The recent FDA approval of Padcev plus Keytruda for locally advanced/metastatic, chemotherapy-ineligible bladder cancer offers an “exciting opportunity” for this difficult-to-treat patient population, an expert said.
The recent approval of Padcev (enfortumab vedotin-ejfv) plus Keytruda (pembrolizumab) to treat patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) provides another promising therapy for patients who may have other health conditions or kidney issues, deeming them ineligible for chemotherapy, one expert said.
In April of this year, the Food and Drug Administration (FDA) granted an accelerated approval to Padcev plus Keytruda for patients with locally advanced or metastatic urothelial carcinoma (bladder cancer).
“The reason that this approval is important and exciting is mainly because of the population they are putting it into,” Dr. Evan Pisick, a medical oncologist at City of Hope in Chicago, said in an interview with CURE®. “To be quite honest, a lot of patients with bladder cancer are older patients with lots of other medical issues — including things like diabetes and high blood pressure — so their kidneys may not be great. Having a drug like Padcev, which really has very little to no side effects or toxicities for the kidneys, is really important.”
Pisick noted that he has used Padcev many times to treat patients with bladder cancer, either as their initial therapy or as a second-line regimen. He noticed that patients tend to tolerate Padcev better than chemotherapy, meaning that they experience fewer side effects. Additionally, unlike many of the chemotherapy agents, Padcev treats disease that has spread to the liver.
Further, in the two studies that led to the Padcev-Keytruda combination’s approval, giving the two drugs together resulted in a 12% complete response rate, meaning that all signs of cancer disappeared in these patients. Additionally, a total of 68% of patients saw their disease shrink after being treated with Padcev plus Keytruda.
“Historically, it has been difficult to treat patients with this type of disease. … We have worked for many years trying to find options for treatment that will help extend patients’ lives,” Dr. Alex Helfand, a medical oncologist at Allegheny Health Network and assistant professor of medicine at Drexel University College of Medicine in Philadelphia, said in an interview with CURE®. “So this particular drug combination is an exciting opportunity given the positive results we’re seeing in earlier trials.”
Padcev plus Keytruda was granted an accelerated approval by the FDA, meaning that the clinical trial data that backed the approval did not compare the regimen to the current standard of care. As such, continued approval will be contingent on findings from the ongoing, randomized EV-302 trial, which is comparing Padcev plus Keytruda to chemotherapy.
Findings from that trial may even lead to the use of the drug duo in patients with locally advanced or metastatic bladder cancer regardless of their eligibility to receive chemotherapy.
“Quite honestly, if it works well for the patients who have bad kidneys, it’s probably going to work equally well in those with good kidneys,” Pisick said. “We’ll have to wait and see what the full FDA approval is, because sometimes when they approve (drugs), they’ll say it will only be for one setting, and then clinicians decide: are we going to give it to just the people who can’t get chemo, or are we going to give it to everybody, because it may be more beneficial for them.”
Helfand echoed that Padcev plus Keytruda could be an “attractive option,” but there are side effects from the regimen that patients should be aware of, too, such as peripheral neuropathy, elevated blood sugar, rash, lab abnormalities and all the known side effects from immunotherapy drugs like Keytruda.
“I would urge patients to speak with your oncologist and speak with other doctors about all of the different options you have for treating your bladder cancer, thinking about what the very best possible option would be for you to live longer and have a good quality of life,” Helfand said.
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