Just last week I reviewed the favorable results in a randomized phase II clinical trial with the novel vascular-targeting immunotherapy bavituximab, which was associated with an approximate doubling of median overall survival when added to Taxotere (docetaxel) and compared with Taxotere alone, along with a much more modest improvement in response rate and progression-free survival. I also noted that we should be cautious about “irrational exuberance” about these still preliminary phase II data and suggested we need to wait until a much larger phase III trial is completed before concluding that these data will represent a major step forward.
Hmm….about that…I didn’t think the reminder to be skeptical would come in under a week, but this morning Peregrine Pharmaceuticals, who sponsored the trial with bavituximab, put out a press release that acknowledged “major discrepancies in treatment group coding”. That’s ambiguous, and there’s really no detail about what this means, but Peregrine highlights that these errors were made by the research oversight team in charge of the phase II trial, rather than Peregrine, and that they were blinded to this information, but they also note that “investors should not rely on clinical data disclosed” at the time of the presentation of the trial results at the Chicago lung cancer meeting. How did investors respond? Peregrine Pharmaceuticals (PPHM) is currently down 76% for the day.
Last week I argued that the favorable data didn’t mean that bavituximab was a miracle, but by the same token, I think that now that the tables have turned, there’s still reason to have hope that it can be beneficial, even if not miraculous, for patients. I don’t want to throw out that baby with the bathwater here. We definitely need to learn the extent of the “discrepancies” and whether the results completely compromised the data. If so, we’re left with bavituximab and clinical research being tainted, and no real information about whether this agent can truly help patients.
What do you think of this disclosure? Does it shake your confidence in the clinical research enterprise? Do you feel manipulated by the fast turns in the story, from oncology darling to scorned lover? To put it in immediate terms, would you participate in the phase III trial with bavituximab, or have you lost faith?