Tisotumab vedotin shows superior survival results in advanced cervical cancer
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Key takeaways:
- Treatment with tisotumab vedotin resulted in a 30% lower risk for death compared with chemotherapy.
- Both treatment options had similar adverse event rates.
Tisotumab vedotin for recurrent cervical cancer resulted in significantly longer survival outcomes compared with chemotherapy alone, according to results from a phase 3 randomized study published in The New England Journal of Medicine.
Researchers observed no new safety signals associated with use of the agent as second- or third-line treatment while also noting toxicity comparable with chemotherapy.
“The innovaTV 301 trial showed that tisotumab vedotin resulted in significantly greater efficacy, including longer overall survival, than chemotherapy in patients with recurrent cervical cancer,” Ignace Vergote, MD, PhD, a gynecologist-oncologist at University Hospital Leuven, Belgium, and researchers wrote.
Background, methodology
Researchers conducted the open-label innovaTV 301 trial to assess the efficacy and safety of tisotumab vedotin (Tivdak; Seagen, Genmab) — an antibody-drug conjugate — as second- or third-line therapy in women with recurrent or metastatic cervical cancer.
They randomly assigned 502 women to receive either 2 mg/kg tisotumab vedotin monotherapy every 3 weeks (n = 253) or investigator’s choice of chemotherapy (n = 249).
OS served as the study’s primary end point.
Results, next steps
Researchers reported significantly longer median OS among patients who received tisotumab vedotin compared with chemotherapy, resulting in a 30% lower risk for death with tisotumab vedotin (11.5 vs. 9.5 months; HR = 0.7; 95% CI, 0.54-0.89).
They also observed significantly longer median PFS of 4.2 months with tisotumab vedotin vs. 2.9 months with chemotherapy (HR = 0.67; 95% CI, 0.54-0.82).
Patients in the tisotumab vedotin cohort had a confirmed objective response rate of 17.8% vs. 5.2% in the chemotherapy cohort (OR = 4; 95% CI, 2.1-7.6).
A total of 98.4% of patients in the investigational cohort experienced at least one adverse event during the treatment period, whereas 99.2% of patients in the chemotherapy cohort experienced at least one adverse event.
Grade 3 or greater adverse events occurred in 52% of patients in the tisotumab vedotin cohort and 62.3% of patients in the chemotherapy cohort; 14.8% of patients stopped therapy with tisotumab vedotin due to treatment-related toxicity.
“Taken together, these data suggest that tisotumab vedotin may be a preferred second-line or third-line treatment option over chemotherapy for patients with recurrent cervical cancer,” Vergote and colleagues wrote.
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Vergote I, et al. N Engl J Med. 2024;doi:10.1056/NEJMoa2313811.
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