Genmab A SGMAB

GMAB is an oncology research site. In the SGNTV-03 trial, 52.0% of patients in the tisotumab vedotin arm experienced Grade >=3 AEs, compared to 62.3% in the chemotherapy arm. Treatment-related Grade 3 or higher AEs in the SGNTV 003 trial had p-values of 0.020 and 0.033. In the tisotumab vedotin arm, specific Grade 3 or higher adverse events included neutropenia (3.6%), fatigue (3.6%), peripheral sensory neuropathy (2.8%), keratitis (2.8%), anaemia (3.6%), and urinary tract infection (4.4%). Abdominal pain (grade >=3) was observed in 4% of patients in the tisotumab vedotin arm.

In the chemotherapy arm, Grade >=3 AEs included neutropenia (13.4%), urinary tract infection (7.1%), and anaemia (27.6%). Across all tumour types, 31.7% of patients experienced treatment-related grade >=3 AEs. In the SGNTV-003 trial, 130 subjects experienced >= Grade 3 TEAE, and 4 subjects experienced Grade 5 TEAE, representing 1.6% of subjects. In Pool 1 (All Cervical), Grade 3-4 adverse events included fatigue (5%), pyrexia (1%), asthenia (2%), pruritus (0.5%), and abdominal pain (3%).