Nov. 2, 2023 -- Drug makers Seagen Inc. and Genmab A/S say Phase 3 trial results show a 30% drop in the risk of death from cervical cancer compared with chemotherapy.
“Patients with cervical cancer have few treatment options once their cancer comes back or spreads after initial treatment,” said Ignace B. Vergote, MD, co-founder of European Network of Gynaecological Oncological Trial groups (ENGOT) and lead investigator in the clinical trial. “The positive data, seen in a representative patient population of recurrent or metastatic cervical cancer, demonstrate the potential for TIVDAK to reshape clinical practice and provide hope for patients who need a new treatment option.”
TIVDAK (tisotumab vedotin)showed a 33% decrease in the risk of worsening disease or death, Fox News reported. And the intravenous drug showed an improved objective response rate of 17.8% compared to chemotherapy at 5.2%.
“The trial also measured the disease control rate, which is the percentage of patients who experience complete response, partial response or stable disease,” Fox News wrote. “TIVDAK displayed a 75.9% disease control rate, while chemo showed a 58.2% rate.”
The results are a “game changer,” Brian Slomovitz, MD, of Mount Sinai Medical Center in Miami Beach, Florida, told Fox.
"To have an overall survival advantage in this disease is extremely, extremely rare," he said. "It changes the second-line standard of care for this disease. Now, all patients who recur after first-line therapy should be considered for this therapy."
Slomovitz has worked on the trials and said the new class of drugs delivers chemotherapy more precisely because it attacks a certain protein on the cell. “So, it doesn’t give a lot of peripheral side effects that we see with traditional chemotherapy.”
He said he hopes the FDA will fully approve the drug soon.