- Phase I study shows bioequivalence between BI 695502 and Avastin® (bevacizumab) in healthy individuals
- Phase III study underway to investigate the safety and efficacy of BI 695502 compared to Avastin® in lung cancer
INGELHEIM, Germany I November 16, 2016 I Boehringer Ingelheim today announced new data from the Phase I INVICTAN®-1 study, which show that BI 695502, its bevacizumab biosimilar candidate, is bioequivalent to U.S.-licensed and –EU approved Avastin®.* Avastin® is an angiogenesis inhibitor that is used to treat a variety of cancers.
BI 695502 met all the pre-defined primary and secondary endpoints in the INVICTAN®-1 study. These data were presented in a poster (link is external) at the American Association of Pharmaceutical Scientists Annual Meeting in Denver, CO, November 13 – 17.
“Findings from this study are an important step to confirm that BI 695502 is biosimilar to Avastin, and we look forward to the completion of the ongoing pivotal Phase III trial in lung cancer,” said Sandeep Athalye, MD, Vice President and Head, Clinical Development and Medical Affairs Biosimilars, Boehringer Ingelheim. “These data show our commitment to develop high-quality therapeutic options for patients with cancer and contribute to the long-term sustainability of global healthcare systems.”
About BI 695502 and INVICTAN®
BI 695502, a bevacizumab biosimilar candidate to Avastin®, is a monoclonal antibody that may slow or stop the growth of certain tumor types by preventing the growth of blood vessels that supply the tumor.1
INVICTAN-1 (NCT01608087 (link is external)) is a randomized, blinded, single-dose, parallel-arm Phase I clinical study, evaluating bioequivalence (how a drug is absorbed, distributed, metabolized and excreted in the body) of BI 695502 to Avastin®. The study enrolled 91 healthy male individuals who were randomized evenly across treatment groups. BI 695502 was well-tolerated in this study, with no clinically relevant differences in safety or immunogenicity evaluations between the BI 695502 and bevacizumab treatment groups.2
INVICTAN -2 (NCT02272413 (link is external)) is a randomized, double-blind Phase III study, evaluating efficacy and safety of BI 695502 plus chemotherapy versus Avastin® plus chemotherapy in patients with advanced non-squamous non-small cell lung cancer.
About Boehringer Ingelheim in Biologics and Biosimilars
Boehringer Ingelheim is one of the largest producers of biologic medicines in the world. As a pioneer in biologics with more than 35 years of experience, the company has manufactured more than 25 biologic medicines for global markets. This includes monoclonal antibodies in oncology and immunology, interferons, and other targeted medicines that are routinely used to treat many patients across a broad range of therapeutic areas. Boehringer Ingelheim further builds on its commitment to oncology and immunology to develop biosimilars as high quality, safe, and effective treatment options to patients with cancer and autoimmune diseases.
Boehringer Ingelheim currently has two biosimilar monoclonal antibodies in late stage clinical development: BI 695501, adalimumab biosimilar candidate to Humira®* and BI 695502, bevacizumab biosimilar candidate to Avastin®*. All public information on our clinical trials is available on: http://clinicaltrials.gov/ (link is external).
Boehringer Ingelheim
Boehringer Ingelheim is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally through 145 affiliates and a total of some 47,500 employees. The focus of the family-owned company, founded in 1885, is on researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.
Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects through, for example, the initiative “Making More Health” while also caring for employees. Respect, equal opportunity and reconciling career and family form the foundation of mutual cooperation. The company also focuses on environmental protection and sustainability in everything it does.
In 2015, Boehringer Ingelheim achieved net sales of about 14.8 billion euros. R&D expenditure corresponds to 20.3 per cent of net sales.
For more information please visit www.boehringer-ingelheim.com
Intended audiences:
This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.
Footnotes
*Avastin® is a registered trademark of Genentech, Inc. (USA) and Humira® is a registered trademark of AbbVie, Inc.
References
1 Angiogenesis Inhibitors Fact Sheet. National Cancer Institute. Available: https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/angiogenesis-inhibitors-fact-sheet. Accessed October 2016.
2 Hettema W et al., A randomized, single-blind, Phase I trial (INVICTAN®-1) assessing the pharmacokinetic bioequivalence and safety of BI 695502, a bevacizumab biosimilar candidate, in healthy subjects. Abstract accepted at the 2016 American Association of Pharmaceutical Scientists Annual Meeting, 13-17 November in Denver, Colorado. Abstract 1302.1. Available: http://abstracts.aaps.org/Verify/AAPS2016/PosterSubmissions/08W1230.pdf. Accessed October 2016.
SOURCE: Boehringer Ingelheim
