Many good news (accelerated approval, impressive tumor response rates, strong pipeline fill-up, reasonable attrition rate) for the complex antibody-drug conjugate technology, but final technological, clinical and comercial validation needed
SITGES, Spain | September 19, 2011 | The Business Intelligence firm La Merie S.L. analysed antibody-drug conjugate technologies, stakeholders and the R&D Pipeline of 23 active clinical stage, 11 discontinued clinical stage, 7 close to phase I and 20 preclinical stage ADC compounds. The recent accelerated approval of Seattle Genetics’ antibody-drug conjugate (ADC) Adcetris based on stunning tumor response rates raised great enthusiasm among stakeholders in this field. Analysts expect strong sales of the expensive therapy. However, the FDA requests post-approval studies showing that the high response rates translate into improved survival and that the clinical benefit seen in a small study population can be confirmed in a larger population – Pfizer’s Mylotarg failed to show such a survival benefit. Genentech will be the next company to come up with survival data of its solid tumor ADC trastuzumab emtansine expected for 2012-2014. So far, only two controlled studies with ADC compounds have been published: one with Mylotarg failed to show a survival benefit, but T-DM1 pleased with an improved safety profile versus the combination of naked antibody with systemic chemotherapy.
Results of early stage clinical trials of a number of ADC projects promise anti-tumor activity in hematologic malignancies as well as in solid tumors, but also dose-limiting toxicities which still narrow the therapeutic window for the currently used drugs and linkers. Nevertheless, about half of the currently clinical stage ADC projects entered clinical development within the last year indicating a high interest in the industry which also is reflected by the numerous licensing deals of the technology providers with pharmaceutical and biotech companies. The attrition rate of ADC development projects so far is well within the rate in oncology, or even better. However, ADC technologies still can be improved and candidates are emerging but need more time for validation and maturation. These results and more were found in the search conducted by La Merie. The report can be acquired at La Merie’s online store (www.pipelinereview.com).
The report “Antibody-Drug Conjugates 2011 – real breakthrough still to come: A Technology, Stakeholder and R&D Pipeline Analysis” published in September 2011 provides the most complete compilation of information about antibody-drug conjugate (ADC) companies, technologies and products in R&D. A comprehensive analysis of the state of the art and key trends guides the reader through this complex subject. Stakeholders in the field of antibody-drug conjugates are analysed and their contribution to the growth of ADC technology and products is assessed. A critical appraisal of the clinical results of active and discontinued ADC projects and products is provided. ADC technologies and products are challenged for their commercial value and growth potential.
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PipelineReview.com is the News Center and Online Store of La Merie Business Intelligence focused on Research and Development in the Biopharmaceutical Industry. For more information visit www.pipelinereview.com.