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Novartis Pharmaceuticals Corporation (NVS) Highlights Advances for Patients With Breast Cancer and Hematological Diseases With Over 160 SABCS and ASH Abstracts


12/2/2011 11:45:16 AM

EAST HANOVER, N.J., Dec. 2, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.

The CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held from December 6-10, will feature data presentations from Phase III studies of Afinitor® (everolimus) tablets for investigational uses and Zometa® (zoledronic acid) 4mg/5mL Injection, as well as early-stage studies of the investigational drug BKM120, an inhibitor of PI3K, a key cancer pathway(1).

The American Society of Hematology (ASH) annual meeting in San Diego, held from December 10-13, will showcase key data for Tasigna® (nilotinib), Exjade® (deferasirox) and the investigational drug INC424 (ruxolitinib)(*). Several early-stage studies will also be presented, including everolimus in Hodgkin lymphoma and Waldenstrom's macroglobulinemia and LBH589 (panobinostat) in relapsed and bortezomib (BTZ)-refractory multiple myeloma(2).

"These important data are examples of our research and development strategy to focus on significant unmet medical needs by targeting the fundamental mechanisms of disease," said Herve Hoppenot, President, Novartis Oncology. "Through our collaborations with the scientific and patient communities, we continue to advance our goal of transforming patients' lives."

Highlights at SABCS include:

  • Everolimus Updated data from the BOLERO-2 (Breast cancer trials of OraL EveROlimus) Phase III trial of everolimus in combination with exemestane for postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with the hormonal therapies letrozole or anastrozole (SABCS abstract #S3-7; December 8, 9:30 11:15AM).
  • Zometa ABCSG-12 (Austrian Breast & Colorectal Cancer Study Group Trial) long-term data will examine possible carry-over anticancer benefits of zoledronic acid three years after treatment completion in premenopausal women with endocrine-responsive early breast cancer receiving adjuvant goserelin and endocrine therapy (SABCS abstract #S1-2; December 7, 9:15 11:30AM) and five-year ZO-FAST (ZOmeta-Femara Adjuvant Synergy Trial) follow-up data on long-term overall survival outcomes among postmenopausal women with hormone receptor-positive early breast cancer receiving adjuvant zoledronic acid and letrozole (SABCS abstract #S1-3; December 7, 9:15 11:30AM).
  • BKM120 Two studies investigating the activity of BKM120, a pan-PI3K inhibitor, in advanced breast cancer: data from a trial evaluating the safety profile and clinical activity of BKM120 as a single agent for the treatment of patients with metastatic breast cancer (SABCS abstract #P31601; December 8, 5:00 7:00PM) and data from a Phase I/II study evaluating BKM120 in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer resistant to trastuzumab-containing therapy (SABCS abstract #PD0903; December 9, 5:00 7:00PM).

Highlights at ASH include:

