Presented is an international, multi-center, open-label, phase 1/2 study in patients with mUC after the failure of anti-PD-1/PD-L1. All patients in the study will receive SG on day 1 and 8 of 21-day cycles until progression or unacceptable toxicity. Cohort 1 includes patients in third-line therapy after platinum-based chemotherapy and anti-PD-1/anti-PD-L1 immunotherapy. Cohort 2 includes patients in second-line therapy, ineligible for cisplatin-based therapy and after anti-PD-1/anti-PD-L1 immunotherapy. CT/MRI scans were obtained at 8-week intervals to assess treatment response.
The primary outcome measures were safety and objective response rate (ORR) by RECIST 1.1. Secondary outcome measures included the duration of response (DOR), progression-free survival (PFS) and overall survival (OS).
The study start date was 2018 and the estimated completion date is 2020; a total of 140 participants are estimated to enroll. The ORR was 14/45 (31%), with 2 complete and 12 partial responses. In patients with visceral involvement, the ORR was 9/33 (27%). The ORR in immunotherapy-treated patients was 4/17 (23%). Median PFS and OS were 7.3 months and 18.9 months respectively. The adverse events profile was consistent with prior reports as summarized below.
![UroTodayASCOGU2019 IMMU 132](/images/UroTodayASCOGU2019-IMMU-132_.png)
In conclusion, in preliminary studies, SG demonstrated clinical activity in patients with relapsed/refractory mUC including those previously treated with immunotherapy (check-point inhibitors) and those with visceral metastases.
Presented by: Scott T. Tagawa, MD, MS, Weill Cornell Medicine, New York, New York
Written by: Selma Masic, MD, Urologic Oncology Fellow (SUO), Fox Chase Cancer Center, @selmasic at the 2019 American Society of Clinical Oncology Genitourinary Cancers Symposium, (ASCO GU) #GU19, February 14-16, 2019 - San Francisco, CA