Ariad Pharmaceuticals Inc.
) 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
Data revealed that AP26113 demonstared strong anti-tumor
activity in anaplastic lymphoma kinase positive (ALK+) NSCLC
patients. These patients were resistant to
) 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 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.
Ariad carries a Zacks Rank #3 (Hold). Currently, companies
which look attractive include
) with a Zacks Rank #1 (Strong Buy) and a Zacks Rank #2 (Buy),
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