500 --> 336
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