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Novartis presents key advances in cancer research at ASCO and EHA from four new pivotal studies in lung, blood and skin cancers

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Friday, May 23, 2014

Novartis will showcase the results of research efforts to target disease pathways with more than 150 abstracts at two upcoming cancer-focused meetings, including updated data in ALK+ non-small cell lung cancer and the first-ever presentations of key data in polycythemia vera, multiple myeloma (blood) and locally advanced or metastatic basal cell carcinoma (skin).

Clinical data featured at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO; May 30-June 3, Chicago) and the 19th Congress of the European Hematology Association (EHA; June 12-15, Milan) will include Zykadia(TM) (ceritinib), Jakavi®[*] (ruxolitinib), Tasigna® (nilotinib), Afinitor® (everolimus) and Exjade® (deferasirox),  as well as pipeline compounds LBH589 (panobinostat), LDE225 (sonidegib) and others[1],[2].

"Our research strategy continues to focus on the underlying cause of disease to develop targeted compounds or combinations of therapies," said Alessandro Riva, MD, President, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs. "The approach has been shown to be successful in treating patients with lung, blood and breast cancers, and this latest research shows that we may have potential new treatments to continue addressing critical needs in cancer care."

Data highlights include:

Key pivotal data across four oncology compounds

  • Ceritinib: Ceritinib in advanced anaplastic lymphoma kinase (ALK)-rearranged (ALK+) non-small cell lung cancer (NSCLC): Results of the ASCEND-1 trial (ASCO oral presentation, abstract #8003; June 2, 3:48 PM CDT)
  • Ruxolitinib: Results of a prospective, randomized, open-label Phase III study of ruxolitinib in polycythemia vera patients resistant to or intolerant of hydroxyurea: the RESPONSE trial (ASCO oral presentation, abstract #7026; June 3, 9:57 AM CDT; EHA oral presentation, abstract #LB-2436; June 14, 2:00 PM CEST)
  • Panobinostat: PANORAMA 1: A randomized, double-blind, Phase III study of panobinostat or placebo plus bortezomib and dexamethasone in relapsed or relapsed and refractory multiple myeloma (ASCO oral presentation, abstract #8510; June 2, 8:00 AM CDT; EHA oral presentation, abstract #S641; June 14, 8:00 AM CEST)
  • Sonidegib: Randomized, double-blind study of sonidegib (LDE225) in patients with locally advanced or metastatic basal cell carcinoma (ASCO oral presentation, abstract #9009a; June 1, 8:00 AM CDT)

Emerging data on key Novartis marketed treatments, early combination studies and innovative clinical trial designs

  • Everolimus: Meta-analysis of stomatitis incidence in everolimus clinical studies and its relationship with efficacy (ASCO abstract #645; June 2, 8:00 AM CDT)
  • Everolimus: Prevention of stomatitis in patients with hormone receptor-positive advanced breast cancer treated with everolimus plus exemestane: A Phase II study of a steroid-based mouthwash (ASCO trials in progress abstract #TPS661; June 2, 8:00 AM CDT)
  • Everolimus: Identification and validation of predictive biomarkers for everolimus in metastatic renal cell carcinoma: Analysis of 442 patients on RECORD-3 (ASCO abstract #4531; May 30, 1:00 PM CDT)
  • Nilotinib: Treatment-free remission following nilotinib in patients with chronic myeloid leukemia in chronic phase: ENESTfreedom, ENESTop, ENESTgoal, and ENESTpath (ASCO trials in progress abstract #TPS7124; June 2, 1:15 PM CDT)
  • Nilotinib: ENESTnd 5-year update: Long-term outcomes of patients with chronic myeloid leukemia in chronic phase treated with frontline nilotinib vs imatinib (ASCO abstract #7073; June 2, 1:15 PM CDT; EHA oral presentation, abstract #S677; June 14, 8:15 AM CEST)
  • Nilotinib: Effect of continued imatinib in patients with detectable BCR-ABL after >= 2 years on study on deep molecular responses (MR): 36-month update from ENESTcmr (ASCO abstract #7025; May 31, 1:15 PM CDT; EHA oral presentation, abstract #S1361; June 15, 10:45 AM CEST)
  • Ruxolitinib: Phase Ib, dose-finding study of ruxolitinib plus panobinostat in patients with myelofibrosis (ASCO abstract #7022; May 31, 1:15 PM CDT; EHA abstract #P410; June 13, 5:45-7:00 CEST)
  • Deferasirox: Deferasirox-deferoxamine combination therapy reduces cardiac iron with rapid liver iron removal after 24 months in patients with severe transfusional iron overload (HYPERION) (EHA abstract #S661; June 14, 8:00 AM CEST)
  • The signature program, a series of tissue-agnostic, mutation-specific signal finding trials (ASCO trials in progress abstract #TPS2646; June 1, 8:00 AM CDT)

