Genentech, a member of the Roche Group(SIX: RO, ROG; OTCQX: RHHBY), today announced that the Phase III IMpower133 study met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) at its first interim analysis. The study demonstrated that initial (first-line) treatment with the combination of TECENTRIQ® (atezolizumab) plus chemotherapy (carboplatin and etoposide) helped people with extensive-stage small cell lung cancer (ES-SCLC) live significantly longer compared to chemotherapy alone. The TECENTRIQ-based combination also reduced the risk of disease worsening or death (PFS) compared to chemotherapy alone. 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. These data will be presented at an upcoming medical meeting.
“These are the first positive Phase III survival results for any immunotherapy-based combination in the initial treatment of extensive-stage small cell lung cancer, a particularly difficult-to-treat type of disease,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “The clinically meaningful results from the IMpower133 study add to the growing body of evidence demonstrating that TECENTRIQ-based combinations may be an effective treatment for different types of advanced lung cancer. We look forward to working with health authorities globally to bring this potential treatment option to people with this type of disease as soon as possible.”
This is the fourth positive Phase III lung cancer study evaluating a TECENTRIQ-based combination to read out this year and the fifth positive study overall. Currently, Genentech has eight Phase III lung cancer studies underway evaluating TECENTRIQ alone or in combination with other medicines across different types of lung cancer.
IMpower133 is a Phase III, multicenter, double-blinded, randomized placebo-controlled study evaluating the efficacy and safety of TECENTRIQ in combination with carboplatin and etoposide versus chemotherapy (carboplatin plus etoposide) alone in chemotherapy-naïve people with ES-SCLC. The study enrolled 403 people who were randomized 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 Tumors 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 intention-to-treat (ITT) population
- OS in the ITT population
IMpower133 met its OS and PFS co-primary endpoints as per the study protocol.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.