Tisotumab Vedotin Shows Promise in Prolonging Survival in Recurrent Cervical Cancer
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Reviewed & Translated by Dat Tien Nguyen, B.A, ScM.
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Posted on August 26th, 2024
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Despite the use of anti–programmed cell death protein (PD-1) and ligand (PD-L1) therapies, the prognosis for cervical cancer remains bleak, with a 5-year survival rate of just 19%. This highlights the urgent need for new treatments, such as tisotumab vedotin. Tisotumab vedotin is a novel agent composed of monomethyl auristatin E, a microtubule-disrupting compound, conjugated to an antibody that targets tissue factor, which is highly expressed in cervical tumors. In response to this need, pharmaceutical companies Genmab and Pfizer sponsored a study to investigate the effectiveness of tisotumab vedotin in treating recurrent cervical cancer.
The phase 3 clinical trial enrolled 502 participants with recurrent or metastatic cervical cancer, with an average age of 50 years. Histological analysis revealed that 63.1% of the cohort had squamous-cell carcinoma, 31.9% had adenocarcinoma, and the remainder had adenosquamous carcinoma. All participants had previously undergone radiation therapy in addition to standard systemic chemotherapy, including paclitaxel with cisplatin, carboplatin, or topotecan. Furthermore, 27.5% had been treated with anti-PD-1 or anti-PD-L1 agents, and 63.9% had received the monoclonal antibody bevacizumab, which targets vascular endothelial growth factor A. Participants were randomly assigned to receive either intravenous tisotumab vedotin at a dose of 2.0 mg per kilogram of body weight every 3 weeks or standard chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). After a median follow-up of 10.8 months, researchers found that tisotumab vedotin significantly outperformed the current standard of care, reducing the risk of death by 30%. However, they also noted that 14.8% of those treated with tisotumab vedotin discontinued treatment due to the drug's toxic effects.
The phase 3 clinical trial enrolled 502 participants with recurrent or metastatic cervical cancer, with an average age of 50 years. Histological analysis revealed that 63.1% of the cohort had squamous-cell carcinoma, 31.9% had adenocarcinoma, and the remainder had adenosquamous carcinoma. All participants had previously undergone radiation therapy in addition to standard systemic chemotherapy, including paclitaxel with cisplatin, carboplatin, or topotecan. Furthermore, 27.5% had been treated with anti-PD-1 or anti-PD-L1 agents, and 63.9% had received the monoclonal antibody bevacizumab, which targets vascular endothelial growth factor A. Participants were randomly assigned to receive either intravenous tisotumab vedotin at a dose of 2.0 mg per kilogram of body weight every 3 weeks or standard chemotherapy (topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed). After a median follow-up of 10.8 months, researchers found that tisotumab vedotin significantly outperformed the current standard of care, reducing the risk of death by 30%. However, they also noted that 14.8% of those treated with tisotumab vedotin discontinued treatment due to the drug's toxic effects.