Paul G. Richardson, MD: In terms of patients with different characteristics entering the trial, it’s important to note that we were able to enroll 25 patients who were over 75 years of age in the trial, recognizing that this is a particularly vulnerable subgroup. It’s important to note that the baseline characteristics for this group were very similar to the group overall in terms of prior treatment characteristics. It’s important to also note that the adverse-effect profile we saw in our older patients was very similar to that seen more broadly. There were no specific adverse effects that stood out in the older-patient group.
It’s important to note that there were no treatment-related deaths. It’s also important to note that we had relatively low rates of infection. Very importantly, we did see myelosuppression with low blood counts and low platelet counts. There were very few incidences of any kind of bleeding and no serious bleeding events that were considered related. Very importantly, febrile neutropenia occurred in only a small minority of patients. With that in mind, there is also no alopecia or mucositis seen with melflufen, which is another advantage for it.
While myelosuppression is real, the important message is that serious adverse events were relatively uncommon. In the older population, they were similarly consistent with what we saw. Specifically, rates of pneumonia were around 16% for the study group overall. In the older population, these were relatively uncommon as well, which was great to see.
What’s also very important to note is that the response rates seen in the older population were also quite nice. Our overall response rate in patients age 75 years and older was 32%, including 4 patients with very good partial response. That was quite nice to see. In this older population, the median overall survival was 13.6 months, which was quite nice to see compared with other subgroups within the study.
Transcript Edited for Clarity