- Study Evaluated Efficacy and Safety of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer
- Primary Efficacy Analysis Demonstrates Clinical Equivalence; Safety, Immunogenicity Comparable to Bevacizumab
THOUSAND OAKS, CA, USA and DUBLIN, Ireland I September 23, 2015 I Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced a Phase 3 study of biosimilar candidate ABP 215 met its primary and secondary endpoints. The study evaluated the efficacy and safety of ABP 215 compared with Avastin® (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).
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.
“Amgen is committed to bringing high-quality, reliably supplied medicines to patients and we’re excited to leverage our development and manufacturing capabilities in oncology for our biosimilars. The positive Phase 3 results from ABP 215 study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Non-small cell lung cancer is the leading cause of cancer death in both men and women in the U.S. and the EU. ABP 215 holds the potential to advance access to treatment options for oncology patients.”
“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 David Nicholson, executive vice president and president of Global Research and Development of Allergan. “Allergan is committed to developing biosimilars that provide safe, high-quality and effective therapies in key disease areas for patients.”
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of nine biosimilars in development. Allergan is also independently developing biosimilars.
Study Design
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 European Union (EU). In the U.S., there were an estimated 226,160 new cases and 160,340 deaths due to NSCLC in 2012, and in the EU there were an estimated 265,600 new cases and 236,000 deaths due to NSCLC in 2006.1,2 NSCLC arises from the epithelial cells of the lung of the central bronchi to terminal alveoli. The histological type of NSCLC depends on the cells of origin, most commonly squamous cell carcinoma, large cell carcinoma and adenocarcinoma. Cigarette smoking is the primary risk factor for NSCLC, and other risks include exposure to second hand smoke, family history, radon exposure and exposure to air pollution.3-6
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 the Amgen and Allergan Collaboration
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 will assume primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.
About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients suffering from serious illnesses. Biosimilars offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.
For more information, visit www.amgenbiosimilars.com and follow us www.twitter.com/amgenbiosim.
About Amgen
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan’s website at www.allergan.com.
SOURCE: Amgen
Post Views: 649
- Study Evaluated Efficacy and Safety of ABP 215 Compared With Bevacizumab in Patients With Advanced Non-small Cell Lung Cancer
- Primary Efficacy Analysis Demonstrates Clinical Equivalence; Safety, Immunogenicity Comparable to Bevacizumab
THOUSAND OAKS, CA, USA and DUBLIN, Ireland I September 23, 2015 I Amgen (NASDAQ:AMGN) and Allergan plc. (NYSE:AGN) today announced a Phase 3 study of biosimilar candidate ABP 215 met its primary and secondary endpoints. The study evaluated the efficacy and safety of ABP 215 compared with Avastin® (bevacizumab) in adult patients with advanced non-squamous non-small cell lung cancer (NSCLC).
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.
“Amgen is committed to bringing high-quality, reliably supplied medicines to patients and we’re excited to leverage our development and manufacturing capabilities in oncology for our biosimilars. The positive Phase 3 results from ABP 215 study showed clinical equivalence in efficacy, and comparable safety and immunogenicity, to bevacizumab,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Non-small cell lung cancer is the leading cause of cancer death in both men and women in the U.S. and the EU. ABP 215 holds the potential to advance access to treatment options for oncology patients.”
“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 David Nicholson, executive vice president and president of Global Research and Development of Allergan. “Allergan is committed to developing biosimilars that provide safe, high-quality and effective therapies in key disease areas for patients.”
Amgen and Allergan are collaborating on the development and commercialization of four oncology biosimilars. Amgen has a total of nine biosimilars in development. Allergan is also independently developing biosimilars.
Study Design
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 European Union (EU). In the U.S., there were an estimated 226,160 new cases and 160,340 deaths due to NSCLC in 2012, and in the EU there were an estimated 265,600 new cases and 236,000 deaths due to NSCLC in 2006.1,2 NSCLC arises from the epithelial cells of the lung of the central bronchi to terminal alveoli. The histological type of NSCLC depends on the cells of origin, most commonly squamous cell carcinoma, large cell carcinoma and adenocarcinoma. Cigarette smoking is the primary risk factor for NSCLC, and other risks include exposure to second hand smoke, family history, radon exposure and exposure to air pollution.3-6
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 the Amgen and Allergan Collaboration
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 will assume primary responsibility for developing, manufacturing and initially commercializing the oncology antibody products.
About Amgen Biosimilars
Amgen Biosimilars is committed to building upon Amgen’s experience in the development and manufacturing of innovative human therapeutics to expand Amgen’s reach to patients suffering from serious illnesses. Biosimilars offer the potential to increase patient access to vital medicines, and Amgen is well positioned to leverage its 35 years of experience in biotechnology to create high-quality biosimilars and reliably supply them to patients worldwide.
For more information, visit www.amgenbiosimilars.com and follow us www.twitter.com/amgenbiosim.
About Amgen
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.
For more information, visit www.amgen.com and follow us on www.twitter.com/amgen.
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing innovative branded pharmaceuticals, high-quality generic and over-the-counter medicines and biologic products for patients around the world.
Allergan markets a portfolio of best-in-class products that provide valuable treatments for the central nervous system, eye care, medical aesthetics, gastroenterology, women’s health, urology, cardiovascular and anti-infective therapeutic categories, and operates the world’s third-largest global generics business, providing patients around the globe with increased access to affordable, high-quality medicines. Allergan is an industry leader in research and development, with one of the broadest development pipelines in the pharmaceutical industry and a leading position in the submission of generic product applications globally.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.
For more information, visit Allergan’s website at www.allergan.com.
SOURCE: Amgen
Post Views: 649
