Who’s Making Moves at ASCO 2009?

The American Society
of Clinical Oncology (ASCO) meeting is one of the biggest annual events in the
healthcare industry.  This weekend over 30,000 oncologists, educators,
industry leaders and investors will gather in balmy Orlando, Florida to review
the latest developments in cancer treatment.

Our team of analysts
conducted a review of the data abstracts to determine their impact on a range
of Biotech and Pharma stocks.  Over the next four days we will see full
data from a number of clinical trials that could change the future of oncology
therapy options.

  • Data around molecular profiling of patients will be discussed
    and, with future validation, could allow physicians to determine the best
    treatment options of targeted therapies in patient subsets and improve clinical
  • Maturing biologics are now being tested in adjuvant setting in
    an attempt to generate new avenues for growth.

Impact on Global
Non-small cell lung cancer (NSCLC) and Hepatocellular carcinoma (HCC) could
take center stage as AstraZeneca, Lilly, GlaxoSmithKline, and Roche release new
data on drugs targeting these indications. 

  • The picture isn’t pretty for AstraZeneca whose ZEST and ZEAL studies failed to
    demonstrate superiority of Zactima over Roche and OSI’s Tarceva and Lilly’s Alimta in advanced
    NSCLC patients.  In addition, Zactima’s safety profile is not very robust
    and could pose challenges in its approval.
  • While Lilly’s Alimta has shown better efficacy than Tarceva, the
    Tarceva+Avastin combo in NSCLC (data expected at ASCO) is likely to be a strong
    competitor.  Avastin, which has had success in KRAS wild type patients,
    and Tarceva, which has had success irrespective of a patient’s KRAS status, may
    compliment each other.  
  • Roche and OSI’s Avastin + Tarceva in maintenance therapy in NSCLC (ATLAS
    study) met its primary endpoint (improvement in Progression Free Survival) and
    we expect further details to be compelling. The extent of benefit on PFS would
    be the key determinant for upside.
  • GlaxoSmithKline’s Pazopanib has shown strong clinical efficacy in both naïve and
    cytokine refractory patients with advanced Renal Cell Carcinoma.  We
    estimate positive upside when the full data is released as this drug could
    potentially challenge Pfizer’s Sutent.

Rising Stars and
Innovative Approach to Drug Development

Rising Star (or unprofitable Biotech) technologies and novel target data
continue to breathe life into the oncology arena. 

  • Promising data from Seattle Genetics (SGN-35, PhI, Hodgkins
    lymphoma) andImmunogen (trastuzumab-DM1, PhII metastatic
    breast cancer, partner Roche) suggest that the value of Antibody drug
    conjugate (ADC) technology
     is likely to unfold in the next few years.  This
    technology could provide an opportunity to 1) develop “better biologics”, and
    2) become an important tool in life cycle management of existing
    biologics.  With Global Pharma companies facing patent expiry of their
    blockbuster drug, we expect them to examine developing better biologics as a
    way forward.
  • Data from a range of novel targets like c-Met, DR5, PARP,
    IGF-IR, and IL-21 will be presented at ASCO, but our scientific team views
    c-Met and DR5 as the leading targets which could evince interest at
    ASCO.  c-Met inhibitors could play a
    role in disease stabilization but not improve overall survival.  DR5, on the other
    a Tumor necrosis factor receptor superfamily member and contains an
    intracelluar death domain; Amgen’s DR5-inhibitor, AMG-655 is one to watch.

Impact on Mature
While Mature Biotech companies, like Genentech, were the movers and shakers of
past ASCO meetings, this year they will largely provide the particulars on
previously presented data. 

  • Amgen will see some positive traction as they highlight
    favorable Denosumab data in bone health and cancer.
  • Nexavar has propelled Onyx forward as the only approved
    worldwide targeted therapy for HCC.  However competition in HCC is on the
    rise and additional Nexavar data in colorectal cancer is not sufficient to
    dislodge Pfizer’s Sutent. 

Biomarkers and
Evidence Based Medicine Coming of Age
Evidence-based medicine, driven by discovery, validation of key biomarkers, and
genetic profiling in different tumor types, is likely to determine the choice
of targeted therapy in the coming years.  However, known targets like
EGFR, KRAS, and HER have already started to make an impact on the eligibility
of patients suitable for anti EGFR therapies (LLY/BMY’s Erbitux, AMGN’s
Vectibix, Roche’s Herceptin, etc.)  Studies on various diagnostics and
prognostics markers, and further validation of these findings through clinical
trials over the next few years could redefine the treatment paradigm for drugs
like Erbitux (LLY/BMY), Avastin (Roche), Tarceva (OSIP/ROG) and Tykerb (GSK)
and set new standards for other targeted therapies.  

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