Late-stage successes for Amgen and Roche
pharmafile | February 5, 2015 | News story | Sales and Marketing | Amgen, Bendamustine, Gazyva, Genentech, Humira, Levact, Napp, Roche, adalimumab, obinutuzumab
Roche and Amgen have both posted successful late-stage trial results that they say will contribute to their applications for regulatory approvals for key new drugs.
Roche’s biotech arm Genentech says a Phase III trial of its non-Hodgkin’s lymphoma drug Gazyva (obinutuzumab) met its primary endpoint, as did an Amgen study of its biosimilar version of Abbvie’s Humira (adalimumab).
The Genentech trial compared treatments in 413 people with indolent non-Hodgkin’s lymphoma who had not responded to treatment with MabThera (rituximab). The study compared people who were treated with Gazyva and Napp’s Levact (bendamustine) followed by Gazyva alone, or Levact alone, for up to two years.
The trial was stopped early after independent assessors decided there was more benefit from having the combination treatment. In a statement, Genentech says the study showed that people lived significantly longer without disease worsening or death (the study’s primary endpoint) when treated with the combination than Levact alone.
Sandra Horning, chief medical officer and head of global product development at the Roche group, says: “[This study] is the first of our pivotal Phase III studies of Gazyva to be completed in the non-Hodgkin’s lymphoma setting, building on the positive results we have seen in chronic lymphocytic leukemia. We are delighted that this study could be evaluated early due to the strength of its data, which we believe supports Gazyva’s potential.”
Amgen’s Phase III trial looked at whether its biosimilar candidate ABP 501 is equivalent to Humira. The study, in 526 patients with moderate to severe rheumatoid arthritis who had not responded to treatment with methotrexate, met its primary endpoint – a 20% improvement in symptoms after six months.
Sean Harper, executive vice president of R&D at Amgen says: “The positive results from Amgen’s biosimilar Phase 3 rheumatoid arthritis study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to adalimumab.
“Amgen’s success on both our ABP 501 psoriasis and rheumatoid arthritis studies underscores our expertise in the research and development of high-quality biologic therapies.”
Amgen has nine biosimilar molecules in development and expects to launch five of these biosimilars between 2017 and 2019. Humira is an anti-TNF-α monoclonal antibody that is already approved in many countries for the treatment of different types of arthritis, psoriasis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. Abbvie’s patents for Humira begin to expire in late 2016.
Lilian Anekwe
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