$ARIAD Announces Initiation of Randomized, First-Line Phase 3 Trial

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ARIAD Announces Initiation of Randomized, First-Line Phase 3 Trial of Brigatinib in Treatment of ALK-Positive Non-Small Cell Lung Cancer

ARIAD Pharmaceuticals, Inc. (ARIA) today announced the initiation of a randomized, first-line Phase 3 clinical trial of brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, in adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously been treated with an ALK inhibitor. The ALTA 1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial is designed to assess the efficacy of brigatinib in comparison to crizotinib based on evaluation of the primary endpoint of progression free survival (PFS).

“We are pleased to be advancing brigatinib into a pivotal Phase 3 trial as a potential new therapy for patients with ALK+ NSCLC who have not yet received an ALK inhibitor,” said Tim Clackson, Ph.D., president of research and development and chief scientific officer of ARIAD. “We believe that the encouraging results shown in our preclinical and ongoing Phase 1/2 studies suggest brigatinib has the potential to improve outcomes for ALK+ NSCLC patients as compared to treatment with crizotinib.”

Trial Design

The ALTA 1L trial is a randomized, open-label, multicenter, international study that is designed to compare the efficacy and safety of brigatinib to crizotinib in adult patients with ALK+ NSCLC who have not previously received an ALK inhibitor. The trial is expected to be conducted at approximately 150 investigational sites in North America, Europe and the Asia Pacific region. Patients in the trial must be at least 18 years of age, have stage IIIB or stage IV NSCLC with ALK rearrangement, have received no more than one regimen of systemic anticancer therapy in the locally advanced or metastatic setting, and have not received prior therapy with an ALK inhibitor.

Approximately 270 patients are expected to be randomized one-to-one to receive brigatinib (90 mg given orally once daily for seven days followed by escalation to 180 mg once daily) or crizotinib (250 mg given orally twice daily). ARIAD expects to complete patient enrollment in the ALTA 1L trial in 2018.

The primary endpoint of the trial is progression free survival (PFS), per RECIST criteria as assessed by a blinded Independent Review Committee (BIRC). Tumor response assessments will be performed every eight weeks. Key secondary endpoints include objective response rate (ORR), intracranial ORR, intracranial PFS, duration of response, overall survival (OS), safety and tolerability. Health related quality of life data will also be assessed.

“This head-to-head study will directly test brigatinib against crizotinib in the TKI-naïve ALK+ setting – where innovative therapies are needed to improve response rates and to delay progression that can occur through the emergence of secondary resistance mutations in ALK and progression in the central nervous system,” said D. Ross Camidge, M.D., Ph.D., director of thoracic oncology at the University of Colorado. “In patients who have experienced crizotinib failure, brigatinib has already exhibited very impressive progression free survival and marked activity in patients with CNS metastases – features that suggest that in the ALK TKI-naive setting, it could potentially change patients’ natural history by better suppressing ALK+ disease from the beginning.”

About Brigatinib

Brigatinib is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with ALK+ NSCLC. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 for the treatment of patients with ALK+ NSCLC whose tumors are resistant to crizotinib on the basis of an ongoing Phase 1/2 trial. Brigatinib is currently being evaluated in the global Phase 2 ALTA trial in ALK+ NSCLC patients who have progressed on crizotinib, which is anticipated to form the basis for a new drug application planned for submission later in 2016.

About ARIAD

ARIAD Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts and Lausanne, Switzerland, is an orphan oncology company focused on transforming the lives of cancer patients with breakthrough medicines. ARIAD is working on new medicines to advance the treatment of various forms of chronic and acute leukemia, lung cancer and other difficult-to-treat orphan cancers. ARIAD utilizes computational and structural approaches to design small-molecule drugs that overcome resistance to existing cancer medicines. For additional information, visit http://www.ariad.com or follow ARIAD on Twitter (@ARIADPharm).

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