The randomised, double-blind comparative JASMINE study evaluated the efficacy and safety of biosimilar candidate ABP 798 compared to Rituxan in lymphoma patients.
A total of 256 adult patients were enrolled and randomised for the trial to receive either ABP 798 or rituximab at a dose of 375mg/m².
ABP 798 was administered as an intravenous (IV) infusion once weekly for four weeks followed by dosing at weeks 12 and 20.
The trial’s primary endpoint was an assessment of overall response rate (ORR) by week 28.
It was found to be within the prespecified margin for ABP 798 compared to Rituxan and highlighted clinical equivalence.
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Amgen Research and Development executive vice-president David Reese said: “Today’s results with ABP 798 demonstrate another positive development from Amgen’s robust pipeline of biosimilar medicines and we look forward to working with regulatory agencies to bring this treatment to patients.
“We continue to leverage our deep expertise and heritage in biologics across innovative and biosimilar medicines as part of our commitment to providing a range of treatment options for patients with the most serious diseases, including cancer.”
The latest trial of ABP 798 is the second of two studies aimed at supporting regulatory submissions for the drug candidate.
Amgen carried out the first study in patients with moderate-to-severe rheumatoid arthritis (RA).
In January, Amgen and Allergan reported positive top-line results from a Phase l/lll trial of ABP 798 in comparison with rituximab to treat patients with moderate-to-severe RA.
Amgen has ten biosimilars in its portfolio, including three approved in the US.