Fourth Quarter & Full Year 2022 Financial & Business Update
Robust TUKYSA Development Program Includes Studies in Earlier
Stages of Breast and Colorectal Cancer
New indication approved by FDA for 2L+ HER2+
mCRC with NCCN guideline update as a primary
treatment option1,2
Responses
Tucatinib +
Trastuzumab
Cohorts A + B
(n=84)
Tucatinib
Monotherapy
Tucatinib +
Trastuzumab
Cohort C
Post-Crossover
(n=30)
(n=28)
Confirmed
38.1
3.3
ORR, %
17.9
Best overall response per BICR, %
CR
3.6
0
0
PR
34.5
3.3
17.9
Enrolling MOUNTAINEER-03 phase 3 potential
U.S. confirmatory study in 1L mCRC
• Intended to serve as basis for global submissions
Seagen Regional collaboration with
MERCK
TUKYSA
tucatinib
50 mg 150 mg tablets
TUKYSA combination
now NCCN category 1
preferred regimen for the
treatment of HER2+ 3L
metastatic breast
cancers3
TUKYSA combined with Kadcyla could improve
efficacy in 2L+ mBC, including patients with brain
metastases
•
HER2CLIMB-02 topline data expected 1H 2023
Exploring combinations with other ADCs
.
Planned studies in combination with DV
•
Ongoing signal-seeking study with Enhertu (HER2CLIMB-04)
Progressing additional studies in early-stage
BC and other HER2-expressing tumors
• Basket study data is planned for 1H 2023
1 This indication is approved under accelerated approval; continued approval for this indication may be contingent upon verification and description
of clinical benefit in confirmatory trials.; 2 MOUNTAINEER Data Presented at ESMO 2022; 3 TUKYSA+ trastuzumab + capecitabine is now preferred
in the 3L setting and remains Category 1 level of evidence per NCCN guidelines; refer to TUKYSA USPI for complete safety information,
including WARNINGS AND PRECAUTIONS for diarrhea, hepatotoxicity, and embryo-fetal toxicity
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