Squamous cell carcinoma of the head and neck (SCCHN) mainly occurs in the mucous membranes of the mouth, nose, and throat. It is a cancer produced by a special type of cell called squamous cells. According to the data published at the 2022 Multidisciplinary Head and Neck Oncology Symposium, Tivdak has shown promising preliminary evidence of antitumor activity in patients with squamous cell carcinoma of the head and neck who have developed after platinum chemotherapy and immunotherapy regimens.
Tivdak's latest treatment data
InnovaTV 207 (NCT03485209) is an ongoing open-label multicenter trial studying intravenous injection of 2 mg/kg of Tivdak every 3 weeks. The patients with squamous cell carcinoma of the head and neck in the trial had received up to 3 systematic treatments before, and the median treatment time was 12 weeks (range 3-36 weeks).
The median age of patients in the treatment group was 65 years old. 14 patients underwent surgery for primary tumors and 24 patients underwent radiation therapy for primary tumors. Previous systematic treatments included immunotherapy (27 patients) and cetuximab (18 patients), and all 31 patients received at least platinum treatment.
The study results showed a confirmed objective response rate (ORR) of 16% and an overall disease control rate of 58%, with tolerable safety. Of the 31 patients who received Tivdak, 5 had a partial response, 16 had stable disease, 8 had disease progression, and 2 were not evaluable. The median progression-free survival (PFS) was 4.2 months (95% CI, 2.7–4.8 months), and the median overall survival (OS) was 9.4 months (95% CI, 8.1–11.8 months).
In the head and neck squamous cell carcinoma cohort of the innovaTV 207 study, at least one or more treatment-emergent adverse events (TEAEs) were observed in all 31 patients, but these events were manageable. TEAEs in 28 patients were related to Tivdak use. There was one fatal TEAE, but it was not related to Tivdak. The most common Grade 3 AEs associated with Tivdak were anemia in 10% of patients and asthenia in 6%. Additionally, the most common AEs associated with Tivdak were nausea, myalgia, and epistaxis, each in 29% of patients.
Currently, Part C of the innovaTV 207 study focuses on second-line and later patients, using 1.7 mg/kg of Tivdak on day 1 and day 15, once every 28 days. Part D is studying patients with ineffective treatment in first-line settings, using pembrolizumab and platinum dual-drug treatment, and using Tivdak every 3 weeks.
Introduction to new drugs of Tivdak
Product name: Tivdak
Drug name: tisotumab wedotin
Manufacturer: Genmab, Seattle Genetics
Tivdak is an investigational ADC (anti-cancer drug) targeting tissue factor (TF). It aims to target the TF antigen on cancer cells and deliver the cytotoxic agent MMAE (monomethylolpropamine E) directly into the cancer cells. In cancer biology, TF is a protein involved in tumor signaling and angiogenesis, and it is overexpressed in the vast majority of solid tumors, including cervical, ovarian, lung, pancreatic, colorectal, and head and neck cancers. Based on the high expression and rapid internalization of TF in many solid tumors, TF has become an ideal target for the development of ADC drugs.
Reminder: Patients with squamous cell carcinoma of the head and neck developed progressive diseases after receiving platinum chemotherapy and immunotherapy, and they showed good safety and preliminary efficacy after receiving Tivdak treatment.
