March 18, 2010 A tale of two trials for Abraxis and Human Genome Sciences lung cancer data Lisa Urquhart The difficult nature of coming up with effective treatments for lung cancer was neatly demonstrated this week by the varying fortunes of Abraxis BioScience and Human Genome Sciences. Abraxis saw its shares rise by 30% yesterday after the Los Angeles-based group announced positive, if very detail light, phase III results for its lead product Abraxane in advanced non-small cell lung cancer (NSCLC), an event analysts believe could add an additional $500m to sales of the product. Conversely, HGS was not so lucky with its phase II trial of monoclonal antibody HGS-ETR1 (mapatumumab), which failed to show either any benefit in disease response or progression free survival when combined with paclitaxel and carboplatin. Tough nut to crack But the mixed fortunes of the two groups is to be expected given the nature of advanced lung cancer, which has meant that few approved treatments extend overall survival beyond the usual 10 months achieved using standard chemotherapy products. Even the mighty Avastin, which has proved successful in other cancers in pushing out overall survival, has only shown a two-month advantage over standard chemotherapy in this disease. But this has still been enough to hand the drug approximately $1.8bn in sales for NSCLC, analysts believe. The paucity of treatments in the space is due to the high failure rate in lung cancer due both to the very aggressive nature of the disease and the difficulty in getting positive results in trials where the primary end point is overall survival. Recently some of the more prominent developmental scalps have included Pfizer’s figitumumab, trials of which were halted in December after failing to show any improvement in overall survival rates, and the spectacular failure of Novelos’ NOV-002 (Failure of Novelos’ lead drug proves talk is cheap, February 25, 2010). As such the market reaction to the Abraxane data is not surprising. Riding high Fortunately for HGS, expectations for HGS-ETR1 were low, with investors and analysts alike still focusing on the group’s lupus treatment Benlysta. Shares in HGS only finished the day 1% lower at $31.24. For Abraxis, however, the result that showed Abraxane combined with carboplatin was superior to Taxol plus carboplatin in terms of overall response rate pushed the shares to an 11-month high of $52. A more detailed analysis of the results is expected at this year’s Asco conference in June. What the results of the trial might also do is make former partner AstraZeneca regret its decision to hand back rights to the drug in 2008, following what the UK group saw as a disappointing return on its $200m investment in Abraxane over five and a half years, in return for a 22% share of sales (Abraxis and AstraZeneca set to part ways over Abraxane,November 25, 2008). Upgrades If the drug continues to perform well in trials and does eventually get approval, then the $714m in sales by 2014 being forecast by Merriman Curhan Ford could be easily surpassed and upgrades could follow these results. Additionally, Abraxane’s apparent success in NSCLC is bound to give hope that the drug will be equally as efficacious in the various other indications where it is in phase III studies, which include: melanoma, ovarian cancer, prostate and pancreatic cancer, which could add further upside. It is currently approved to treat metastatic breast cancer. Abraxis, which had previously agreed its trial design with the FDA, is now planning on filing a supplemental NDA for Abraxane in NSCLC next year, and if successful it would be the second approved indication for the drug in the US and more importantly a much needed alternative treatment for lung cancer sufferers. More from Evaluate Vantage Evaluate HQ 44-(0)20-7377-0800 Evaluate Americas +1-617-573-9450 Evaluate APAC +81-(0)80-1164-4754 © Copyright 2021 Evaluate Ltd..