Immunotherapy breakthrough in bladder cancer

CANCER DIGEST – Nov. 25, 2023 – A large Dutch trial confirms the results of a US study showing the addition of immunotherapy to chemotherapy can improve survival for patients with bladder cancer.

The phase 3 CheckMate 901 clinical trial led by Michael van der Heijden, a medical oncologist at the Netherlands Cancer Institute involved 304 patients treated with the standard chemotherapy (gemcitabine-cisplatin) and 304 treated with the addition of the immunotherapy drug nivolumab (Opdivo®).

The immunotherapy group had 22 percent lower risk of death compared to chemotherapy alone, and a significant increase in the time the cancer was halted (progression-free survival.)

“These results mark a milestone in bladder cancer research, providing the first evidence of a survival benefit of combination therapy involving immune checkpoint inhibitors over chemotherapy,” van der Heijden said in a press release. “This is an exciting development in our field, as these findings will thoroughly change the treatment landscape for advanced bladder cancer. It is a testament to the collaborative efforts of researchers, and most importantly, the resilience of all patients who participated in this study."

The results were presented at the European Society of Medical Oncology (ESMO) conference held in Madrid, Oct. 20-24, and were subsequently published in the Nov. 9, 2023 study New England Journal of Medicine.

Those results confirm similar outcomes of a phase 2 trial conducted by Matthew Galsky’s team at Mt. Sinai Tisch Cancer Center in New York. In that study of 76 patients published Oct. 2, 2023, 33 (43 percent) achieved a complete response, and two years of follow-up showed no signs of recurrent cancer in 70 percent of the patients.

Both Galsky and van der Heijden suggest the results of their respective trials could lead to a shift in standard therapy for bladder cancer.

Sources: Netherlands Cancer Institute press release and New England Journal of Medicine