Cascadian Therapeutics (NASDAQ:CASC), a clinical-stage biopharmaceutical company, today announced an overview of recent progress for tucatinib, an investigational oral, small molecule kinase inhibitor that is highly selective for HER2 and the Company’s lead product in development for the treatment of HER2 overexpressing cancers, in addition to several anticipated key objectives for 2018.
"2017 was a very productive year across all aspects of our business, and we delivered on our key objectives we set at the beginning of the year," said Scott D. Myers, President and Chief Executive Officer of Cascadian Therapeutics. "Our pivotal registrational trial of tucatinib for patients with HER2-positive metastatic breast cancer with or without brain metastases remains on track and enrolling patients in North America, Western Europe and Australia. In 2018, we plan to update the market on HER2CLIMB enrollment status after carefully assessing our European site performance. We also look forward to the interim results from a Phase 2 study of tucatinib in HER2 amplified metastatic colorectal cancer, known as MOUNTAINEER, where there is an increasing need for effective and well-tolerated treatment options."
Recent Progress Update
The following accomplishments occurred during the fourth quarter of 2017:
Tucatinib Development
In December 2017, the Company reported results from a subgroup analysis from its two ongoing combination studies of tucatinib, which demonstrated prolonged progression-free survival benefit regardless of presence of brain metastases or patient characteristics. These results were presented at the 2017 San Antonio Breast Cancer Symposium (SABCS).
In December 2017, the first patient was enrolled in the investigator-initiated Phase 1b/2 trial known as TULiP that is evaluating tucatinib in combination with an aromatase inhibitor and CDK4/6 agent for patients with hormone receptor-positive and HER2-positive (HR+/HER2+) metastatic breast cancer. Based on the activity of tucatinib in combination with multiple agents in patients with brain metastases observed in prior studies, the trial will also include these patients.
As of December 2017, the investigator-initiated open label Phase 2 study of tucatinib in combination with trastuzumab for patients with HER2+/RAS wild type metastatic colorectal cancer, known as MOUNTAINEER, was enrolling ahead of the lead investigator’s anticipated timeline.
As of December 2017, the Company has successfully manufactured sufficient supply of tucatinib to complete all currently ongoing trials, including HER2CLIMB.
Regulatory
In December 2017, the European Medicines Agency (EMA) granted a full product-specific waiver for the Pediatric Investigation Plan (PIP), which means the Company is exempt from any requirements to perform pediatric development of tucatinib for the treatment of HER2+ metastatic breast cancer.
In December 2017, EMA’s Scientific Advice Working Group provided guidance on the planned manufacturing program for tucatinib, to ensure that Cascadian’s manufacturing plans will be acceptable for filing and commercial release in the EU.
In November 2017, Health Canada validated the potential for the ongoing HER2CLIMB pivotal clinical trial and nonclinical programs to be sufficient for tucatinib registration, if data are supportive.
Corporate
In December 2017, Cascadian Therapeutics was officially added to the Nasdaq Biotechnology Index.
As of September 30, 2017, cash, cash equivalents and investments totaled $113 million and no debt. The Company plans to provide 2018 guidance during its fourth quarter and year-end 2017 results announcement.
2018 Key Objectives Planned
The Company plans to pursue the following key objectives during 2018:
Continue enrolling the HER2CLIMB randomized pivotal trial of tucatinib in locally advanced or metastatic HER2+ breast cancer with and without brain metastases and provide an update on planned enrollment completion as appropriate.
Publish data from two Phase 1b studies of tucatinib in combination with other approved agents in HER2+ breast cancer in peer-reviewed journals.
Report on early inter...
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