People in the U.S. with certain gynecological cancers that are resistant to first-line chemotherapies now have a new treatment option: The U.S. Food and Drug Administration (FDA) has approved the use of the immune-modulating therapies Keytruda (pembrolizumab) and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) for these patients.
The new regulatory approval covers the medications’ use in combination with the chemotherapy paclitaxel, with or without bevacizumab (sold as Avastin, among others). Both drugs are indicated for use in people with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal carcinoma, who have received one or two previous lines of treatment.
To be eligible for the newly approved therapy, patients must have a tumor that expresses a protein called PD-L1, as determined using an FDA-approved test.
According to Merck, the company that markets Keytruda and Keytruda Qlex, this approval makes these therapies the first in their class to win FDA approval for adults with gynecological cancers that are resistant to platinum-based chemotherapy.
Keytruda is administered by slow infusion into the bloodstream, whereas Keytruda Qlex is given by injection under the skin.
“Historically, the prognosis has been poor for patients living with platinum-resistant recurrent ovarian cancer who have limited treatment options that may reduce the risk of disease progression or death,” Gursel Aktan, PhD, vice president of global clinical development at Merck Research Laboratories, said in a company press release announcing the FDA decision.
“These approvals mark an important moment for the ovarian cancer community, reflecting years of focused investment in Keytruda,” Aktan said.
In a variety of cancer types, tumor cells can express PD-L1, a protein that binds to receptors on immune cells and signals them not to attack. Pembrolizumab, the active agent in both Keytruda and Keytruda Qlex, is designed to block this interaction, unleashing immune cells to attack the cancer.
Keytruda, the original medication, is primarily given as an intravenous, or into-the-vein infusion, administered by a healthcare professional and taking about 30 minutes. The newer medication Keytruda Qlex, which typically takes about five minutes to administer, is given via a subcutaneous, or under-the-skin, injection. Keytruda Qlex has been shown to deliver a comparable amount of the active drug as the original.
Keytruda cut risk of death by 24% in cancer patients in trial
The FDA’s approval of the immune-modulating meds for platinum-resistant gynecological cancers was based on positive data from a global clinical trial called KEYNOTE-B96 (NCT05116189),
That Phase 3 trial enrolled more than 600 people with platinum-resistant gynecological cancers. All patients received paclitaxel and had the option to receive bevacizumab. The patients were additionally randomly assigned to receive either Keytruda or a placebo.
For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback — it’s when options can become limited, and the reality patients face can change very quickly.
The results showed that the addition of Keytruda significantly reduced the risk of death, by about 24%, in patients whose tumors express PD-L1. Median overall survival time was 18.2 months with the Keytruda regimen versus 14 months with the placebo in these patients, the data showed.
According to Merck, Keytruda “[reduced] the risk of disease progression or death by 28%” among trial participants.
“For many patients with ovarian cancer, the disease can become platinum-resistant, at which point recurrence is not just a setback — it’s when options can become limited, and the reality patients face can change very quickly,” said Bradley Monk, MD, gynecologic oncologist and medical director of the late-stage clinical research program at the Florida Cancer Specialists and Research Institute.
“For patients who have been previously treated with standard platinum-based therapies, the FDA approvals of these [Keytruda]-based regimens offer the possibility of more time,” Monk said.
Like many cancer therapies, the new Keytruda regimen has a high risk of serious side effects. More than half of patients given the Keytruda regimens in KEYNOTE-B96 experienced serious safety issues, including infections, low blood cell counts, digestive upset, and hormonal issues. Fatal adverse reactions were reported in 3.9% of patients given Keytruda, and many patients discontinued or paused treatment due to safety concerns.
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