Seagen (SGEN) Posts Positive Data from New Study on Tukysa
Seagen Inc. SGEN announced positive topline data from the pivotal phase II MOUNTAINEER study. The study is evaluating its oral tyrosine kinase inhibitor, Tukysa (tucatinib), in combination with Roche's RHHBY Herceptin (trastuzumab) in patients with previously-treated HER2-positive metastatic colorectal cancer (“mCRC”).
The study showed that the combo of Tukysa plus Herceptin demonstrated a confirmed objective response rate of 38.1% per blinded independent central review (“BICR”). The median duration of response was 12.4 months per BICR.
Also, the combo of Tukysa + Herceptin was generally safe and well-tolerated.
Data from this study will support the planned supplemental new drug application (“sNDA”) for Tukysa to the FDA under its Accelerated Approval Program.
Please note that pharma giant Merck MRK is commercializing Tukysa in ex-U.S markets, Canada and Europe.
MRK also plans to discuss the above-mentioned data with other health authorities to accelerate the regulatory filing of Tukysa in its territory.
The open-label, phase II MOUNTAINEER is investigating the combination of Tukysa plus Herceptin or as a single agent in patients with HER2-positive metastatic/unresectable colorectal cancer following previous standard-of-care therapies.
Shares of Seagen have declined 9.9% so far this year compared with the industry’s fall of 23.7%.
Image Source: Zacks Investment Research
In April 2020, the FDA approved Tukysa in combination with Roche's Herceptin and Xeloda (capecitabine) to treat adult patients with HER2-positive locally advanced or metastatic breast cancer and those who have received at least two prior anti-HER2 treatment regimens.
The European Commission granted marketing authorization to the same Tukysa combo for the same indication in February 2021.
In the first quarter of 2022, Tukysa generated sales worth $90.5 million, reflecting an increase of 29% on a year-over-year basis. A potential label expansion of the drug is likely to boost sales further in 2022 and beyond.
Zacks Rank & Stock to Consider
Seagen currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the biotech sector is Leap Therapeutics, Inc. LPTX, which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Leap Therapeutics’ loss per share has narrowed 11.1% for 2022 and 5.9% for 2023 over the past 60 days.
Earnings of Leap Therapeutics have surpassed estimates in three of the trailing four quarters and missed the same on the other occasion. LPTX delivered an earnings surprise of 1.92%, on average.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
Roche Holding AG (RHHBY) : Free Stock Analysis Report
Merck & Co., Inc. (MRK) : Free Stock Analysis Report
Seagen Inc. (SGEN) : Free Stock Analysis Report
Leap Therapeutics, Inc. (LPTX) : Free Stock Analysis Report
To read this article on Zacks.com click here.
