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Oncolytics Biotech, Inc. Message Board

  • carrivechio carrivechio Mar 1, 2013 3:45 PM Flag

    PFS data vs OS data - ONCY confident in finalizing the H&N Phase III trial without PFS peak

    When ONCY initially announced that the company would be using PFS to determine whether it would be moving into the second part of the H&N Phase IIII, ONCY made it clear that overall patient survival (OS) was the primary endpoint in this trial.

    Now that ONCY has decided that PFS data would not be needed to be viewed, may I be so bold to suggest that ONCY has seen enough results to turn confident enough to move straight on to obtaining the OS data which will be used in the filing of the BLA. ONCY's recent move appears evident enough to conclude that ONCY did not need to see the PFS data before they made their decision to move straight through to satisfying the primary endpoint of the H&N Phase III, which is overall survival (OS).

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    • so so sad.

    • MC answered this question last week. They are waiting for OS data and not using PFS as a proxy for OS based on the trial split they announced in December. So MC gave the concrete answer last week - waiting for OS now. Once OS data is published, then it should be off to the races. Since it will be at least another month or two until OS stabilizes (and potentially 4 or more months), expect to see the short bashing take off again like we saw today.

      Sentiment: Hold

    • Frankly, that's the last straw that I am holding onto, but from what I have read there doesn't seem to be an answer forthcoming from the company with its intentions. Why is there no concrete answer on this?

      • 1 Reply to amy_locator1
      • ONCY's intentions are quite clear. Listen to Matt Coffey's comments during the February 26th RBC Capital Markets Healthcare Conference.

        [Matt Coffey:]

        {11:30} Now it’s interesting we looked at early tumor changes, and at 6 weeks what we wanted to determine is where the virus was having the most effect in terms of percentage of patients responding,
        as well as magnitude of response, and it was competing better on the test arm of 6 weeks, than the
        control overall, but it was very dramatic on the metastatic disease. We actually reached statistical
        significance with close to 30 to 40% increase in the percentage of patients without shrinkage and
        magnitude of response at 6 weeks was about 14%. Now this isn’t a clinical endpoint, what it is, is a
        scientific endpoint to tell us where those responses are the best. And we had 105 patients with
        metastatic disease that we could really look at and see was disease in the liver really doing as well as
        disease in the lungs and lymph nodes. Now H&N cancer a lot of it moves to the lung. We had 55
        patients, and by cutting the sample size in half, we actually improved the p value. So what we’re seeing
        is very dramatic responses in disease that’s moving to the lung. There were only 19 patients with liver
        metastasis, but there the p value is .08 It’s very very striking. "

        {13:50} When we went back and looked at the squamous cell results in lung it’s the same histology, and all of it is localized to basically lung tissue and some instances lymphatic. And that’s the first study we see objective response rate of 43% and clinical benefit approaching 90%. So we’re able to take a very aggressive disease and basically control it in close to 90% of the instances. And we saw that both in squamous cell non small cell lung as well as non small cell lung and the non squamous pathology. And I think why it does so well is basically we’ve tied what we understand about the molecular biology to the distribution of the agent"

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