November 14, 2014

AbbVie Presents Results from Study of ABT-414 in Patients with Glioblastoma Multiforme at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology

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- Data include results from a Phase 1 study of ABT-414 as monotherapy and in combination with radiation and/or chemotherapy in patients with newly diagnosed and recurrent/unresectable glioblastoma multiforme
- AbbVie will initiate a randomized Phase 2 trial of ABT-414 in patients with glioblastoma multiforme

NORTH CHICAGO, Ill., Nov. 14, 2014 /PRNewswire/ -- AbbVie (NYSE: ABBV) released updated interim results from a Phase 1 clinical trial of ABT-414 in patients with glioblastoma multiforme, an aggressive form of brain cancer, which showed that of those with measurable disease and epidermal growth factor receptor (EGFR) amplification, four of 12 patients (33%) achieved an objective response, including two whom achieved complete responses. The results from the three-arm clinical trial, which evaluated ABT-414 as a monotherapy, in combination with chemotherapy, or in combination with radiation and chemotherapy, were presented at the 19th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology (SNO), November 13-16 in Miami.

An objective response in oncology is a measurable response to cancer treatment. A complete response is sometimes called complete remission, and refers to the disappearance of all signs of cancer in response to cancer treatment.1

Of the two patients who achieved a complete response, one was enrolled in the monotherapy arm and the other in the arm evaluating ABT-414 as an addition to chemotherapy. These patients each had disease that recurred after radiation and chemotherapy; a patient population where effective therapies are very limited.

"The objective responses, including two complete responses, in this Phase 1 trial suggest further evaluation of ABT-414's potential as both a monotherapy and as an adjuvant to chemotherapy and radiation in glioblastoma multiforme is warranted," said Hui Gan, medical oncologist at Austin Health and senior research fellow at the Ludwig Institute for Cancer Research, Heidelberg, Australia. "These early results are encouraging in an aggressive brain cancer with some of the worst outcomes."

"As one of the most aggressive types of primary brain tumors with few treatment options, patients with glioblastoma multiforme are in need of new targeted treatment options," said Gary Gordon, M.D. vice president, oncology clinical development, AbbVie. "The data presented at SNO highlights the commitment of AbbVie's research and development program in oncology. We are pleased to share these data with the neuro-oncology community, as primary care givers of these patients."

About the Study
The Phase 1, open-label, multicenter, international trial evaluated the safety, pharmacokinetics and maximum tolerated dose of ABT-414. Results were presented from all three arms of the study, which evaluated ABT-414 with concurrent radiotherapy and temozolomide in patients with newly diagnosed glioblastoma (Arm A), with temozolomide in patients with recurrent/unresectable glioblastoma (Arm B) or as monotherapy in patients with recurrent glioblastoma (Arm C). Pharmacokinetic and safety data from arms A, B and C support recommended Phase 2 doses of 2.0, 1.25 and 1.25 mg/kg, respectively. Other important assessments included adverse events, pharmacokinetic parameters, objective response and tumor tissue epidermal growth factor receptor biomarkers.

Common adverse events in Arms A, B and C included fatigue, blurred vision, nausea, photophobia, constipation, increased aspartate aminotransferase, increased alanine aminotransferase, keratitis, thrombocytopenia, dry eye, eye pain and foreign body sensation in the eye. Grade 3/4 AEs included keratitis, lymphopenia and thrombocytopenia. Dose-limiting toxicities occurred at multiple doses and affected the eye (keratitis) and liver.

Based on these results, AbbVie will advance ABT-414 – which was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) earlier this year – to a randomized Phase 2 clinical trial in patients with glioblastoma multiforme.

About ABT-414
ABT-414 is an investigational anti-EGFR (epidermal growth factor receptor) monoclonal antibody drug conjugate (ADC) being evaluated for the treatment of patients with various cancer and tumor types. As an ADC, ABT-414 is designed to be stable in the bloodstream and only release the potent cytotoxic agent once inside targeted cancer cells. Developed by AbbVie researchers with components in-licensed from Life Science Pharmaceuticals, Inc. and Seattle Genetics, ABT-414 is currently being investigated for the treatment of glioblastoma multiforme, the most common and most aggressive malignant primary brain tumor. ABT-414 is also in clinical trials for the treatment of patients with squamous cell tumors, including non-small cell lung cancer. 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 Multiforme
Glioblastoma multiforme is the most common and most aggressive type of malignant primary brain tumor. Prior to diagnosis, most patients experience a serious symptom of glioblastoma multiforme, such as a seizure.2 Typically patients succumb to the disease approximately 15 months after diagnosis.2,3 Treatment for glioblastoma multiforme remains challenging and no long-term treatments are currently available. Standard treatment is surgical resection, radiotherapy and concomitant adjunctive chemotherapy.3

About AbbVie Oncology
AbbVie's oncology research is focused on the discovery and development of targeted therapies that work against the processes cancers need to survive. By investing in new technologies and approaches, we are breaking ground in some of the most widespread and difficult-to-treat cancers, including multiple myeloma and chronic lymphocytic leukemia. Our oncology pipeline includes multiple new molecules in clinical trials being studied in more than 15 different cancers and tumor types. For more information on AbbVie Oncology and our oncology portfolio, please visit http://abbvie.com/oncology.

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. AbbVie employs approximately 25,000 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.

1 National Cancer Institute website. "NCI Dictionary of Cancer Terms."  http://www.cancer.gov/dictionary?CdrID=45652. Accessed October 30, 2014.

2 National Brain Tumor Society web site. "Tumor Types." http://www.braintumor.org/brain-tumor-information/understanding-brain-tumors/tumor-types/#glioblastoma-multiforme. Accessed October 17, 2014. 

3 American Brain Tumor Association. (2012) "Glioblastoma and Malignant Astrocytoma."http://www.abta.org/secure/glioblastoma-brochure.pdf Accessed October 17, 2014.

SOURCE AbbVie

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