Results in The New England Journal of Medicine confirm Novartis drug
Femara® is superior to tamoxife
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ * Data validate Femara alone for five years following hormone-receptor positive breast cancer surgery as an optimal first treatment vs. tamoxifen in postmenopausal women * Results show long-term superiority of Femara in improving disease-free survival (P=0.03) and reducing risk of distant metastases (P=0.05) compared with tamoxifen * Femara for five years following surgery is first aromatase inhibitor to suggest survival benefit versus tamoxifen; 13% reduction in risk of death (P=0.08, non-significant)Basel, August 19, 2009 - Newly published data in The New EnglandJournal of Medicine affirm five-year upfront use of Femara®(letrozole) following surgery as an optimal treatment approach versustamoxifen for postmenopausal women with early stage breast cancer(hormone-receptor positive).The data include an analysis from the Breast International Group(BIG) 1-98 trial that evaluated patients taking either a sequence ofFemara and tamoxifen for five years or Femara alone (as monotherapy)for five years. Also included is the update of the Monotherapy ArmsAnalysis (MAA) conducted 10 years after initiation of the study,comparing five years of Femara alone versus five years of tamoxifenalone following surgery (adjuvant setting). The BIG 1-98 trial wasconducted by the International Breast Cancer Study Group (IBCSG).Results from the Sequential Treatments Analysis (STA) concluded thatsequential treatment with tamoxifen and Femara in the first fiveyears after breast cancer surgery did not improve disease-freesurvival compared with Femara alone for the same duration aftersurgery. In the 10-year MAA analysis, Femara monotherapy demonstratedsignificant long-term improvement of disease-free survival (P=0.03)and significant long-term reduction in risk of distant disease spread(metastasis) (P=0.05) compared with tamoxifen. In patients treatedwith Femara monotherapy, a non-statistically significant relativereduction in the risk of death of 13% versus tamoxifen (P=0.08) wasobserved."The BIG 1-98 study results suggest survival benefit with five yearsof letrozole therapy after surgery compared to tamoxifen for the sametime period following surgery, confirming the benefit of initial useof letrozole in the adjuvant breast cancer setting," said Henning T.Mouridsen, MD, PhD, Professor of Oncology, Copenhagen UniversityHospital and BIG 1-98 investigator. "Letrozole is the only aromataseinhibitor versus tamoxifen to demonstrate early and significantreduction in the risk of distant metastases, significant improvementin disease-free survival and this suggestion in overall survivalbenefit in primary breast cancer patients."Sequential Treatments Analysis (STA)Results of the STA (median follow-up of 71 months) concluded thatsequential treatment with tamoxifen did not improve disease-freesurvival compared with Femara alone. In the study, patients eitherreceived sequential treatment with Femara and tamoxifen (two years ofFemara followed by three years of tamoxifen or two years of tamoxifenfollowed by three years of Femara) or five years of Femara alone.Five-year disease-free survival rates for the three groups ofpatients in the STA were 87.9% for those patients receiving Femaraonly, 86.2% for those patients receiving tamoxifen followed by Femaraand 87.6% for those patients receiving Femara followed by tamoxifen.Monotherapy Arms Analysis (MAA)Updated results from the MAA (median follow-up of 76 months) confirmthe significant long-term benefit of Femara. The data demonstratedthat patients who took Femara alone for five years following surgeryexperienced a significant reduction in the risk of distant metastases(15%, P=0.05) with a corresponding reduction in risk of disease-freesurvival events (12%, P=0.03) compared with patients treated withtamoxifen alone for the same duration.The analysis also revealed a non-significant trend towards an overallsurvival benefit with five years of Femara therapy following surgery(13% reduced risk of death, P=0.08) versus tamoxifen for five yearsfollowing surgery. This occurred even though approximately 25% ofpatients in the tamoxifen arm selectively crossed over to Femaratherapy after the tamoxifen arm was unblinded in 2005 due to thesuperiority of Femara over tamoxifen[1]. This crossover confounds theevaluation of the true differences between letrozole and tamoxifen.The study group therefore, conducted a retrospective censoredanalysis that was not protocol-defined and in which observation timeswere censored at the date of crossover. Time and events beyond thecrossover were ignored in patients who selectively crossed over toFemara. In this censored analysis, there was an improved survivalbenefit for patients receiving five years of Femara versus tamoxifen(19%; HR 0.81; 95% CI: 0.68, 0.96). According to the