Daiichi Sankyo Presents Breakthrough ENHERTU Data at ASCO 2025 with Two Late-Breaking Phase 3 Trials
核心洞察
ENHERTU combined with pertuzumab demonstrated superior progression-free survival compared to standard taxane, trastuzumab and pertuzumab therapy as first-line treatment for HER2 positive metastatic breast cancer (搜索) in the DESTINY-Breast09 phase 3 trial.
The DESTINY-Gastric04 phase 3 trial showed ENHERTU achieved superior overall survival versus ramucirumab and paclitaxel as second-line treatment in patients with HER2 (搜索) positive metastatic gastric or gastroesophageal junction adenocarcinoma (搜索).
Daiichi Sankyo now has six breast cancer and two gastric cancer randomized trials demonstrating significant survival improvements with ENHERTU, marking the fourth consecutive year of practice-changing data presentations at ASCO.
Daiichi Sankyo will showcase transformative clinical data at the 2025 American Society of Clinical Oncology (ASCO) Scientific Program, featuring two late-breaking oral presentations that could redefine treatment standards for HER2 (搜索) positive cancers. The company will present results from over 20 abstracts across multiple cancer types, highlighting significant advances in its antibody-drug conjugate (ADC) portfolio.
ENHERTU Demonstrates Superior Efficacy in Breast and Gastric Cancers
The DESTINY-Breast09 phase 3 trial (LBA #1008) represents a potential paradigm shift in first-line treatment for HER2 positive metastatic breast cancer (搜索). ENHERTU (trastuzumab deruxtecan) in combination with pertuzumab demonstrated superior progression-free survival compared to the current standard of care, taxane, trastuzumab and pertuzumab (THP). This marks a significant advancement in treating patients with HER2 positive metastatic breast cancer from the outset of their treatment journey.
In gastric cancer, the DESTINY-Gastric04 phase 3 trial (LBA #4002) showed ENHERTU achieved superior overall survival compared to ramucirumab and paclitaxel as a second-line treatment in patients with HER2 (搜索) positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. Both studies will be featured in ASCO press briefings, underscoring their clinical significance.
"This year's ASCO marks the fourth in a row where potential practice-changing ENHERTU data will be showcased," said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. "With the results of DESTINY-Breast09 and DESTINY-Gastric04, we now have six breast and two gastric cancer randomized trials that have demonstrated significant survival improvements with ENHERTU."
Expanding Evidence Base Across Multiple Indications
Additional ENHERTU data at ASCO will include an oral presentation featuring an exploratory circulating tumor DNA analysis from the DESTINY-Breast06 phase 3 trial (#1013). This study evaluated ENHERTU compared to physician's choice of chemotherapy in hormone receptor (HR) positive, HER2 (搜索) low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) metastatic breast cancer.
The PRO-DUCE study (#1545) will present updated results examining vital sign monitoring compared to usual care in patients with metastatic breast cancer receiving ENHERTU. A trials-in-progress poster will feature the DESTINY-Gastric05 phase 3 trial (TPS4207) evaluating ENHERTU in combination with fluoropyrimidine-based chemotherapy and pembrolizumab compared to trastuzumab with platinum-based chemotherapy and pembrolizumab in previously untreated patients with unresectable, locally advanced or metastatic HER2 (搜索) positive gastric or GEJ cancer.
Lung Cancer Portfolio Advances with DXd ADC Technology
Daiichi Sankyo will present updated combination data for DATROWAY (datopotamab deruxtecan) across three early-phase trials in patients with early or advanced non-small cell lung cancer (搜索) (NSCLC). The TROPION-Lung02 phase 1b trial (#8501) will feature updated results evaluating DATROWAY plus pembrolizumab with or without platinum-based chemotherapy in patients with previously untreated advanced NSCLC without actionable genomic alterations.
The presentation will include results from an exploratory analysis using quantitative continuous scoring (QCS), AstraZeneca's proprietary computational pathology platform. Additional lung cancer data includes the TROPION-Lung04 phase 1b trial (#8521) evaluating DATROWAY and rilvegostomig, AstraZeneca's PD-1/TIGIT bispecific antibody, in patients with advanced or metastatic NSCLC.
The HERTHENA-Lung02 phase 3 trial (#8506) will present data on patritumab deruxtecan (HER3 (搜索)-DXd) versus platinum doublet chemotherapy in patients with locally advanced or metastatic EGFR-mutated NSCLC (搜索) with disease progression following EGFR (搜索) tyrosine kinase inhibitor (TKI) treatment.
Comprehensive ADC Platform Development
The company's DXd ADC Technology platform consists of monoclonal antibodies attached to topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers. The portfolio includes ENHERTU (HER2 (搜索)-directed), DATROWAY (TROP2 (搜索)-directed), patritumab deruxtecan (HER3 (搜索)-directed), ifinatamab deruxtecan (B7-H3 (搜索)-directed), and raludotatug deruxtecan (CDH6 (搜索)-directed).
Additional presentations will highlight the TUXEDO-3 phase 2 trial (#2005) evaluating patritumab deruxtecan in patients with metastatic breast cancer or advanced NSCLC with active brain metastases and leptomeningeal carcinomatosis. The company will also present data on valemetostat, a dual EZH1 (搜索) and EZH2 (搜索) inhibitor, in pediatric patients with malignant solid tumors.
Expanding Beyond Core Oncology Programs
Daiichi Sankyo's second ADC platform utilizes a monoclonal antibody attached to a modified pyrrolobenzodiazepine (PBD) payload. DS-9606, a CLDN6 directed PBD ADC, represents the first of several planned ADCs in clinical development using this platform.
The company will also present data on VANFLYTA (quizartinib) in the QuANTUM-Wild phase 3 trial (TPS6580) evaluating the drug in combination with chemotherapy in patients with FLT3 (搜索)-ITD negative acute myeloid leukemia (搜索). A first-in-human phase 1 trial of DS-2243 (TPS2668), a potential first-in-class bispecific T-cell engager targeting HLA-A*02/NY-ESO in patients with advanced solid tumors, will also be featured.
Daiichi Sankyo will hold a virtual investor conference call on Monday, June 2, 2025, where executives will provide an overview of the ASCO research data and address questions about the company's oncology development pipeline.