TROPHY-U-01: A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Metastatic Urothelial Carcinoma Progressing After Platinum-Based Chemotherapy and Checkpoint Inhibitors

Author:

Tagawa Scott T.1ORCID,Balar Arjun V.2,Petrylak Daniel P.3ORCID,Kalebasty Arash Rezazadeh4ORCID,Loriot Yohann5,Fléchon Aude6,Jain Rohit K.7,Agarwal Neeraj8ORCID,Bupathi Manojkumar9,Barthelemy Philippe10,Beuzeboc Philippe11,Palmbos Phillip12,Kyriakopoulos Christos E.13ORCID,Pouessel Damien14,Sternberg Cora N.1ORCID,Hong Quan15,Goswami Trishna15,Itri Loretta M.15,Grivas Petros16ORCID

Affiliation:

1. Weill Cornell Medicine, New York, NY

2. Perlmutter Cancer Center at NYU Langone Health, New York, NY

3. Smilow Cancer Center, Yale School of Medicine, New Haven, CT

4. Norton Cancer Institute, Louisville, KY

5. Institut de Cancérologie Gustave Roussy, Villejuif, France

6. Centre Léon Bérard, Lyon, France

7. H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL

8. Huntsman Cancer Hospital, Salt Lake City, UT

9. Rocky Mountain Cancer Centers, Littleton, CO

10. Hôpitaux Universitaires de Strasbourg/Institut de Cancérologie Strasbourg Europe, Strasbourg, France

11. Hôpital Foch, Suresnes, France

12. University of Michigan Comprehensive Cancer Center, Ann Arbor, MI

13. University of Wisconsin Carbone Cancer Center, Madison, WI

14. Institut Claudius Regaud/Cancer Comprehensive Center, IUCT, Toulouse, France

15. Immunomedics, a subsidiary of Gilead Sciences, Inc, Morris Plains, NJ

16. Fred Hutchinson Cancer Research Center, University of Washington, Seattle Cancer Care Alliance, Seattle, WA

Abstract

PURPOSE Patients with metastatic urothelial carcinoma (mUC) who progress on platinum-based combination chemotherapy (PLT) and checkpoint inhibitors (CPIs) have limited options that offer objective response rates (ORRs) of approximately 10% with a median overall survival (OS) of 7-8 months. Sacituzumab govitecan (SG) is a TROP-2–directed antibody-drug conjugate with an SN-38 payload that has shown preliminary activity in mUC. METHODS TROPHY-U-01 (ClinicalTrials.gov identifier: NCT03547973 ) is a multicohort, open-label, phase II, registrational study. Cohort 1 includes patients with locally advanced or unresectable or mUC who had progressed after prior PLT and CPI. Patients received SG 10 mg/kg on days 1 and 8 of 21-day cycles. The primary outcome was centrally reviewed ORR; secondary outcomes were progression-free survival, OS, duration of response, and safety. RESULTS Cohort 1 included 113 patients (78% men; median age, 66 years; 66.4% visceral metastases; median of three [range, 1-8] prior therapies). At a median follow-up of 9.1 months, the ORR was 27% (31 of 113; 95% CI, 19.5 to 36.6); 77% had decrease in measurable disease. Median duration of response was 7.2 months (95% CI, 4.7 to 8.6 months), with median progression-free survival and OS of 5.4 months (95% CI, 3.5 to 7.2 months) and 10.9 months (95% CI, 9.0 to 13.8 months), respectively. Key grade ≥ 3 treatment-related adverse events included neutropenia (35%), leukopenia (18%), anemia (14%), diarrhea (10%), and febrile neutropenia (10%), with 6% discontinuing treatment because of treatment-related adverse events. CONCLUSION SG is an active drug with a manageable safety profile with most common toxicities of neutropenia and diarrhea. SG has notable efficacy compared with historical controls in pretreated mUC that has progressed on both prior PLT regimens and CPI. The results from this study supported accelerated approval of SG in this population.

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

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