Roche and Pharmacyclics agree leukaemia pact
pharmafile | October 17, 2014 | News story | Research and Development, Sales and Marketing | BMS, CLL, Cancer, Gazyva, Pharmacyclics, Roche, imbruvica, leukaemia
Pharmacyclics’s cancer drug Imbruvica will be tested in combination with Roche’s Gazyva in a new partnership announced by the firms.
The combined drugs will be evaluated for use in patients with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia/small lymphocytic lymphoma (CLL/SLL).
Both products are already approved for the treatment of CLL. Imbruvica (ibrutinib) is used in patients who have received one prior therapy, and Gazyva (obinutuzumab) is used with the chemotherapy drug chlorambucil in previously-untreated CLL.
“We are committed to evaluating the potential activity of Imbruvica as a single agent and in combination with other agents to determine the benefits that Imbruvica may provide through a variety of uses across several hematologic malignancies,” says Bob Duggan, chairman and chief executive of Pharmacyclics.
The only study planned at the moment is a Phase III study in CLL/SLL that will be conducted by Pharmacyclics, but the firms say that the agreement allows for multiple studies to be considered and conducted.
CLL is the most common leukaemia in Europe and represents 25-30% of all forms of the disease. It is responsible for around 13,000 deaths across Europe every year.
Imbruvica is jointly-developed and commercialised by both Pharmacyclics and Janssen. It works as a protein inhibitor, blocking signals that tell malignant cells to multiply and spread uncontrollably. It is also approved for the treatment of mantle cell lymphoma (MCL) and is the only product to have received three breakthrough therapy designations from the FDA.
Gazyva, marketed as Gazyvaro in the EU, is an antibody drug that attacks targeted cells both directly and together with the immune system. Roche will be hoping that the drug can act as a next-generation version of its blockbuster MabThera (rituximab), which will lose its patents in the near future.
The drugs were approved in the EU around the same time as each other, and had looked to be competitors in the market.
Pharmacyclics and Janssen also recently partnered with Bristol-Myers Squibb to investigate Imbruvia in combination with BMS’s Opdivo (nivolumab) for the treatment of CLL and NHL, as well as diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL).
Pharmacyclics say that a study of the investigational combination of Imbruvica and Gazyva through several investigator-sponsored trials also is being considered.
George Underwood
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