Amgen Inc. and Allergan PLC's biosimilar medicine ABP 798 worked as well as Roche Holding AG and Biogen Inc.'s blockbuster Rituxan in a second clinical trial, this time in patients with a type of blood cancer.
The companies evaluated the efficacy and safety of ABP 798 compared to Rituxan, or rituximab, in patients with B-cell non-Hodgkin lymphoma having a mutation of the CD20 protein. The study, dubbed Jasmine, included 256 adults who received either ABP 798 or Rituxan.
Non-Hodgkin lymphoma, one of the most common cancers in the U.S., originates in the lymph system, part of the body's immune system. It occurs when the body produces too many abnormal lymphocytes — a type of white blood cell that helps in fighting disease. About 85% of cases originate in B cells, a type of lymphocyte, the companies said.
After 28 weeks of treatment the trial's main goal of overall response rate — the percentage of patients whose tumors shrank by a predefined amount and for a minimum amount of time — was within the prespecified margin for ABP 798 compared to Rituxan, showing clinical equivalence, the companies said.
Thousand Oaks, Calif.-based Amgen and Irish drugmaker Allergan noted that the safety and immunogenicity — the ability of a substance to provoke an immune response — of the biosimilar therapy were comparable to Rituxan.
Biosimilars are biological products that act in the same way as their reference products, typically brand-name medicines that have been on the market for some time. A biosimilar is intended to be a lower-cost version of biologic therapy, a type of treatment derived from living organisms.
Rituxan is approved in many regions for treating adult patients with non-Hodgkin lymphoma; chronic lymphocytic leukemia; a type of blood vessel inflammation disorder called microscopic polyangiitis; and autoimmune disorders such as moderate to severe rheumatoid arthritis, pemphigus vulgaris and granulomatosis with polyangiitis.
Amgen Executive Vice President of Research and Development David Reese said the companies look forward to working with regulatory agencies to bring the treatment to patients.
The cancer trial was the second of two studies that will support regulatory submissions for ABP 798, the companies said in their Aug. 22 press release. In January, ABP 798 was seen to be as good as Rituxan in treating rheumatoid arthritis — an autoimmune disorder that leads to swollen and painful joints — in a phase 1/ phase 3 study.
Amgen and Allergan, which is being acquired by AbbVie Inc. in an $84.2 billion deal, teamed up in December 2011 to develop and commercialize four oncology antibody biosimilar medicines.
Amgen noted that it has 10 biosimilars in its portfolio, including three that are approved in the U.S.
Roche said in its 2018 annual report that Rituxan saw its sales decline in Europe by 47% as a result of the entry of biosimilars. The drug generated revenues of CHF6.75 billion globally in 2018, down 8%, year over year.
