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Oncolytics Biotech Inc. Message Board

  • nomenome91 nomenome91 Jan 29, 2013 1:36 PM Flag

    PFS data for collorectal on website.

    The poster shows PFS data for Kras patients.

    The PFS for these patients is 7.4 months. This is 154% of the OS (not PFS) for Cetuximab + chemo. They could literally get a tripling of OS realtive to the SOC!!!!!

    This is pretty much a slam dunk.

    Sentiment: Strong Buy

    SortNewest  |  Oldest  |  Most Replied Expand all replies
    • PFS: 5.7 months
      OS: 11.2 months

      These new numbers are likely the ones we have to beat.

      google: fda.gov approved avastin

      Sentiment: Strong Buy

    • I did not make (and do not require) the assumption that you attribute to me. Thanks for your interest.

      rjc

    • Nomenome91 says of Oncolytics’ REO-022 Reo/FOLFIRI patients, that “The PFS for these patients is 7.4 months. This is 154% of the OS (not PFS) for Cetuximab + chemo. They could literally get a tripling of OS relative to the SOC!!!!!’

      The apples/oranges point is (fairly) raised though by futureiznow, that Cetuximab + chemo could perform differently to FOLFIRI.

      I have found an abstract (No. 59) from the Jan 24-26, 2013 ASCO GI Symposium - titled “Survival outcomes in U.S. patients with metastatic colorectal cancer (mCRC)” (see below for text). It reports on 1,066 patients , where “The most common 1L, 2L, and 3L regimens were FOLFOX plus bevacizumab (34.52%), FOLFIRI plus bevacizumab (21.83%), and irinotecan plus cetuximab (15.83%)”. While still not a perfect match, this one might be more representative.

      The results are expressed in the “Survival Outcomes” abstract as median OS from first diagnosis, so I have turned them into the easier to read median OS from the start of (1st, 2nd, or 3rd line) treatment. Here’s what we see …

      =-=-=-=-=-=-=-=-=-=-=-=-=-=-
      - 3.31 months median from diagnosis to 1st line treatment
      - 32.46 months median OS following start of 1st line treatment
      - 1.36 months median OS following start of 2nd line treatment
      - 0.97 months median OS following start of 3rd line treatment
      =-=-=-=-=-=-=-=-=-=-=-=-=-=-

      Our REO-022 patients are 2nd line patients, and so match with a median OS of 1.36 months from the “Survival Outcomes” abstract. Even if we add in the 3rd line treatment, that only boosts median OS to 1.36 + 0.97 = 2.33 months (well below out median PFS at 7.4 months). With such short median life extension, I get the feeling that these “Survival Outcomes” patients didn’t stop progressing at all on 2nd or 3rd line treatments.

      As to median OS vs median PFS, this means that by the time that our median patient got to the “Survival Outcomes” median date of death (1.36 or 2.33 months), our patient hadn’t even started to enter progressive disease, and wouldn’t for at least 5 more months.

      There are assumptions made here that probably aren’t valid because the Trials were not identical (and probably for other reasons too); but in my opinion, we are seeing dramatic improvements in REO-022, over the standard of care.

      rjc


      Note: A link to this abstract is available on the oncyV2 board.

      =-=-=-=-=-=-=-=-=-=-=-=-=-=-
      From 2013 ASCO Gastrointestinal Cancers Symposium
      Abstract No: 559 - Survival outcomes in U.S. patients with metastatic colorectal cancer (mCRC).

      Background: The increase in survival seen in recent years in patients with mCRC has been attributed to improvements in treatments, including the introduction of targeted biologic agents. The objectives of this retrospective, observational study are to investigate recent treatment patterns in US mCRC patients and examine real-world survival outcomes.

      Methods: Data were obtained from a large U.S. database (SDI/IMS Health) of mCRC patients diagnosed from January 1, 2004 to June 30, 2011, ≥18 y at diagnosis, and who received chemotherapy and/or biologic treatment. Complete follow-up was defined as those who either died before June 2011 or who had at least 1 claim within 30 days of June 30, 2011. Kaplan-Meier curves were generated to determine overall survival (OS) from the date of mCRC diagnosis.

      Results: 1,066 stage IV mCRC patients with complete follow-up were identified (57.5% male; mean age, 61.6 y). Approximately 80% were diagnosed with mCRC after 2006; 51.7% had liver metastases.

      The most common 1L, 2L, and 3L regimens were FOLFOX plus bevacizumab (34.52%), FOLFIRI plus bevacizumab (21.83%), and irinotecan plus cetuximab (15.83%), respectively. A total of 445 patients died during the study period, yielding a mortality rate of 41.74%.

      Mean time from diagnosis to first treatment was 3.31 months (SD=7.13).

      All patients received 1L therapy; OS from diagnosis was 35.77 months (95% CI: 32.57-38.10); 5-year survival was approximately 28%.

      After 1L, 591/1066 (55%) patients went on to receive 2L therapy; for these patients, median survival from diagnosis was 37.13 months (95% CI: 34.07-40.43) and 5-year survival was approximately 25%.

      After 2L, 278/591 (47%) patients received 3L therapy; for these patients, median survival from diagnosis was 38.10 months (95% CI: 34.83-43.13); 5-year survival was approximately 25%.

      Conclusions: In this study, OS (35.77 months) was longer than for other mCRC observational studies that have reported survival from start of treatment, but is more comparable when the ~3 months from diagnosis to start of treatment are not included. Addition of targeted agents and novel chemotherapy has prolonged OS in mCRC patients. Because of poor 5-year survival rates, the need for additional agents in later lines of therapy still exists.
      =-=-=-=-=-=-=-=-=-=-=-=-=-=-

      • 3 Replies to rjc2827
      • That is a huge cliff from first line to second line!

        32.46months - 1.36months

        That data, if it holds up under a randomized trial, will make it nigh impossible for any right-thinking administrator from blocking Fast Track.

        Sentiment: Strong Buy

      • You make a fundamental error in your "easier to read" segment. You cannot determine the median OS in the second or third line treatments from the data presented. You can only (generally) determine the added longevity. The data say nothing about WHEN the second or third line treatments were initiated. To put in an easier format, docs don't wait until one day before the median survival from first line and then say "quick put him on second line and give him another 1.3 months." That's just like that old henny youngman joke "I went to the doctor and he gave me six months to live but I couldn't pay by then so he gave me another 6 months." At the risk of talking down to guys like armedescape, efficacy will be determined by comparing the trial compound with a control arm, measured from the date of the initiation of treatment.

        Median survival in mCRC is as you point out, more in the 30-33 month range for mCRC, older studies pegged it at 14 months. One thing is certain, nomeme's assertion that median OS is something like 5 months is unlikely to be true. Just as it has proven to be true in the botched H&N trial

      • What I find interesting also is that the randomized Canadian colorectal cancer trial is going for all colorectal not just "Kras mutant". I guess they felt that they have enough information from the Kras mutant trial and other trials (Reo 013 and others) that treated all types of colorectal patients to go for all colorectal patients in the Canadian trial. Setting up to be a challenge to cetuximab maybe ???

    • Median os for metastatic colorectal cancer is 14 mos my friend.

    • Impressive, but apples and oranges.

      Is there any comparable study with Folforinox only data in a similar patient profile?

      Sentiment: Strong Buy

 
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