Roche's Tecentriq in combination with chemotherapy helped people live significantly longer as an initial treatment for people with extensive-stage small cell lung cancer - Seite 2

The data will be presented at the International Association for the Study of Lung Cancer (IASLC) 2018 World Conference on Lung Cancer (WCLC) Presidential Symposium on Tuesday, September 25, 2018,
9:00 - 9:15 a.m. EDT (Abstracts PL02.07 Oral). The data will be simultaneously published in the New England Journal of Medicine, and will be featured in the WCLC press conference at 09:45-10:30 a.m. EDT.

About the IMpower133 study
IMpower133 is a Phase III, multicentre, double-blinded, randomised placebo-controlled study evaluating the efficacy and safety of Tecentriq in combination with chemotherapy (carboplatin and etoposide) versus chemotherapy (carboplatin plus etoposide) alone in chemotherapy-naïve people with ES-SCLC.

The study enrolled 403 people who were randomised equally (1:1) to receive:  

• Tecentriq in combination with carboplatin and etoposide (Arm A), or
• Placebo in combination with carboplatin and etoposide (Arm B, control arm)
   

During the treatment-induction phase, people received treatment on 21-day cycles for four cycles, followed by maintenance with Tecentriq or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumours Version 1.1 (RECIST v1.1). Treatment could be continued until persistent radiographic PD or symptomatic deterioration was observed.

The co-primary endpoints were:

• PFS as determined by the investigator using RECIST v1.1 in the ITT population
• OS in the ITT population

IMpower133 met its OS and PFS co-primary endpoints as per the study protocol. A summary of the results is included below:

Arm A (Tecentriq plus chemotherapy) vs Arm B (Placebo plus chemotherapy) in ITT
	Arm A n=201		Arm B n=202
Median OS (95% CI), months	12.3 (10.8, 15.9)		10.3 (9.3, 11.3)
HR (95% CI); P value	0.70 (0.54, 0.91); p=0.0069
1-year OS rate	51.7%	38.2%
ORR, %	60%	64%
Median DOR, months	4.2	3.9
HR (95% CI)	0.70 (0.53, 0.92)
Median PFS