Immunotherapy has proven to be an important strategy in oncology, although not for all tumors in the same way. In urothelial carcinoma now, for the first time, the addition of an immunotherapy molecule – nivolumab – to chemotherapy proves to be a winning strategy because patients who had a statistically significant and clinically relevant survival benefit compared to cisplatin-based chemotherapy, which is the standard of care in the first-line treatment of patients with unresectable or metastatic urothelial carcinoma eligible for cisplatin. The new data was selected for presentation at the 2023 Presidential Symposium of the European Society for Medical Oncology Congress.
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The therapeutic sequence involved the administration of nivolumab in association with cisplatin-based chemotherapy followed by nivolumab monotherapy. At a median follow-up of approximately 33 months, the combination treatment reduced the risk of death by 22%. At the 12- and 24-month baseline analyses, patients treated early with nivolumab plus chemotherapy reported overall survival rates of 70.2% and 46.9%, respectively, compared to 62.7% and 40.7 % with chemotherapy. In patients treated with the nivolumab-based combination, the risk of death or disease progression was reduced by 28%.
“In patients with metastatic urothelial carcinoma we often observe poor duration of responses with chemotherapy alone in first-line treatment. This has long been a major challenge in treating patients with this difficult-to-treat disease,” says Michiel S. van der Hejiden, MD, Ph.D., Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands. “The survival benefit observed with nivolumab in combination with cisplatin-based chemotherapy represents an epochal result that can give hope to patients suffering from urothelial cancer since it is the first concomitant combination of chemo-immunotherapy to demonstrate such an improvement compared to the standard of care of cisplatin-based combinations. The implications of these data have the potential to change clinical practice and transform the way cisplatin-eligible patients are treated.”
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“Historically we have not had effective immunotherapy-based options available in the first-line setting for patients with unresectable or metastatic urothelial carcinoma eligible for cisplatin. We are proud of these results that demonstrate that nivolumab plus cisplatin-based chemotherapy can offer patients hope and survival benefits with this immunotherapy approach,” says Dana Walker, MD, MSCE, Vice President, global program lead, genitourinary cancers, Bristol Myers Squibb. “The CheckMate -901 results reinforce our research which has shown improved overall survival with nivolumab-based treatments in several types of cancers including genitourinary cancers.”