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Sacituzumab Govitecan in Patients with Relapsed/Refractory Advanced Head and Neck Squamous Cell Carcinoma: Results
Loren Michel1, Antonio Jimeno2, Ammar Sukari3
1Memorial Sloan Kettering Cancer Center, New York, New York.
Purpose:
Treatment options for advanced head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based chemotherapy and a 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.
Patients And Methods:
TROPiCS-03 (NCT03964727) is an open-label, multicohort, phase II 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-(L)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 the investigator-assessed objective response rate. Secondary endpoints included duration of response, clinical benefit rate, progression-free survival, overall survival, and safety.
Results:
Patients (N = 43) received a median of 3 (range, 2-9) prior anticancer regimens. The objective response rate was 16% [95% confidence interval (CI), 7%-31%], with seven confirmed partial responses. The clinical benefit rate was 28% (95% CI, 15%-44%). The median (95% CI) duration of response, progression-free survival, and overall survival 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 (TEAE) were diarrhea (47%), nausea (47%), and neutropenia (47%). Grade ≥3 TEAE occurred in 58% of patients. Three patients died from TEAE, 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.
Insights
Sacituzumab govitecan shows promise for advanced head and neck squamous cell carcinoma (HNSCC) patients who have not responded to prior treatments. This Trop-2-directed therapy offers a new option for this difficult-to-treat cancer.
Area of Science:
- Oncology
- Translational Research
- Clinical Trials
Background:
- Advanced head and neck squamous cell carcinoma (HNSCC) has limited treatment options after progression on platinum-based chemotherapy and PD-1 inhibitors.
- Trophoblast cell-surface antigen 2 (Trop-2) is a promising target due to its high expression in HNSCC.
- Sacituzumab govitecan (SG) is an antibody-drug conjugate targeting Trop-2, with prior approvals for other solid tumors.
Purpose of the Study:
- To evaluate the efficacy and safety of sacituzumab govitecan (SG) in patients with advanced HNSCC previously treated with chemotherapy and immunotherapy.
- To assess the objective response rate (ORR) as the primary endpoint in this heavily pretreated population.
Main Methods:
- TROPiCS-03 is an open-label, phase II study evaluating SG in advanced solid tumors, including HNSCC.
- Adult patients with locally advanced or metastatic HNSCC progressing after platinum-based chemotherapy and anti-PD-(L)1 therapy received SG (10 mg/kg) on days 1 and 8 of 21-day cycles.
- Key secondary endpoints included duration of response, clinical benefit rate, progression-free survival, overall survival, and safety.
Main Results:
- Forty-three heavily pretreated patients received SG, with a median of 3 prior regimens.
- The objective response rate (ORR) was 16% (95% CI, 7%-31%), with 7 partial responses. The clinical benefit rate (CBR) was 28% (95% CI, 15%-44%).
- Median duration of response, progression-free survival, and overall survival were 4.2, 4.1, and 9.0 months, respectively. Common adverse events included diarrhea, nausea, and neutropenia; 58% experienced Grade ≥3 TEAEs.
Conclusions:
- Sacituzumab govitecan demonstrated clinical activity in patients with advanced HNSCC who were heavily pretreated.
- The Trop-2-directed therapy shows potential as a treatment option for this patient population with limited alternatives.
- Further investigation is warranted to optimize the use of SG in advanced HNSCC.
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