Swiss pharmaceutical giant Novartis AG (NVS) revealed Wednesday that a five-month extended late stage study showed that its everolimus (Afinitor) tablets plus hormonal therapy exemestane boosted progression-free survival in women with hormone receptor-positive breast cancer. However, the indication is yet to be approved by the U.S. Food and Drug Administration.
The findings from the phase 3 BOLERO-2 breast cancer trials of Oral Everolimus was earlier presented in late September during a Presidential Symposium at the 2011 European Multidisciplinary Cancer Congress in Stockholm. The company said the first worldwide regulatory filings are planned by the end of the year on the basis of this trial.
The results of the current longer-term trial, presented today at the San Antonio Breast Cancer Symposium, showed improved "progression-free survival," a term experts use to measure the length of time during and after medication that the cancer does not get worse.
The longer-term trial results showed that the combination therapy nearly doubled progression-free survival to 7.4 months, compared to the 3.2 months that patients experienced on the placebo.
Earlier, the phase 3 BOLERO-2 trial met its primary endpoint, showing that treatment with everolimus improved progression-free survival to 6.9 months, compared to 2.8 months by local investigator assessment. The study also showed that the combination reduced risk of progression by 57 percent compared to hormonal therapy alone.
Afinitor, or everolimus, targets the mTOR protein in cancer cells, which acts as an important regulator of tumor cell division, blood vessel growth and cell metabolism.
Most women with metastatic disease do not respond to initial treatment with hormonal therapy, which is the cornerstone of treatment for women with advanced breast cancer, and almost all initial responders develop resistance. Additionally, life expectancy is significantly shortened due to the worsening of the disease.
The Breast cancer trials of OraL EveROlimus-2, dubbed BOLERO-2 , examined the safety and efficacy of everolimus in combination with exemestane, compared to exemestane alone in postmenopausal women with ER+HER2- advanced breast cancer. These patients had recurred or progressed while on or following previous treatment with hormonal therapies, letrozole or anastrozole.
The phase 3, randomized, double-blind, placebo-controlled, multicenter study was conducted at 189 sites worldwide and enrolled 724 patients. Patients who met the study criteria were randomized 2:1 to receive everolimus 10 mg per day orally or placebo, plus oral exemestane 25 mg per day. The primary endpoint was progression-free survival, or PFS, based on local investigator radiology assessment.
Afinitor is approved in over 70 countries and regions including the U.S. and the European Union in the oncology settings of advanced renal cell carcinoma, following vascular endothelial growth factor -targeted therapy and advanced progressive neuroendocrine tumors of pancreatic origin. The new use for the drug may generate as much as $1 billion annually.
In a similar result presented at the symposium, Genentech, a member of Roche Holding AG (RHHBY.PK), reported a significant improvement in progression-free survival for patients who received the combination of pertuzumab, Herceptin and chemotherapy, compared to those who received Herceptin and chemotherapy alone, in the late-stage CLEOPATRA study in people with previously untreated HER2-positive metastatic breast cancer or mBC.
The median progression-free survival improved by 6.1 months for pertuzumab, Herceptin and chemotherapy to 18.5 months from 12.4 months for Herceptin and chemotherapy.
NVS closed Wednesday's regular trading session at $54.81, up $0.52 or 0.96 percent on a volume of 2.26 million.
by RTT Staff Writer
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