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 outcomes.
  • Maturing biologics are now being tested in adjuvant setting in an attempt to generate new avenues for growth.

Impact on Global Pharma 
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 hand, is 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 Biotech 
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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