Reference Detail

Ref Type

PMID

Authors

Y. Loriot, A.V. Balar, D.P. Petrylak, S.T. Tagawa, A. Rezazadeh, A. Fléchon, R. Jain, N. Agarwal, M. Bupathi, P. Barthélémy, P. Beuzeboc, P.L. Palmbos, C.E. Kyriakopoulos, D. Pouessel, C.N. Sternberg, Q. Hong, T. Goswami, L.M. Itri, P. Grivas

Title

LBA24 - TROPHY-U-01 cohort 1 final results: A phase II study of sacituzumab govitecan (SG) in metastatic urothelial cancer (mUC) that has progressed after platinum (PLT) and checkpoint inhibitors (CPI)

Journal	Vol	Issue	Date	Pages	Journal Short Title
Annals of Oncology	31	suppl_4

URL

https://www.annalsofoncology.org/article/S0923-7534(20)42335-X/abstract

Abstract Text

Background Patients with mUC have limited options after progression on PLT/ CPI. SG is an antibody-drug conjugate composed of a humanized IgG1 kappa anti–Trop-2 monoclonal antibody coupled to SN-38 via a unique hydrolyzable linker. TROPHY-U-01 cohort 1 interim results (n=35) reported a 29% objective response rate (ORR). FDA has granted fast track designation for SG (TRODELVY™) in mUC. Methods TROPHY-U-01 (NCT03547973) is a multicohort, global, open-label, phase 2 study evaluating SG clinical activity (10 mg/kg, days 1 and 8 of 21-day cycles) in patients with unresectable locally advanced or mUC with measurable disease, ECOG PS 0–1, and creatinine clearance ≥30 mL/min. Cohort 1 includes patients progressing after PLT and CPI, with unlimited prior lines of therapy. Primary objective was ORR evaluated by RECIST v1.1 via central review; secondary objectives were progression-free survival (PFS), overall survival (OS), duration of response (DOR), and safety. This cohort had a Simon two-stage design with 90% power to reject the null hypothesis of ORR ≤12%. Results 113 patients (78% male; median age 66 y; 72% ECOG PS 1; Bellmunt score 0 [12%],1 [54%], 2 [27%],3 [6%]; 62% with visceral metastases) received a median of 3 prior therapies. Central review confirmed an ORR of 27% (31/113; 95% CI 19–37) with 6 complete responses, 25 partial responses and 25% (95% CI 11.5–43.4) ORR in patients with liver metastases. Median DOR was 5.9 mo (95% CI 4.7–8.6) and clinical benefit rate was 37% (42/113). Median PFS and OS were 5.4 mo (95 %CI 3.5- 6.9) and 10.5 mo (95 %CI 8.2–12.3), respectively. Key grade ≥3 treatment-related adverse events were neutropenia (35%), anemia (14%), febrile neutropenia (10%), and diarrhea (10%). There was no treatment-related grade >2 ocular toxicity, neuropathy or interstitial lung disease. There was 1 treatment-related death (neutropenic sepsis). Conclusions SG demonstrated meaningful efficacy with manageable toxicity. These results confirm interim findings, suggest that SG may be a treatment option for mUC, and support a randomized phase III trial. Clinical trial identification NCT03547973. DOI:https://doi.org/10.1016/j.annonc.2020.08.2253

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Molecular Profile	Treatment Approach

Gene Name	Source	Synonyms	Protein Domains	Gene Description	Gene Role

Therapy Name	Drugs	Efficacy Evidence	Clinical Trials

Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description

Gene	Variant	Impact	Protein Effect	Variant Description	Associated with drug Resistance

Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References