ASCO 2022 Highlights

from the beginning

ASCO Highlights

Forward-Looking Statements

ASCO Highlights 2022: IR conference call

1. Introduction

5-Year Business Plan (FY2021-FY2025) for Sustainable Growth

Strategic Pillars for the 5-Year Business Plan (FY2021-FY2025)-1st pillar: Maximize 3ADCs-

Launch Plan for 3ADCs-Expand 3ADCs in broader cancer types and treatment lines-

Strategic Pillars for the 5-Year Business Plan (FY2021-FY2025)-3rd pillar: Identify and build pillars for further growth

Rising Stars: DS-7300 & DS-6000

Daiichi Sankyo’s Multi-modality Strategy

DS Strategy to Enrich Our Delivery to Patients

Daiichi Sankyo’s Purpose and R&D Vision

Data Highlights from ASCO & ESMO BC

2. Shift the paradigm for HER2-low BC

Opening a new treatment paradigm for patients with HER2-low Breast Cancer

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DESTINY-Breast04 Summary and Impact

DESTINY-Breast04: First Randomized Phase 3b Study of T-DXd for HER2-low mBC

Baseline Characteristics

Prior Therapies

PFS in HR+ and All Patients

OS in HR+ and All Patients

PFS and OS in HR? (Exploratory Endpoints)

Subgroup Analysis: PFS in HR+

Confirmed ORR

Best Change in Target Lesions (All Patients)

Drug-Related TEAEs in ?20% of Patients

Overall Safety Summary

Adverse Events of Special Interest

DESTINY-Breast04 Establishes T-DXd as the New Standard of Care in HER2-low, HR+/HR? mBC

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Results: Prevalence and Concordance

Conclusions

ENHERTUR: HER2-low Breast Cancer Clinical Development Highlights

HER2-low Breast Cancer Key Takeaways

3. Build trust in HER2+ Breast Cancer

ENHERTUR Approved in the U.S. for 2L HER2+ BC

ENHERTUR: DESTINY-Breast03 study

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DESTINY-Breast03 Study Design

Safety Update Overview (September 7, 2021)

Exposure-Adjusted Incidence Rates (EAIRs)a

Drug-Related TEAEsa Reported in ?20% of Patients in Either Treatment Arm

Time to First Onset of TEAEs

Adjudicated Drug-Related ILD/Pneumonitis

Conclusions

Guidelines and recommendations for the multidisciplinary diagnosis and management of ILD/pneumonitis in patients receiving T-DXd (1/2)

Guidelines and recommendations for the multidisciplinary diagnosis and management of ILD/pneumonitis in patients receiving T-DXd (2/2)

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DESTINY-Breast03 PRO & Hospitalization Endpoints & Analyses

TDD in PRO Measures of Interest

Hospitalization-Related Endpoints

Conclusions

”Is ENHERTUR Effective in Brain Metastasis?”

PFS KM Curves for Patients With and Without BM

Intracranial Response per BICR using RECIST 1.1 SABCS 2021

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Study Design

Primary Endpoint

Conclusions

HER2+ Breast Cancer Key Takeaways

4. Addressing further needs in BC

Address Further Unmet Needs in Breast Cancer

Address Further Unmet Needs in Breast Cancer

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BEGONIA (NCT03742102) Study Design

Antitumor Responses

Antitumor Responses

Safety Summary

Most Reported Adverse Events (?15% all grades)

Conclusions

Dato-DXd: Breast Cancer Clinical Development Highlights

ENHERTUR & Dato-DXd: Breast Cancer Clinical Development Highlights

Exploring Possibility as Another Option in Breast Cancer

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Study Design

Clinical Activity of HER3-DXd Across BC Subtypes

Change in Tumor Size From Baseline

Overall Safety Profile of HER3-DXd

TEAEs in Patients Treated with 4.8 mg/kg and 6.4 mg/kg

Conclusions

Address Further Needs in Breast Cancer Key Takeaways

5. Rising Stars

Rising Stars: DS-7300 & DS-6000

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Background

DS-6000a Was Designed With 7 Key Attributes

Study Design

Baseline Patient and Disease Characteristics

Patient and Treatment Summary

Treatment Related TEAEs (Any Grade) Occurring in ?10% of Patients

Treatment-Related TEAEs (Grade ?3)

Change From Baseline in Target Lesions: OVC and RCC Evaluable Populationa

Change From Baseline in CA-125 Levels

Conclusions

Our DXd-ADC Pipeline

6. Future news flow

FY2022 Future News Flow

FY2022 Future News Flow

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Q&A

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