The European Society for Medical Oncology (ESMO) will kick off its 2012 annual meeting on Friday, September 28 in Vienna, Austria. ESMO reports that this year’s meeting will be bigger and better than ever as abstract submissions increased by 30% compared to the previous year. The society has highlighted a number of indications for which potentially game-changing results will be presented. These include lung cancer, renal cell carcinoma, melanoma, early and metastatic breast cancer, gastrointestinal tumours, CNS tumours, ovarian cancer, and sarcoma. Targeted therapies are a clear theme throughout the conference, and point to a continuing trend towards the incorporation of personalised medicine in the treatment patterns for many cancers.
Although the ESMO conference doesn’t attract the media maelstrom associated with the American Society of Clinical Oncology (ASCO) annual meeting, GlobalData is eagerly anticipating data from a number of presentations. We are especially interested in the late-breaking abstracts to be presented at the Presidential Symposia on Sunday, September 30 and Monday, October 1. Many of these abstracts are not yet available to the public, as they are embargoed until after the start of the symposia at which they will be presented. For the first time, data will be presented from the PROFILE 1007 Phase III study of Pfizer’s receptor tyrosine kinase inhibitor Xalkori (crizotinib) versus Eli Lilly’s Alimta (pemetrexed) or Sanofi’s Taxotere (docetaxel) chemotherapy in advanced, recurrent non-small cell lung cancer (NSCLC) harbouring the anaplastic lymphoma kinase (ALK) mutation. Long-awaited data showing that Xalkori prolongs these patients’ progression-free survival (PFS) compared to standard chemotherapy is likely to be presented, as Pfizer announced in June that the trial had met its primary endpoint. However, the magnitude of the PFS improvement has not yet been revealed.
Xalkori was granted accelerated approval by the FDA in August 2011 based on data from two early-phase trials that showed between 50% and 61% of 255 patients with ALK-mutant locally advanced or metastatic NSCLC demonstrated an objective tumour response to the drug. Pfizer has also filed a Marketing Authorisation Application (MAA) and is seeking a conditional marketing approval from the European Medicines Agency (EMA) based on the same early-phase data. Xalkori will likely have no problem gaining conditional marketing approval from the EMA following the July 2012 positive opinion from the Committee for Medicinal Products for Human Use (CHMP); this conditional marketing approval must be renewed annually. However, in order to be granted a normal marketing authorisation, Pfizer will need to submit the PFS data from the PROFILE 1007 study. GlobalData expects that the data presented at ESMO 2012 will be adequate to support this filing. The anticipated European approval of Xalkori will further illustrate a global trend towards personalised medicine for the treatment of NSCLC.
Pfizer isn’t the only company looking to score at ESMO. Roche/Genentech will present data that will promote the use of their personalised blockbuster Herceptin (trastuzumab) in patients with early-stage HER2 (human epidermal growth factor receptor 2) positive breast cancer. Herceptin is a therapeutic antibody that kills cancer cells by targeting HER2 and blocking HER2 signalling. This year at ESMO, Roche and the Breast International Group are scheduled to present the final analysis of the Phase III HERA (HERceptin Adjuvant) study. HERA investigated whether one or two years of adjuvant Herceptin treatment impacted the disease-free survival of patients with localised, HER2-positive breast cancer who had completed standard chemotherapy. The final results of this study are unlikely to change whether or not doctors prescribe adjuvant Herceptin; the drug has been approved for this indication in the US since 2008 and in the European Union since 2011. However, the recommended duration of adjuvant Herceptin is currently one year, and the final HERA data could potentially show that two years of Herceptin significantly improves patients’ disease-free survival compared to one year of treatment. If this is the case, this data could have a major impact on the duration that physicians prescribe the drug and, ultimately, increase Herceptin sales.
As competition from Herceptin biosimilars is expected as early as 2015, data supporting two years of adjuvant Herceptin treatment would help Roche maximise its assets while Herceptin is still under patent protection. However, it’s possible that alternative data presented at ESMO may thwart Roche’s plan to increase adjuvant Herceptin sales. The French National Cancer Institute will be presenting data from its own Protocol of Herceptin Adjuvant with Reduced Exposure (PHARE) study. PHARE investigated whether only six months of adjuvant Herceptin was as effective as the currently prescribed full year of treatment in women with localised disease who had completed standard chemotherapy. While the Roche-sponsored study has the potential to increase Herceptin’s revenue, data from the French National Cancer Institute study could prove that a full year of adjuvant Herceptin treatment is unnecessary, sending the drug’s sales downward. To add to the anticipation, both abstracts are slated to be presented back to back in the Presidential Symposium on Monday, October 1. Since the abstracts are embargoed, physicians and investors will have to wait until then to determine the likely impact on Herceptin prescribing patterns and sales.
These are only a few of the many interesting studies scheduled to be presented at ESMO 2012. In addition to clinical data, the conference will host discussions on the direct and indirect economic burdens of cancer in Europe, hereditary cancer and screening protocols, and of course, personalised medicine. GlobalData hopes that between these discussions and the release of new clinical data, ESMO 2012 will be a forum that improves cancer care for patients in Europe and around the globe.