Shares of the large-cap biopharma Seattle Genetics, Inc. SGEN were advancing strongly Monday following a clinical trial readout from the company.
Primary, Secondary Endpoints Met
A pivotal Phase 2 trial dubbed HER2CLIMB that evaluated tucatinib in combination with Roche Holdings AG Basel ADR RHHBY's Herceptin and chemotherapy medication capecitabine versus Herceptin and capecitabine alone in patients with locally advanced unresectable or metastatic HER2-positive breast cancer met the primary as well as both key secondary endpoints, Seattle Genetics said in a press release.
The comparator study showed that the trial met the primary endpoint of progression-free survival, with tucatinib found superior to Herceptin and capecitabine alone and achieving a 46% reduction in the risk of disease progression or death.
Interim analysis also showed that the trial met two key secondary points: an overall improvement in overall survival, with a 34% reduction in the risk of death, and superior progression-free survival in breast cancer patients with brain metastases at baseline, Seattle Genetics said.
The company acquired the asset through its 2018 acquisition of Cascadian Therapeutics for $614 million.
The triplet therapy was generally well-tolerated, with a manageable safety profile, the company said. Significant Unmet Need
Seattle Genetics said there is a significant unmet need following treatment with Herceptin, pertuzumab and T-DM1 in patients with metastatic HER-2 positive breast cancer.
"The addition of tucatinib to the commonly used doublet of trastuzumab and capecitabine represents a potential significant clinical advance for patients with metastatic HER2-positive breast cancer, importantly, including those with brain metastases," Roger Dansey, chief medical officer at Seattle Genetics, said in a statement.
What's Next
Based on the findings, Seattle Genetics plans to unblind the trial and offer tucatinib in patients on the control arm.
It is also intends to submit an NDA to the FDA in the first quarter of 2020.
Additional results from the study will be presented Dec. 11 at the 2019 San Antonio Breast Cancer Symposium, the company said.
Seattle Genetics shares were rallying by 14.73% to $100.27 off the open Monday.
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