Talk clinical trial results to me Sangijuelas9 Nov 2021 20:33
0518 + Keytruda (the big one)
132 patients in the phase 1/2 study should be able to show a statistically significance improvement vs keytruda alone as well as a good safety profile.
Given the extensive use of keytruda in oncology, I believe any statistically significant improvement in anti-tumour effects vs keytruda alone would cause an incredible re-rate.
The primary endpoints of the trial relate to safety (As phase 1/2) but the secondary end point (efficacy) is where the money is.
To put a number on it, 30% enhancement in performance of standard anti-tumour measures, would in my opinion ensure accelerated progression to approval and revolutionise the standard of care.
0518 + radiology vs pancreatic cancer
This being a P1 trial of only 15 people, we are looking to see that the biotheraputic is well tolerated with clear examples of patients who look to have benefited compared to standard of care.
Given the extremely high mortality rate in pancreatic cancer, we will notice this improvement in survival time and time with no progression of disease.
Asthma -
As someone who had poorly managed childhood asthma I am very interested in this one.
The p1 top line will I expect focus on safety and grounds for completing the remainder of the trial.
Given that treatment of asthma is usually measured on a self identification scale, the comparison to the placebo arm will be critical.