~ 50% More Women Respond to Femara® than Arimidex® ~
MONTREAL, QUEBEC (May 19, 2002) -- While efficacy against tamoxifen is well documented, for the first time there is comparative data on leading drugs to treat advanced breast cancer, say researchers at the 38th annual meeting of the American Society of Clinical Oncology (ASCO) being held in Orlando, Florida.
The head-to-head worldwide study of the two leading aromatase inhibitors shows that 50% more women respond to Femara® (letrozole) than Arimidex® (anastrozole) in advanced breast cancer. This means that women who responded to treatment with Femara® had at least a 50% reduction in the size of their tumour.
"It is becoming increasingly evident that aromatase inhibitors are challenging and are likely to replace tamoxifen in the treatment of postmenopausal women with endocrine-dependent breast cancer. Studies like this are important because they provide evidence to identify the aromatase inhibitor most likely to work best," said Canadian investigator Dr. Maureen Trudeau, Head of the Systemic Therapy Program at Toronto Sunnybrook Regional Cancer Centre, Head of the Division of Medical Oncology/Hematology at Sunnybrook and Woman's College Health Sciences Centre and Associate Professor, Faculty of Medicine at the University of Toronto in Toronto, Ontario. "The data in this trial show that more women respond to Femara® than to Arimidex, which is important information for physicians to consider when prescribing aromatase inhibitors."
"And from a patient's perspective this is big news. What this means is that with Femara®, tumours are more likely to shrink than with Arimidex, which in turn has a positive impact on a patient's quality of life," added Dr. Trudeau.
Study Design
The study was conducted in 19 countries and compared the efficacy of Femara® vs. Arimidex in women with metastatic breast cancer following failure of anti-oestrogen therapy (e.g., tamoxifen). More importantly, seven sites in Canada participated in the trial which included one site in St. John's, Newfoundland, three sites in Montreal, Quebec, two sites in Toronto, Ontario and one site in Fraser Valley, British Columbia.
The data was compiled from a randomised, open-label study of 713 postmenopausal women, whose tumours were either oestrogen and/or progesterone receptor positive (ER+ and/or PgR+) or ER/PgR status unknown.
The key endpoints of the study included: overall tumour response rate, time to disease progression, duration of objective response, overall clinical benefit rate, time to treatment failure and survival. Patients were randomised to receive either Femara® 2.5 mg once-daily or Arimidex 1 mg once-daily.
Study Findings
The data showed that 50% more women responded to Femara® than to Arimidex based on overall tumour response rate (Femara® group 19% vs. Arimidex group 12%, p=0.013).
According to Dr. Trudeau, "The findings of the study are also positive when you consider that complete response rate of Femara® almost doubled that of Arimidex (7% Femara® vs. 4% Arimidex)."
The data also showed that the overall tumour response rate in patients with soft tissue disease (i.e. soft tissue dominant, no bone or visceral involvement) was two times higher for women receiving Femara® compared to women receiving Arimidex (Femara® 37% vs. Arimidex 19%). In visceral dominant disease (viscera +/- bone +/- soft tissue) overall tumour response rate to Femara® was also higher than to Arimidex (Femara® 14% vs. Arimidex 10%). There was no statistical difference in any other endpoints.
Both Femara® and Arimidex were generally well-tolerated and there were no significant differences between treatment arms in reported frequencies of adverse events, including serious adverse events.
The data from the head to head study of Femara® versus Arimidex are the most recent in a series of clinical studies that support the consistent superiority of Femara®- as both an aromatase inhibitor and an anti-tumour agent in breast cancer.
Femara®, an aromatase inhibitor, is a once-a-day oral first-line treatment for postmenopausal women with advanced breast cancer and second-line therapy for the hormonal treatment of advanced metastatic breast cancer.
Femara® is contraindicated in patients with known hypersensitivity to Femara® or any of its excipients. Femara® is generally well tolerated and adverse reaction rates in the first-line study in which Femara® was compared to tamoxifen were similar to those seen in second-line studies. The most commonly reported adverse events for Femara® vs. tamoxifen were bone pain, hot flushes, back pain, nausea, dyspnoea or labored breathing and arthralgia. Femara® may cause fetal harm when administered to pregnant women. There is no clinical experience to date on the use of Femara® in combination with other anticancer agents.
This release contains certain "forward-looking statements" relating to the Company's business, which can be identified by the use of forward-looking terminology such as "looking forward," "encouraging,", "recent data" or similar expressions, or by discussions of strategy, plans or intentions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results with Femara® to be materially different from any future results, performance or achievements expressed or implied by such statements. Many factors could cause the actual results, performance or achievements of the Company to be materially different from any future results, performances or achievements that may be expressed or implied by such forward-looking statements. Some of these are uncertainties relating to unexpected regulatory delays; unexpected clinical trial results with Femara®; additional analysis of clinical data; new data; government regulation or competition in general; as well as factors discussed in the Company's Form 20F filed with the Securities and Exchange Commission.
Should one or more of these risks or uncertainties materialise, or should underlying assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed, estimated or expected.
About Novartis (NYSE:NVS)
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well being of all Canadians. Novartis Pharmaceuticals Canada conducts hundreds of clinical trials across the country seeking new treatments for cardiovascular disease, diabetes, cancer, organ transplantation and glaucoma. In 2001, the Company invested $34 million in research and development. Novartis Pharmaceuticals Canada Inc. employs over 600 people in Canada and its headquarters are located in Dorval, Quebec.
In addition to Novartis Pharmaceuticals Canada Inc., the Novartis Group in Canada consists of Novartis Animal Health Canada Inc., Novartis Consumer Health Canada Inc., (including Novartis Nutrition Corporation) and CIBA Vision Canada Inc. Worldwide in 2001, the Novartis Group's businesses achieved sales of $28.6 billion and a net income of $6.3 billion. The Group invested approximately $3.8 billion in R&D. Headquartered in Basel, Switzerland, Novartis employs about 71,000 people and operates in over 140 countries around the world.
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