ESMO 2025 | ASPEN-03: evorpacept & pembrolizumab in unresectable, PD-L1+ R/M HNSCC

So the ASPEN-03 trial was a study of the anti-CD47 antibody. So this is an Fc-disabled anti-CD47 that tries to block the don’t-eat-me signal on cancer cells and which also tries to increase DC, dendritic cell-mediated T cell activation. So in the ASPIN-03 study, we asked the question, could we combine an anti-CD47 antibody called evorpacept with pembrolizumab and to compare that with the standard of care single agent pembrolizumab that came from the KEYNOTE048 study from 2019. So in this study, we took patients in the first-line treatment setting who had relapsed and or metastatic disease and randomized them between either pembrolizumab plus evorpacept or pembrolizumab. So again, in about 150 patients, randomized two to one, we gave these two therapies. We saw that there was no difference in terms of response rate because the comparator here was again the historical control coming from the keynote 048 data set. We saw no improvement with evorpacept plus pembrolizumab compared with the standard of care from that regimen. The inter-arm comparison showed that there was numerically greater number of responses in the evorpacept plus pembrolizumabarm, but it did not reach statistical significance. The combination was safe. There were additional toxicities, but they were manageable and no significant new safety signal was seen. But regrettably, because the study failed to meet its primary endpoint, the decision has been taken not to develop evorpacept further in this context.

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