Ariad Pharmaceuticals Inc. (ARIA) provided updated data from an ongoing phase I/II study on its tyrosine kinase inhibitor (:TKI) candidate, AP26113, being evaluated for the treatment of advanced non-small cell lung cancer (:NSCLC).
Data revealed that AP26113 demonstared strong anti-tumor activity in anaplastic lymphoma kinase positive (ALK+) NSCLC patients. These patients were resistant to Pfizer Inc.’s (PFE) Xalkori (crizotinib) and were TKI-naïve. The data was presented at the European Cancer Congress.
The open-label, dose-escalating, phase I portion of the study included patients having advanced solid tumors resistant to available therapies or tumors for which there are no treatments available. Assessment of safety and tolerability, pharmacokinetics, and preliminary anti-tumor activity of AP26113 were the objectives of the phase I portion.
Ascertaining the recommended dose of AP26113 for further study was also one of the objectives of the phase I portion. The study was successful in identifying a once-daily oral 180 mg dosage of AP26113.
AP26113 was observed to be well-tolerated with common adverse events being nausea, fatigue and diarrhea. Grade 3 or higher adverse events were uncommon. Dyspnea, fatigue, diarrhea, hypoxia and pneumonitis were the only treatment-related side-effects found in two or more patients.
Early-onset pulmonary symptoms were found in 3 out of 26 patients in the phase II portion of the study after the first 180 mg dosage of AP26113. Less frequent similar events were also found at lower doses. However, a 90 mg or lower dosage did not cause any such event.
A dosage of 90 mg per day for 1 week of AP26113 will now precede the recommended dosage of 180 mg of AP26113 for reducing the early pulmonary symptoms.
Objective responses were found both in ALK+ NSCLC patients and patients who had not received or were resistant to Xalkori. Ariad will be moving AP26113 into registrational studies in ALK-positive NSCLC patients who are resistant to Xalkori.
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