AbbVie’s Pharmacyclics unit has filed a lawsuit against BeiGene, alleging that the biotech’s Brukinsa (zanubrutinib) infringes a patent on its own blood cancer drug Imbruvica (ibrutinib).
Brukinsa and Imbruvica are both BTK inhibitors approved to treat chronic lymphocytic leukaemia (CLL) and small lymphocytic lymphoma (SLL).
CLL and SLL are essentially the same diseases, treated in the same way, but are named depending on where most cancer cells are found. In CLL, malignant cells are concentrated in the blood and bone marrow, while in SLL they appear in the lymph nodes.
Imbruvica, which was jointly developed by AbbVie’s Pharmacyclics and the Janssen Pharmaceutical Companies of Johnson & Johnson, was approved in the US in 2014 as a treatment option for CLL. Its label has since been updated supporting its expanded use in SLL patients.
Brukinsa was approved in the US for both indications in January this year and had its patent issued on Tuesday last week. Through its complaint, filed the same day in federal court in Delaware, US, AbbVie is seeking a declaratory judgment of infringement, as well as damages.
BeiGene said in a statement that it will “vigorously defend” against all allegations of patent infringement.
“It is an unfortunate but rather regular occurrence that companies make allegations that a competitive product potentially infringes their intellectual property rights, even more so in response to a clearly differentiated medicine for cancer patients as Brukinsa,” the company said.
The US approval for Brukinsa was supported by two global head-to-head phase 3 clinical trials in which the drug demonstrated superior efficacy against Imbruvica in patients with relapsed/refractory CLL or SLL, as well as against bendamustine plus rituximab in treatment-naïve CLL or SLL patients.
In the head-to-head ALPINE study against Imbruvica, Brukinsa achieved a superior overall response rate of 80.4% versus 72.9%, as well as superior progression-free survival. Significantly lower rates of atrial fibrillation/flutter were also observed in Brukinsa-treated patients, meaning the treatment has the potential to offer a more tolerable treatment option for certain patients.
The National Comprehensive Cancer Network recently placed Brukinsa above Imbruvica in several areas, based on their compared toxicity.