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NewLink Genetics Corporation Message Board

  • gasmanchad1 gasmanchad1 Nov 17, 2012 7:11 PM Flag

    Abraxane cause of Newlink Selloff?

    I am not surprised that NLNK is having a pullback, but the magnitude is surprising. It is definitely underperforming even other small cap biotech last few weeks. I wonder if it is tied to Celgene's Abraxane having good trial results in its pancreatic cancer treatment trials? I would think since it works by a totally different mechanism (and Abraxane not a cure, only extends survival) that Hyperacute is not really in direct competition. However, maybe other investors think otherwise and this is causing the selloff?

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    • post-rationalization is a funny thing. It could equally be MM's looking for inventory ahead of the event-buyers, who must be circling.

    • Are you being serious? Abraxane's trial (as well as Clovis) was for metastatic pancreatic cancer while NewLink's is for surgically resected pancreatic cancer. Totally different.

    • I think you are right. Newlinks produces an overall survival of 24.1 mos and Abraxane produces 12.2 mos while carrying significant toxicity. Never the less, some dummies will see Dr's chosing the less effective more toxic drug. I think they are wrong and Newlinks will be a real hit.
      "Pancreatic cancer is another matter.
      In late 2011, investigators from Abraxis published results from a single-arm phase I/II study of Abraxane plus gemcitabine in front-line metastatic pancreatic cancer in the Journal of Clinical Oncology. These data showed an impressive 48% overall response rate with median progression-free survival of 7.9 months and***** median overall survival of 12.2 months.****** These data compare favorably to historical results for gemcitabine monotherapy in pancreatic cancer -- progression-free survival of 3.5 months and overall survival in the range of 6-7 months.
      Based on the positive phase I/II data, Celgene initiated a randomized phase III trial of Abraxane plus gemcitabine compared to gemcitabine monotherapy. Originally slated to enroll 630 front-line pancreatic cancer patients, investigators increased the trial's size to 842 patients in the fall of 2010. As far as I can tell, this is the largest clinical trial ever in pancreatic cancer. The primary endpoint is overall survival.
      Even if the combination meaningfully underperforms earlier results in the Phase III study and single-agent gemcitabine outperforms expectations, it seems likely that Abraxane will show a statistically significant, 2-3 month survival benefit over the control group.
      The more challenging questions about Abraxane have to do with the drug's tolerability and whether or not any observed survival benefit will be clinically meaningful. Tarceva was approved in pancreatic cancer but is rarely used because the drug was shown to improve survival by a paltry 12 days over gemcitabine monotherapy.
      Likewise, some physicians suggest that in order for Abraxane to garner widespread use in pancreatic cancer, it will have to outperform FOLFIRINOX, a four-drug chemotherapy regimen.
      It's hard for me to believe that physicians wouldn't consider a 2-3 month survival benefit clinically meaningful, but the concern about the drug's absolute survival seems plausible.
      Let's take a closer look at FOLFIRINOX.
      In the FOLFIRINOX study, 48% of patients survived for one year and median overall survival reached 11.1 months. My "worst reasonable case" estimate -- which excludes outright failure -- is that Abraxane-gemcitabine patients will report a median overall survival of 9.8 months. I think it's more likely that the respective survival duration for Abraxane and FOLFIRINOX will be similar"

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