- Seagen Inc SGEN announced topline results from phase 2 MOUNTAINEER trial investigating Tukysa (tucatinib) in combination with trastuzumab in previously treated HER2-positive metastatic colorectal cancer (mCRC) patients.
- Trastuzumab is sold under the name Herceptin by Genentech, a unit of Roche Holdings AG RHHBY.
- Data from this trial will form the basis of a planned supplemental marketing application to the FDA under the FDA's Accelerated Approval Program.
- Also Read: Amid Domestic Violence Allegation, Longtime Seagen CEO Takes Leave of Absence.
- Merck & Co Inc MRK is commercializing Tukysa in regions outside the U.S., Canada, and Europe.
- Results showed a 38.1% confirmed objective response rate (cORR).
- The median duration of response (DoR) was 12.4 months. The combination of tucatinib and trastuzumab was generally well-tolerated. The most common adverse treatment-emergent events were diarrhea, fatigue, nausea, and infusion-related reaction, primarily low-grade.
- Price Action: SGEN shares are up 0.82% at $140.79 during the market session on the last check Monday.
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