EAST HANOVER, N.J., Sept. 19, 2021 /PRNewswire/ — Novartis right now introduced outcomes of the ultimate general survival (OS) evaluation of the Part III MONALEESA-2 examine, which evaluated Kisqali® (ribociclib) together with letrozole in comparison with placebo plus letrozole in postmenopausal ladies with hormone receptor-positive, human epidermal progress issue receptor 2-negative (HR+/HER2-) superior or metastatic breast most cancers with no prior systemic remedy for superior illness. These information will likely be introduced as a late-breaker oral presentation on the European Society for Medical Oncology (ESMO) Congress 2021 on September 19 (#LBA17).
Kisqali together with letrozole met its key secondary endpoint of OS, demonstrating a statistically vital and clinically significant enchancment in survival (median 63.9 vs. 51.4 months; HR=0.76; 95% CI: 0.63-0.93; p=0.004)2. The evaluation discovered that after a median follow-up of over six and a half years, the longest for any CDK4/6 inhibitor trial to this point, the advance within the median OS was over one yr2. MONALEESA-2 confirmed that after 5 years, sufferers handled with Kisqali together with letrozole had greater than a 50% likelihood of survival (52.3% vs. 43.9%; 95% CI: 46.5-57.7 vs. 38.3-49.4)2.
“These outstanding ribociclib general survival information are extremely encouraging and symbolize the longest reported median survival from a randomized trial in HR+/HER2- superior breast most cancers. This extension of life is nice information for our sufferers and the constructing block for additional progress,” mentioned Gabriel N. Hortobagyi, MD, FACP, professor of medication with The College of Texas MD Anderson Most cancers Heart. “I’ve spent the final 45 years researching and growing our scientific understanding of breast most cancers, so it’s extremely rewarding to see simply how far we have come.”
In MONALEESA-2, a 12-month delay in time to chemotherapy was noticed with Kisqali (median 50.6 vs. 38.9 months; HR=0.74; 95% CI: 0.61-0.91) in comparison with these taking letrozole alone2. With this longer follow-up, no new security alerts have been noticed; opposed occasions have been in line with beforehand reported Part III trial outcomes for Kisqali.
“As we reimagine drugs and try for cures, our MONALEESA program continues to push boundaries by demonstrating that Kisqali is exclusive in its capability to present individuals dwelling with superior breast most cancers extra time,” mentioned Susanne Schaffert, PhD, President, Novartis Oncology. “Our mission is to enhance and lengthen the lives of these with most cancers. For individuals with HR+/HER2- superior breast most cancers, these information aren’t simply numbers and should imply extra life milestones — but, we won’t relaxation as we proceed to analyze the total potential that Kisqali can deliver to sufferers.”
In MONALEESA-2, the first endpoint progression-free survival (PFS) was met on the preliminary evaluation [median PFS; 95% CI (19.3 months – not reached) vs. 14.7 months (13.0 – 16.5 months); HR=0.556; p=0.00000329]5. These new OS outcomes mark the third statistically vital and clinically significant survival profit achieved by Kisqali within the MONALEESA program. Novartis will submit the information to world well being authorities to help label updates.
“When remedy affords lengthy general survival—and on this case, the longest ever reported in HR+/HER2- superior breast most cancers—sufferers have extra time to be with household and family members and to pursue no matter makes them comfortable. These information supply new hope for individuals with superior or metastatic breast most cancers, which stays the main explanation for most cancers loss of life in ladies worldwide,” mentioned Shirley A. Mertz, President, Metastatic Breast Most cancers Community (MBCN).
Go to https://www.hcp.novartis.com/virtual-congress/esmo-2021/ for the most recent info from Novartis, together with our dedication to the Oncology group, and entry to our ESMO2021 Digital Scientific Program information shows (for registered individuals).
About Kisqali® (ribociclib)
Kisqali is the CDK4/6 inhibitor with the biggest physique of medical trial proof demonstrating constant and superior general survival profit in comparison with endocrine remedy alone. General survival outcomes from MONALEESA-7 and MONALEESA-3 have been introduced at ASCO 2019 and ESMO 2019 respectively, in addition to printed within the New England Journal of Medication, with up to date exploratory analyses introduced at SABCS 2020 and ASCO 2021, demonstrating Kisqali plus endocrine remedy considerably extends life in pre/perimenopausal or postmenopausal ladies with HR+/HER2- superior breast most cancers3,4,6,7.
