Array BioPharma Announces Clinical Data Presentations At The 2013 ASCO Annual Meeting
BOULDER, Colo., May 15, 2013 /PRNewswire/ — Array BioPharma Inc. (NASDAQ: ARRY) today announced presentations on its MEK inhibitors, MEK162 (licensed to Novartis) and selumetinib (licensed to AstraZeneca) at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held May 31 – June 4, 2013 in Chicago, Illinois. Both MEK inhibitors are expected to advance into Phase 3 trials in 2013: Novartis expects to evaluate MEK162 in NRAS- and BRAF-mutant melanoma and Array expects to evaluate MEK162 in low-grade serous ovarian cancer. In addition, AstraZeneca expects to begin Phase 3 or pivotal registration trials with selumetinib in non-small cell lung cancer and thyroid cancer.
The following is a summary of the presentations that will be given at ASCO:
ORAL PRESENTATIONS ------------------ Title: Phase II study of selumetinib versus temozolomide in gnaq/Gna11 mutant uveal melanoma (Abstract # CRA9003) Final results will be presented at ASCO. ---------------------------------- Presenter: Richard D. Carvajal, MD Date: Saturday, June 1, 2:15-2:30 p.m. CDT (Oral Presentation) Embargo: ASCO's embargo for this abstract will lift on Saturday, June 1 at 6:30 a.m. CDT. --------------------------------- Press Conference ASCO will feature this study in the 2013 ASCO Annual Meeting press program on Saturday, June 1 from 8 - 9 a.m. CDT.
Title: Phase II double-blind, randomized study of selumetinib plus dacarbazine versus placebo plus DTIC as first-line treatment for advanced BRAF-mutant cutaneous or unknown primary melanoma (Abstract # 9004) Presenter: Mark R. Middleton, PhD, FRCP Date: Saturday, June 1, 2:30-2:45 p.m. CDT
POSTER PRESENTATIONS -------------------- Title: Preliminary results from a Phase Ib/II, open- label, dose-escalation study of the oral BRAF inhibitor LGX818 in combination with the oral MEK1/2 inhibitor MEK162 in BRAF V600- dependent advanced solid tumors* (Abstract #9029) Presenter: Richard Kefford, MB, BS, PhD Date: Monday, June 3, 8 a.m. - 12 p.m. and 11:30 - 12:30 p.m. CDT (Poster Discussion Session) Title: DOC-MEK: A double-blind randomized Phase II trial of docetaxel with or without selumetinib (AZD6244; ARRY-142886) in wt BRAF advanced melanoma (Abstract # 9068) Presenter: Avinash Gupta, MBBS BSc MRCP Date: Saturday, June 1, 8 - 11:45 a.m. CDT Title: Custom (Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer and Thymic Malignancies trial (Abstract # 7513) Presenter: Giuseppe Giaccone, MD, PhD Date: Saturday, June 1, 8 - 11:45 a.m. CDT Title: Two parallel randomized Phase II studies of selumetinib and erlotinib in advanced non- small cell lung cancer selected by KRAS mutations (Abstract # 8026) Presenter: Corey A. Carter, MD Date: Saturday, June 2, 8 a.m. - 12 p.m. CDT Title: SWOG S1115: Randomized Phase II clinical trial of selumetinib (AZD6244; ARRY 142886) hydrogen sulfate (NSC-748727) and MK-2206 (NSC- 749607) versus mFOLFOX in patients with metastatic pancreatic cancer after prior chemotherapy (Abstract # TPS4145) Presenter: Vincent M. Chung, MD Date: Sunday, June 2, 8 - 11:45 a.m. CDT Title: The MEK inhibitor selumetinib, AZD6244, ARRY- 142886) plus irinotecan as second-line therapy for KRAS-mutated metastatic colorectal cancer (Abstract #3587) Presenter: Howard S. Hochster, MD Date: Sunday, June 2, 8 - 11:45 a.m. CDT Title: Dual MEK/EGFR inhibition for advanced, chemotherapy-refractory pancreatic cancer: A multicenter phase II trial of selumetinib (AZD6244; ARRY-142886) plus erlotinib (Abstract # 4014) Presenter: Andrew H. Ko, MD Date: Monday, June 3, 1:15 - 5:15 p.m. CDT
ASCO’s embargo for the abstract discussing the Phase 2 results of selumetinib versus temozolomide in uveal melanoma (Abstract # CRA9003) will lift on Saturday, June 1 at 6:30 a.m. CDT. ASCO’s embargo for the remaining abstracts in this release will lift on Wednesday, May 15 at 6:00 p.m. EDT. All abstracts can be accessed through the ASCO website, http://abstract.asco.org/. After the presentations and posters are public, they will be available as PDFs on Array’s website at www.arraybiopharma.com.
*The MEK162 abstract submitted only incorporates data as of early 2013. Up-to-date clinical data will be included during the presentation at the Annual Meeting.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. Array is evolving into a late-stage development company and currently expects significant progress toward generating data to support our upcoming Phase 3 / pivotal trial decisions. Novartis expects to begin Phase 3 trials evaluating Array-invented MEK162 in NRAS- and BRAF-mutant melanoma in 2013. In addition, Array expects to begin a Phase 3 trial evaluating MEK162 in low-grade serous ovarian cancer under the license agreement with Novartis in 2013. AstraZeneca expects to begin Phase 3 or pivotal registration trials with selumetinib (an Array-invented drug) in non-small cell lung cancer and thyroid cancer during the second half of 2013. Three other Array-invented drugs are also approaching Phase 3 or pivotal trial decisions which are expected by the end of 2013. These include Array’s wholly-owned drugs, ARRY-520 and ARRY-614, and one partnered program, danoprevir (with InterMune/Roche). For more information on Array, please go to www.arraybiopharma.com.
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