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Seagen Announces Positive Topline Results Of Phase 2 MOUNTAINEER Trial Of TUKYSA With Trastuzumab

Seagen Inc. (SGEN) announced Monday positive topline results from the pivotal phase 2 MOUNTAINEER clinical trial investigating TUKYSA (tucatinib) in combination with trastuzumab in patients with previously treated HER2-positive metastatic colorectal cancer (mCRC).

The results showed a 38.1% confirmed objective response rate (cORR) per blinded independent central review (BICR). The median duration of response (DoR) per BICR was 12.4 months. The combination of tucatinib and trastuzumab was generally well-tolerated.

The company said data from this trial will form the basis of a planned supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) under the FDA's Accelerated Approval Program.

Merck, known as MSD outside the U.S. and Canada, is commercializing TUKYSA in regions outside of the U.S., Canada and Europe and plans to discuss these results with health authorities as it continues to accelerate the filing of TUKYSA in its territory.

People with HER2-positive previously treated metastatic colorectal cancer have a significant unmet need for new therapies.

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