Better care for cancer patients may be on the horizon.
A new prescription drug to treat cervical cancer has shown positive results in clinical trials.
In global phase 3 trials, TIVDAK (tisotumab vedotin) was associated with an overall 30% reduction in the risk of death compared to chemotherapy.
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TIVDAK also demonstrated a 33% reduction in the risk of disease worsening or death.
Additionally, the intravenous drug showed an improved objective response rate of 17.8% compared to chemotherapy of 5.2%.
The trial also measured disease control rate, which is the percentage of patients with complete response, partial response, or stable disease.
TIVDAK showed a disease control rate of 75.9%, while chemotherapy showed a rate of 58.2%.
In an interview with Fox News Digital, Dr. Brian Slomovitz, director of gynecologic oncology at Mount Sinai Medical Center in Miami Beach, Florida, emphasized the importance of these findings.
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“To have an overall survival advantage from this disease is extremely, extremely rare,” he said.
“This changes the second-line standard of care for this disease. Now all patients who recur after first-line treatment should be considered for this treatment,” he added. “So this is a game changer.”
Slomovitz, who was directly involved in the trials, explained that the new class of drugs attacks a certain protein in the cell, which allows the chemotherapy to be delivered to the cell “in a precise way.”
He said: “So it doesn’t cause a lot of the peripheral side effects that we see with traditional chemotherapy.”
“In the past, we just didn’t have active drugs and our patients were left with ineffective therapies, and they just died.”
TIVDAK has shown ocular side effects such as conjunctivitis (pink eye), peripheral neuropathy (weakness, numbness, and pain due to nerve damage), and some bleeding — but Dr. Kathleen Moore, associate director of clinical research at Stephenson Cancer Center in Oklahoma City, said she thought it was manageable.
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Moore has been administering TIVDAK to his patients since accelerated FDA approval in 2021.
She said they had no difficulty managing and compensating for the side effects. Patients typically find relief by using prescription eye drops before starting treatment and cold compresses to alleviate potential toxicity, she said.
“There has not been a single issue with a patient unable to use the eye drops and comply with all mitigation strategies in order to receive the benefits of this medication,” she said.
Only 5% of patients had to discontinue treatment due to side effects, Slomovitz reported.
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In comparison, chemotherapy has a “much higher risk” of side effects, including anemia, nausea, hair loss and neutropenia, according to Slomovitz.
“We hope that a treatment like (TIVDAK) will be something that patients prefer over the chemotherapy option,” he said.
“As clinicians, we think the side effects are very manageable – and given the overall increase in effectiveness, it’s something our patients are willing to experience.”
Moore mentioned that Oklahoma has “quite a bit of experience” with TIVDAK because there is a large population of cervical cancer patients who have “very advanced disease or metastatic disease to the time of diagnosis” and require treatment, she said.
“They feel better because their illness is diminishing.”
The doctor, who also develops drugs, said his patients do “very well” and appreciate its effectiveness and accessibility through insurance.
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“This is unheard of,” she said. “In the past, we just didn’t have active drugs and our patients were left with ineffective therapies, and they just died.”
Patients recognize that TIVDAK has helped shrink their tumors, Moore said, leading to less pain and a reduction in drug dose.
“They feel better because their illness is lessening,” she said.
TIVDAK has been used in practice since phase 2 trials led to accelerated approval by the FDA in the United States.
The drug, however, was unable to gain full FDA approval before the end of Phase 3, Slomovitz noted.
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“We hope that the FDA will approve this for a confirmatory trial in this setting, which would obviously have a big impact on the care of our patients,” he said.
Slomovitz said he is optimistic that the drug will be fully approved by the FDA in the “near future.”
Both doctors shared their hopes for global FDA approval of the drugs.
“We are finally starting to see improvements in therapies for patients with advanced metastatic cervical cancer, all improving overall survival,” Moore said. “So it looks brighter.”
Cervical cancer is the fourth deadliest cancer among female patients, according to Slomovitz.
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Moore emphasized that the best way to avoid cervical cancer is to prevent it through annual screenings and vaccinations.
“It’s a completely preventable disease,” she said.
“The right way to cure is to prevent, so that’s what we should do too.”
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