Daiichi Sankyo : ASCO highlight briefing session materia

ASCO Highlights 2024

DAIICHI SANKYO CO., LTD.

June 3rd (US)/ 4th (JP), 2024

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ASCO Highlights 2024: IR conference call

Hiroyuki Okuzawa	Ken Takeshita	Mark Rutstein
President and COO	Head of Global R&D	Head of Global Oncology
		Development

Content will be delivered on-demand after the meeting

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Agenda

1. Welcome message
2. R&D strategy
3. Highlights from ASCO 2024
4. Q&A

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Agenda

1. Welcome message
2. R&D strategy
3. Highlights from ASCO 2024
4. Q&A

5

Agenda

1. Welcome message
2. R&D strategy
3. Highlights from ASCO 2024
4. Q&A

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ASCO 2024

With over 30 presentations* across 8 assets and multiple tumor types,

Daiichi Sankyo has delivered scientific outcome not limited to but highlighted by;

• Substantial progress in ENHERTU breast cancer development
• • Highlights IR call discusses DESTINY-Breast06,DESTINY-Breast03 and DESTINY-Breast07
• Steady progress in lung cancer development among DXd ADCs
• • Highlights IR call discusses DESTINY-Lung02 and TROPION-Lung02

* 5 online abstract publications (T-DXd) are included	7

Establish and expand DXd ADCs to address the broader

spectrum of Breast Cancer

HER2+

20%

Neoadjuvant

DESTINY-Breast11

Adjuvant

DESTINY-Breast05

Residual Disease

1L

DESTINY-Breast09

2L+

DESTINY-Breast01/02/03

Evaluating

TNBC

15%

TROPION-Breast04

TROPIONBreast03

Residual Disease

TROPION -Breast02

CPS<10 or IO ineligible

TROPION -Breast05

CPS≥10

			potential
	DESTINY-Breast04
	HER2 low

Neoadjuvant

Adjuvant

ET		post 1-2L ET		post 1-2L chemotherapy

	HER2 low							DESTINY
	60%	Evaluating Potential or Preparing Study Plans	DESTINY	-Breast04
HR+						-Breast06
65%	HER2
	ultralow							TROPION-Breast01
	25%
	HER2
	null
	15%
	Launched	On-going	ENHERTU®	Dato-DXd	HER3-DXd	• Box size does not reflect the patient population

Evaluating

potential

Pivotal studies only (not exhaustive). CPS, combined positive score; ET, endocrine therapy; HR, hormone receptor; IHC: immunohistochemistry, pCR: pathological complete response, TNBC, triple-	8
negative breast cancer

Establish and expand DXd ADCs to address the broader

spectrum of Lung Cancer

Stage I - III

	1L
PD-L1 < 50%	PD-L1 > 50%

2L+

EGFRm

HER2m

NSCLC	Others
AGA
~84%
	Non
	-SQ

SQ

SCLC

~13%

TROPION-Lung14

DESTINY-Lung04

TROPION-Lung10

TROPION-Lung07

TROPION-Lung08

Evaluating Potential or	Capping TROPION-Lung08 SQ
Preparing Study Plans	population

	HERTHENA		HERTHENA
	-Lung02		-Lung01
					Lung01
	TROPION-Lung15
	DESTINY-Lung01/02		PanTumor02/-DESTINY	3+)
	TROPION-Lung01	HER2+(IHC

IDeate-		IDeate-
Lung02		Lung01

Launched

									• Pivotal studies and major Ph2 only, not exhaustive
On-going		ENHERTU®		Dato-DXd		HER3-DXd		I-DXd
				•	Box size does not reflect the patient population

ADC: antibody-drug conjugate, AGA: actionable genomic alteration, Non-SQ: non- squamous, NSCLC: non-small cell lung cancer, SCLC: small cell lung cancer, SQ: squamous	9

Dato-DXd TROPION-Lung15 study

New Ph3 study in 2L EGFR mutated NSCLC for Dato-DXd monotherapy and Osimertinib combination comparing to PBC

TROPION-Lung15 study design

Key Eligibility
•	Advanced or metastatic NSCLC who have	R
	progressed on prior Osimertinib
	1:1:1
• ≤ 2 prior lines of EGFR TKI treatments
•	Sensitizing EGFR mutations
		N=630

• Two primary endpoints for Dato-DXd monotherapy and combination were set independently
• Study start planned in FY2024 H1

Dato-DXd 6mg/kg q3w

• Osimertinib QD
  Dato-DXd 6mg/kg q3w

Platinum-based Doublet

Chemotherapy

Primary endpoint

• PFS (assessed by BICR) mono vs CTX
• PFS (assessed by BICR) combo vs CTX Secondary endpoint
• OS, PFS (inv assessed), ORR, DOR, DCR, Safety

BICR: blinded independent central review, CTX: 5-Fluorouracil, folinic acid and cisplatin, DCR: disease control rate, DOR: duration of response, NSCLC: non small cell lung cancer, ORR:	10
objective response rate, OS: overall survival, PBC: platinum-based chemotherapy, PFS: progression-free survival, QD: quaque die, q3w: every 3 weeks, TKI: tyrosine kinase inhibitor