authors, thesecensored results may be an overestimate of the Femara benefit sincewomen who had recurrent disease were not candidates for thecrossover. It is likely that the most accurate assessment of thesurvival benefit with Femara is between these two analyses - 13-19%reduction in the relative risk of death compared with tamoxifen[2].BIG 1-98 is the only clinical trial designed to explore both ahead-to-head comparison of an aromatase inhibitor versus tamoxifenmonotherapy, as well as sequencing of an aromatase inhibitor andtamoxifen therapy in the first five years following breast cancersurgery, in order to determine the most effective way to minimizebreast cancer recurrence. In the initial adjuvant setting, Femara isthe only aromatase inhibitor to have consistently demonstrated anearly significant reduction in distant metastases versus tamoxifen ata median follow-up of 26, 51 and 76 months."Femara is the only aromatase inhibitor to demonstrate consistent,early and significant reduction in risk of distant metastases," saidAlessandro Riva, MD, Global Head Oncology Development, NovartisOncology. "Based on these results, starting with Femara monotherapyfor five years in the adjuvant setting instead of tamoxifen may offerbreast cancer patients the opportunity for a better outcome."Study detailsThis Phase III, randomized, double-blind, controlled clinical trialenrolled more than 8,000 postmenopausal women with early breastcancer in 27 countries[2].Patients were randomly assigned one of four treatment regimens: (1)five years of tamoxifen only; (2) five years of Femara only; (3) twoyears of tamoxifen followed by three years of Femara; (4) two yearsof Femara followed by three years of tamoxifen.The primary endpoint of the study was disease-free survival, definedas the time from randomization to the first of any of the followingevents: recurrence at local, regional, or distant sites; a newinvasive cancer in the contralateral breast; any second, non-breastcancer; or death without a previous cancer event. Other endpointsincluded time to breast cancer recurrence, time to distant breastcancer recurrence and overall survival.In 2005, following initial results showing superiority of Femaramonotherapy over tamoxifen monotherapy in improving disease-freesurvival and reducing the risk of recurrence, the tamoxifen-onlytreatment arm was unblinded and approximately one quarter of thosepatients selectively crossed over to Femara treatment. The otherthree treatment arms remained blinded. Subsequent analyses weredesigned to estimate the extent to which the crossover affected thecomparative benefit of Femara.With the long-term follow-up in the analysis conducted more than 10years after the start of the study, adverse events for Femara andtamoxifen were found to be consistent with the known safety profilesof both drugs. Patients will be monitored for the rest of their livesto track disease status, safety and overall survival. The long-termBIG 1-98 findings add to the large body of clinical evidenceregarding the established safety profile of Femara.About FemaraFemara is a leading once-daily oral aromatase inhibitor available inmore than 100 countries, including the US, major European countriesand Japan. It is approved for a number of indications: * Adjuvant treatment of postmenopausal women with hormone receptor-positive early breast cancer* * Extended adjuvant treatment of hormone-dependent early breast cancer in postmenopausal women who have had prior standard adjuvant tamoxifen therapy for five years** * First-line treatment in postmenopausal women with hormone-dependent advanced breast cancer * Advanced breast cancer in women with natural or artificially induced postmenopausal status after relapse or disease progression who have been treated with antiestrogens * Pre-operative therapy in postmenopausal women with localized hormone receptor-positive breast cancer which allows subsequent breast-conserving surgery in patients not originally considered suitable for this type of surgery.* Femara is also approved as neo-adjuvant (pre-operative) therapy inJapan, and in some countries for patients with metastatic disease.** Not all indications are approved in every country.Important Safety InformationFemara should not be taken by women who have previously had anyunusual or allergic reactions to letrozole or any of its ingredients.Femara should not be taken by women who are pregnant orbreastfeeding. Only women who are of postmenopausal endocrine statusshould take Femara. Patients with severe liver impairment should bemonitored closely. The use of Femara in patients with significantlyimpaired kidney function warrants careful consideration.The most frequent adverse reactions of Femara are hot flushes,nausea, fatigue and arthralgia. Other common side effects areanorexia, appetite increase, peripheral oedema, headache, dizziness,malaise, vomiting, dyspepsia, constipation, diarrhea, alopecia,increased