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Novartis to present highlights of investigational uses of current therapies & investigational agents during ASCO
Basel | Thursday, June 3, 2010, 08:00 Hrs  [IST]

Novartis announced that nearly 170 abstracts highlighting investigational uses of current therapies and investigational agents in the Novartis Oncology portfolio will be presented at the 46th Annual Meeting of the American Society of Clinical Oncology (ASCO) from June 4 through June 8 in Chicago, Illinois. These data include results with Tasigna (nilotinib), Zometa (zoledronic acid), Afinitor (everolimus) tablets, panobinostat (LBH589) and targeted pipeline therapies that underscore the Company's dedication to improving treatment for cancer patients around the world by developing therapies based on the molecular pathways of various cancers and tumour types.

"Our scientific presence at ASCO speaks to our commitment to improve cancer treatment by discovering, developing and making available individualized therapies for diseases where there is unmet medical need," said Herve Hoppenot, president, Novartis Oncology. "Through our robust discovery and development programme, we will continue to be a leader in the oncology community, working to bring forth significant treatment advances that strive to improve the lives of patients suffering from cancer."

Notable data with Novartis treatments include the following oral presentations.

Abstract #6501: 18-month (median follow-up) study results with Tasigna in adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase.
Abstract #8021: Results from a large, phase III study evaluating the addition of Zometa to chemotherapy versus oral clodronate plus chemotherapy in patients with newly diagnosed multiple myeloma. Abstract #2004: Findings on everolimus in patients with subependymal giant cell astrocytomas (SEGAs) associated with tuberous sclerosis (TS), a genetic disorder which causes tumors to form in many vital organs, including the brain. There are currently no FDA-approved treatments, although invasive brain surgery can be used to remove tumours.

Two oral presentations will highlight panobinostat (LBH589) in Hodgkin lymphoma and multiple myeloma. Interim results from a phase-II study (abstract #8007) of panobinostat in heavily pre-treated patients with relapsed/refractory Hodgkin lymphoma and updated data from a Phase Ib study (abstract #8001) of oral panobinostat in combination with bortezomib in patients with relapsed or relapsed and refractory multiple myeloma will be presented. Also, Novartis will present PANORAMA-2, a new phase-II study (abstract #TPS308) on panobinostat in bortezomib-refractory multiple myeloma patients.

Data from the Novartis Oncology pipeline include innovative, targeted therapies in various solid tumor types.

Abstract #3005: Results from the first-in-human phase-I study of the oral PI3K inhibitor BEZ235 in patients with advanced solid tumours. Abstract #3003: phase-I dose-escalation study of BKM120, an oral pan-class I PI3K inhibitor, in advanced solid tumours. Abstract #2500: phase-I dose-escalation study of LDE225, a smoothened antagonist, in solid tumours.

Tasigna has been approved in more than 80 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 Glivec. The effectiveness of Tasigna for this indication is based on confirmed hematologic and unconfirmed cytogenetic response rates. There are no controlled trials demonstrating a clinical benefit, such as improvement in disease-related symptoms or increased survival.

Tasigna is not approved for the treatment of newly diagnosed Ph+ CML-CP.

Glivec is approved in more than 90 countries, including the US, EU and Japan, for the treatment of all phases of Ph+ CML.

Zometa is indicated for the prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcemia) in patients with advanced malignancies involving bone.

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