  • Tasigna ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials) 36-month update of the ENESTnd study comparing Tasigna to Gleevec® (imatinib mesylate) tablets(**) in patients with newly diagnosed chronic phase Ph+ chronic myeloid leukemia (ASH abstract #452; December 12, 10:30AM 12:00PM) and results from ENESTcmr trial assessing the efficacy and safety of switching patients with residual molecular disease on Gleevec treatment to Tasigna (ASH abstract #606; December 12, 2:45 4:15PM).
  • Exjade Data from the first randomized, placebo-controlled study evaluating the reduction of liver iron concentration and serum ferritin in patients with non-transfusion-dependent thalassemia after one year of treatment with Exjade oral iron chelation therapy (ASH abstract #902; December 13, 7:30 9:00AM) and data from a retrospective analysis of hematological response during iron chelation therapy in patients with myelodysplastic syndrome (MDS) and aplastic anemia with transfusional iron overload (ASH abstract #611; December 12, 2:45 4:15PM).
  • INC424 Data from multiple research programs will be presented, including two pivotal Phase III studies evaluating INC424 benefit versus placebo (COMFORT-I [COntrolled MyeloFibrosis study with ORal JAK inhibitor Therapy]) (ASH abstract #278; December 12, 7:00 8:30AM) and versus best available therapy (COMFORT-II) (ASH abstract #795; December 12, 4:30 6:00PM). These data will assess measures of spleen reduction, symptom improvement, health-related quality of life and overall survival.
  • Everolimus Results from a Phase II study evaluating everolimus as a monotherapy in relapsed/refractory Hodgkin lymphoma (ASH abstract #2717; December 11, 6:00 8:00PM) and data from a Phase I trial of everolimus in combination with rituximab or in combination with BTZ and rituximab in relapsed/refractory Waldenstrom's macroglobulinemia (ASH abstract #2705; December 11, 6:00 8:00PM).
  • LBH589 Results from PANORAMA-2 (PANobinostat ORAl in Multiple myelomA), a Phase II study of LBH589 in combination with BTZ and dexamethasone in patients with relapsed and BTZ-refractory multiple myeloma (ASH abstract #814; December 12, 4:30 6:00PM). Data from two trials in myelofibrosis: final results from a Phase I trial of prolonged low dose therapy with LBH589 in myelofibrosis patients (ASH abstract #794; December 12, 4:30 6:00PM) and a preclinical study of LBH589 in combination with INC424 in JAK2V617F-driven disease (ASH abstract #798; December 12, 4:30 6:00PM).

About everolimus
In the US, Afinitor® (everolimus) tablets is approved for the treatment of progressive neuroendocrine tumors of pancreatic origin (pNET) in patients with unresectable, locally advanced or metastatic disease and for the treatment of patients with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib. The US Food and Drug Administration (FDA) determined that the safety and effectiveness of Afinitor in the treatment of patients with carcinoid tumors have not been established.

Afinitor is also approved in the US to treat patients with SEGA associated with TS who require therapeutic intervention but are not candidates for curative surgical resection. The effectiveness of everolimus is based on an analysis of change in SEGA volume. Clinical benefit such as improvement in disease-related symptoms or increase in overall survival has not been shown.

In the US, everolimus is available from Novartis in different dosage strengths and for different uses in non-oncology patient populations under the trade name Zortress®. Everolimus is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

Not all indications are available in every country. Access to everolimus outside of the approved indications has been carefully controlled and monitored in clinical trials designed to better understand the potential benefits and risks of the compound. As an investigational compound, the safety and efficacy profile of everolimus has not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that everolimus will become commercially available for additional indications anywhere else in the world.

Afinitor (everolimus) tablets Important Safety Information
Patients should not take Afinitor if they are allergic to Afinitor or to any of its ingredients. Patients should tell their healthcare provider before taking Afinitor if they are allergic to sirolimus (Rapamune®#) or temsirolimus (Torisel®#).

Afinitor can cause serious side effects including lung or breathing problems, infections and kidney failure, which can lead to death. If patients experience these serious side effects, they may need to stop taking Afinitor for a while or use a lower dose. Patients should tell their healthcare provider right away if they have any of these symptoms: new or worsening cough, shortness of breath, chest pain, difficulty breathing or wheezing.

Afinitor may make patients more likely to develop an infection, such as pneumonia, or a bacterial, fungal or viral infection. Viral infections may include reactivation of hepatitis B in people who have had hepatitis B in the past. In some people these infections may be severe, and can even lead to death. Patients may need to be treated as soon as possible. Patients should tell their healthcare provider right away if they have a temperature of 100.5F or above, chills or do not feel well. Symptoms of hepatitis B or infection may include the following: fever, skin rash, joint pain and inflammation, tiredness, loss of appetite, nausea, pale stool or dark urine, yellowing of the skin or pain in the upper right side.

Afinitor can cause mouth ulcers and sores, which are the most frequently occurring side effects occurring in approximately 44%-70% advanced kidney cancer and advanced pancreatic NET patients taking Afinitor. Eighty-six percent of patients taking Afinitor for SEGA developed mouth ulcers/sores. Patients should tell their healthcare provider if they have pain, discomfort or open sores in their mouth. Their healthcare provider may tell them to use a special mouthwash or mouth gel that does not contain alcohol or peroxide.

