Nivolumab Combination Regimen Improved Survival of Patients with Bladder Cancer By A Third Compared to Chemotherapy Alone


The novel combination met the co-primary endpoints of progression-free survival and overall survival during the CheckMate -901 trial, also demonstrating sizeable improvement in objective response.

Nivolumab (Opdivo; Bristol Myers Squibb) plus gemcitabine–cisplatin increased the overall survival (OS) rate to 70.2% vs gemcitabine–cisplatin alone (46.9%) in patients with unresectable or metastatic urothelial carcinoma (UC) who are eligible to receive cisplatin treatment. These findings from the phase 3 CheckMate -901 trial were presented at the European Society of Medical Oncology (ESMO) Congress 2023 and were published in the New England Journal of Medicine.1

Image credit: Dr_Microbe -

Image credit: Dr_Microbe -

“The survival benefit seen with nivolumab in combination with cisplatin-based chemotherapy represents a momentous accomplishment that may provide hope for [patients with UC] as the first concurrent chemo-immunotherapy combination to demonstrate such an improvement compared to standard-of-care cisplatin-based combinations,” said Michiel S. van der Hejiden, MD, PhD, Department of Medical Oncology, Netherlands Cancer Institute, Amsterdam, Netherlands, in a press release.1

OS, a co-primary endpoint of the study, was significantly higher in the nivolumab arm at median follow-up (33.6 months). Median OS was 21.7 months (95% CI, 18.6 to 26.4) with the nivolumab-combination therapy vs 18.9 months (95% CI, 14.7 to 22.4) with gemcitabine–cisplatin alone.2

The other endpoint during the CheckMate -901 trial was progression-free survival (PFS), and PFS was longer in the nivolumab arm (hazard ratio for progression or death, 0.72; 95% CI, 0.59 to 0.88; P=0.001). Median PFS was 7.9 months with nivolumab-combination therapy and 7.6 months with cisplatin-based therapy alone. The rates of PFS at 12 months were 34.2% with nivolumab-combination and 21.8% with gemcitabine–cisplatin; they were 23.5% and 9.6% at 24 months, respectively.2

UC accounts for 90% of all bladder cancer cases—bladder cancer is considered one of the top 10 most common cancers in the world. Approximately half of all patients with UC will experience disease recurrence or progression within a few years of primary surgery to remove the tumor, and up to 25% of these patients will have metastatic disease. First-line treatment for metastatic disease is chemotherapy, but it is not associated with durable response.1

Moreover, patients with unresected or metastatic disease and cisplatin eligibility have not previously had access to effective immunotherapy-based treatment options, according to vice president Dana Walker, MD, MSCE, global program lead, genitourinary cancers, Bristol Myers Squibb, in the press release.1

The phase 3, open-label CheckMate -901 study randomly assigned 608 patients with metastatic disease and cisplatin chemotherapy-eligibility into groups that either received 1) nivolumab (360 mg; intravenous [IV]) and cisplatin (gemcitabine–cisplatin; nivolumab combination) every 3 weeks for a maximum of 6 cycles, followed by 480 mg nivolumab every 4 weeks for up to 2 years or 2) cisplatin every 3 weeks for a maximum of 6 cycles.2

“The CheckMate -901 results bolster our existing body of research, which has shown OS improvements with nivolumab-based treatments across multiple tumor types, including in genitourinary cancers,” Walker said in the press release.1

In an additional exploratory analysis of CheckMate -901 trial, many patients also achieved overall objective response of 57.6% with the nivolumab combination and 43.1% with gemcitabine–cisplatin. The nivolumab combination was also associated with an almost 3-times longer duration of response (DOR). Median DOR for patients on nivolumab was 37.1 months vs 13.2 months with chemotherapy. 1

Nivolumab with gemcitabine–cisplatin offers statistically significant and clinically meaningful improvements in survival among patients with metastatic UC, and other studies also show that these treatments are effective for advanced renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, metastatic melanoma, and esophageal squamous cell carcinoma.1

“The implications of these data have the potential to be practice-changing and transform the way cisplatin-eligible patients are treated,” Hejiden concludes.1


  1. Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy Followed by Opdivo Demonstrates Significant Survival Benefits for Cisplatin-Eligible Patients with Unresectable or Metastatic Urothelial Carcinoma in Phase 3 CheckMate -901 Trial. BMS. News Release. October 17, 2023. Accessed on October 23, 2023.
  2. Jeijden MS, Sonpavde G, Powles T, et al. Nivolumab plus Gemcitabine–Cisplatin in Advanced Urothelial Carcinoma. The NEJM. October 22, 2023; DOI:10.1056/NEJMoa2309863
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