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  • GlobeNewswire

    Novartis Provides Update on AVXS-101 Intrathecal Clinical Development Program

    * Novartis Gene Therapies to initiate new pivotal confirmatory study to evaluate use of AVXS-101 intrathecal (IT) formulation in older patients with SMA to further support registration Basel, September 23, 2020 – Novartis Gene Therapies recently received feedback from the US Food and Drug Administration (FDA) following their review of data from the STRONG study of the intrathecal (IT) formulation of AVXS-101 in older patients with spinal muscular atrophy (SMA). The FDA has acknowledged the potential of AVXS-101 IT in this patient population and recommends a pivotal confirmatory study to supplement the existing STRONG data and further support the regulatory submission for AVXS-101 IT.This guidance provides clarity on the path to registration for AVXS-101 IT. Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinical development program will be provided at a future time following further discussions with health authorities. This request for a study is unrelated to the partial clinical hold on AVXS-101 IT, and the new study will not be initiated in the US until the hold has been lifted by the FDA. Novartis Gene Therapies remains confident in the overall benefit-risk profile for patients on treatment. This does not impact marketed Zolgensma® (onasemnogene abeparvovec) and the company continues to advance its regulatory filings and intravenous clinical studies. Novartis Gene Therapies reaffirms its commitment to the SMA community and to pursuing solutions for patients with all types of SMA, including older children and adults. All patients deserve a gene therapy designed to address the genetic root cause of their disease with a single dose. Zolgensma is approved in the US, Japan and, most recently, Brazil, for patients with SMA under the age of two. Zolgensma also continues to have a strong launch in Europe where it is approved for babies and young children with a clinical diagnosis of SMA Type 1 or SMA with up to three copies of the SMN2 gene, with dosing guidance provided up to 21 kg. More than 600 patients have benefited from Zolgensma, including through clinical trials, commercially and through the managed access program. This number is expected to continue to grow as this transformative gene therapy is approved in additional markets and as the company pursues additional studies to fully explore the impact of Zolgensma across a broad population of patients with SMA. The company’s commitment to SMA extends beyond gene therapy to branaplam (LMI070), an oral, once-weekly RNA splicing modulator also currently under development, to expand the treatment options for SMA patients.  About Zolgensma® (onasemnogene abeparvovec) Zolgensma® is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time IV infusion. Zolgensma was approved by the US Food and Drug Administration in May 2019 and represents the first approved therapeutic in the company’s proprietary platform to treat rare, monogenic diseases using gene therapy. In addition to the US, Zolgensma is approved in Japan, Europe and Brazil. More than 600 patients have been treated with Zolgensma, including clinical trials, commercially and through the managed access program. Novartis Gene Therapies is pursuing registration in close to three dozen countries with regulatory decisions anticipated in Switzerland, Canada, Israel, Australia, and South Korea in late-2020 or early 2021. About Spinal Muscular Atrophy SMA is the leading genetic cause of infant death. If left untreated, SMA Type 1 leads to death or the need for permanent ventilation by the age of two in more than 90% of cases. SMA is a rare, genetic neuromuscular disease caused by a lack of a functional SMN1 gene, resulting in the rapid and irreversible loss of motor neurons, affecting muscle functions, including breathing, swallowing and basic movement. It is imperative to diagnose SMA and begin treatment, including proactive supportive care, as early as possible to halt irreversible motor neuron loss and disease progression. This is especially critical in SMA Type 1, where motor neuron degeneration starts before birth and escalates quickly. Loss of motor neurons cannot be reversed, so SMA patients with symptoms at the time of treatment will likely require some supportive respiratory, nutritional and/or musculoskeletal care to maximize functional abilities. More than 30% of patients with SMA Type 2 will die by age 25.About Novartis Gene Therapies Novartis Gene Therapies (formerly AveXis) is reimagining medicine to transform the lives of people living with rare genetic diseases. Utilizing cutting-edge technology, we are turning promising gene therapies into proven treatments, beginning with our transformative gene therapy for spinal muscular atrophy (SMA). This therapy is now approved in the US, Japan, Europe and Brazil, and additional registrations are being pursued in close to three dozen countries, with regulatory decisions anticipated in Switzerland, Canada, Israel, Australia, Argentina and South Korea in late 2020 or early 2021. Our robust AAV-based pipeline is advancing treatments for Rett syndrome; a genetic form of amyotrophic lateral sclerosis (ALS) caused by mutations in the superoxide dismutase 1 (SOD1) gene; and Friedreich’s ataxia. We are powered by the world’s largest gene therapy manufacturing footprint of more than one million square feet, enabling us to bring these therapies to patients around the world at quality and scale.Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “to initiate,” “to evaluate,” “to further support,” “potential,” “recommends,” “to supplement,” “being evaluated,” “will,” “to advance,” “could,” “anticipated,” “remains,” “continues,” “to advance,” “reaffirms,” “commitment,” “to pursuing,” “to address,” “explore,” “investigational,” “launch,” “under development,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for AVXS-101 IT, Zolgensma and branaplam, or regarding potential future revenues from AVXS-101 IT, Zolgensma and branaplam. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that AVXS-101 IT or branaplam will be submitted or approved for sale in any market, or at any particular time. Neither can there be any guarantee that Zolgensma will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that AVXS-101 IT, Zolgensma or branaplam will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews For Novartis multimedia content, please visit https://www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.com Novartis Media Relations E-mail: media.relations@novartis.comAnja von Treskow Novartis External Communications +41 79 392 8697 (mobile) anja.von_treskow@novartis.com   Eric Althoff Novartis US External Communications +1 646 438 4335 eric.althoff@novartis.comFarah Bulsara Speer SVP, Corporate Communications, Novartis Gene Therapies +1 312 543 2881 (mobile) farah.speer@novartis.com     Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.comCentral North America  Samir Shah+41 61 324 7944Sloan Simpson+1 862 778 5052 Thomas Hungerbuehler         Isabella Zinck+41 61 324 8425 +41 61 324 7188

