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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

Nachrichtenquelle: GlobeNewswire
25.09.2018, 15:00  |  204   |   |   

F. Hoffmann-La Roche Ltd / 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 . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

  • First Phase III study to show a cancer immunotherapy-based combination significantly improved overall survival (OS) and progression-free survival (PFS) in the initial treatment of extensive-stage small cell lung cancer (ES-SCLC)
Data will be presented at the 2018 World Conference on Lung Cancer (WCLC) Presidential Symposium, featured in the press programme and simultaneously published in the New England Journal of Medicine on 25 September 2018

Basel, 25 September 2018 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the Phase III IMpower133 study of Tecentriq (atezolizumab) plus carboplatin and etoposide (chemotherapy) for the initial (first-line) treatment of people with previously-untreated extensive-stage small cell lung cancer (ES-SCLC). The analysis showed that Tecentriq and chemotherapy helped people live significantly longer compared with chemotherapy alone (overall survival [OS]=12.3 versus 10.3 months; hazard ratio [HR]=0.70, 95% CI: 0.54-0.91; p=0.0069) in the intention-to-treat (ITT) population. [1] The Tecentriq -based combination also significantly reduced the risk of disease worsening or death (progression-free survival, PFS) compared with chemotherapy alone (PFS=5.2 versus 4.3 months; HR=0.77, 95% CI: 0.62-0.96; p=0.017). [1] Safety for the Tecentriq and chemotherapy combination appeared consistent with the known safety profile of the individual medicines, and no new safety signals were identified with the combination.

"The results with this Tecentriq combination in the initial treatment of extensive-stage small cell lung cancer represent the first clinically meaningful advance in the disease in over 20 years," said Sandra Horning, MD, Roche's Chief Medical Officer and Head of Global Product Development. "Our goal is to find treatment options for all types of lung cancer, and we are eager to work with global health authorities to bring this Tecentriq regimen to people living with this particularly difficult-to-treat form of lung cancer as soon as possible."

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
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