November 2, 2023 – Drugmakers Seagen Inc. and Genmab A/S say Phase 3 trial results show a 30% decline Risk of dying from cervical cancer in comparison with chemotherapy.
“Cervical cancer patients have few treatment options if their cancer recurs or spreads after the first treatment,” said Ignace B. Vergote, MD, co-founder of the European Network of Gynecological Oncological Trial Groups (ENGOT) and principal investigator of the clinical trial. “The positive data observed in a representative patient population with recurrent or metastatic cervical cancer demonstrates the potential of TIVDAK to reshape clinical practice and provide hope for patients in need of a new treatment option.”
TIVDAK (tisotumab vedotin) showed a 33 percent reduction in the chance of worsening disease or death. Fox News reported. And the intravenous drug showed an improved objective response rate of 17.8% in comparison with chemotherapy's 5.2%.
“The study also measured the disease control rate, which is the percentage of patients who had a complete response, a partial response or stable disease,” Fox News wrote. “TIVDAK demonstrated a disease control rate of 75.9%, while chemotherapy demonstrated a rate of 58.2%.”
The results are “groundbreaking,” said Dr. Brian Slomovitz of Mount Sinai Medical Center in Miami Beach, Florida, told Fox.
“Having an overall survival benefit in this disease is extremely, extremely rare,” he said. “It changes the standard of second-line therapy for this disease. Now all patients who relapse after first-line therapy should be considered for this therapy.”
Slomovitz worked on the studies and said the brand new class of medication delivers chemotherapy more precisely because they attack a selected protein within the cell. “So there aren’t a lot of peripheral side effects that we see with traditional chemotherapy.”
He said he hopes the FDA will fully approve the drug soon.