Coherus BioSciences : CHOICE-01 Interim Data at WCLC

CHOICE-01: A Phase 3 Study of Toripalimab versus Placebo In Combination with First-Line Chemotherapy for Advanced NSCLC

Jie Wang, MD, PhD

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

• Peking Union Medical College Beijing, China

Presenter DISCLOSURES

Prof. Jie WANG does not have any financial relationship to disclose.

CHOICE-01 Study Design

CHOICE-01 is a randomized, double-blind,placebo-controlled, multicenter, phase 3 trial comparing the efficacy and safety of toripalimab versus placebo in combination with first-line standard chemotherapy for treatment-naïve, advanced non- small cell lung cancer (NSCLC)

Key Eligibility Criteria	Toripalimab 240 mg, IV, day 1 Q3W (up to 2 years)
+ Pemetrexed +cisplatin/carboplatin (4-6 cycles)
• Advanced NSCLC (SQ & NSQ)	followed by pemetrexed for NSQ
• Stage IIIB-IV	+ Nab-paclitaxel + carboplatin (4-6 cycles) for SQ
• Treatment-naïve for locally advanced	N=450 R
or metastatic setting	2:1
• No known sensitizing EGFR mutation	Placebo, IV, day 1 Q3W (up to 2 years)

or ALK fusion	+ Pemetrexed + cisplatin/carboplatin (4-6 cycles)
• Measurable disease per RECIST v1.1
followed by pemetrexed for NSQ
• ECOG PS score 0-1
+ Nab-paclitaxel + carboplatin (4-6 cycles) for SQ
• Tumor tissue available for PD-L1
expression testing1

PD

Survival

follow-up

PD

Active cross-over

Stratification factors:

• PD-L1expression (TC≥1% vs TC<1%)2
• Smoking status (often3 vs never/occasional）
• Histology (squamous vs non-squamous)

1 Based on JS311 IUO Assay

2 Patients with tumor unevaluable for PD-L1 included in TC<1% group 3 defined as ≥400 pack years

Pemetrexed 500mg/m2 IV day 1	Carboplatin AUC５IV day 1
Nab-paclitaxel 100mg/m2 IV d1,8,15	Cisplatin 75mg/m2 IV day 1

Primary endpoint

PFS per RECIST v1.1 by investigator

Secondary end points

OS, PFS by BIRC, ORR, DoR, DCR, TTR, and safety

SQ=Squamous; NSQ=Non-Squamous;

BIRC= Blinded Independent Review Committee

Meet the criteria for crossover treatment

Toripalimab	PD
240 mg

Baseline Characteristics

		Toripalimab+ Chemo	Placebo+Chemo
		(N=309)	(N=156)
Age, Median (range), Years		63 (36 - 75)	61 (29 - 75)
Sex, Male, n(%)		247	(79.9)	130	(83.3)
ECOG	0	66	(21.4)	36	(23.1)
	1	243	(78.6)	120	(76.9)
Histology, n (%)	Squamous	147	(47.6)	73	(46.8)
	Non-squamous	162	(52.4)	83	(53.2)
PD-L1 expression, n (%)	TC ≥1%	201	(65.0)	103	(66.0)
	TC <1%	108	(35.0)	53	(34.0)
Smoking Status, n (%)	Frequent	213	(68.9)	107	(68.6)
	Never/Occasional	96	(31.1)	49	(31.4)
Stage at Study Entry1, n (%)	IIIB/IIIC	49	(15.9)	23	(14.7)
	IVA	141	(45.6)	82	(52.6)
	IVB	119 (38.5)	51	(32.7)
Sites of Metastases, n (%)	Brain	5	(1.6)			0
	Liver	26	(8.4)	14	(9.0)
	≥3 metastatic sites	53	(17.2)	24	(15.4)
Prior Adjuvant/Neo-adjuvant therapy, n (%)	13	(4.2)	9	(5.8)
1. Based on AJCC 8th Edition					Data cut-off date: November 17th, 2020

Efficacy

PFS per RECIST v1.1 by Investigator

Survival	1.0
0.8										62.3%
Free	0.6
Progression-	0.4							41.5%
	0.2
				Toripalimab 240mg (n=309)
	0.0				Placebo (n=156)
	0	1	2	3	4	5	6	7	8	9	10	11
Subject at risk
											Months
Toripalimab 240mg	309	296	276	244	227	165	110	82	69	55	36	28
Placebo	156	153	141	115	102	69	34	29	23	18	9	8

	Toripalimab +chemo		Placebo
	(n=309)		+ chemo (n=156)
Events (%)	130 (42.1)		88 (56.4)
Median PFS, months (95% CI)	8.3 (6.9-8.7)		5.6 (5.4-6.4)
HR (95%CI)	0.58 (0.442-0.769)
P-value	0.0001
ORR	63.4%		41.7%
DoR, months (95%CI)	8.3 (6.8, 8.7)		4.2 (4.0, 5.7)

32.6%

13.1%

12	13	14	15	16	17	18	19
20	8	7	2	2	1	1	0
4	2	2	0

• PFS in squamous subgroup HR=0.55 (95% CI: 0.38-0.83);non-squamous subgroup HR=0.59 (95% CI: 0.40-0.87)
• IRC-assessedPFS for squamous and non-squamous patients was consistent with Investigator's assessed PFS

Data cut-off date: November 17th, 2020