sweating, rash, myalgia, bone pain, osteoporosis, bonefractures, weight increase, hypercholesterolemia and depression.Other rare, but potentially serious adverse events includeleukopenia, cataract, cerebrovascular accident or infarction,thrombophlebitis, pulmonary embolism, arterial thrombosis, generaledema, ischemic cardiovascular disease, angioedema, anaphylacticreaction, hepatitis, toxic epidermal necrolysis and erythemamultiforme.This press release is not intended for UK media.DisclaimerThe foregoing release contains forward-looking statements that can beidentified by terminology such as "long-term," "risk," "suggest,""suggestion," "will," "may," "likely," "designed to explore," orsimilar expressions, or by express or implied discussions regardingpotential new indications or labeling for Femara or regardingpotential future revenues from Femara. You should not place unduereliance on these statements. Such forward-looking statementsreflect the current views of management regarding future events, andinvolve known and unknown risks, uncertainties and other factors thatmay cause actual results with Femara to be materially different fromany future results, performance or achievements expressed or impliedby such statements. There can be no guarantee that Femara will besubmitted or approved for any additional indications or labeling inany market. Nor can there be any guarantee that Femara will achieveany particular levels of revenue in the future. In particular,management's expectations regarding Femara could be affected by,among other things, the company's ability to obtain or maintainpatent or other proprietary intellectual property protection;competition in general; unexpected regulatory actions or delays orgovernment regulation generally; unexpected clinical trial results,including unexpected new clinical data and unexpected additionalanalysis of existing clinical data; government, industry and generalpublic pricing pressures; the impact that the foregoing factors couldhave on the values attributed to the Novartis Group's assets andliabilities as recorded in the Group's consolidated balance sheet,and other risks and factors referred to in Novartis AG's current Form20-F on file with the US Securities and Exchange Commission. Shouldone or more of these risks or uncertainties materialize, or shouldunderlying assumptions prove incorrect, actual results may varymaterially from those anticipated, believed, estimated or expected.Novartis is providing the information in this press release as ofthis date and does not undertake any obligation to update anyforward-looking statements contained in this press release as aresult of new information, future events or otherwise.About NovartisNovartis provides healthcare solutions that address the evolvingneeds of patients and societies. Focused solely on healthcare,Novartis offers a diversified portfolio to best meet these needs:innovative medicines, cost-saving generic pharmaceuticals, preventivevaccines, diagnostic tools and consumer health products. Novartis isthe only company with leading positions in these areas. In 2008, theGroup's continuing operations achieved net sales of USD 41.5 billionand net income of USD 8.2 billion. Approximately USD 7.2 billion wasinvested in R&D activities throughout the Group. Headquartered inBasel, Switzerland, Novartis Group companies employ approximately99,000 full-time-equivalent associates and operate in more than 140countries around the world. For more information, please visithttp://www.novartis.com.References[1] Thürlimann B et al. A Comparison of Letrozole and Tamoxifen inPostmenopausal Women with Early Breast Cancer. N Engl J Med. 2005 Dec29; 353(26); 2807-9.[2] Mouridsen H for the BIG 1-98 Collaborative Group. Letrozole Aloneor in Sequence with Tamoxifen for Postmenopausal Women with BreastCancer. N Engl J Med. 2009 Aug 20; 361(8); 22-32. # # #Novartis Media RelationsCentral media line : +41 61 3242200Eric Althoff Megan HumphreyNovartis Global Media Relations Novartis Pharma Communications+41 61 324 7999 (direct) +1 862 778 6724 (direct)+41 79 593 4202 (mobile) +1 908 217 5379 (mobile)eric.althoff(at)novartis.com megan.humphrey(at)novartis.come-mail: media.relations(at)novartis.comNovartis Investor RelationsCentral phone: +41 61 324 7944Ruth Metzler-Arnold +41 61 324 9980 North America:Pierre-Michel +41 61 324 1065 Richard +1 212Bringer Jarvis 830 2433John Gilardi +41 61 324 3018 Jill Pozarek +1 212 830 2445Thomas +41 61 324 8425 Edwin +1 212Hungerbuehler Valeriano 830 2456Isabella Zinck +41 61 324 7188e-mail: investor.relations(at)novartis.comhttp://hugin.info/134323/R/1335978/317735.pdf --- End of Message ---Novartis International AGPosfach Basel WKN: 904278; ISIN: CH0012005267; Index: SLCI, SMI, SPI, SLIFE;Listed: Main Market in SIX Swiss Exchange, ZLS in BX Berne eXchange;
Datum: 19.08.2009 - 23:00 Uhr
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