Kisqali is accepted by the US Meals and Drug Administration (FDA) and by the European Fee (EC) as preliminary endocrine-based remedy for postmenopausal ladies with HR+/HER2- domestically superior or metastatic breast most cancers together with an aromatase inhibitor. Kisqali together with an aromatase inhibitor is accepted for the remedy of pre-, peri- or postmenopausal ladies as preliminary endocrine-based remedy, and in addition indicated to be used together with fulvestrant as each first- or second-line remedy in postmenopausal ladies by the FDA and by the EC9. Kisqali is accepted in over 95 nations1.
Novartis is continuous to reimagine most cancers with extra trials of Kisqali. NATALEE is a big confirmatory medical trial of Kisqali with endocrine remedy within the adjuvant remedy of HR+/HER2- early breast most cancers being performed in collaboration with Translational Analysis In Oncology (TRIO)10. Novartis can be collaborating with SOLTI, who’s main the Part III HARMONIA medical trial evaluating Kisqali in comparison with palbociclib in sufferers with HR+/HER2- superior breast most cancers with aggressive tumor biology, outlined as HER2-enriched1.
Kisqali was developed by the Novartis Institutes for BioMedical Analysis (NIBR) below a analysis collaboration with Astex Prescribed drugs.
Essential Security Info
KISQALI could cause extreme or life-threatening irritation of the lungs. Sufferers ought to inform their well being care supplier immediately in the event that they expertise respiration issues or chest pains. KISQALI could cause a coronary heart downside often known as QT prolongation. This situation could cause an irregular heartbeat and should result in loss of life. KISQALI just isn’t indicated for concomitant use with tamoxifen on account of an elevated threat of QT prolongation. Sufferers ought to inform their well being care supplier immediately if they’ve a change of their heartbeat (a quick or irregular heartbeat), or in the event that they really feel dizzy or faint. KISQALI could cause severe liver issues. Sufferers ought to inform their well being care supplier immediately in the event that they get any of the next indicators and signs of liver issues: yellowing of the pores and skin or the whites of the eyes (jaundice), darkish or brown (tea-colored) urine, feeling very drained, lack of urge for food, ache on the higher proper facet of the abdomen space (stomach), and bleeding or bruising extra simply than regular. Low white blood cell counts are quite common when taking KISQALI and should end in infections which may be extreme. Sufferers ought to inform their well being care supplier immediately if they’ve indicators and signs of low white blood cell counts or infections similar to fever and chills.
Earlier than taking KISQALI, sufferers ought to inform their well being care supplier if they’re pregnant, or plan to grow to be pregnant as KISQALI can hurt an unborn child. Females who’re in a position to grow to be pregnant and who take KISQALI ought to use efficient contraception throughout remedy and for at the very least 3 weeks after the final dose of KISQALI. Don’t breastfeed throughout remedy with KISQALI and for at the very least 3 weeks after the final dose of KISQALI.
Sufferers ought to inform their well being care supplier about the entire medicines they take, together with prescription and over-the-counter medicines, nutritional vitamins, and natural dietary supplements since they could work together with KISQALI. Sufferers ought to keep away from grapefruit or grapefruit juice whereas taking KISQALI.
The commonest unintended effects (incidence ≥20%) embody white blood cell rely decreases, nausea, infections, tiredness, diarrhea, vomiting, hair loss, headache, constipation, rash, and cough. The commonest grade 3/4 unintended effects (incidence >5%) have been low neutrophils, low leukocytes, irregular liver perform checks, and low lymphocytes. Abnormalities have been noticed in hematology and medical chemistry laboratory checks.
Please see full Prescribing Info for KISQALI, accessible at www.kisqali.com.
About Novartis in Superior Breast Most cancers
Novartis tackles breast most cancers with superior science, collaboration and a ardour for reworking affected person care. We have taken a daring method to our analysis by together with affected person populations typically uncared for in medical trials, figuring out new pathways or mutations that will play a task in illness development and creating therapies that not solely preserve, but in addition enhance, high quality of life for sufferers. Our precedence over the previous 30 years and right now is to ship therapies confirmed to enhance and lengthen lives for these identified with superior breast most cancers.