New findings from combination studies across oncology pipeline and presentations on CAR T cell therapy

  • INC280: Safety and efficacy of INC280 in combination with gefitinib in patients with EGFR-mutated, MET-positive NSCLC: A single-arm Phase lb/ll study (ASCO abstract #8017; June 3, 8:00 AM CDT)
  • LEE011: Phase Ib/II study of LEE011, everolimus, and exemestane in postmenopausal women with ER+/HER2- metastatic breast cancer (ASCO abstract #535; June 1, 8:00 AM CDT)
  • LEE011: Phase Ib study of LEE011 and BYL719 in combination with letrozole in estrogen receptor-positive, HER2-negative breast cancer (ASCO abstract #533; June 1, 8:00 AM CDT)
  • CTL019: Genetically Engineered T Cells and Beyond: Immune Modulation Therapy in Chronic Lymphocytic Leukemia (ASCO; June 2, 1:55 PM CDT)
  • CTL019: Future Directions in Immune Targeting (ASCO; June 2, 1:35 PM CDT)

Throughout ASCO and EHA, Novartis Oncology will host a dedicated webpage (http://www.novartisoncology.com/asco-2014.jsp) that will provide unique insights and perspectives into emerging areas of cancer care and research.

Product Information

Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

For full prescribing information including important safety information about marketed products, please the following websites: www.zykadia.com, www.jakavi.com, www.tasigna.com, www.glivec.com, www.afinitor.com and www.exjade.com.

Because LBH589, LDE225, INC280, LEE011, BYL719 and CTL019 are investigational compounds, the safety and efficacy profiles have not yet been fully 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 the uncertainty of clinical trials, there is no guarantee that LBH589, LDE225, INC280, LEE011, BYL719 and/or CTL019 will ever be commercially available anywhere in the world.

About Novartis

Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, eye care, cost-saving generic pharmaceuticals, preventive vaccines, over-the-counter and animal health products. Novartis is the only global company with leading positions in these areas. In 2013, the Group achieved net sales of USD 57.9 billion, while R&D throughout the Group amounted to approximately USD 9.9 billion (USD 9.6 billion excluding impairment and amortization charges). Novartis Group companies employ approximately 135,000 full-time-equivalent associates and sell products in more than 150 countries around the world. For more information, please visit http://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at http://twitter.com/novartis.

References

[1] American Society of Clinical Oncology. ASCO Annual Meeting Program. Available at: http://abstracts.asco.org. Accessed May 2014.

[2] European Hematology Association. EHA Annual Meeting Program. Available at https://b-com.mci-group.com/EventProgramme/EHA19.aspx. Accessed May 2014.

Contact:

Novartis Media Relations

Central media line: +41 61 324 2200

Eric Althoff

Novartis Global Media Relations

+41 61 324 7999 (direct)

+41 79 593 4202 (mobile)

eric.althoff@novartis.com

Source: Novartis
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