On July 11, 2017 Cascadian Therapeutics, Inc. (NASDAQ:CASC), a clinical-stage biopharmaceutical company, reported the outcome of discussions with the European Medicines Agency (EMA) regarding the development of tucatinib, an investigational medicine for the treatment of HER2-positive metastatic breast cancer (Press release, Cascadian Therapeutics, JUL 11, 2017, View Source [SID1234519781]). Following these discussions, the Company has received confirmation that positive results from its ongoing pivotal trial of tucatinib, known as HER2CLIMB, could serve as a single registrational trial for submission of a Marketing Authorization Application (MAA) to the EMA and potential marketing approval. The Company had received similar confirmation from the U.S. Food and Drug Administration (FDA) in 2016. Schedule your 30 min Free 1stOncology Demo! "Our interactions with regulators in the U.S. and Europe continue to support the design of our pivotal trial as a registrational pathway for tucatinib in both regions," said Marc Lesnick, Ph.D., Senior Vice President Regulatory Affairs and Quality at Cascadian Therapeutics. "We look forward to continued productive discussions in our future interactions with the EMA, the FDA and other health authorities."
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Scott Myers, President and Chief Executive Officer, Cascadian Therapeutics, added, "This is an important milestone for the company. We had anticipated providing an update on our European regulatory strategy later this year; and we are pleased with this early feedback from the EMA that the current design of the global HER2CLIMB trial, if positive, could support approval and a potentially shorter path to the European market for tucatinib. Site and patient enrollment is currently ahead of schedule in North America, and we are now poised to begin enrolling patients in HER2CLIMB in other countries."
About Tucatinib
Tucatinib is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER2 without significant inhibition of EGFR. Inhibition of EGFR has been associated with significant toxicities, including skin rash and diarrhea. Tucatinib has shown activity as a single agent and in combination with both chemotherapy and other HER2 directed agents such as trastuzumab.1,2 Studies of tucatinib in these combinations have shown activity both systemically and in brain metastases. HER2 is a growth factor receptor that is overexpressed in multiple cancers, including breast, ovarian and gastric cancers. HER2 mediates cell growth, differentiation and survival. Tumors that overexpress HER2 (HER2-positive) are more aggressive and historically have been associated with poor overall survival, compared with HER2-negative cancers.
About HER2CLIMB Pivotal Trial
HER2CLIMB is a randomized (2:1), double-blind, placebo-controlled pivotal clinical trial comparing tucatinib vs. placebo, each in combination with capecitabine and trastuzumab and without loperamide or budesonide prophylaxis, in patients with locally advanced or metastatic HER2-positive breast cancer who have had prior treatment with a taxane, trastuzumab, pertuzumab and ado-trastuzumab emtansine, also known as T-DM1. The primary endpoint is progression-free survival (PFS) based upon independent radiologic review. Key objectives related to assessing activity in brain metastases include a key secondary endpoint of PFS in a subset of patients with brain metastases. All patients will be followed for overall survival. HER2CLIMB is currently enrolling patients in the United States, Canada, Western Europe and Australia. Additional information is available at www.HER2CLIMB.com.
About HER2-Positive Metastatic Breast Cancer
Patients with HER2-positive breast cancer have tumors with high levels of a protein called human epidermal growth factor receptor 2 (HER2), which promotes the aggressive spread of cancer cells. The American Cancer Society estimates that 20-25 percent of the approximately 246,660 annual new cases of breast cancer diagnoses in the U.S. are HER2-positive. Historically, HER2 disease has been associated with shorter survival times as well as a higher risk of recurrence and CNS disease (brain metastases). Approximately 30 to 50 percent of HER2-positive breast cancer patients develop brain metastases over time.3,4 Over the past two decades, the approvals of four targeted treatments (trastuzumab, pertuzumab, lapatinib, and T-DM1) have led to improved time to progression and survival rates of patients with HER2-positive breast cancer. Despite these advances, there is still a significant need for new therapies that can impact metastatic disease, including brain metastases, and be tolerated for longer periods of time.