Genitope halts MyVax work, examines future bizjournals.com
... said it will suspend work on its cornerstone personalized
cancer vaccine, MyVax, for follicular non-Hodgkin's lymphoma.
re: This is so very disappointing. In fact,
it sucks. My heart breaks for the patients, Genitope employees,
and investors. It's very deflating for personalized medicine.
does the FDA need an overhaul? What happens to all of the people
who benefited from MyVax? ~ Lynn
Regarding the FDA I think it's very likely that the agency consulted experts
in this area ... and each expert (Longo/Bendandi) that I consulted stated
flatly that FDA could not approve a drug that's failed to meet the primary
endpoint as a matter of precedence and principle.
.... The principle being the legal requirement to show clear and convincing
evidence of clinical benefit before drugs can be licensed for use. The
knock on this study data, as I understand it, being that an immune response
to idiotype would be seen in any patient with immune competence (the ability
to produce antibodies against an antigen) and that this competence following
treatment is a plausible explanation for the longer remissions in the
subset; and that detecting an immune response to idiotype could have been a
marker of immune competence and not a causal factor in the improved outcomes
in the subset. That is, approving MyVax based on *this data* we run the
risk of approving an agent that does not really work. (Which is not the
same as saying the data proves it does not work.)
... The precedence issue is tied to the principle, but speaks to the outcry
that would result from other sponsors if exceptions were made regarding the
level of evidence required to win approval for new therapies.
The sad part, for me, is that Genitope does not appear to have the will or
financial ability to follow through. I like to think if the belief was
strong for MyVax among the principals of Genitope (and experts in the field)
that a way would be found. That is, if the FDA interpretation of the
results was flawed, that the experts would be weighing in on it, and that a
vote of confidence for the MyVax data (yet lacking) would lead to the
capital needed to complete the test of MyVax. (Noting too, that Genitope
could also ask for an advisory board [ODAC] review.)
We had hoped Genitope would be able to extend the follow-up of the same
study to see if a statistically significant difference could emerge with
more time as recommended by Andy (advisor to PAL). For example, if two years from now most
patients in the subset were still free of disease while patients in the
control continue to relapse, the primary endpoint could still be met. ...
I think patients should ask why this is not considered a feasible or
reliable way to determine if MyVax provides clinical benefit; and be
*determined* to get the straight answer.
Also, we should learn why immune competence could account for the better
outcomes *informally reported* in the subset of immune responders within the
vaccine arm of the study. Is there's any data outside this trial that points
to this as a factor that predicts durable remissions in follicular NHL
A final note. It will be important to have the raw data in hand before we
can provide truly informed comment on the FDA interpretation and Genitope's
decision. Hopefully that will be forthcoming soon, as well as comments from experts in the field that address these and other remaining questions.
FDA is bound to confidentiality agreements and thus cannot provide public
comment on their interpretations. I think the answers must first come from
Genitope, starting with the release of the raw data.
~ KarlS (President)