Janssen CLL treatment combination sees success in trials

pharmafile | June 14, 2021 | News story | Sales and Marketing CLL, Janssen 

Janssen has announced positive data from its Phase III GLOW study, with the combination of imbruvica (ibrutinib) plus venetoclax (I+V) outperforming chlorambucil plus obinutuzumab (Clb+O), for the first-line treatment of elderly or unfit patients with chronic lymphocytic leukaemia (CLL).

The study demonstrated superior progression-free survival (PFS) of a once-daily, all-oral, fixed-duration regimen of I+V versus Clb+O and also showed improved duration of remission and significantly improved depth of remission.

CLL is typically a slow-growing blood cancer of the white blood cells. The overall incidence of CLL in Europe is approximately 4.92 cases per 100,000 persons per year and is about 1.5 times more common in men than in women.

The disease eventually progresses in the majority of patients, and they are faced with fewer treatment options with each relapse. Patients are often prescribed multiple lines of therapy as they relapse or become resistant to treatments.

Arnon Kater, deputy head of haematology at the University of Amsterdam Faculty of Medicine and principal study investigator, said: “In the GLOW study, two very active blood cancer treatments are combined to create a complementary therapeutic regimen with the hope that deep responses might enable treatment-free remission for patients.

“The data from GLOW showed that ibrutinib in an oral, once-daily, fixed-duration combination with venetoclax outperformed a standard chemoimmunotherapy regimen for older or unfit patients, providing the first comparative evidence that this approach has the potential to improve depth of response and, therefore, extends time to progression versus standard therapy.”

Ibrutinib is a once-daily, Bruton’s tyrosine kinase (BTK) inhibitor that is administered orally, and is jointly developed and commercialised by Janssen Biotech, and Pharmacyclics LLC. Ibrutinib blocks the BTK protein which sends important signals that tell B cells to mature and produce antibodies. BTK signalling is needed by specific cancer cells to multiply and spread and by blocking BTK, ibrutinib may help move abnormal B cells out of their nourishing environments in the lymph nodes, bone marrow, and other organs.

Edmond Chan, EMEA Therapeutic Area Lead Haematology, Janssen-Cilag, said: “Ibrutinib has been used to treat more than 230,000 patients worldwide and continues to be a mainstay in the treatment of CLL.

“This latest data is an encouraging step forward, meaning ibrutinib could be an option both for patients who require continuous treatment as well as those for whom a fixed-duration treatment is most appropriate.”

Ibrutinib is approved in more than 100 countries, and, to date, has been used to treat more than 230,000 patients worldwide. Ibrutinib was first approved by the European Commission in 2014, and approved indications to date include:

  • Chronic lymphocytic leukaemia (CLL): As a single agent or in combination with rituximab or obinutuzumab for the treatment of adult patients with previously untreated CLL, and as a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy.
  • Mantle cell lymphoma (MCL): As a single agent for the treatment of adult patients with relapsed or refractory MCL.
  • Waldenström’s macroglobulinemia (WM): As a single agent for the treatment of adult patients who have received at least one prior therapy or in first-line treatment for patients unsuitable for chemo-immunotherapy, and in combination with rituximab for the treatment of adult patients.

Kat Jenkins

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