[Slide 1]
DESTINY
Gastric04
In Memory of Dr. Toshinori Agatsuma
Dr. Toshinori Agatsuma of Daiichi Sankyo led the
development of T-DXd from the beginning.
His vision, along with the dedication of teams at
Daiichi Sankyo & AstraZeneca, made this a reality.
Cancer Therapy: Preclinical
Clinical
Cancer
Research
DS-8201a, A Novel HER2-Targeting ADC with
IN MEMORIAM
a Novel DNA Topoisomerase I Inhibitor,
DR. TOSHINORI AGATSUMA
Demonstrates a Promising Antitumor Efficacy
with Differentiation from T-DM1
Yusuke Ogitani1, Tetsuo Aida, Katsunobu Hagihara', Junko Yamaguchi,
Chiaki Ishii', Naoya Harada, Masako Soma', Hiromi Okamoto', Masataka Oitate
Shingo Arakawa, Takehiro Hirai2, Ryo Atsumi¹, Takashi Nakada, Ichiro Hayakawa,
Yuki Abe', and Toshinori Agatsuma
2025 ASCO
#ASCO25
PRE SENTED BY: Kohei Shitara, MD
ASCO
AMERICAN SOCIETY OF
CLINICAL ONCOLOGY
ANNUAL MEETING
Presentation is property of the author and ASCO Permission required for reuse contact permissions@asco.org
KNOWLEDGE CONQUERS CANCER
[Slide 1]
Passion for Innovation.
Compassion for Patients.™
Daiichi-Sankyo
Press Release
ENHERTU® Demonstrated Statistically Significant and Clinically
Meaningful Improvement in Overall Survival in Patients with HER2
Positive Metastatic Gastric Cancer at Interim Analysis of DESTINY-
Gastric04 Phase 3 Trial
Phase 3 results confirm the efficacy of Daiichi Sankyo and AstraZeneca's ENHERTU in second-line
metastatic gastric cancer
DESTINY-Gastric04 will be unblinded at interim analysis based on the superior efficacy of ENHERTU
Results will be shared with global regulatory authorities
Tokyo and Basking Ridge, NJ - (March 3, 2025) - Positive topline results from the DESTINY-Gastric04
phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and
clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to
ramucirumab and paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+)
unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
At a planned interim analysis, the Independent Data Monitoring Committee recommended unblinding the
trial based on the superior efficacy of ENHERTU.
[Slide 1]
17:31 M
Voi) LTE %77
ENHERTU®
Demonstrated
Statistically Significant
and Clinically Meaningful
Improvement in Overall
Survival in Patients with
HER2 Positive Metastatic
Gastric Cancer at Interim
Analysis of DESTINY-
Gastric04 Phase 3 Trial
Download the PDF version of
Article
March 03, 2025
Phase 3 results confirm the
efficacy of Daiichi Sankyo and
AstraZeneca's ENHERTU in
second-line metastatic gastric
cancer
DESTINY-Gastric04 will be
unblinded at interim analysis
based on the superior efficacy of
ENHERTU
Results will be shared with glob
regulatory authorities
[Slide 1]
Passion for Innovation.
Compassion for Patients.™
Daiichi-Sankyo
Press Release
ENHERTU® Demonstrated Statistically Significant and Clinically
Meaningful Improvement in Overall Survival in Patients with HER2
Positive Metastatic Gastric Cancer at Interim Analysis of DESTINY-
Gastric04 Phase 3 Trial
Phase 3 results confirm the efficacy of Daiichi Sankyo and AstraZeneca's ENHERTU in second-line
metastatic gastric cancer
DESTINY-Gastric04 will be unblinded at interim analysis based on the superior efficacy of ENHERTU
Results will be shared with global regulatory authorities
Tokyo and Basking Ridge, NJ - (March 3, 2025) - Positive topline results from the DESTINY-Gastric04
phase 3 trial showed ENHERTU® (trastuzumab deruxtecan) demonstrated a statistically significant and
clinically meaningful improvement in the primary endpoint of overall survival (OS) compared to
ramucirumab and paclitaxel in patients with second-line HER2 positive (IHC 3+ or IHC 2+/ISH+)
unresectable and/or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.
At a planned interim analysis, the Independent Data Monitoring Committee recommended unblinding the
trial based on the superior efficacy of ENHERTU.
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by
Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and
AstraZeneca (LSE/STO/Nasdaq: AZN).
Gastric cancer is associated with a poor prognosis, particularly in advanced stages of the disease where the
five-year survival rate is 5% to 10%. 1,2 Following disease progression in the first-line metastatic setting of
HER2 positive gastric cancer, there historically have been no HER2 directed medicines that have
demonstrated a survival benefit in the second-line metastatic setting in a randomized clinical trial.³
DESTINY-Gastric04 confirms T-DXd superiority over ramucirumab+paclitaxel in 2L HER2+ gastric/GEJ in a Western-inclusive phase 3 population. Supports T-DXd as a preferred 2L+ regimen; ILD monitoring remains essential.
FDA APPROVED Enhertu — Adults with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma who have received a prior trastuzumab-based regimen.
Median PFS was 6.7 months with trastuzumab deruxtecan (T-DXd) vs. 5.6 months with ramucirumab+paclitaxel (HR 0.74, 95% CI 0.59-0.92, P=0.007). Primary endpoint met.
Median OS was 14.7 months with T-DXd vs. 11.4 months with ramucirumab+paclitaxel (HR 0.7, 95% CI 0.55-0.90, P=0.0044). Clinically meaningful OS benefit.
Interstitial lung disease/pneumonitis occurred in 13.9% of T-DXd patients (mostly grade 1-2); ongoing ILD monitoring remains essential per class labeling. Overall safety profile consistent with known T-DXd toxicity.
✅ Phase 3 confirmatory evidence for T-DXd in 2L HER2+ gastric/GEJ. DESTINY-Gastric04 confirms T-DXd superiority over ramucirumab+paclitaxel in 2L HER2+ gastric/GEJ in a Western-inclusive phase 3 population. Supports T-DXd as a preferred 2L+ regimen; ILD monitoring remains essential.
