It's been an interesting weekend in Milan at the European Society of Medical Oncology (ESMO) meeting and rather than cover the same news as everyone else based on the press briefings, I'm going to take a slightly different slant in my roundup today and tomorrow.
In the past, the ESMO meeting has sadly been used as a dumping ground for negative data as it is less likely to draw as much attention as say, making the same announcement at it's big sister, ASCO. This year was different though, with quite a few companies announcing positive data, which was nice to hear.
I thought this was a good sign until I noticed in the small print that they were mainly small phase II trials. Many of us know that it's very hard to extrapolate 30-100 patients to a broader universe, as we have seen with the very high attrition rate in phase III cancer trials over the last 18 months, often despite promising earlier data. A single arm, single agent study in a small sample also tends to have some element of bias compared with a randomised, blinded and well controlled trial in a 1,000 plus patients.
What this means is that what was once a positive efficacy signal has all but disappeared over time with larger patient cohorts free of investigator bias. It would therefore be fairer, and more accurate, to say that these studies are "early, but promising" or something similar.
Instead, we get bombarded with screaming headlines.
Ok, I understand CEO's want to maintain their share of voice and keep the positive data coming to drive the share price, but really, part of me wants to wince or cringe and say that perhaps a little circumspection goes a long way. It may be more realistic to say under promising and over delivering is always better than the other way round. These trials are very early.
To paraphrase Jerry McGuire: "Show me the phase III data!"
Then I'll start getting excited and enthusiastic if the results hold up without any excessively nasty toxicities that would make me think twice about taking something.