Thanks for this. The sample increase from 30 patients to 50...

Thanks for this. The sample increase from 30 patients to 50 patients is significant.

There are other nuances that are worth mentioning. While the number of evaluable patients hasn't substantially changed (i.e. 10 to 11 patients), the ORR hasn't declined since the SITC 2016 in November. In fact, it has increased slightly from 7/10 (70%) to 8/11 (73%). I think this is particularly important as the responses continue to be sustained and none of the responders appear to have experienced subsequent disease progression.

A quick literature search on other combination studies might be worth mentioning. I might have repeated studies in a past post but still believe it's relevant for comparison. Long et al. (2016) reported a 57% ORR using a combination of Keytruda + Yervoy with a larger sample size though (n=107). Hodi et al. (2016) reported a similar result with 59% ORR (n=95) using Opdivo + Yervoy with a evidence of durable responses. A Phase II trial reported a 61% ORR for a combination study using Opdivo + Yervoy. In all cases, the safety profiles were less than desirable than the CAPRA study.

Clearly there is a disadvantage of the much smaller sample size for the CAPRA study which I think has led to bumping the 30 patients to 50 patients. This is a good move to further legitimise the results in order to compare against the aforementioned studies. The issue now is the speed at which they recruit without compromising research quality - we have all been waiting for quite some time!

This result is good because they have been sustained but the real difference is only an additional evaluable patient. If these results hold or improve further into the study, we are looking at a far superior combination drug against the commercial drugs if solely comparing ORRs above. Both CAPRA and MITCI taken together (with larger sample sizes and continued positive results) will challenge existing combination results in the melanoma space and I expect should boost likelihood of Phase III or commercialisation potential. I have my worries about the MITCI results being temporarily withdrawn as with the lack of detail for the STORM study. I am eagerly waiting for the posters to be released. Nonetheless, it remains promising.