Daiichi Sankyo Showcases Bold Leadership in Oncology with Survival Improvements for Certain Patients with Cancer at ASCO and EHA

• ENHERTU data from historic DESTINY-Breast04 trial in patients with HER2 low metastatic breast cancer has the potential to redefine how breast cancer is categorized and treated

• First presentation of DS-6000 and new patritumab deruxtecan results further support the strength of Daiichi Sankyo’s DXd ADC technology across multiple cancers including breast, lung, ovarian and renal cell carcinoma

• Survival benefit of quizartinib in combination with chemotherapy demonstrated in QuANTUM-First trial in patients with newly diagnosed FLT3-ITD positive AML

Daiichi Sankyo (TSE: 4568) will present new clinical research across its oncology portfolio at the 2022 American Society of Clinical Oncology Scientific Program (#ASCO22) and the European Hematology Association Congress (#EHA22).

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Presentations, including a Plenary Session (LBA#3) at ASCO featuring the DESTINY-Breast04 trial of ENHERTU (trastuzumab deruxtecan) and a Presidential Symposium at EHA (S100) highlighting the QuANTUM-First trial of quizartinib, underscore the company’s leadership in developing multiple transformative medicines that significantly improve survival for certain patients with cancer. Both DESTINY-Breast04 and QuANTUM-First data will be featured in press briefings at ASCO and EHA.

“We will be showcasing impressive data from two of our late-stage clinical development programs at ASCO and EHA, where our medicines are demonstrating significant survival advantage in certain patients with metastatic breast cancer and acute myeloid leukemia,” said Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo. “Our ambition is to push the boundaries of science to change the way cancer is treated. The results of the DESTINY-Breast04 trial of ENHERTU will transform the practice of how breast cancer is treated, as this is the first time that a HER2 directed therapy has demonstrated an improvement in survival in patients with HER2 low metastatic breast cancer, a cancer category distinct from HER2 positive breast cancer.”

Redefining How Breast Cancer is Categorized and Treated
Data from the historic DESTINY-Breast04 phase 3 trial evaluating ENHERTU versus the current standard of care of physician’s choice of chemotherapy in patients with HER2 low metastatic breast cancer will be highlighted during the ASCO Plenary Session (LBA#3) and included in an ASCO Press Briefing on Sunday, June 5.

ENHERTU is the first ever HER2 directed medicine to show efficacy in HER2 low breast cancer. ENHERTU demonstrated a statistically significant and clinically meaningful benefit in progression-free survival (PFS) and overall survival (OS) compared to standard treatment in patients with HER2 low metastatic breast cancer (defined as IHC 1+ or IHC 2+/ISH-negative), potentially redefining how breast cancer will be categorized and treated in the future.

The safety profile of ENHERTU in DESTINY-Breast04 was consistent with previous clinical trials with no new safety concerns identified. Overall interstitial lung disease (ILD) rates were consistent with that observed in late-line HER2 positive breast cancer trials of ENHERTU with a lower rate of grade 5 ILD observed, as determined by an independent adjudication committee.

Other ENHERTU data being presented at ASCO includes an update of safety data from the head-to-head DESTINY-Breast03 phase 3 trial versus trastuzumab emtansine and preliminary data from DESTINY-Breast07 and DESTINY-Breast08, two phase 2 dose-finding trials evaluating ENHERTU in combination with other breast cancer treatments in patients with HER2 positive and HER2 low breast cancer, respectively.

ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed by Daiichi Sankyo and AstraZeneca.

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Strength of the Daiichi Sankyo DXd ADC Technology Across Multiple Cancers
Data from a phase 1/2 trial of patritumab deruxtecan (HER3-DXd), a potential first-in-class HER3 directed ADC, in patients with HER3 expressing metastatic breast cancer will be featured at ASCO. These results show promising clinical activity in several HER3 high breast cancer subtypes including HER2 positive breast cancer, hormone receptor positive/HER2 negative breast cancer and triple negative breast cancer. Additionally, preliminary phase 1 data of patritumab deruxtecan from a cohort of patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-activating mutations will be presented for the first time.

First ever preliminary phase 1 results of DS-6000 in patients with advanced ovarian cancer and renal cell carcinoma also will be highlighted. DS-6000 is a potential first-in-class CDH6 directed ADC and the fifth DXd ADC from Daiichi Sankyo’s pipeline to report encouraging early clinical data.

A trial-in-progress presentation of the TROPION-Lung08 phase 3 trial of datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab as first-line treatment of patients with metastatic NSCLC in PD-L1 ≥50%, without actionable genomic alterations will be presented.

Daiichi Sankyo will hold a conference call for investors and analysts on Tuesday, June 7 from 5:30 to 7:00 pm CDT. Ken Takeshita, MD, Global Head, R&D, Daiichi Sankyo and Gilles Gallant, BPharm, PhD, FOPQ, Global Head, Oncology Development will provide an overview of the ASCO research data and address questions from investors and analysts.

Improving Survival for Patients with Newly Diagnosed FLT3-ITD AML
Data from the pivotal QuANTUM-First phase 3 trial of quizartinib in combination with standard chemotherapy in patients with newly diagnosed FLT3-ITD positive acute myeloid leukemia (AML) will be featured during the EHA Presidential Symposium and included in an EHA Press Briefing on Saturday, June 11.

Results from QuANTUM-First demonstrated that patients who received quizartinib in combination with standard induction and consolidation chemotherapy and then continued with single agent quizartinib for up to 36 cycles had a statistically significant and clinically meaningful improvement in OS compared to those who received standard treatment alone. The safety of quizartinib was shown to be manageable and consistent with the known safety profile.

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