VESPER Clinical Study
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 Outperforms Platinum-Based Chemotherapy in Metastatic Cervical Cancer
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.