Sacituzumab Govitecan in Patients With Relapsed/Refractory Advanced Head and Neck Squamous Cell Carcinoma: Results From the Phase 2 TROPiCS-03 Basket Study.

IF 10 1区医学 Q1 ONCOLOGY

Clinical Cancer Research Pub Date : 2024-12-12 DOI:10.1158/1078-0432.CCR-24-2523

Loren Michel, Antonio Jimeno, Ammar Sukari, J Thaddeus Beck, Joanne Chiu, Elizabeth Ahern, John Hilton, Caroline Even, Sylvie Zanetta, Sabeen Mekan, Jilpa Patel, Tia Wu, Ecaterina E Dumbrava

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引用次数: 0

Abstract

Purpose: Treatment options for advanced head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and a programmed death-1 (PD-1) inhibitor are limited. Trophoblast cell-surface antigen 2 (Trop-2) is highly expressed in HNSCC. Sacituzumab govitecan (SG) is a Trop-2-directed antibody-drug conjugate approved for patients with certain previously treated solid tumors.

Methods: TROPiCS-03 (NCT03964727) is an open-label, multicohort, phase 2 study evaluating SG in advanced solid tumors, including HNSCC. Adults with locally advanced or metastatic HNSCC that progressed following platinum-based chemotherapy and anti-PD-(ligand)1 therapy (given sequentially [either order] or in combination) were administered SG 10 mg/kg on days 1 and 8 of a 21-day cycle. The primary endpoint was investigator-assessed objective response rate (ORR). Secondary endpoints included duration of response (DoR), clinical benefit rate (CBR), progression-free survival (PFS), overall survival (OS), and safety.

Results: Patients (N=43) received a median of 3 (range, 2-9) prior anticancer regimens. ORR was 16% (95% confidence interval [CI], 7-31%), with 7 confirmed partial responses. CBR was 28% (95% CI, 15-44%). Median (95% CI) DoR, PFS, and OS were 4.2 (2.6-not reached), 4.1 (2.6-5.8), and 9.0 (7.1-10.5) months, respectively. The most common treatment-emergent adverse events (TEAEs) were diarrhea (47%), nausea (47%), and neutropenia (47%). Grade ≥3 TEAEs occurred in 58% of patients. Three patients died owing to TEAEs, with one event (septic shock) considered related to SG.

Conclusions: These data demonstrate the clinical potential of Trop-2-directed therapy in managing heavily pretreated patients with advanced HNSCC.

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来源期刊

Clinical Cancer Research 医学-肿瘤学

CiteScore

20.10

自引率

1.70%

发文量

1207

审稿时长

2.1 months

期刊介绍： Clinical Cancer Research is a journal focusing on groundbreaking research in cancer, specifically in the areas where the laboratory and the clinic intersect. Our primary interest lies in clinical trials that investigate novel treatments, accompanied by research on pharmacology, molecular alterations, and biomarkers that can predict response or resistance to these treatments. Furthermore, we prioritize laboratory and animal studies that explore new drugs and targeted agents with the potential to advance to clinical trials. We also encourage research on targetable mechanisms of cancer development, progression, and metastasis.