Fourth Quarter & Full Year 2022 Financial & Business Update
Percentage of change from baseline (%)
Advancing Disitamab Vedotin (DV) in Urothelial Cancer and other
Solid Tumors with Global Rights Excluding Parts of Asia¹
100
90
80-
70-
1L/2L HER2+ mUC data reinforce vedotin ADC
combinability with anti-PD1s²
DV + anti-PD1 data presented by RemeGen at ASCO³
HER2 Status:
HERO
HER 1+
HER 2+ HER 3+
DV + toripalimab demonstrated a 71.8% CORR, which compares to
response rates of ~50% seen with DV monotherapy
Seagen
Disitamab
Vedotin
Differentiated HER2-
targeted antibody
conjugated to vedotin
drug-linker and MMAE
payload
Ongoing phase 2 monotherapy study in 2L MUC
for potential FDA accelerated approval
• Granted FDA Breakthrough Therapy Designation
⚫ Phase 3 Keytruda combination 1L mUC trial to initiate in 2023
Additional studies planned in HER2 low BC
.
and other HER2-expressing solid tumors
HER2 low BC studies to include monotherapy and
combinations with TUKYSA or Keytruda
⚫ Gastric cancer and other solid tumor monotherapy and
combination trials planned with TUKYSA
1 RemeGen maintains development and commercialization rights for Asia, excluding Japan and Singapore; 2 Not a pivotal trial; 3 Sheng, et al, ASCO 2022 Abstract 4518; not approved for use; most
common TRAES were AST increase (65.9%), ALT increase (63.4%) and peripheral sensory neuropathy (63.4%)
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