US-based ARIAD Pharmaceuticals has completed patient enrolment in its pivotal Phase II ALTA trial of its investigational anaplastic lymphoma kinase (ALK) inhibitor, brigatinib, to treat non-small cell lung cancer (NSCLC).
In the trial, a total of 220 patients were enrolled at approximately 75 sites in North America, Europe, and Asia.
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Brigatinib (AP26113) is an investigational, targeted cancer medicine currently in development to treat patients with ALK+ NSCLC that is resistant to crizotinib.
The trial is designed to determine the safety and efficacy of brigatinib in refractory NSCLC patients who test positive for the ALK oncogene (ALK+) and who have been treated with and progressed on their most recent crizotinib therapy.
ARIAD president of research and development and chief scientific officer Timothy Clackson said: "We are proud to have completed patient enrolment in the ALTA trial in the time frame we established at the outset.
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"We expect data from this trial to form the basis for an NDA filing of brigatinib in patients with refractory non-small cell lung cancer in the third quarter of next year."
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By GlobalDataThe trial’s primary endpoint is objective response rate (ORR) as measured by RECIST criteria.
Last year, the company has also received breakthrough therapy designation for brigatinib from the US Food and Drug Administration (FDA).
In the trial, median time on treatment for patients is less than four months, and follow-up data are limited at this time.
As a result, the company now expects that first data from the trial will be submitted for presentation at the American Society of Clinical Oncology (ASCO) annual meeting in 2016.
The company noted that presenting data at ASCO will also align more closely with the expected filing for marketing approval of brigatinib in the US in the third quarter of next year.
Early next year, the company will start a randomised front-line Phase III clinical trial, which compare brigatinib to crizotinib in around 300 patients with ALK+ NSCLC, who have not received prior ALK inhibitors.
