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Postmenopausal Women With Breast Cancer Who Switch to Letrozole Tablets Experience Dramatic Reduction in Risk of Recurrence, Distant Metastasis and Improvement in Survival

• Femara treatment after standard tamoxifen regimen reduced overall risk of breast cancer returning by 69% and risk of distant metastases by 72% despite up to five years of no treatment

• Improvement in overall survival observed in patients at increased risk of recurrence – those with node positive disease and treated with chemotherapy post surgery, new subset analysis finds

• Post menopausal women off tamoxifen for up to five years may now consider further treatment with Femara to reduce their risk of recurrence

• Results reported by the National Cancer Institute of Canada Clinical Trials Group

EAST HANOVER, NJ -- June 15, 2006 -- Women with hormone-sensitive early breast cancer at higher risk of recurrence who switched to FemaraŽ (letrozole tablets) from placebo as part of the MA-17 trial experienced significant improvements in overall survival, disease-free survival and distant metastases, according to new data presented at the 2006 American Society of Clinical Oncology Annual Meeting. The higher risk groups included those with node positive disease and prior chemotherapy.

New Subset Analysis
This updated subset analysis of the landmark MA-17 trial showed extended adjuvant use of Femara even after years of no anti-cancer therapy provides significant benefit for two subgroups of women who are at particularly increased risk of recurrence – those whose cancer had already spread to the lymph nodes (node positive) at diagnosis and/or those who had been treated with chemotherapy. Node positive patients experienced a 64% better chance of survival than those who had not continued treatment and women previously treated with chemotherapy had a 65% greater chance of survival. These women also experienced significant reductions lowering their risk of breast cancer recurrence and the risk of their cancer spreading to other parts of the body (distant metastases). The risk reductions for these women were respectively 61% and 70% for node positive women and 66% and 76% for women previously treated with chemotherapy.

Overall Analysis
The MA-17 post-unblinding analysis represents the first time an aromatase inhibitor had demonstrated a benefit in starting therapy up to five years after a patient finishes taking tamoxifen, another medicine used in the treatment of hormone-related breast cancers. Overall, women in the MA-17 study who switched from placebo to Femara experienced a 69% reduction that their breast cancer would return. In addition, overall a 72% reduction in distant metastasis and a 47% reduction in risk of dying was observed. These observations must be confirmed by additional analysis and longer-term follow-up.

"These data further support that women can benefit from Femara even years after the completion of tamoxifen therapy. The findings may have a substantial impact on the overall treatment outcomes for postmenopausal women with early breast cancer," said Diane Young, MD, vice president, global head, Clinical Development, Novartis Oncology.

The findings came from an analysis of women who had been originally in the placebo arm of the MA-17 trial. In 2003, compelling results of an interim analysis based on 24 months of treatment showed that Femara reduced the risk of breast cancer coming back by 42% compared to placebo. These data prompted an independent Data Safety Monitoring Board to recommend the unblinding of study results. Since then, among the 2,268 women originally assigned to placebo, 1,655 women have chosen to switch to Femara, while another 613 women did not pursue further treatment.

About MA-17
MA-17 is a phase 3, international, double-blinded, randomized, multi-center trial. It is coordinated by the National Cancer Institute of Canada Clinical Trials Group at Queen's University in Kingston, Ontario, Canada with funding from the Canadian Cancer Society and supported by Novartis.

The incidence of adverse events in the post-unblinding analysis was similar to that seen in the earlier MA-17 analysis. Key safety findings presented included fractures (3.2% in the Femara-switched group vs. 2.8% in the placebo group); patient-reported osteoporosis (3.9% vs. 1.6%); and cardiovascular disease (2.8% vs. 2.9%).

About Femara
FemaraŽ (letrozole tablets) is approved for the adjuvant (following surgery) treatment of postmenopausal women with hormone-receptor positive early breast cancer. The benefits of Femara in clinical trials are based on 24 months of treatment. Further follow-up will be needed to determine long-term results, including safety and efficacy.

Femara is also approved for the extended adjuvant treatment of early stage breast cancer in postmenopausal women who are within three months of completion of five years of tamoxifen therapy. The benefits of Femara in the extended adjuvant setting are based on 24 months of treatment. Further follow-up will need to determine long-term results, including side effects.

Femara is also approved for the first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor-unknown locally advanced or metastatic breast cancer. Femara is also indicated for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.

Important safety information
Patients should talk to their doctor if they are allergic to Femara or any of its ingredients. Patients should not take Femara if they are pregnant as it may cause fetal harm. Patients must be postmenopausal to take Femara. Some women reported fatigue and dizziness with Femara. Until a patient knows if Femara affects them, they should use caution before driving or operating machinery. Some patients taking Femara had an increase in cholesterol. Additional follow-up is needed to determine the risk of bone fracture associated with long-term use of Femara.

In the adjuvant setting, commonly reported side effects are generally mild to moderate. Side effects that are comparable between Femara and tamoxifen include night sweats, weight gain, nausea, and tiredness. Side effects seen more often with tamoxifen vs. Femara were hot flashes and vaginal bleeding. Joint pain was experienced more often with Femara vs. tamoxifen. The incidence of stroke was 1.1% for women on Femara and 1.0% for women on tamoxifen, and the incidence of other cardiovascular events was 6.6% for Femara vs. 6.2% for tamoxifen. The percentage of women on Femara reporting bone fracture was 5.6% vs. 4% for women on tamoxifen. The percentage of women reporting osteoporosis was 2% for Femara vs. 1.1% for tamoxifen.

In the extended adjuvant setting, commonly reported side effects are generally mild to moderate. Those seen more often with Femara vs. placebo were hot flashes (50% vs. 43%), joint pain (22% vs. 18%) and muscle pain (7% vs. 5%). Other side effects, which were comparable to placebo, include fatigue (34% vs. 32%), swelling due to fluid retention (18% vs. 16%), headache (20% vs. 20%), increase in sweating (24% vs. 22%) and increase in cholesterol (16% vs. 16%). The percentage of patients on Femara vs. placebo reporting a fracture was 5.9% vs. 5.5%. The percentage of patients reporting osteoporosis was 6.9% vs. 5.5%. Bisphosphonates, drugs to increase bone strength, were given to 21.1% of Femara patients and 18.7% of placebo patients.

In the metastatic setting, commonly reported side effects are generally mild to moderate and may include bone pain, hot flashes, back pain, nausea, joint pain, shortness of breath, fatigue, coughing, constipation, limb pain, chest pain, and headache.


SOURCE: Novartis

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