  • Novartis Announces Data on Tafinlar, Mekinist & Piqray at ESMO
    Zacks

    Novartis Announces Data on Tafinlar, Mekinist & Piqray at ESMO

    Novartis (NVS) announces data from late-stage studies on Tafinlar, Mekinist and Piqray at ESMO 2020.

  • GlobeNewswire

    Novartis Piqray® data show survival benefit for patients with HR+/HER2- advanced breast cancer with a PIK3CA mutation

    * In SOLAR-1 final analysis, Piqray (alpelisib) plus fulvestrant demonstrated 8 months clinically relevant improvement in overall survival (OS) in HR+/HER2- advanced breast cancer (aBC) patients with a PIK3CA mutation compared to fulvestrant alone1   * 14+ months OS improvement was achieved in patients with lung or liver metastases, which are observed in 41% of postmenopausal women with HR+ aBC, and considered more aggressive and challenging to treat1-3    * Data add to growing body of evidence for Piqray, the first and only treatment specifically approved for aBC with a PIK3CA mutation  Basel, September 19, 2020 — Novartis today announced results of the final overall survival (OS) analysis from the SOLAR-1 trial, which evaluated Piqray® (alpelisib) in combination with fulvestrant, compared to fulvestrant alone, in hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer patients with tumors harboring a PIK3CA mutation. Piqray is the only treatment approved in Europe, the United States and 15 other countries specifically for people with HR+/HER2- advanced breast cancer with a PIK3CA mutation. These data will be presented as a late-breaking oral presentation during the ESMO Virtual Congress 2020.In the study, there was a clinically relevant improvement in OS of eight months for patients with a PIK3CA mutation taking Piqray plus fulvestrant compared to fulvestrant alone (median OS 39.3 months vs. 31.4 months; one-sided p≤0.0161; HR=0.86; 95% CI: 0.64-1.15; p=0.15)1. This difference did not reach the prespecified threshold of statistical significance set for the secondary objective of OS in patients with PIK3CA-mutated breast cancer. A more than 14 month OS improvement was observed in patients with lung or liver metastases, which signify more aggressive disease (median OS 37.2 months vs. 22.8 months; HR=0.68; 95% CI: 0.46-1.00)1-3.“These results build on previous data showing that alpelisib nearly doubled median progression-free survival in this patient population,” said Fabrice André, MD, PhD, research director and head of INSERM Unit U981, professor in the Department of Medical Oncology at Institut Gustave Roussy in Villejuif, France, and global SOLAR-1 principal investigator. “Patients whose tumors have a PIK3CA mutation, particularly those with lung or liver metastases, have a more aggressive, harder to treat cancer, so these results showing alpelisib offers longer life, are promising.” In addition, data showed the need for chemotherapy was delayed in patients taking Piqray plus fulvestrant by nine months compared to those taking fulvestrant alone (23.3 months vs. 14.8 months; HR=0.72; 95% CI: 0.54-0.95)1. Quality of life (QOL) was maintained for people taking Piqray plus fulvestrant.