So a little background, BXCL701 is an oral dipeptidyl peptidase and FAP inhibitor in this study, phase two study, we’re combining with pembrolizumab in patients with second-line metastatic pancreatic ductal adenocarcinoma. This regimen is quite well tolerated. BXCL701 is associated with hypotension and anemia. We do start at a lower dose for the first week to exclude patients with low baseline blood pressures to start them at a lower dose but aside from two patients we’ve really been able to treat everybody at the full dose and even at the lower dose nobody’s had any significant issues with hypotension or anemia which is another known side effect of BXCL701 ...
So a little background, BXCL701 is an oral dipeptidyl peptidase and FAP inhibitor in this study, phase two study, we’re combining with pembrolizumab in patients with second-line metastatic pancreatic ductal adenocarcinoma. This regimen is quite well tolerated. BXCL701 is associated with hypotension and anemia. We do start at a lower dose for the first week to exclude patients with low baseline blood pressures to start them at a lower dose but aside from two patients we’ve really been able to treat everybody at the full dose and even at the lower dose nobody’s had any significant issues with hypotension or anemia which is another known side effect of BXCL701 . One side effect we have seen in two patients who were treated for beyond six months was immune-related arthralgias and arthritis one of whom did require corticosteroids the other did not but otherwise we haven’t seen significant adverse events the regimen’s been quite well tolerated, and normal side effects that one would see with drugs like pembrolizumab. The goal of this study, the primary objective was disease stability, so progression-free survival at 18 weeks, so the second nine-week scan. We’re also incorporating pre- and on-treatment biopsies to do a lot of correlative science associated with this study. We’ve seen that four out of 16 evaluable patients have had stable disease or better at the 18-week scan for its assignment two-stage design so we’re aiming to have at least seven out of the first 19 available patients. Of the patients we’ve analyzed who are available so far the response rate’s been 17 percent. One of those patients was MSI high so the MSS response rate is 12 percent with a disease control rate around 40 percent. So this has been you know quite striking in a patient population where we don’t expect to see you know really much activity of Pembrolizumab by itself including three patients who have had stable disease or or better for six months or beyond. Median progression-free survival is 2.3 months overall survival not yet reached. Again, this is an actively ongoing study where we’re also hoping to gain a lot from the cohort of scientific analysis.
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