* Avastin shows promising trend in trial but not significant
* Scientific abstract had reported statistical significance
* Good Phase I results with new gene-targeted drug PLX4032
By Ben Hirschler
BERLIN, Sept 23 Roche's ROG.VX drug Avastin
missed its goal in a keenly watched melanoma study, confounding
initial expectations, researchers said on Wednesday.
There was an encouraging trend suggesting patients with the
notoriously difficult-to-treat cancer of the skin did better
when given Avastin in addition to chemotherapy, but it was not
A late-breaking abstract from the ECCO-ESMO cancer congress
in Berlin had earlier said the drug was the first ever in
melanoma to show a meaningful improvement in overall survival,
raising hopes of a breakthrough. [ID:nLL728528]
But a last-minute review of the clinical data changed the
outcome and researchers said the Phase II study in fact failed
to meet its primary goal of proving that Avastin extended the
time melanoma patients lived without their disease progressing.
It also failed to show a statistically significant increase
in overall survival.
Despite the disappointment, principal investigator Steven
O'Day of the Angeles Clinic and Research Institute in California
said the data collected on Avastin were "very encouraging and
warrant continued investigation".
The 214-patient study found the median overall survival in
the Avastin arm was 12.3 months, against 9.2 months in the
control arm, but there was a 19 percent likelihood that this
result happened by chance.
To prove statistical significance, clinical trials require a
5 percent or less likelihood that a finding is due to chance.
On the plus side, researchers also announced early-stage
results from a Phase I trial with a different drug, called
PLX4032, which produced impressive results in a sub-set of
melanoma patients with a particular gene mutation.
Roche is developing the new gene-targeted drug with
privately-held U.S. biotech company Plexxikon.