“These data demonstrating survival benefit give the 40% of HR+/HER2- advanced breast cancer patients with PIK3CA mutations in their tumors more time to spend with loved ones and do what they value most,” said Susanne Schaffert, PhD, President, Novartis Oncology. “We are committed to reimagining a world where advanced breast cancer becomes a curable disease, and these data reinforce our confidence as we continue to explore the potential use of Piqray in other types of breast cancer with PIK3CA mutations.”No new safety signals were observed; adverse events were consistent with previously reported SOLAR-1 results.Visit https://www.virtualcongress.novartis.com/ESMO20 for the latest information from Novartis including our bold approach to reimagining cancer care, and access to our ESMO Virtual Congress 2020 symposia and data presentations (for registered participants).In July 2020, the European Commission (EC) approved Piqray in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2- locally advanced or metastatic breast cancer with a PIK3CA mutation after disease progression following endocrine therapy as monotherapy.About Piqray® (alpelisib) Piqray is a kinase inhibitor developed for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with HR+/HER2-, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after endocrine-based regimen. Piqray is approved in 48 countries, including the US and European member states.About SOLAR-1 SOLAR-1 is a global, Phase III, randomized, double-blind, placebo-controlled trial studying Piqray in combination with fulvestrant for postmenopausal women, and men, with PIK3CA-mutated HR+/HER2- advanced or metastatic breast cancer that progressed on or following aromatase inhibitor treatment with or without a CDK4/6 inhibitor7-9.The trial randomized 572 patients. Patients were allocated based on central tumor tissue assessment to either a PIK3CA-mutated cohort (n=341) or a PIK3CA non-mutated cohort (n=231). Within each cohort, patients were randomized in a 1:1 ratio to receive continuous oral treatment with Piqray (300 mg once daily) plus fulvestrant (500 mg every 28 days + Cycle 1 Day 15) or placebo plus fulvestrant. Stratification was based on visceral metastases and prior CDK4/6 inhibitor treatment7-9. Patients and investigators are blinded to PIK3CA mutation status and treatment.The primary endpoint is local investigator assessed PFS using RECIST 1.1 for patients with a PIK3CA mutation. The key secondary endpoint is overall survival, and additional secondary endpoints include, but are not limited to, overall response rate, clinical benefit rate, health-related quality of life, efficacy in PIK3CA non-mutated cohort, safety and tolerability7-9.About Novartis in Advanced Breast Cancer Novartis tackles breast cancer with superior science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.Important Safety Information from the PIQRAY EU SmPC The most common ADRs and the most common grade 3 / 4 ADRs (reported at a frequency >20% and ≥2%, respectively) were plasma glucose increased, creatinine increased, gamma-glutamyltransferase increased, rash, lymphocyte count decreased, nausea, alanine aminotransferase increased, anaemia, fatigue, lipase increased, decreased appetite*, stomatitis, vomiting*, weight decreased, hypocalcaemia, plasma glucose decreased*, activated partial thromboplastin time prolonged*, alopecia**, diarrhoea, hypokalaemia, hypertension, nausea, creatinine increased, and mucosal inflammation (*<2% grade 3/4 ADRs reported, ** no grade 3/4 ADRs reported).Piqray can cause serious side effects such as severe hypersensitivity, severe cutaneous reactions, hyperglycaemia, pneumonitis, diarrhoea and osteonecrosis of the jaw.The following should be taken into consideration prior to or during treatment with Piqray: Piqray should be permanently discontinued in patients with serious hypersensitivity reactions.Piqray should not be initiated in patients with a history of severe cutaneous reactions, should be interrupted if signs or symptoms of severe cutaneous reactions are present, and permanently discontinued if a severe cutaneous reaction is confirmed.Fasting glucose and HbA1c levels should be monitored