Afinitor may cause kidney failure. In some people this may be severe and can even lead to death. Patients should have tests to check their kidney function before and during their treatment with Afinitor.

Patients will have regular blood tests before they start and as needed during their treatment with Afinitor. These tests will include tests to check the patient's blood cell count, kidney and liver function and blood sugar levels. Patients who receive Afinitor for the treatment of SEGA will need regular blood tests to measure how much Afinitor is in their blood since this will help their doctor decide how much Afinitor they need to take.

Afinitor may affect the way other medicines work, and other medicines can affect how Afinitor works. Using Afinitor with other medicines can cause serious side effects. Patients should tell their healthcare provider about all of the medicines they take, including prescription and non-prescription medicines, vitamins and herbal supplements such as: St. John's Wort, and medicine for fungal infections, bacterial infections, tuberculosis, seizures, HIV-AIDS, heart conditions or high blood pressure and medicines that suppress their immune system. Patients should not drink grapefruit juice or eat grapefruit during their treatment with Afinitor as it may make the amount of Afinitor in their blood increase to a harmful level.

Patients should not take Afinitor tablets which are broken or crushed. Patients should not chew or crush the tablets.

The amount of Afinitor in the blood was increased in patients who had liver problems. Patients should tell their healthcare provider about all their medical conditions, including if they have or have had liver problems, diabetes or high blood sugar, high cholesterol levels, infections, hepatitis B or other medical conditions.

Patients should tell their healthcare provider if they are scheduled to receive any vaccinations. Patients should not receive a live vaccine or be around people who have recently received a live vaccine during treatment with Afinitor.

It is not known if Afinitor will harm an unborn baby. Women should use effective birth control while using Afinitor and for eight weeks after stopping treatment.

Common side effects of Afinitor in patients with advanced pancreatic neuroendocrine tumors include mouth ulcers, rash, diarrhea, swelling of arms, hands, feet, ankles, face or other parts of the body, abdominal pain, nausea, fever and headache. Common side effects of Afinitor in patients with advanced kidney cancer include mouth ulcers, infections, feeling weak or tired, cough and diarrhea. Common side effects of Afinitor in patients with SEGA include mouth ulcers, infections of the respiratory tract, sinuses and ears and fever.

Please see full Prescribing Information for Afinitor.

About ZOMETA
ZOMETA (zoledronic acid) 4 mg/5 mL Injection is a treatment for hypercalcemia of malignancy (HCM; a condition resulting in high calcium blood levels due to cancer). ZOMETA is also used to reduce and delay bone complications due to multiple myeloma and bone metastases from solid tumors; used with anti-cancer medicines. ZOMETA is not an anti-cancer therapy. If you have prostate cancer, you should have failed treatment with at least one hormonal therapy prior to taking ZOMETA.

ZOMETA Important Safety Information
Do not use ZOMETA if you have had a severe allergic reaction to zoledronic acid or any components of ZOMETA. These reactions, including rare cases of hives and angioedema (swelling often near your eyes and lips), and very rare cases of life-threatening allergic reactions, have been reported. ZOMETA is in a class of drugs called bisphosphonates, and contains the same active ingredient as that found in Reclast®(***) (zoledronic acid). If you are treated with ZOMETA, you should not be treated with Reclast.

If you have HCM, you should drink plenty of clear fluids before using ZOMETA. If you have kidney problems, tell your doctor. The risk of adverse reactions (especially related to the kidney) may be greater for you. ZOMETA treatment is not for patients with severe kidney problems. Patients with kidney problems on multiple cycles of ZOMETA or other bisphosphonates are at greater risk for further kidney problems. It is important to get your blood tests while you are receiving ZOMETA. Your doctor will monitor your kidney function before each dose. Tell your doctor if you are on other drugs, including aminoglycosides, loop diuretics, and drugs which may be harmful to the kidney.

