Updated, 60-month follow-up results from a Neuvax phase II study scheduled for presentation next month at the American Society of Clinical Oncology (ASCO) annual meeting don't appear to be new or consistent with previously reported data.Galena presented the same 60-month NeuVax analysis last December at the San Antonio Breast Cancer Symposium except the numbers are different. Asked to explain the discrepancies between NeuVax data from last December and "new" NeuVax data coming next month at ASCO, Galena spokeswoman Remi Bernarda told me, "I don't have answers from the company at this time." Let's dig into the controversy: The NeuVax research abstract submitted for next month's ASCO meeting -- posted on May 16 -- describes a subset of 53 patients from the phase II trial (187 patients were enrolled overall) who were "optimally dosed" with booster shots every six months following an initial set of six monthly injections. The booster shots were designed to enhance or prolong the immunotherapeutic effect of NeuVax. At a median follow up of 60 months, the recurrence rate was 3.8% for the boosted NeuVax patients compared to 18.9% for the study's control group. Recurrence rate refers to the percentage of patients diagnosed with a re-emergence of their breast cancer. A low recurrence rate is preferred for obvious reasons. Conversely, a higher "disease-free survival rate" is also preferred. DFS rate is defined as the percentage of patients still alive without their breast cancer returning. It's easy to switch back and forth between recurrence rate and DFS rate since DFS rate equals 100 minus the recurrence rate. In Galena's ASCO abstract, therefore, the DFS rate for the 53 "optimally dosed" NeuVax patients is 96.2% versus a DFS rate of 81.1% for the control arm patients. Here's where we get to the problem. Last December, Galena presented a poster at the San Antonio Breast Cancer Symposium detailing results from the same 53 breast cancer patients treated with NeuVax booster shots every six months. Galena issued a press release on Dec. 7, 2011 to announce the results, which reads in part: "Of the 53 patients who received at least one booster inoculation, a statistically significant disease-free survival rate of 95.9% was seen versus 79.7% in the control group…" Hmmm. The DFS rate from December's analysis of the 53 "optimally dosed" NeuVax patients is not the same as the DFS rate outlined in the ASCO abstract. How can that be? If Galena is describing the same patient subgroup (and it certainly seems like they are) the numbers should be the same. Perhaps the data in the ASCO abstract is an update of the data presented last December? That's possible, although both reports say the analysis was done at a median follow-up of 60 months. If the ASCO abstract reflects a later, more updated analysis, how is it possible that the NeuVax DFS rate of 96.2% in the ASCO abstract is higher than the NeuVax DFS rate of 95.9% observed in December?
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