frequently in the first 4 weeks of treatment, and patients should be advised of the signs and symptoms of hyperglycaemia.In case of new or worsening respiratory symptoms, the patient should be evaluated for pneumonitis.Patients should be advised to notify their physician if diarrhoea occurs.Caution should be exercised when Piqray and bisphosphonates or denosumab are used together or sequentially. Piqray should not be initiated in patients with ongoing osteonecrosis of the jaw.The efficacy and safety of Piqray has not been studied in patients with symptomatic visceral disease.Animal studies suggest that Piqray may cause fetal harm in pregnant women. Therefore, as a precaution, women of childbearing potential should use effective contraception while receiving Piqray during treatment and at least 1 week after stopping treatment. Women should not breast feed for at least 1 week after the last dose of Piqray. Piqray may affect fertility in males and females.Please see full Prescribing Information for Piqray, available at www.Piqray.com.Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.About Novartis Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews For Novartis multimedia content, please visit https://www.novartis.com/news/media-library For questions about the site or required registration, please contact media.relations@novartis.comReferences 1.    André F, Ciruelos EM, Juric D, et al. Overall Survival (OS) Results From SOLAR-1, a Phase 3 Study of Alpelisib (ALP) + Fulvestrant (FUL) for Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2–) Advanced Breast Cancer (ABC). Presented at the European Society for Medical Oncology (ESMO) Congress, September 19, 2020 (LBA18).    2.    Harb, WA. Management of patients with hormone receptor-positive breast cancer with visceral disease: challenges and treatment options. Cancer Manag Res. 2015;7:37-46. 3.    Wang R, Zhu Y, Liu X, et al. The Clinicopathological features and survival outcomes of patients with different metastatic sites in stage IV breast cancer. BMC Cancer. 2019;19(1):1091. 4.    The Cancer Genome Atlas Network. Comprehensive molecular portraits of human breast tumours. Nature. 2012;490(7418):61-70. 5.    Miller TW, Rexer BN, Garrett JT, Arteaga CL. Mutations in the phosphatidylinositol 3-kinase pathway: role in tumor progression and therapeutic implications in breast cancer. Breast Cancer Res. 2011. 6.    Saal LH, Johansson P, Holm K, et al. Poor prognosis in carcinoma is associated with a gene expression signature of aberrant PTEN tumor suppressor pathway activity. Proc Natl Acad Sci U S A. 2007;104(18):7564-7569. 7.    Piqray (alpelisib) Prescribing Information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; May 2019. 8.    André F, Ciruelos E, Rubovszky G. Alpelisib for PIK3CA-Mutated, Hormone-Receptor-Positive Advanced Breast Cancer. N Eng J Med. 2019. 9.    André F, Ciruelos EM, Rubovszky G et al. Alpelisib (ALP) + fulvestrant (FUL) for advanced breast cancer (ABC): Results of the phase III SOLAR-1 trial. Annals of Oncology, Vol 29, Suppl 8, October 2018, Abstract LBA3_PR. Novartis Media Relations E-mail: media.relations@novartis.comAnja von Treskow Novartis External Communications +41 79 392 8697 (mobile) anja.von_treskow@novartis.com   Eric Althoff Novartis US External Communications +1 646 438 4335 eric.althoff@novartis.com Julie Masow Novartis Oncology Media Relations +1 862 579 8456 (mobile) julie.masow@novartis.com   Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.comCentral   North America   Samir Shah +41 61 324 7944 Sloan Simpson +1 862 778 5052 Thomas Hungerbuehler  Isabella Zinck +41 61 324 8425 +41 61 324 7188