NICE says yes to J&J, AbbVie first-line leukaemia regimen

Patients in England with chronic lymphocytic leukaemia (CLL) will be able to access a new combination therapy based on Johnson & Johnson’s Imbruvica plus AbbVie’s Venclyxto, following new guidance from NICE.

The health technology assessment (HTA) organisation published final draft guidance today that says BTK inhibitor Imbruvica (ibrutinib) and BCL-2 inhibitor Venclyxto (venetoclax) are an option for previously-untreated adult CLL patients.

J&J’s drug is already used in the NHS as a single agent or in combination with rituximab or Roche’s Gazyva (obinutuzumab) for newly-diagnosed adults with CLL, an incurable blood cancer that affects white blood cells and bone marrow.

The new combination is the first all-oral, once-daily, chemotherapy-free fixed-duration regimen for patients with CLL, the most common type of leukaemia in adults, which affects around 3,800 people diagnosed in the UK each year.

Amanda Cunnington, director of patient access at J&J’s Janssen-Cilag Ltd unit in the UK, said the company was delighted with the decision, especially as the combination has been recommended for use in the entire indicated population in England.

“The availability of this combination therapy will bring a much-needed new treatment option for those living with CLL, and Janssen is proud to have added to our existing ibrutinib-based treatment options for patients across England and Wales,” she added.

The combination was approved last year, mainly on the strength of the GLOW and CAPTIVATE studies. In GLOW, median progression-free survival (PFS) was not reached for the combo after a median follow-up of 27.7 months, which compared with the PFS of 21 months in a control group receiving Gazyva and chlorambucil.

CAPTIVATE, meanwhile, revealed a 56% complete response rate and progression-free survival (PFS) after 24 months of 95%. Overall survival (OS) at the same timepoint was 98%.

In its appraisal document, NICE said that ibrutinib plus venetoclax’s fixed treatment duration and better toxicity profile than current treatments made it a “highly valued treatment option.”

The chair of patient organisation CLL Support, Hilary Lindsey, said the regimen’s endorsement by NICE is “a great step forward in the treatment of CLL and will, we are sure, prove to be of huge benefit to patients.”

At the moment, current options for first-line treatment of CLL in the NHS include AstraZeneca’s BTK inhibitor Calquence (acalabrutinib), the rarely-used combination of fludarabine plus cyclophosphamide and rituximab (FCR), Imbruvica alone, Gazyva plus chlorambucil, and Gazyva plus Venclyxto.