Shares of the large-cap biotech stock Seattle Genetics (NASDAQ: SGEN) saw significant gains on Monday following impressive news regarding one of its leading drug candidates. Specifically, the company reported that its signature breast cancer drug had seen strong performance in a clinical trial.
Seattle Genetics revealed positive results from a double-blind, placebo-controlled trial that evaluated the use of their breast cancer drug, tucatinib, and the effect it had when taken alongside other medications.
Overall, the addition of tucatinib to the previous drug combination led to an impressive 46% reduction in the risk of breast cancer progression or death, meeting the primary endpoint for the study.
The study also met two of its other secondary endpoints, one of which is how the drug compared to a subset of patients with brain metastases (secondary tumors that have grown at a distance from the primary cancer location). For this subgroup of patients, there was an impressive 52% reduction in the risk of death or disease progression.
“There is significant unmet medical need following treatment with trastuzumab, pertuzumab and T-DM1 in patients with metastatic HER2-positive breast cancer,” said Roger Dansey, M.D., and Chief Medical Officer of Seattle Genetics. “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. Based on these findings, we plan to unblind the trial and offer tucatinib to patients on the control arm. We also plan to submit a New Drug Application (NDA) to the FDA in the first quarter of 2020, with the goal of bringing a much-needed new medicine to patients.”
At the moment, there’s a lack of viable treatments for patients who have already tried conventional breast cancer drugs without much success. This would give the drug significant upside potential and could easily become a major blockbuster in the years to come.
The only downside to the drug was data that suggested a greater degree of liver damage than compared to the control group. Around 5% of patients that took tucatinib showed elevated levels of a crucial liver damage biomarker, in comparison to the 1% of patients of the original control group.
Overall, however, prospects for the drug remain quite optimistic. Seattle Genetics initially paid out $614 million to acquire Cascadian Therapeutics back in 2018 specifically for this breast cancer treatment, a decision that seems to be justified. Shares of Seattle Genetics were up 15.4% on Monday in the response to the news, trading around $100 per share. Over the past six months, shares of the biotech stock have risen by just under 50%.
Seattle Genetics is a biotech firm focused on the development of monoclonal antibody-based therapies. The company’s lead product, Adcetris, has received approval for advanced frontline, relapsed/refractory and post-consolidation Hodgkin lymphoma, anaplastic large-cell lymphoma, and two other subtypes of cutaneous T-cell lymphoma. The company has several other early-stage programs in trials. Seattle Genetics also licenses its antibody-drug conjugate technology to a number of leading biotechnology and pharmaceutical companies. – Warrior Trading News