June 5, 2016

AbbVie Presents Encouraging Phase 1 Data for Investigational Medicine ABT-414 as Monotherapy in Patients with an Aggressive Brain Cancer at the 2016 American Society of Clinical Oncology Annual Meeting

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- Results of expansion cohort of open-label Phase 1 study found no dose-limiting toxicities and frequent, reversible eye toxicities
- Preliminary efficacy results showed an estimated 30 percent progression-free survival at six months
- AbbVie will be advancing ABT-414 to a randomized Phase 2 clinical trial in patients with EGFR-amplified glioblastoma

NORTH CHICAGO, Ill., June 5, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced safety and preliminary efficacy data from a Phase 1 study of ABT-414 – an investigational antibody drug conjugate (ADC) for epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM) – showed no dose-limiting toxicities and frequent, reversible ocular toxicities. Additionally, an estimated 30 percent (n=44) of patients treated with ABT-414 as monotherapy were progression free at six months [95% CI=17, 44] (secondary endpoint). These results, from an expansion cohort of one arm (Arm C) of a three-arm open-label study, were presented today at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.1  Amplified EGFR is the most common genetic mutation associated with malignant GBM, an aggressive brain cancer.2

As of January 7, 2016, the most common serious adverse event (>1 patient) (n=48) was seizure (8%). Additionally, Best Response Assessment in Neuro-Oncology (RANO) Criteria, an assessment of tumor response used in GBM, identified two partial responses, 18 patients with stable disease, and 24 with progressive disease for a total of 44 patients with complete data.1 

"With standard of care therapy,3 patients with GBM, the most common and most aggressive form of brain cancer,4 have a median survival of 15 months after diagnosis and two-year survival is 30%.5 There remains an urgent unmet need for new treatment options for this devastating brain cancer," said Martin van den Bent, M.D., Ph.D., head, Neuro-Oncology Unit, Erasmus MC Cancer Institute, the Netherlands, and lead investigator of the study. "These data are important as they demonstrate the potential of ABT-414 and underscore the need for further investigation in glioblastoma."  

Additional Safety Findings
Grade 3/4 treatment emergent adverse events (TEAEs) (>1 patient) were keratitis (15%), corneal epithelial microcysts (8%), hemiparesis (6%), hyperglycemia (6%), muscular weakness (6%), seizure (6%), blurred vision (4%) and ulcerative keratitis (4%).The most common TEAEs (?25% patients) in this study arm were blurred vision (60%), headache (29%), photophobia (29%), dry eye (27%), eye pain (27%), and fatigue (27%). The most common serious adverse event (>1 patient) (n=48) was seizure (8%).1

"These results suggest that ABT-414 may have important activity for certain groups of patients with glioblastoma and support the continuation of the ongoing randomized studies," said Gary Gordon, M.D., vice president, oncology clinical development, AbbVie. "AbbVie is committed to continuing to invest in technologies and approaches, including antibody drug conjugates like ABT-414, with the goal of delivering a remarkable impact on cancer treatment." 

Based on these results, together with previously presented data from this study, AbbVie advanced ABT-414 to a randomized Phase 2 clinical trial in patients with EGFR-amplified GBM.1 

About this Study
The Phase 1, open-label trial was designed to evaluate the safety, pharmacokinetics and maximum tolerated dose of ABT-414. Three study arms evaluated ABT-414 with radiotherapy and temozolomide (TMZ) in patients with newly diagnosed glioblastoma (GBM) (Arm A), with TMZ in patients with newly diagnosed glioblastoma who have just completed radiation and TMZ or recurrent GBM (Arm B) or as monotherapy in patients with recurrent GBM (Arm C).1 

Eligible patients in Arm C were adults with a Karnofsky Performance Status (KPS) score ?70, EGFR amplification (confirmed centrally), recurrent GBM, normal end-organ function and no prior treatment with bevacizumab. Forty-eight EGFR-amplified recurrent GBM patients were treated in this arm. The median age was 59 years (range, 35-80). Most patients had prior therapies: 40 percent had one, 48 percent had two, and 10 percent had three or more prior therapies.1

About ABT-414
ABT-414 is an investigational monoclonal antibody drug conjugate (ADC) targeting EGFR (epidermal growth factor receptor) developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics.1 It is being evaluated for the treatment of patients with EGFR-amplified glioblastoma, an aggressive malignant primary brain tumor.1,4 In 2014, the FDA and the European Medicines Agency granted orphan drug designation for the treatment of glioblastoma and glioma, respectively.6,7 ABT-414 is an investigational compound and its efficacy and safety have not been established by the FDA or any other health authority.

About Glioblastoma
Glioblastoma is the most common and most aggressive type of malignant primary brain tumor.4 Mutations in EGFR are the most common genetic abnormality associated with glioblastoma, with a frequency of about 50 percent.2 Prior to diagnosis, patients may experience headache, vision problems, nausea/vomiting, personality changes and seizures.4 For adults with more aggressive glioblastoma, treated with standard therapy, median survival is about 15 months.5 Treatment for glioblastoma remains challenging.4 Standard treatment is surgical resection, radiotherapy and concomitant adjunctive chemotherapy.5 

About AbbVie
AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries.

For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

About AbbVie in Oncology
AbbVie is striving to outsmart cancer by working with scientists, physicians, industry peers, patient advocacy groups and most importantly patients, to discover, develop and provide new therapies that will have a remarkable impact on the lives of people around the world affected by cancer. Our goal is to provide medicines that make a transformational improvement in cancer treatment and outcomes for cancer patients. By exploring and investing in new pathways, technologies and approaches, AbbVie is breaking ground in some of the most widespread and difficult-to-treat cancers. We are also exploring solutions to help patients obtain access to our cancer medicines. With the acquisition of Pharmacyclics in 2015, and through several collaborations, AbbVie's oncology portfolio consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in nearly 200 clinical trials in 20 different tumor types. For more information about AbbVie Oncology, please visit http://abbvieoncology.com.   

Forward-Looking Statements
Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

1 van den Bent M et al. Efficacy of a novel antibody-drug conjugate (ADC), ABT-414, as monotherapy in epidermal growth factor receptor (EGFR) amplified, recurrent glioblastoma (GBM). Poster presentation #2542; presented at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois, June 5, 2016.
2 Taylor T et al. Targeting EGFR for treatment of glioblastoma: Molecular basis to overcome resistance. Curr Cancer Drug Targets. 2012;12(3):197-209.
3 Stupp R et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;325(10):987-996.
4 Omuro A and DeAngelis L. Glioblastoma and other malignant gliomas: A clinical review. JAMA. 2013;310(17):1842-1850.
5 American Brain Tumor Association (2014). Glioblastoma (GBM). http://www.abta.org/brain-tumor-information/types-of-tumors/glioblastoma.html. Accessed on May 4, 2016.
6 U.S. Food and Drug Administration (2014). Orphan Drug Designations and Approvals. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=433214. Accessed May 2016.
7 European Medicines Agency (2014). Public summary of opinion of orphan designation.   http://www.ema.europa.eu/docs/en_GB/document_library/Orphan_designation/2014/09/WC500171954.pdf. Accessed May 4, 2016.

SOURCE AbbVie

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