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Sacituzumab Govitecan Plus Pembrolizumab Proves Active In Advanced Urothelial Carcinoma – Renal And Urology News –

Sacituzumab govitecan and pembrolizumab can produce a “high response rate” in patients with advanced urothelial carcinoma previously treated with platinum-based chemotherapy, according to researchers.

These results come from cohort 3 of the TROPHY-U-01 trial ( identifier: NCT03547973) and were published in the Journal of Clinical Oncology.

The phase 2 TROPHY-U-01 trial was designed to assess sacituzumab govitecan, given alone or in combinations, in patients with locally advanced or metastatic urothelial carcinoma.

Cohort 3 enrolled patients whose disease progressed after they received platinum-based chemotherapy in the advanced/metastatic setting or within 12 months of receiving platinum-based chemotherapy in the (neo)adjuvant setting. Patients had not received prior treatment with an immune checkpoint inhibitor.

The 41 patients in this cohort had a median age of 67 years (range, 46-86), 83% were men, and 78% had metastatic disease. Patients had received 1 to 2 prior treatment regimens. All had received prior platinum-based chemotherapy (71% cisplatin and 29% carboplatin), and 41% had received prior (neo)adjuvant therapy.

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On study, the patients received sacituzumab govitecan at 10 mg/kg on days 1 and 8 and pembrolizumab at 200 mg on day 1 of each 21-day cycle. Patients were treated until disease progression, unacceptable toxicity, or withdrawal of consent.

The median follow-up was 14.8 months, and the median treatment duration was 5.1 months. Patients received a median of 8 cycles (range, 1-32) and 15 doses (range, 2-63) of sacituzumab govitecan.

The objective response rate was 41%. Eight patients had a complete response, and 9 patients had a partial response. Nine patients had stable disease, and 10 had progressive disease. Responses were generally similar across subgroups.

The median duration of response was 11.1 months. The median progression-free survival was 5.3 months, and the median overall survival was 12.7 months.

“Despite inherent differences in the trial design and baseline patient and disease characteristics, these results compare favorably with historical data in the post-platinum setting, including KEYNOTE-045, CheckMate 275, and JAVELIN 100 Bladder Solid Tumor studies,” the researchers wrote.

All patients in cohort 3 experienced treatment-related adverse events (TRAEs). The most common TRAEs were diarrhea (71%), nausea (56%), neutropenia (51%), anemia (49%), asthenia (41%), alopecia (39%), fatigue (32%), vomiting (29%), decreased appetite (29%), leukopenia (27%), pruritus (24%), stomatitis (17%), and hypomagnesemia (17%).

The rate of grade 3 or higher TRAES was 61%. The most common grade 3 or higher TREAs were neutropenia (37%), diarrhea (20%), leukopenia (20%), anemia (17%), febrile neutropenia (10%), nausea (7%), fatigue (7%), asthenia (7%), decreased appetite (5%), and pneumonitis (5%). There were no treatment-related deaths.

The researchers concluded that the “high response rate” and “overall manageable toxicity profile” of sacituzumab govitecan and pembrolizumab “support further evaluation” of sacituzumab govitecan with an immune checkpoint inhibitor in advanced urothelial carcinoma.

Disclosures: This research was supported by Gilead Sciences, Inc. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.

This article originally appeared on Cancer Therapy Advisor