On 21 November 2018, the FDA granted accelerated approval to venetoclax (Venclexta®, AbbVie/Genentech) in combination with either azacitidine, or decitabine, or low-dose cytarabine (LDAC), for the treatment of newly-diagnosed acute myeloid leukaemia (AML) patients ≥75 years old or in those with comorbidities precluding intensive induction chemotherapy.

Study M14-358 and Study M14-387

The non-randomised, open-label Study M14-358 (NCT02203773) investigated the combination of venetoclax with azacitidine (N=67) or decitabine (N=13) in newly-diagnosed patients with AML of >75 years old or those who had comorbidities precluding the use of intensive induction chemotherapy. The efficacy measures included the complete remission (CR) rate and the CR duration or the observed in-remission time, defined as the time from the start of CR to the data cut-off date or relapse-date from CR.

Of the 67 patients who received venetoclax plus azacitidine, 25 achieved a CR (37%; 95% CI, 26-50). The median observed in-remission time was 5.5 (range: 0.4-30 ) months. In the 13 patients treated with venetoclax plus decitabine, 7 patients achieved a CR (54%; 95% CI, 25-81) with a median observed an in-remission time of 4.7 (range: 1.0-18) months.

The non-randomised, open-label Study M14-387 (NCT02287233) investigated the combination of venetoclax plus LDAC  (N=61) in newly-diagnosed AML patients, including those with prior exposure to a hypomethylating agent for an antecedent haematologic disorder. The efficacy measures included the complete remission (CR) rate and the CR duration or the observed in-remission time, defined as the time from the start of CR to the data cut-off date or relapse-date from CR.

Of the 67 patients who received venetoclax plus LDAC, 13 patients achieved a CR (21%; 95% CI, 12-34). The median observed in-remission time was 6 (range: 0.03-25) months.

Safety

Common adverse reactions (≥30%) observed in the combined studies of venetoclax plus azacitidine or decitabine and venetoclax plus LDAC included nausea, diarrhoea, thrombocytopenia, constipation, neutropenia, febrile neutropenia, fatigue, vomiting, peripheral oedema, pneumonia, dyspnoea, haemorrhage, anaemia, rash, abdominal pain, sepsis, back pain, myalgia, dizziness, cough, oropharyngeal pain, pyrexia, and hypotension.

Full prescribing information Venclexta®.

Disclaimer

This article is not medical advice. Patients should seek personal assessment by a licenced specialist. Physicians are recommended to read the full publication(s) as cited in the article before making medical decisions. This article does not supersede nor replace the published article(s).

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