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Amgen And Allergan Announce Positive Top-line Results From Phase 3 Study of Biosimilar Candidate ABP 215
The primary endpoint, an assessment of objective response rates (ORR), was within the prespecified margin for ABP 215 compared to bevacizumab, showing clinical equivalence. Safety and immunogenicity of ABP 215 were comparable to bevacizumab. Secondary endpoint results were consistent with the primary finding and included risk difference of ORR, duration of response and progression-free survival (PFS).
ABP 215 is being developed as a biosimilar to bevacizumab, a recombinant immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that binds to vascular endothelial growth factor (VEGF) and inhibits the interaction of VEGF with its receptors, VEGF receptor-1 and VEGF receptor-2, thus inhibiting establishment of new blood vessels necessary for the maintenance and growth of solid tumors.
"The positive Phase 3 clinical results of ABP 215 mark an important step forward in the development of biosimilar treatment options for patients with advanced non-small cell lung cancer," said
This was a randomized, double-blind, active-controlled study (study number 20120265) that evaluated safety and efficacy of ABP 215 compared to bevacizumab in adult patients with advanced non-squamous NSCLC receiving first-line chemotherapy with carboplatin and paclitaxel. There were 642 patients enrolled and randomized (1:1) to receive investigational product (ABP 215 or bevacizumab) at a dose of 15 mg/kg administered as an IV infusion every 3 weeks (Q3W) for up to 6 cycles. Among them, there were 328 patients randomized to the ABP 215 group and 314 patients to the bevacizumab group.
The duration of the treatment included a screening period of up to 4 weeks, followed by up to 6 Q3W treatment cycles and an end of treatment visit 21 days after the last dose of investigational product or study specified chemotherapy. Following the end of treatment visit, patients were followed for disease progression and overall survival (OS) until the end of the clinical study, consent was withdrawn, they were lost to follow-up, death or had proscribed therapy (e.g. commercial bevacizumab, non-study anti-cancer treatment).
Clinical equivalence of the primary endpoint was demonstrated by comparing the confidence interval of the risk ratio in ORR between ABP 215 and bevacizumab to a prespecified margin. Response was determined by independent review based on RECIST criteria.
About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) is the leading cause of cancer death in both men and women in the U.S. and the
For patients with metastatic (Stage IV) NSCLC or recurrent NSCLC following surgery and adjuvant chemotherapy, treatment usually consists of combination chemotherapy with a platinum-based regimen, such as cisplatin and gemcitabine or carboplatin and paclitaxel, in repeated 3-week cycles for up to 6 cycles. For patients without squamous cell histology or a recent history of hemoptysis, addition of the anti-VEGF antibody bevacizumab to this regimen improves ORR and prolongs PFS.7-9
Based on these and other data, bevacizumab has been approved in the U.S., EU and elsewhere for first-line treatment in patients with advanced or recurrent non-squamous NSCLC in combination with platinum-based chemotherapy.
About ABP 215
ABP 215 is being developed as a biosimilar to bevacizumab, which is approved in specific combinations in the U.S., EU and other regions for the treatment of patients with unresectable, locally advanced, recurrent or metastatic non-squamous NSCLC as well as metastatic carcinoma of the colon or rectum; metastatic renal cell carcinoma; and other region-specific indications.
About Amgen Biosimilars
Amgen Biosimilars is committed to building upon
Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.
With commercial operations in approximately 100 countries,
For more information, visit
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No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us and our partners to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. We depend on third parties for a significant portion of our manufacturing capacity for the supply of certain of our current and future products and limits on supply may constrain sales of certain of our current products and product candidate development.
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Statements contained in this press release that refer to future events or other non-historical facts are forward-looking statements that reflect
Avastin® is registered trademark of Genentech.
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