Novartis Data on 19 Compounds at AACR Highlight Strong Cancer Pipeline Across Multiple Molecular Targets and Biological Pathways?

Novartis has announced that early-stage data on 19 investigational compounds in its oncology pipeline will be presented at the annual meeting of the American Association of Cancer Research (AACR), 5–9 April 2014 in San Diego, CA. The AACR annual meeting highlights basic, translational and clinical discoveries in oncology. The investigational compounds featured in these Novartis studies are directed at multiple molecular targets and pathways. Currently Novartis Oncology is exploring more than 30 targets involved in cancer[1].

"Our research approach is driven by an understanding of cancers on a genomic level and developing therapies directed at those targets," said Alessandro Riva, President, Novartis Oncology ad interim and Global Head, Oncology Development and Medical Affairs. "The AACR presentations demonstrate the depth and breadth of our pipeline, which allows us to test various combinations at an early stage to target different pathways and mutations involved in cancer."

Among the data being presented are single agent and combination studies with key investigational compounds in the Novartis Oncology breast cancer development program, including an early phase study of the CDK4/6 inhibitor LEE011 and PI3K inhibitors BKM120 and BYL719. LEE011 and BKM120 are currently in Phase III and BYL719 is in Phase I trials for the treatment of advanced breast cancer.

In addition, preclinical data on ALK-inhibitor LDK378 (ceritinib) in ALK-positive non-small cell lung cancer (NSCLC) will be presented at the meeting. LDK378 was granted Breakthrough Therapy Designation by FDA in 2013 and is currently under review by FDA.

Early data will be presented on three additional investigational compounds including BGJ398, a highly specific fibroblast growth factor receptor (FGFR) inhibitor that Novartis is exploring in a variety of FGFR-driven solid tumours. A Phase I study of BGJ398 provides the first clinical evidence of activity against cancers that are driven by dysregulation of the FGFR pathway. In addition, the first data on CGM097, a selective p53-Mdm2 inhibitor currently under evaluation in Phase I trials in patients with p53 wild type tumours, and EGF816, a mutant-selective third generation EGFR inhibitor that is entering Phase I trials, will be presented.

More than 50 abstracts involving Novartis investigational compounds will be presented at AACR.

Reference
[1] American Association of Cancer Research. AACR 2014 Annual Meeting Program.

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