1) SWOG 1801 did not test a sandwich scheme of nivo but of pembro
2) there pooled analyses and a small randomized phase 2 trial that indicated that neoadjuvant ipi+nivo induces higher MPR rates (60 vs 30%), which is a very strong surrogate marker for long-term outcome after neoadjuvant checkpoint inhibition (see 3y and 5y updates from OpACIN, OpACIN-neo and PRADO); the pooled analyses from the INMC (Menzies et al) showed also a better EFS for the combination as compared to aPD-1 monotherapy
3) adjuvant therapy in non responders improved the RFS from about 33% to > 60% in a pooled analysis (see Reijers et al ASCO 2023)
4) the data here presented are indeed early, but are due to meeting the pre-defined p value, the final EFS data, that needed to be directly presented in my view (to prevent going on comparing novel neoadjuvant combinations to adjuvant nivo or pembro (that have no OS benefit even after >5-7 years FU)
5) I never argued for amending all current trials towards the NADINA scheme, but to neoadjuvant (please check my ASCO comment thoroughly)
6) OS data will come in two years (also stated in the ASCO presentation)
7) toxicity is indeed higher but the quality of life is identical to adjuvant nivo (also presented at ASCO and also mentioned in my presentation) - why do you ignore that fact, and only mention the physicians view, and not the patient's view?
8) I am more than happy to proceed with the scientific discussion with you and are looking forward to your comments on my comments
My comments on your comments on NADINA:
1) SWOG 1801 did not test a sandwich scheme of nivo but of pembro
2) there pooled analyses and a small randomized phase 2 trial that indicated that neoadjuvant ipi+nivo induces higher MPR rates (60 vs 30%), which is a very strong surrogate marker for long-term outcome after neoadjuvant checkpoint inhibition (see 3y and 5y updates from OpACIN, OpACIN-neo and PRADO); the pooled analyses from the INMC (Menzies et al) showed also a better EFS for the combination as compared to aPD-1 monotherapy
3) adjuvant therapy in non responders improved the RFS from about 33% to > 60% in a pooled analysis (see Reijers et al ASCO 2023)
4) the data here presented are indeed early, but are due to meeting the pre-defined p value, the final EFS data, that needed to be directly presented in my view (to prevent going on comparing novel neoadjuvant combinations to adjuvant nivo or pembro (that have no OS benefit even after >5-7 years FU)
5) I never argued for amending all current trials towards the NADINA scheme, but to neoadjuvant (please check my ASCO comment thoroughly)
6) OS data will come in two years (also stated in the ASCO presentation)
7) toxicity is indeed higher but the quality of life is identical to adjuvant nivo (also presented at ASCO and also mentioned in my presentation) - why do you ignore that fact, and only mention the physicians view, and not the patient's view?
8) I am more than happy to proceed with the scientific discussion with you and are looking forward to your comments on my comments
Greetings
Christian Blank
Disappointing that they haven't replied to your comments.