Venclexta seeks to join the acute myelogenous leukaemia club

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Though the small-molecule Bcl2-targeting drug Venclexta was touted as a revolutionary treatment for chronic lymphocytic leukaemia it has had a low profile since launch, eclipsed by such therapies as Imbruvica and Gazyva. So its additional development for acute myelogenous leukaemia (AML) might have gone virtually unnoticed – until now. Its joint originators, Roche and Abbvie, today said a US filing for chemo-ineligible first-line AML had been submitted; the drug is already available for second-line chronic lymphocytic leukaemia with the aggressive 17p deletion genotype. AML, an intractable cancer, has seen some progress at last, with the recent approvals of Novartis’s Rydapt, in first-line patients with FLT3 mutations, and Celgene’s Idhifa, in relapsed/refractory disease with an IDH2 mutation. Still, AML remains tough to treat, and a measure of this is the extremely early data on which Venclexta has been filed: two open-label, dose-escalation, phase I/II studies.

Venclexta trials used to support AML filing
Study Design Complete remission Median overall survival Trial ID
M14-358 400-1,200mg Venclexta + decitabine or azacitadine 67% (76% for 400mg) 17.5mth (not reached for 400mg) NCT02203773
M14-387 600-800mg Venclexta + low-dose cytarabine 54% (62% for 600mg) 11.4mth NCT02287233
Source: ASCO 2018 for M14-358; EHA 2017 for M14-387. Treatment with low-dose cytarabine in this population typically gives CRs of 11–19% and median overall survival of 5-6 months.
Forecast sales in AML ($m)
Product Company 2018e 2024e
Tibsovo Agios Pharmaceuticals 36 844
Amnolake Syros Pharmaceuticals - 714
Venclexta Roche/Abbvie - 654
Idhifa Celgene 81 613
Gilteritinib Astellas Pharma 1 558
SL-401 Stemline Therapeutics - 541
Rydapt Novartis 160 422
ARGX-110 Argenx - 410
Quizartinib Daiichi Sankyo 0 329
GMI-1271 Glycomimetics - 281
Source: EvaluatePharma sales by indication data.

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