Amgen, Allergan report positive results from comparative study of ABP 798, biosimilar candidate to Rituxan to treat patients with CD20-positive B-cell NHL
Amgen and Allergan plc announced positive top-line results from a comparative clinical study evaluating the efficacy and safety of ABP 798, a biosimilar candidate to Rituxan (rituximab), compared to Rituxan in patients with CD20-positive B-cell non-Hodgkin's lymphoma. The primary endpoint, an assessment of overall response rate (ORR) by week 28, was within the prespecified margin for ABP 798 compared to Rituxan, showing clinical equivalence. safety and immunogenicity of ABP 798 were comparable to Rituxan.
This is the second of two studies intended to support regulatory submissions for ABP 798. The first study was conducted in patients with moderate-to-severe rheumatoid arthritis (RA) and met the primary endpoint of pharmacokinetic similarity. This RA study demonstrated clinical equivalence within the prespecified efficacy margin, and a similar safety and immunogenicity profile.
"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," said David M. Reese, MD, executive vice president of research and development at Amgen. "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."
ABP 798 is being developed as a biosimilar candidate to Rituxan, an anti-CD20 monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Amgen has a total of 10 biosimilars in its portfolio, including three that are approved in the United States (US).
The JASMINE study was a randomized, double-blind comparative clinical study (study number NCT02747043) that evaluated the efficacy, safety and immunogenicity of ABP 798 compared to rituximab in patients with non-Hodgkin's lymphoma. There were 256 adult patients enrolled and randomized to receive either ABP 798 or rituximab at a dose of 375 mg/m2 administered as an intravenous (IV) infusion once weekly for four weeks followed by dosing at weeks 12 and 20. The primary endpoint of the study was risk difference of overall response rate.
Non-Hodgkin's lymphoma is a type of cancer that originates in the lymph system, part of the body's immune system, and occurs when the body produces too many abnormal lymphocytes, a type of white blood cell. Non-Hodgkin's lymphoma is one of the most common cancers in the US, and about 85 percent of cases originate in B cells. There are several subtypes, and follicular lymphoma is one of the most common.
ABP 798 is being developed as a biosimilar candidate to Rituxan (rituximab), an anti-CD20- monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.
This is the second of two studies intended to support regulatory submissions for ABP 798. The first study was conducted in patients with moderate-to-severe rheumatoid arthritis (RA) and met the primary endpoint of pharmacokinetic similarity. This RA study demonstrated clinical equivalence within the prespecified efficacy margin, and a similar safety and immunogenicity profile.
"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," said David M. Reese, MD, executive vice president of research and development at Amgen. "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."
ABP 798 is being developed as a biosimilar candidate to Rituxan, an anti-CD20 monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis.
Amgen has a total of 10 biosimilars in its portfolio, including three that are approved in the United States (US).
The JASMINE study was a randomized, double-blind comparative clinical study (study number NCT02747043) that evaluated the efficacy, safety and immunogenicity of ABP 798 compared to rituximab in patients with non-Hodgkin's lymphoma. There were 256 adult patients enrolled and randomized to receive either ABP 798 or rituximab at a dose of 375 mg/m2 administered as an intravenous (IV) infusion once weekly for four weeks followed by dosing at weeks 12 and 20. The primary endpoint of the study was risk difference of overall response rate.
Non-Hodgkin's lymphoma is a type of cancer that originates in the lymph system, part of the body's immune system, and occurs when the body produces too many abnormal lymphocytes, a type of white blood cell. Non-Hodgkin's lymphoma is one of the most common cancers in the US, and about 85 percent of cases originate in B cells. There are several subtypes, and follicular lymphoma is one of the most common.
ABP 798 is being developed as a biosimilar candidate to Rituxan (rituximab), an anti-CD20- monoclonal antibody that is approved in many regions for the treatment of adult patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, moderate-to-severe rheumatoid arthritis, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. The active ingredient of ABP 798 is a monoclonal antibody that has the same amino acid sequence as Rituxan.
In December 2011, Amgen and Allergan plc. (then Watson Pharmaceuticals, Inc.) formed a collaboration to develop and commercialize, on a worldwide basis, four oncology antibody biosimilar medicines. This collaboration reflects the shared belief that the development and commercialization of biosimilar products will not follow a pure brand or generic model and will require significant expertise, infrastructure, and investment to ensure safe, reliably supplied therapies for patients. Under the terms of the agreement, Amgen assumes primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.
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