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    « New York Times' story captures essence of GeneKey strategy | Main | New Melanoma Drug Nearly Doubles Survival »
    Tuesday
    Jun052012

    The Rise of Precision Medicine

    Looks like "precision medicine" has replaced "personalized medicine" as the term of the day to describe therapeutic strategies based on molecular and genomic diagnostics. It's a good description of what we do at GeneKey: using advanced genomic and systems biology methods to understand the biological mechanisms driving an individual patient's cancer, and applying that knowledge to come up with treatment options that target those mechanisms as precisely as the current technology allows.

    Precision medicine is generating news at the ongoing meeting of the American Society of Clinical Oncology (June 1-5, 2012). OncologySTAT provides an overview of the important trends and discoveries that are being discussed. A free subscription is required to read the full story. Here's are some highlights:

    Precision Medicine Will Be in Action at ASCO 

    The idea that the same molecular drivers are present in very different and sometimes apparently unrelated cancers is driving new areas of inquiry in drug development and shaking up the way oncologists think about treating their patients. That research will be on display and under debate at the American Society of Clinical Oncology annual meeting in Chicago June 1-5.

    “We now understand that it’s not sufficient to identify a tumor based on the histology or the organ of origin, as we did traditionally, but rather … tumors are heterogeneous, and we need to understand the particular molecular driver of the tumor to select appropriate therapy,” ASCO President Michael Link said during a May 16 press conference to highlight research being presented at this year’s meeting.

    ...precision medicine can be a saving grace in many settings, particularly when an established approach for front-line therapy has failed. It is common to send tumor samples from relapsed patients for genetic testing to identify a possible second-line therapy based on molecular drivers, Nicholas Vogelzang, who chairs ASCO’s cancer communications committee, said in an interview. A recent example from his practice, he said, is a mesothelioma patient whose cancer appears to be recurring with no approved second-line treatment options. Vogelzang was sending out the sample in hopes of finding a genetic match for the target of an existing therapy. Another is the discovery that a patient’s rare endocrine tumor, a gastrinoma, had a specific BRAF mutation that makes it susceptible to Roche’s Zelboraf (vemurafenib), which was approved for metastatic melanoma.

    “It’s not intuitive,” said Vogelzang. “Unusual tumors have these mutations, so you have to test.”

    ...A “poster drug” for the evolving approach is Pfizer Inc.’s Xalkori (crizotinib), which made national news when the bulk of the ASCO abstracts were made public May 16 and it was revealed that the ALK inhibitor had proved effective against a phenotypically unrelated set of aggressive pediatric cancers. Cleared by FDA along with a companion diagnostic in August 2011 to treat late-stage non-small cell lung cancer in adults, Xalkori was a breakthrough both in treatment of NSCLC and as a highly focused targeted therapy. Another is Zelboraf, which was approved the same month for patients with the V600E BRAF mutation, also identified by a companion diagnostic.

    ...The idea of overhauling the cancer research/drug development enterprise to be more focused on the molecular basis of the disease is a paradigm shift ASCO has been pushing.

    ...A key component of the approach is to develop drugs in combination to attack more than one biological trait of heterogeneous cancer tumors at once, but in the case of one trial being reported at this year’s meeting, the compounds not only increased efficacy in combination, they had a better side effect profile.

    Results from a subset of patients in a large Phase I/II trial investigating two GlaxoSmithKline PLC compounds for melanoma, the BRAF inhibitor dabrafenib (GSK2118436) and the MEK inhibitor trametinib (GSK1120212), show the combination not only generated an improved response against the cancer, but that the MEK inhibitor apparently ameliorated the well-characterized dermatologic side effects of the BRAF class, Jeffrey Weber, H. Lee Moffitt Cancer Center, the lead author on the study, reported during the briefing.

    The concept of drug combinations to tackle different, interacting biological mechanisms in tumors is one that GeneKey has used from the beginning. It's encouraging to see this strategy gain acceptance by the larger oncology community.

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