Currently, the choice of biologics in the personalised setting are anti-EGFR or anti-VEGF therapy.
Previous studies suggested inconsistent results so in the clinical practice setting we don’t draw any
conclusions about what are optimal biologics in the first line setting. So looking at the US
circumstances, bevacizumab is more used in the first line setting over anti-EGFR therapy but a
previous study suggested anti-EGFR is more sensitive in the RAS wild-type left sided tumours. Based
on that data we started a paradigm study with RAS wild-type left sided tumours in the first line setting.
The paradigm study is a first, prospective study to test the superiority of panitumumab over
bevacizumab in combination with a modified FOLFOX6 treatment for the personalised setting for this
patient population. The primary endpoint is overall survival in the left sided population, defined as
descending colon, sigmoid colon, rectosigmoid or rectal.
The findings in this study for the primary endpoint show panitumumab has demonstrated superiority in
the overall survival over bevacizumab with a hazard ratio of around 0.80. So I believe that this has
statistical significance. This trial showed the primary endpoint was met.
This study also was conducted in a hierarchical way and the second primary endpoint, overall survival
in the overall population, defined as left and right sided primary tumour both. We conducted a
statistical analysis showing superiority of overall survival in panitumumab over bevacizumab in the
overall population as well.
So these are the two key findings and there are also additional key findings shown here that the R0
curative resection rate by treatment panitumumab is better than bevacizumab, the average score is
80% versus 10% respectively. So I believe that the panitumumab patients who were allocated
panitumumab plus modified FOLFOX6 have the chance of a cure, [INAUDIBLE] compared to the
bevacizumab allocated patients.
Adverse events, first of all I want to say that no unexpected signal was observed in this study in both
arms. However, acne-like dermatitis, stomatitis, paronychia, hypomagnesaemia, [INAUDIBLE] were higher
with panitumumab than bevacizumab. But I believe that [INAUDIBLE] balancing between efficacy and
safety, I still believe that efficacy over safety. So I believe that [INAUDIBLE] panitumumab FOLFOX is the
most promising treatment so far from now.
The take-away message from me is that this study suggested panitumumab plus modified FOLFOX6
is a new standard of care clinically over bevacizumab plus modified FOLFOX6 in patients with RAS
wild-type left sided primary tumours. It’s my message, that.