Dr Mahvash on the Clinical Impact of the FDA Approval of SIR-Spheres Y-90 Resin Microspheres for Unresectable HCC

“[Patients] can get retreatment [with] Y-90 to maintain their transplant eligibility. [In some] patients, chemo-embolization was not as successful. For the patients [who] are transplant eligible, I think [this approval] is a paradigm shift.”

Armeen Mahvash, MD, an interventional radiologist in the Department of Interventional Radiology in the Division of Diagnostic Imaging at The University of Texas MD Anderson Cancer Center in Houston, discussed the clinical impact of the FDA approval of SIR-Spheres Y-90 resin microspheres for patients with unresectable hepatocellular carcinoma (HCC).

Under the approval, Y-90 is indicated for patients with no macrovascular invasion, Child-Pugh A cirrhosis, well-compensated liver function, and good performance status.

The approval was supported by findings from the prospective, multicenter, open-label, single-arm phase 3 DOORwaY90 trial (NCT04736121), which evaluated the first-line efficacy and safety of Y-90 microspheres in patients with unresectable HCC and well-compensated liver function.

According to Mahvash, treatment with SIR-Spheres produced durable local control and high response rates in this population. Findings from DOORwaY90 showed an objective response rate (ORR) of 98.5%. Notably, no patients experienced tumor progression in the treated liver territory at 1 year of follow-up. These results highlight the capacity of Y-90 radioembolization to achieve sustained disease control in patients who are not candidates for surgical resection.

Additionally, Mahvash emphasized the importance of these findings for patients with HCC awaiting liver transplantation. Because transplant wait times in the United States typically exceed 6 months, maintaining tumor stability during this period is essential, Mahvash noted. Historically, transarterial chemoembolization (TACE) has been the standard bridging therapy; however, Y-90 therapy offers a paradigm shift in this setting, providing prolonged local control, he continued. Additionally, patients who experience recurrence can safely undergo retreatment with Y-90 in an effort to preserve transplant eligibility, Mahvash explained.