According to results from the phase 2 TROPiCS-03 study, sacituzumab govitecan, a TROP-2-directed antibody-drug conjugate, demonstrated efficacy and tolerable safety among patients with heavily pretreated, relapsed or refractory, metastatic or locally advanced head and neck squamous cell carcinoma.

These results were presented at the European Society for Medical Oncology Congress in Madrid, Spain, by lead author, Loren Michel, MD, Memorial Sloan Kettering Cancer Center, New York, New York.

“Although [PD-L1] inhibitors have improved outcomes in [patients] with advanced [head and neck squamous cell carcinoma], most [patients] experience disease progression and need subsequent treatment,” stated Dr Michel and coauthors.

In this open-label, multi-cohort study, 43 adult patients with relapsed or refractory metastatic or locally advanced head and neck squamous cell carcinoma who experienced disease progression after treatment with platinum-based chemotherapy or an anti-PD-L1 therapy were enrolled to receive 10 mg/kg sacituzumab govitecan on days 1 and 8 of a 21-day cycle. The primary end point was objective response rate (ORR). Secondary end points included clinical benefit rate (CBR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety. Patients who received ≥1 dose were included in safety and efficacy analyses.

At a median follow-up of 7.5 months, ORR was 16%, CBR was 26%, median DOR was 4.2 months, and median PFS was 4.1 months. Grade ≥3 treatment-related adverse events occurred in 44% of patients. No treatment-related adverse events led to discontinuation. There were 3 deaths due to adverse events with 1 death related to study treatment. Treatment was ongoing among 5 patients.

“[Sacituzumab govitecan] demonstrated single agent activity and manageable safety, with no [treatment-related adverse events] leading to discontinuation to date,” concluded Dr Michel and coauthors.

Source:

Michel L, Jimeno A, Sukari A, et al. Sacituzumab govitecan (SG) in patients (pts) with relapsed/refractory (R/R) advanced head and neck squamous cell carcinoma (HNSCC): Results from the phase II TROPiCS-03 basket trial. Presented at the 2023 ESMO Congress; October 20- 24, 2023; Madrid, Spain. Abstract 859MO