TIVDAK's bombshell results in phase 3 trial change the 'standard of care,' says lead researcher
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Better care for cancer patients may be on the horizon.
A new prescription medicine for treating cervical cancer has been showing positive results in clinical trials.
In phase 3 global trials, TIVDAK (tisotumab vedotin) was linked to a 30% overall reduction in the risk of death compared to chemotherapy.
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TIVDAK also demonstrated a 33% decrease in the risk of worsening disease or death.
In addition, the intravenous drug showed an improved objective response rate of 17.8% compared to chemotherapy at 5.2%.
TIVDAK is showing promising results after phase 3 clinical trials. (iStock)
The trial also measured the disease control rate, which is the percentage of patients who experience complete response, partial response or stable disease.
TIVDAK displayed a 75.9% disease control rate — while chemo showed a 58.2% rate.
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.
"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," he added. "So it's a game-changer."
Brian Slomovitz, M.D., is director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida. He's been directly involved in the clinical trials and told Fox News Digital, "To have an overall survival advantage in this disease is extremely, extremely rare." (Mount Sinai Medical Center)
Slomovitz, who has been directly involved in the trials, explained that the new class of drugs attacks a certain protein on the cell, which allows chemotherapy to be delivered to the cell "in a precise fashion."
He said, "So, it doesn't give a lot of the peripheral side effects that we see with traditional chemotherapy."
"In the past, we just did not have active medications and our patients really 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 from nerve damage) and some bleeding — but Dr. Kathleen Moore, associate director of clinical research at Stephenson Cancer Center in Oklahoma City, said she felt that is manageable.
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Moore has been administering TIVDAK to her patients since the FDA’s accelerated approval in 2021.
She reported that they haven’t had a difficult time managing and offsetting side effects. Patients usually find relief by using prescription eye drops prior to beginning treatment and cold compresses to mitigate potential toxicity, she said.
The new class of drugs attacks a certain protein on the cell, which allows chemotherapy to be delivered to the cell "in a precise fashion." (iStock)
"There's not been a single issue with a patient not being able to use the eyedrops and be compliant with all the mitigation strategies in order to obtain the benefit from this medication," she said.
Only 5% of patients have had to discontinue treatment due to side effects, Slomovitz reported.
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Chemotherapy, comparatively, shows a "much higher risk" of side effects, including anemia, nausea, hair loss and neutropenia, according to Slomovitz.
"We’re hoping that a treatment like [TIVDAK] is something that the patients prefer as opposed to the chemotherapy option," he said.
"As clinicians, we feel that the side effects are very manageable — and given the overall increase in efficacy, it's something that our patients are willing to have."
TIVDAK side effects differ from chemo in terms of toxicity, one director of clinical research told Fox News Digital. (iStock)
Moore mentioned that Oklahoma has "quite a bit of experience" with TIVDAK, since there is a large population of cervical cancer patients who present with "very advanced disease or metastatic disease at diagnosis" and require the treatment, she said.
"They’re feeling better because their disease is shrinking."
The doctor, who is also a drug developer, said her patients have done "very well" with the drug and appreciate its effectiveness and accessibility through insurance.
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"That's unheard of," she said. "In the past, we just did not have active medications and our patients really were left with ineffective therapies, and they just died."
Patients are recognizing that TIVDAK has worked to shrink their tumors, Moore said, which then leads to less pain and reduced dosage of medication.
A doctor wears a cervical cancer ribbon on her white coat. TIVDAK has been used in practice since phase 2 trials led to accelerated approval by the FDA in the U.S. The drug, however, could not earn full FDA approval until phase 3 was complete. (iStock)
"They’re feeling better because their disease is shrinking," she said.
TIVDAK has been used in practice since phase 2 trials led to accelerated approval by the FDA in the U.S.
The drug, however, could not earn full FDA approval until phase 3 was complete, Slomovitz noted.
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"We're hoping that the FDA approves this for a confirmatory trial in the setting, which would obviously have a great impact on the care of our patients," he said.
Slomovitz said he’s optimistic the FDA will give full approval for the drug in the "near future."
Signage is shown outside Food and Drug Administration (FDA) headquarters in White Oak, Maryland, on Aug. 29, 2020. (REUTERS/Andrew Kelly/File Photo)
Both doctors shared their hopes for FDA drug clearance globally.
"We're starting to see, finally, improvements in therapies for patients who have advanced metastatic cervical cancer, all improving overall survival," Moore said. "So it is looking brighter."
Cervical cancer is the fourth most deadly cancer in female patients, according to Slomovitz.
Moore pointed out that the best way to avoid cervical cancer is to prevent it through annual screenings and vaccinations.
"This is an entirely preventable disease," she said.
"The correct way to cure is to prevent, so that’s what we should be doing, too."
For more Health articles, visit www.foxnews.com/health.
Angelica Stabile is a lifestyle writer for Fox News Digital.
