Dr Sun on Managing TEAEs of Tisotumab Vedotin in Recurrent/Metastatic HSNCC

Lova L. Sun, MD, MSCE, assistant professor, medicine (hematology-oncology), Department of Medicine, the Hospital of the University of Pennsylvania, discusses safety findings observed from part C of the phase 2 innovaTV 207 trial (NCT03485209), which evaluated the efficacy and safety of tisotumab vedotin-tftv (Tivdak) in patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) who received prior treatment with platinum-based chemotherapy and/or an immune checkpoint inhibitor. She also explains the importance of managing adverse effects (AEs) in patients being treated with antibody-drug conjugates (ADCs).

Sun emphasizes that managing toxicity is a pivotal aspect of treating patients with an ADC, since these agents have both a cytotoxic payload and a targeting mechanism.

Updated data from innovaTV 207 presented at the 2024 ASCO Annual Meeting showed that the safety profile of tisotumab vedotin remained consistent with findings from previous studies evaluating the agent as monotherapy. Any-grade treatment-emergent AEs (TEAEs) occurred in 95.0% of patients with HNSCC treated with tisotumab vedotin (n = 40). The rate of grade 3 or higher TEAEs was 67.5%. Serious TEAEs occurred in 47.5% of patients, and TEAEs led to death in 2.5% of patients. Twenty percent of patients discontinued treatment due to TEAEs. AEs of special interest leading to treatment discontinuation included ocular events (7.5%), peripheral neuropathy (5.0%), and bleeding events (2.5%).

The most common any-grade TEAEs included peripheral sensory neuropathy (40.0%), constipation (32.5%), conjunctivitis (30.0%), fatigue (30.0%), and decreased appetite (30.0%).

Notably, any-grade ocular TEAEs, including conjunctivitis, were reported in 52.5% of patients. Other any-grade ocular TEAEs consisted of dry eye (17.5%), eye discharge (10.0%), increased lacrimation (10.0%), and ocular hyperemia (10.0%).

Sun notes that collaborating with other clinicians, such as ophthalmologists, can help the mitigation and management of these TEAEs through preventive measures, such as steroid eyedrops. Mitigating and managing TEAEs associated with tisotumab vedotin can help patients remain on treatment and continue to derive benefit, Sun concludes.