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Seattle Genetics Begins Phase III Study on Tucatinib Combo

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Seattle Genetics, Inc. (SGEN - Free Report) announced that it has dosed the first patient in a phase III study on its investigational oral tyrosine kinase inhibitor tucatinib in combination with Roche's (RHHBY - Free Report) Kadcyla (ado-trastuzumab emtansine) for the treatment of patients with locally advanced/metastatic HER2-positive breast cancer.

The randomized HER2CLIMB-02 study is evaluating tucatinib compared to placebo in combination with Kadcyla for treating the above-mentioned patient population including those having brain metastases and who have had prior treatment with a taxane and Roche’s Herceptin (trastuzumab) in any setting.

The primary endpoint of the study is progression-free survival per Response Evaluation Criteria in Solid Tumors while the secondary endpoints are overall survival, objective response rate and duration of response.

This study is intended to support registration of tucatinib in the United States.

Shares of Seattle Genetics inched up almost 2% following the above news on Thursday. In fact, so far this year, the stock has soared 43.9% against the industry's decline of 8.9%.


We remind investors that in March 2018, Seattle Genetics added tucatinib to its portfolio following the acquisition of Cascadian Therapeutics. In April 2019, the company completed the enrollment in phase III HER2CLIMB study for HER2-positive metastatic breast cancer.

Meanwhile, last month, Seattle Genetics presented initial data from the single arm phase II MOUNTAINEER study on tucatinib.

The study evaluated tucatinib in combination with Roche’s Herceptin for treating patients with HER2-positive RAS wild-type metastatic colorectal cancer, who have already received treatment with first and second-line standard-of-care therapies. The combo regime was well tolerated and demonstrated an encouraging antitumor activity.

The study demonstrated that tucatinib has the potential to treat colorectal cancer.

Zacks Rank & Stocks to Consider

Seattle Genetics currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the healthcare sector include Exact Sciences Corp. (EXAS - Free Report) and Incyte Corp. (INCY - Free Report) , both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Exact Sciences’ loss per share estimates have been narrowed 5.4% for 2019 and 10.1% for 2020 over the past 60 days. The stock has soared 43.5% year to date.

Incyte’s earnings estimates have moved 4.9% north for 2019 and 4.7% for 2020 over the past 60 days. The stock has rallied 19.2% year to date.

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