Trial of DS-6000a Elicits Early Efficacy/Safety Data in RCC and Ovarian Cancer

Erika P. Hamilton, MD, lead investigator and director of the Breast and Gynecologic Cancer Research Program at the Sarah Cannon Research Institute/Tennessee Oncology, discusses the findings from a phase 1 trial of DS-6000a in patients with advanced renal cell carcinoma (RCC) and ovarian cancer (NCT04707248).

Interim data from the trial showed there to be acceptable tolerability and early signals of efficacy in heavily pretreated individuals with advanced RCC and ovarian cancer. These findings were presented at the 2022 American Society of Clinical Oncology Annual Meeting.

Nineteen patients had treatment-emergent adverse events (TEAEs), including fatigue (45.5%), nausea (45.5%), and vomiting (27.3%). There were grade 3 or greater TEAEs observed in 4 patients (18.2%) and the most frequent was neutropenia (13.6%). Grade 3 febrile neutropenia was observed in 1 patient and 1 dose-limiting toxicity of grade 4 thrombocytopenia (9.6 mg/kg) also occurred.

Transcription:

0:08 | We saw that nausea, vomiting and fatigue are the most common side effects, but there were no cases of nausea, vomiting, or fatigue that were grade 3 or greater, meaning that although they were common side effects, they tended to be quite mild. Of our patients that were evaluable, there were 20, and we saw 6 partial responses, 4 that were confirmed, and 2 that were unconfirmed as of this safety data cutoff.

0:35 | We also looked at a tumor marker that we check often in our patients with ovarian carcinoma called CA 125. A lot of times the CA 125 decrease of half or more can be really meaningful for us and for patients kind of regardless of how much shrinkage we get on scans. What we saw was that 8 of our 17 patients evaluable for CA 125 had a decrease of at least 50% while on study. A lot of these actually had stable disease as their best response. Although their tumors hadn't shrunk substantially yet, they had drops in their CA 125 of at least 50%.