Strong study results in two phase 3 clinical trials may soon change go-to care, plus a promising treatment for bladder cancer inches closer to a new indication.
People with metastatic or locally advanced bladder cancer may soon have a new treatment option and some clarity about which of two standard regimens to choose, according to two new studies presented recently at the virtual meeting of the European Society for Medical Oncology (ESMO).
Interim results from one of the studies presented at ESMO found that the drug combination of Balversa (erdafitinib) and cetrelimab is producing meaningful responses in people with newly diagnosed bladder cancer whose cancer has a genetic alteration that renders standard chemotherapy less effective.
The other study found that a multidrug chemotherapy cocktail yielded better tumor control after three years than the standard regimen of gemcitabine and cisplatin in people whose bladder cancer had spread into nearby muscle.
The first study, known as NORSE, aims to provide a treatment option for the 20 percent of people with bladder cancer whose tumor has a fibroblast growth factor receptor (FGFR) alteration.
Balversa received accelerated approval from the U.S. Food and Drug Administration (FDA) in 2019 as an FGFR kinase inhibitor for patients with bladder cancers that have FGFR3 and FGFR2 genetic alterations. Cetrelimab is an experimental PD-1 inhibitor, a category of immunotherapy treatments that have enabled researchers to make headway on a number of tough-to-treat cancers, including bladder cancer.
NORSE compares Balversa combined with cetrelimab to Balversa alone. As of July 2021, two-thirds of patients in the combination group were responding to treatment, while only one-third of the group on Balversa alone had a response. Four of 19 patients had a complete response on the combination treatment, while only 1 of 18 in the Balversa-alone group did. Safety results are comparable for both groups.
NORSE is a phase 1B/2 trial, which means that it can’t be used to make head-to-head comparisons with other existing therapies. The phase 1B part of the trial established that the treatments were safe. This portion of the trial also established the dose that will be used in the phase 2 stage of testing, which is for newly diagnosed patients. Phase 2, which further tests safety and also investigates efficacy, is still enrolling patients.
The second study, known as VESPER, is a phase 3 randomized clinical trial that compares two current standard-of-care (first choice) regimens: gemcitabine with cisplatin with a therapy known as dd-MVAC, a combination of the drugs methotrexate, Velban (vinblastine), Adriamycin (doxorubicin), and Platinol (cisplatin). Judging by the amount of time patients went before their disease spread further, dd-MVAC was superior.
Enrique Grande, MD, PhD, of the MD Anderson Cancer Center Madrid in Spain, who was not part of the research team, found VESPER’s results to be compelling. “Those of us who work in bladder cancer have a long list of questions still to be answered, but VESPER is potentially practice changing,” he said. “The gemcitabine group performed well, too, but this trial clearly supports dd-MVAC as the most active regimen in neoadjuvant muscle-invasive bladder cancer with an acceptable cost in toxicity.”
Keytruda (pembrolizumab), an immunotherapy drug that increases the immune system’s ability to detect and fight tumor cells, has outperformed platinum-based chemotherapy as a first-line treatment for patients with persistent, recurrent, or metastatic cervical cancer, according to a study presented at ESMO and published simultaneously in the New England Journal of Medicine on September 18, 2021.
Keytruda is the first drug of its kind to outperform chemotherapy in a large, well-designed clinical trial for advanced cervical cancer.
In this study, known as Keynote-826, neither patients nor investigators knew which treatments patients received. Patients received one of several chemotherapy regimens as chosen by their physician. If desired, physicians could also supplement with Avastin (bevacizumab), a drug that stops tumor-nourishing blood vessels from forming.
Patients in the Keytruda group had no disease progression for a median of 10.4 months. In the chemotherapy-only group, patients had a median of 8.2 months before their disease spread. The chemotherapy patients had a median overall survival time of 16.3 months, while the median overall survival for those on Keytruda had not yet been reached as of May 2021.
The benefits of Keytruda were seen regardless of whether or not patients received Avastin.
The Keynote-826 lead author, Nicoletta Colombo, MD, PhD, of the European Institute of Oncology in Milan, hopes that the trial’s results will establish a new standard of care for patients with advanced cervical cancer.
“This trial is a game changer for cervical cancer patients with advanced disease, where we haven’t had much hope to offer them. Keynote-826 will change our standard of care in this tragically preventable disease,” said Mansoor Raza Mirza, MD, of Copenhagen University Hospital in Denmark, who was not involved in the study.
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