ARIAD Presents Initial Clinical Proof-of-Concept of AP26113 in Patients with Non-Small Cell Lung Cancer at ESMO 2012 Congress
ARIAD Pharmaceuticals, Inc.Kendra Adams, 617-503-7028orLiza Heapes, 617-621-2315
(NASDAQ: ARIA) today announced the initial clinical results on its investigational, tyrosine-kinase inhibitor, , in patients with advanced non-small cell lung cancer (NSCLC) from an ongoing Phase 1/2 trial. The study provides compelling clinical evidence of the anti-tumor activity of AP26113 at multiple dose levels in patients with anaplastic lymphoma kinase positive (ALK+) NSCLC and initial clinical evidence of anti-tumor activity in patients with epidermal growth factor receptor mutant (EGFR-m) NSCLC. The results are being presented this morning at the ESMO 2012 Congress of the European Society for Medical Oncology being held in Vienna, Austria.
Patients enrolled in the trial have advanced solid tumors that were refractory to available therapies or had no standard or curative treatment available to them. The primary objectives of the Phase 1 portion of the trial are to determine the maximum tolerated dose (MTD) and the recommended dose for further study of AP26113 and to characterize its safety and preliminary anti-tumor activity. The trial uses an open-label, dose-escalating design. Anti-tumor activity was determined by serial CT scans using RECIST criteria.
Thirty-four patients have been enrolled to date in the study in six dose-cohorts ( 30, 60, 90, 120, 180 and 240 mg administered orally once daily). Nineteen patients currently remain on study, with 16 at the three highest dose levels.
Twenty-nine of the patients enrolled to date in the study have NSCLC: 14 who are ALK+ and 11 who are EGFR-m. More than two-thirds of these patients failed three or more regimens of prior treatment, including both targeted therapies and chemotherapy.
“The initial findings from this ongoing study show that AP26113 has impressive anti-tumor activity in ALK+ NSCLC patients, who are either naïve or resistant to crizotinib,” stated Scott Gettinger, M.D., Associate Professor of Medicine at Yale School of Medicine, the study’s presenter at ESMO. “At the same time, it is encouraging to see a partial response in a patient with EGFR-mutant lung cancer and acquired resistance to erlotinib in the Phase 1 dose-escalation portion of the trial.”
Key data from the study presented at ESMO include:
“This is the first demonstration of anti-tumor activity by AP26113 in this ALK+ patient population, and the achievement of partial responses is clear, even at the lower doses and in patients with or without prior ALK inhibitor treatment and with brain metastasis,” stated Frank G. Haluska, M.D., Ph.D., senior vice president of clinical research and development and chief medical officer at ARIAD.
“Further, this is the first report of the anti-tumor activity of AP26113 in a patient resistant to EGFR-inhibitor therapy. The EGFR-mutant patient group is heterogeneous with regard to prior therapy at study entry and EGFR dependence. We look forward to further characterizing this activity as the Phase 1 portion of the trial continues and then transitions into the Phase 2 pre-specified patient cohorts.”
ARIAD will hold an investor conference call and webcast on Monday, October 1, 2012, at 8:00 a.m. ET to review and discuss the data from the ongoing Phase 1/2 trial of AP26113. Scott Gettinger, M.D., Associate Professor of Medicine at Yale School of Medicine, will join members of ARIAD’s management team for the briefing from Vienna. This call will be webcast live and can be accessed by visiting the investor relations section of ARIAD’s website at: and clicking on the link to the AP26113 presentation webcast. The call can be accessed by dialing 1-866-700-0161 (domestic) or 617-213-8832 (international) five minutes prior to the start time and providing the pass code 50829176.
A replay of this investor event will be available on the ARIAD website approximately three hours after the presentation and will be archived for three weeks.
ARIAD Pharmaceuticals, Inc. is an emerging global oncology company focused on the discovery, development and commercialization of medicines to transform the lives of cancer patients. ARIAD’s approach to structure-based drug design has led to several internally discovered, molecularly targeted product candidates for drug-resistant or difficult-to-treat cancers, including certain forms of chronic myeloid leukemia and non-small cell lung cancer. For additional information, visit or follow ARIAD on (@ARIADPharm).
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This press release contains “forward-looking statements” including, but not limited to, statements relating to preclinical and clinical data for AP26113. Forward-looking statements are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, preclinical data and early-stage clinical data that may not be replicated in later-stage clinical studies, the costs associated with our research, development, manufacturing and other activities, the conduct, timing and results of pre-clinical and clinical studies of our product candidates, the adequacy of our capital resources and the availability of additional funding, and other factors detailed in the Company's public filings with the U.S. Securities and Exchange Commission. The information contained in this press release is believed to be current as of the date of original issue. The Company does not intend to update any of the forward-looking statements after the date of this document to conform these statements to actual results or to changes in the Company's expectations, except as required by law.