Better care for cancer patients may be on the horizon with the emergence of a new prescription medicine that has shown positive results in clinical trials. TIVDAK (tisotumab vedotin), a drug for treating cervical cancer, has demonstrated promising outcomes in phase 3 global trials.
Compared to chemotherapy, TIVDAK has been linked to a 30% overall reduction in the risk of death. It also showed a 33% decrease in the risk of worsening disease or death. Additionally, the intravenous drug displayed an improved objective response rate of 17.8% compared to chemotherapy at 5.2%.
The trial also measured the disease control rate, with TIVDAK showing a rate of 75.9% and chemotherapy showing a rate of 58.2%. These findings are significant, according to Dr. Brian Slomovitz, director of gynecologic oncology at Mount Sinai Medical Center in Miami Beach, Florida.
Dr. Slomovitz emphasized that an overall survival advantage in cervical cancer is extremely rare and described TIVDAK as a game-changer in the second-line standard of care for the disease. He explained that the new drug attacks a specific protein on the cell, allowing chemotherapy to be delivered precisely and minimizing peripheral side effects.
While TIVDAK has shown ocular side effects such as conjunctivitis, peripheral neuropathy, and bleeding, Dr. Kathleen Moore, associate director of clinical research at Stephenson Cancer Center, reassured that these side effects are manageable. She reported that patients can use prescription eye drops and cold compresses to alleviate potential toxicity.
Only 5% of patients have had to discontinue treatment due to side effects, according to Dr. Slomovitz. He compared the side effects of TIVDAK to chemotherapy, which carries a higher risk of adverse effects such as anemia, nausea, hair loss, and neutropenia.
Dr. Moore shared her positive experiences with TIVDAK, noting that her patients have done well with the drug and appreciate its effectiveness and accessibility through insurance. She said that patients feel better as their tumors shrink and experience less pain, which can lead to a reduced need for medication.
TIVDAK has been used in practice since phase 2 trials led to accelerated approval by the FDA in the U.S. However, full FDA approval is pending completion of phase 3 trials. Dr. Slomovitz expressed optimism that the FDA will grant full approval for the drug in the near future.
Both doctors expressed their hopes for global FDA drug clearance and highlighted the improvements in therapies for advanced metastatic cervical cancer, leading to improved overall survival. Cervical cancer is the fourth most deadly cancer in female patients.
Dr. Moore emphasized the importance of prevention through annual screenings and vaccinations to avoid cervical cancer altogether. She emphasized that the correct way to cure the disease is through prevention.
Overall, the emergence of TIVDAK represents a significant advancement in the treatment of cervical cancer and may provide better care options for patients in the future.