Biotechnology company Genentech Inc., a unit of Roche Group (RO.SW,ROG.SW,RHHBY.PK), Friday said CLEOPATRA, a pivotal Phase III study of HER2-positive breast cancer, met its primary endpoint of progression-free survival. Based on encouraging results, Roche plans to seek approval with health authorities, the company noted.
The CLinical Evaluation Of Pertuzumab And TRAstuzumab study showed that people with HER2-positive metastatic breast cancer or mBC, who received the combination of two targeted medicines, pertuzumab and Herceptin, plus docetaxel chemotherapy lived significantly longer without their disease getting worse. This is compared to people who received only Herceptin and docetaxel. Pertuzumab is a monoclonal antibody being studied in early-stage and metastatic HER2-positive breast cancer.
In the study, the company said it did not observe any new safety signals, and adverse events were consistent with those seen in previous studies of pertuzumab and Herceptin, either in combination or alone.
Secondary endpoints are overall survival, safety profile, overall response rate, duration of remission, quality of life and correlation of biomarkers with clinical outcomes, the company said.
Genentech will submit the data from the randomized, double-blind, placebo-controlled clinical study for presentation at an upcoming medical meeting.
However, the HER2-positive mBC, which is a particularly aggressive form of breast cancer, remains an incurable disease, despite significant progress, the company said.
Hal Barron, chief medical officer and head, Global Product Development, stated, "These results with pertuzumab combined with Herceptin and docetaxel are very encouraging and represent our commitment to developing potential new personalized options for people with this aggressive disease. We plan to submit the study results for global regulatory approval this year."
RHHBY.PK closed Thursday's regular trading session at $41.51, down $0.05 or 0.12 percent.
by RTT Staff Writer
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