This press launch comprises forward-looking statements throughout the which means of the US Personal Securities Litigation Reform Act of 1995. Ahead-looking statements can typically be recognized by phrases similar to “potential,” “can,” “will,” “plan,” “might,” “may,” “would,” “count on,” “anticipate,” “look ahead,” “consider,” “dedicated,” “investigational,” “pipeline,” “launch,” or related phrases, or by categorical or implied discussions concerning potential advertising and marketing approvals, new indications or labeling for the investigational or accepted merchandise described on this press launch, or concerning potential future revenues from such merchandise. You shouldn’t place undue reliance on these statements. Such forward-looking statements are primarily based on our present beliefs and expectations concerning future occasions, and are topic to vital identified and unknown dangers and uncertainties. Ought to a number of of those dangers or uncertainties materialize, or ought to underlying assumptions show incorrect, precise outcomes might differ materially from these set forth within the forward-looking statements. There could be no assure that the investigational or accepted merchandise described on this press launch will likely be submitted or accepted on the market or for any extra indications or labeling in any market, or at any explicit time. Nor can there be any assure that such merchandise will likely be commercially profitable sooner or later. Particularly, our expectations concerning such merchandise might be affected by, amongst different issues, the uncertainties inherent in analysis and growth, together with medical trial outcomes and extra evaluation of current medical information; regulatory actions or delays or authorities regulation typically; world tendencies towards well being care value containment, together with authorities, payor and common public pricing and reimbursement pressures and necessities for elevated pricing transparency; our capability to acquire or preserve proprietary mental property safety; the actual prescribing preferences of physicians and sufferers; common political, financial and enterprise circumstances, together with the results of and efforts to mitigate pandemic illnesses similar to COVID-19; security, high quality, information integrity or manufacturing points; potential or precise information safety and information privateness breaches, or disruptions of our info expertise programs, and different dangers and components referred to in Novartis AG’s present Type 20-F on file with the US Securities and Change Fee. Novartis is offering the knowledge on this press launch as of this date and doesn’t undertake any obligation to replace any forward-looking statements contained on this press launch on account of new info, future occasions or in any other case.
Positioned in East Hanover, NJ Novartis Prescribed drugs Company – an affiliate of Novartis – is reimagining drugs to enhance and lengthen individuals’s lives. As a number one world medicines firm, we use revolutionary science and digital applied sciences to create transformative therapies in areas of nice medical want. In our quest to seek out new medicines, we constantly rank among the many world’s high corporations investing in analysis and growth. Novartis employs almost 15,500 individuals in the US. For extra info, please go to https://www.novartis.us.
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- Novartis Knowledge on File. Novartis Prescribed drugs Corp: 2021.
- Hortobagyi, et al. General survival (OS) outcomes from the section III MONALEESA (ML)-2 trial of postmenopausal sufferers with hormone receptor optimistic/human epidermal progress issue receptor 2 damaging (HR+/HER2−) superior breast most cancers (ABC) handled with endocrine remedy (ET) ± ribociclib. Introduced on the European Society of Medical Oncology (ESMO) Congress, September 16-21, 2021, (Summary #LBA17).
- Im, S. A. et al. General Survival with Ribociclib plus Endocrine Remedy in Breast Most cancers. N Engl J Med 2019; 381:307-316.
- Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im S-A, et al. General survival with ribociclib plus fulvestrant in superior breast most cancers. N Engl J Med. 2020;382(6):514–24.
- Hortobagyi G, Stemmer S, Burris H, et al. Ribociclib as First-Line Remedy for HR-Optimistic, Superior Breast Most cancers. N Engl J Med. 2016;375:1738-1748.
- Slamon D, Neven P, Chia S, et al. Up to date general survival (OS) outcomes from the Part III MONALEESA-3 trial of postmenopausal sufferers (pts) with HR+/HER2− superior breast most cancers (ABC) handled with fulvestrant (FUL) ± ribociclib (RIB. Introduced on the American Society of Medical Oncology (ASCO) Annual Assembly, June 5, 2021, (Summary #1001).
- Tripathy D, Im S-A, Colleoni M, et al, Up to date general survival (OS) outcomes from the section III MONALEESA-7 trial of pre- or perimenopausal sufferers with HR+/HER2− superior breast most cancers (ABC) handled with endocrine remedy (ET) ± ribociclib. Introduced on the San Antonio Breast Most cancers Symposium, December 9, 2020. Summary #PD2-04.
- Ferlay, J, et al. World Most cancers Observatory: Most cancers Right this moment. Worldwide Company for Analysis on Most cancers. Accessible at: https://gco.iarc.fr/today/online-analysis-table?v=2020&mode=cancer&mode_population=continents&population=900&populations=900&key=asr&sex=2&cancer=39&type=1&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1, accessed August 18, 2021.
- Kisqali (ribociclib) Prescribing info. East Hanover, New Jersey, USA: Novartis Prescribed drugs Company; July 2020.
- Novartis Prescribed drugs and Translational Analysis in Oncology (2018, December 7 – 2026, Could 29). A Trial to Consider Efficacy and Security of Ribociclib With Endocrine Remedy as Adjuvant Remedy in Sufferers With HR+/HER2- Early Breast Most cancers (NATALEE). Identifier NCT03701334. https://clinicaltrials.gov/ct2/show/NCT03701334 .
SOURCE B2/Novartis Prescribed drugs Company