First Look at SARC-041 Results: Dr. Monty Pal on ASCO26 Plenary Research

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[00:00:14]I'm really excited to discuss with you the results of SARC041.

[00:00:18]This is a phase three randomized double-blind study of abemaciclib versus placebo in patients with advanced dedifferentiated liposarcoma. Now, I think that we would all agree having seen this disease that dedifferentiated liposarcoma is a disease that has very limited systemic therapy options. I really applaud the investigators for taking the approach of looking at targeted therapy in this context.

[00:00:41]Cyclin-dependent kinase 4, CDK4, is actually something that we see that's almost always amplified in this subtype of sarcoma, and therefore I think it really constitutes a rational target.

[00:00:52]SARC041 was a phase three randomized study. The study actually enrolled across nine academic centers throughout the US, and 108 patients in total were subjected to receive either abemaciclib or placebo. Abemaciclib, of course, is a CDK4/6 inhibitor that many of you will be familiar with from use in diseases like breast cancer.

[00:01:12]Now, ultimately, what we saw in this study was a statistically significant improvement in progression-free survival, and this is quite dramatic, 9.67 months versus 1.52 months on the control arm. We also saw an improvement in response rate, about 9% versus no responses on the placebo arm. And in fact, median overall survival is not yet reached on the abemaciclib arm. So, so many points in favor, I think, of consideration of abemaciclib in these settings. And again, congrats to the authors for really forging a new direction in the field of a very rare disease, dedifferentiated liposarcoma.