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|Array BioPharma Announces Positive Interim Results for Phase 1 Study of Its HER2 Inhibitor, ARRY-380, in Cancer Patients|
Interim results showed that ARRY-380 at doses greater than or equal to 200 mg BID demonstrated evidence of tumor regression in eight out of ten heavily pre-treated patients with HER2 expressing cancers. Of these eight patients, four had prolonged stable disease for 16 weeks or longer. ARRY-380 has been well-tolerated; the predominant adverse events have been Grade 1 and included nausea, rash and fatigue; only minimal diarrhea has been reported. In completed cohorts, no Grade 3 or 4 treatment-related adverse events and no cardiac adverse events have been observed. The maximum tolerated dose of ARRY-380 in this Phase 1 trial has not yet been achieved, and dose escalation is ongoing.
“I am optimistic about this orally available, selective HER2 inhibitor,
ARRY-380; to date, it has been well-tolerated and has shown activity in
patients previously treated with trastuzumab and lapatinib,” said
“Maintaining tumor remission while improving breast cancer patients’
quality of life represents one of the largest commercial opportunities
in cancer therapy,” said
In addition to the clinical results, preclinical data on ARRY-380 were presented at the SABCS: Poster # 5104 “In Vivo Activity of ARRY-380, a Potent, Small Molecule Inhibitor of ErbB2 in Combination with Trastuzumab, Docetaxel or Bevacizumab.” This poster will also be available as a PDF on Array’s website.
About HER2 and ARRY-380
HER2, also known as ErbB2, is a receptor tyrosine kinase that has been found to be amplified in breast cancer and other cancers such as gastric and ovarian. Recently, Herceptin® (trastuzumab), the intravenously-dosed protein inhibitor that modulates HER2, has been approved as an adjuvant to surgery in early stage breast cancer patients; it had already been approved for the treatment of HER2+ metastatic breast cancer. This new indication has significantly expanded the number of breast cancer patients eligible for treatment with an HER2 inhibitor.
ARRY-380 is a potent, orally active small molecule drug that has been well-tolerated to date and selectively inhibits tumor growth in preclinical models of HER2-dependent tumors. ARRY-380 also demonstrated significant dose-related tumor growth inhibition in preclinical models that was superior to Herceptin and Tykerb® (lapatinib) and was additive for tumor growth inhibition in preclinical models when dosed in combination with the standard of care therapeutics such as Herceptin or Taxotere® (docetaxel). Based on its superior preclinical activity, tolerability and pharmacokinetics, a Phase 1 study was initiated, and is ongoing, to evaluate the safety, tolerability and pharmacokinetic profile and to establish the maximum tolerated dose of ARRY-380 as a single agent in patients with solid tumors.
Array BioPharma Forward-Looking Statement
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about the potential for the results of ongoing
preclinical and clinical trials to support regulatory approval or the
marketing success of a drug candidate and our future plans to progress
and develop our proprietary programs. These statements involve
significant risks and uncertainties, including those discussed in our
most recent annual report filed on form 10-K, in our quarterly reports
filed on Form 10-Q, and in other reports filed by Array with the