Osteonecrosis of the jaw (ONJ) has been reported mainly in cancer patients treated with intravenous bisphosphonates, including ZOMETA. Many of these patients were also receiving anti-cancer drugs and corticosteroids, which may make it more likely to get ONJ. If you have advanced breast cancer or a type of cancer called multiple myeloma, or if you have had dental extraction, periodontal disease, local trauma, including poorly fitting dentures, you may be at greater risk of getting ONJ. Many reports of ONJ involved patients with signs of local infection, including bone/bone marrow inflammation. You should maintain good oral hygiene and have a dental examination with preventive dentistry prior to beginning ZOMETA. While on treatment, avoid invasive dental procedures, if possible, as recovery may take longer. If you develop ONJ while on bisphosphonate therapy, dental surgery may worsen the condition. If you require dental procedures, there are no data available to suggest whether stopping ZOMETA treatment reduces the risk of ONJ. A causal relationship between bisphosphonate use and ONJ has not been established. Based on your condition, your doctor will determine the treatment plan you will receive.

Do not use ZOMETA if you are pregnant or plan to become pregnant, or if you are breast-feeding.

Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking bisphosphonates, including ZOMETA. Do not continue using ZOMETA if severe symptoms develop, as some patients had the symptoms reappear after taking ZOMETA or another bisphosphonate again. In aspirin sensitive patients, bronchoconstriction (tightening of the airways in the lungs) has been observed while taking bisphosphonates.

If you are an HCM patient with liver problems, talk to your doctor about whether ZOMETA is appropriate for you.

HCM patients may experience flu-like symptoms (fever, chills, flushing, bone pain and/or joint or muscle pain). Common side effects in HCM patients include fever, nausea, constipation, anemia, shortness of breath, diarrhea, abdominal pain, worsening of cancer, insomnia, vomiting, anxiety, urinary tract infection, low phosphate levels, confusion, agitation, a fungal infection called moniliasis, low potassium levels, coughing, skeletal pain, low blood pressure, and low magnesium levels. Redness and swelling may occur at the site that you are injected.

Common side effects for patients with multiple myeloma and bone metastases due to solid tumors include bone pain, nausea, fatigue, anemia, fever, vomiting, constipation, shortness of breath, diarrhea, weakness, muscle pain, anorexia, cough, joint pain, lower-limb swelling, worsening of your cancer, headache, dizziness (excluding vertigo), insomnia, decreased weight, back pain, numbness/tingling, and abdominal pain. These side effects are listed regardless of any potential association with the medications used in registration studies of ZOMETA in bone metastases patients.

Eye-related side effects may occur with bisphosphonates, including ZOMETA. Cases of swelling related to fluid build-up in the eye, as well as inflammation of the uvea, sclera, episclera, conjunctiva, and iris of the eye have been reported.

Patients with multiple myeloma and bone metastases from solid tumors should be taking an oral calcium supplement of 500 mg and a multiple vitamin containing 400 IU of vitamin D daily.

Please see full Prescribing Information and talk to your doctor for more information.

About BKM120 and LBH589 (panobinostat)
Because these are investigational compounds, the safety and efficacy profile of BKM120 and LBH589 have not yet been established. Access to these investigational compounds is available only through carefully controlled and monitored clinical trials. These trials are designed to better understand the potential benefits and risks of the compound. Because of uncertainty of clinical trials, there is no guarantee that BKM120 and LBH589 will ever be commercially available anywhere in the world.

About Tasigna
TASIGNA® (nilotinib) is approved for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of TASIGNA for this indication is based on major molecular response and cytogenetic response rates at 12 months. The study is ongoing and further data will be required to determine long-term outcome.

TASIGNA is also approved in more than 90 countries for the treatment of chronic phase and accelerated phase Ph+ CML in adult patients resistant or intolerant to at least one prior therapy, including Gleevec. The effectiveness of TASIGNA for this indication is based on hematologic and cytogenetic response rates.

BOXED WARNING and Important Safety Information for TASIGNA (nilotinib)



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