A study to learn how well enfortumab vedotin (EV) with pembrolizumab works and how safe it is in people with advanced urothelial cancer: a plain language summary of the EV-302/KEYNOTE-A39 study

Plain Language Summary: What is this summary about? This is a summary of the publication of the EV-302/KEYNOTE-A39 study that was published in The New England Journal of Medicine in March 2024. The study helped researchers learn more about a possible new treatment for advanced urothelial cancer. Urothelial cancer starts in the bladder or other parts of the urinary tract.Platinum-based chemotherapy is usually the first therapy used to treat advanced urothelial cancer, but platinum-based chemotherapy does not always work and can have many side effects. In this study, researchers tested how well the study drug enfortumab vedotin (EV),when given with another anticancer drug called pembrolizumab, worked compared to platinum-based chemotherapy in participants with advanced urothelial cancer. What are the key takeaways? Researchers found that overall, participants who received EV (enfortumab vedotin) with pembrolizumab lived about 2 times longer without their cancer growing or spreading after starting treatment compared to participants who received platinum-based chemotherapy. Researchers also found that overall, people who received EV with pembrolizumab lived almost 2 times longer after starting treatment compared to participants who received platinum-based chemotherapy. Almost all participants in both treatment groups had a side effect that happened during the study that was possibly related to their study treatment. About 6 in 10 participants who received EV with pembrolizumab, and about 7 in 10 participants who received platinum-based chemotherapy, had a severe side effect during the study that was possibly related to their study treatment. For participants who received EV with pembrolizumab, the most common side effect was weakness, numbness, and pain from nerve damage in the hands and feet. For participants who received platinum-based chemotherapy, the most common side effect was low numbers of red blood cells (anemia). What were the main conclusions reported by the researchers? Overall, researchers found that EV with pembrolizumab helped participants live longer without their cancer growing or spreading,and helped participants live longer in general, compared to platinum-based chemotherapy. Researchers believe EV with pembrolizumab should be a standard treatment option for most people who have advanced urothelial cancer that has not been treated previously with other anticancer drugs. People who receive EV with pembrolizumab should closely monitor their health and inform their healthcare team of signs of weakness, numbness, or pain in their hands and feet, or other potential side effects such as skin rashes. This is an abstract of the Plain Language Summary of Publication article. View the full Plain Language Summary PDF of this article to read the full-text.