Coherus BioSciences : JUPITER-06 Interim Data at ESMO Congress 2021

JUPITER-06:

A Randomized, Double-blind, Phase 3 Study of Toripalimab versus Placebo In Combination with First-Line Chemotherapy for Treatment Naive Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC)

R.-H. Xu1, F. Wang1, C. Cui2, J. Yao3, Y. Zhang4, G. Wang5, J. Feng6, S. Yang7,

1. Fan8, J. Shi9, X.Zhang10, L. Shen11, Y.Shu12, C. Wang13, T. Dai14, T. Mao15, L. Chen16, Z. Guo17, B. Liu18, H. Pan19, Coherus Biosciences and Shanghai Junshi Biosciences.

1Department of Medical Oncology, Sun Yat-Sen University Cancer Center; State Key Laboratory of Oncology in South China; Collaborative Innovation Center of Cancer Medicine, Guangzhou, China; 2Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences, Beijing, China, 3Medical Oncology, The First Affiliated Hospital of Henan University of Science and Technology, Luoyang, China, 4Gastroenterology, Harbin Medical University Cancer Hospital, Harbin, China, 5MedicalOncology, Army Medical Center of PLA, Chongqing, China, 6Medical Oncology Department, Jiangsu Cancer Hospital, Nanjing, China, 7Department of Internal Medicine, Henan Cancer Hospital & Affiliated Cancer Hospital of Zhengzhou University, Zhengzhou, China, 8Department of Medical Oncology, Zhejiang Cancer Hospital, Hangzhou, China,9Medical Oncology, Linyi Cancer Hospital, Linyi, China, 10Medical Oncology, The Northern Jiangsu People's Hospital, Yangzhou, China, 11Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education), Peking University Cancer Hospital and Institute, Beijing, China, 12Cancer Center, Jiangsu Province Hospital, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China, 13Medical Oncology, Zhongda Hospital Southeast University, Nanjing, China, 14Medical Oncology, The Affiliated Hospital of Southwest Medical University, Luzhou, China, 15Medical Oncology, Shanghai Chest Hospital, Shanghai, China, 16Medical Oncology, Guangxi Medical University Affiliated Tumor Hospital, Nanning, China, 17Medical Oncology, Fujian Cancer Hospital, Fuzhou, China,18Medical Oncology, Shandong Cancer Hospital, Jinan, China, 19Medical Oncology, Sir Run Run Shaw Hospital, Zhejiang University, Hangzhou, China

Presented by Feng Wang MD, PhD at 2021 ESMO Annual Meeting

DECLARATION OF INTERESTS

Feng Wang MD, PhD

No conflicts of interest

Rui-Hua Xu MD, PhD

Consulting or Advisory Role:

Bristol-Myers Squibb, Merck Serono, Roche, Astellas, and AstraZeneca.

Presented by Feng Wang, MD, PhD

Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

Resume

Feng Wang

• Department: Medical Oncology

•	Title：	Professor and Vice Director
•	Email：	[e-mail]
•	Tel：	[phone]

• Profile:

Dr. Feng Wang is currently a professor and vice director in the Department of Medical Oncology at Sun Yat-Sen University Cancer Center, Guangzhou, China. She has extensive experience and expertise in the field of Gastrointestinal Medical Oncology and translation research in gastrointestinal cancers. Dr Wang sees more than 3 thousand patients with gastrointestinal cancers annually and has initiated or participated in many investigator initiated and NMPA approved clinical trials. She presides over a number of research programs including the international (regional) cooperation and exchange program, and general program from the national natural science foundation of China, the Doctoral Program of Higher Education of China, and has participated in several international cooperation, national and provincial level projects. Dr. Wang has published over 90 peer-reviewed articles, including some first author or corresponding author papers in renowned journals such as JAMA Oncology, Cell Research, Annals of Oncology, EMBO Mol Med, Oncogene, etc and has been invited to present her research results at AACR, CSCO, Nature Conference, Chinese Congress of Oncology and other international conferences. She was awarded many prizes including the Second Prize of National Science and Technology Progress Award, First Prize of Chinese Medical Science and Technology Award, the First Prize of Guangdong Province Science and Technology Progress Award, the Outstanding Young Talents of Sun Yat-sen University Cancer Center and the New Stars of Science and Technology in Guangzhou etc. She holds many academic posts, including the vice director of Youth Committee of Professional Committee of Tumor Targeted Therapy, Chinese anti-cancer association and a Chairing Committee member of Chinese Society of Clinical Oncology etc.

Presented by Feng Wang, MD, PhD

Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

JUPITER-06：Study Design

Key Eligibility Criteria

• Histologically or cytologically confirmed advanced or metastatic ESCC
• Treatment-naïvefor metastatic disease
• ECOG PS of 0 or 1
• Measurable disease per RECIST v1.1

Toripalimab 240 mg + Chemotherapy

（Paclitaxel 175 mg/m2 and Cisplatin 75 mg/m2 Q3W for up to 6 cycles）

R (1:1)

Placebo + Chemotherapy

（ Paclitaxel 175 mg/m2 and Cisplatin 75

mg/m2 Q3W for up to 6 cycles）

Toripalimab Maintenance

240mg, Q3Wa

Placebo Maintenance

Q3Wa

Stratification Factors

• Prior Radiation (yes vs no)
• ECOG PS 0 vs 1

• Co-Primaryendpoints：PFS by BICR per RECIST v1.1 and OS
• Secondary endpoints：PFS by the Investigator, ORR , DoR , DCR, and 1-year and 2-year PFS & OS rates, safety, and HRQoL

1. Until progressive disease, intolerable toxicity, withdrawal of consent or investigator's judgement or a maximum treatment of 2 years.

Abbreviation: RECIST, Response Evaluation Criteria in Solid Tumors; ECOG PS, Eastern Cooperative Oncology Group performance status score; BICR, blind independent central review ; IV, intravenously; PFS, progression-free survival; OS, overall survival; ORR, objective response rate; DCR, disease control rate; DoR, duration of response; HRQoL, health-related quality of life.

Presented by Feng Wang, MD, PhD

Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.

Baseline Characteristics

	Characteristic	Toripalimab + chemotherapy	Placebo + chemotherapy
		N=257; n (%)	N=257; n (%)
	Median age (range),years	63.0	(20-75)	62.0	(40-74)
	≥65 years	101 (39.3)	94 (36.6)
	Male	217	(84.4)	220 85.6)
	Previous radiation therapy	35 (13.6)	34 (13.2)
	ECOG PS 1	191(74.3)	192	(74.7)
	Disease status
	Recurrent or unresectable	50(19.5)	59 (23.0)
	Metastatic	206	(80.2)	198	(77.0)
	Not available	1(0.4)		0
	PD-L1 expression
	CPS<1	43 (16.7)	44 (17.1)
	CPS≥1	201	(78.2)	200	(77.8)
	CPS<10	129	(50.2)	147	(57.2)
	CPS≥10	115	(44.7)	97 (37.7)
	Unknown	13 (5.1)	13 (5.1)
Data cut-off date: 22/Mar/2021

Presented by Feng Wang, MD, PhD

Content of this presentation is copyright and responsibility of the author. Permission is required for re-use.