BMS Announces Phase III CheckMate-901 Sub-Study Met Dual Primary Endpoints of OS and PFS with Opdivo Plus Chemotherapy in First-Line Unresectable or Metastatic Urothelial Cancer

On July 11, Bristol-Myers Squibb (BMS) announced that the sub-study of the Phase III CheckMate-901 clinical trial met the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by the Blinded Independent Central Review (BICR) in the final analysis.

CheckMate-901 is the first and only Phase III study to demonstrate a significant survival benefit of an immunotherapy-based combination regimen versus cisplatin-based chemotherapy as first-line treatment for unresectable or metastatic urothelial carcinoma (UC).

CheckMate-901 is a randomized, open-label, Phase III clinical trial in untreated patients with unresectable or metastatic UC, aiming to evaluate the efficacy and safety of Opdivo (nivolumab) + Yervoy (ipilimumab) (primary study) or Opdivo + chemotherapy (sub-study) versus standard chemotherapy. The primary endpoints of the primary study include: OS in patients ineligible for cisplatin-based chemotherapy, and OS in patients with tumor cell PD-L1 expression ≥1%. Key secondary endpoints include: OS, PFS, and safety in all randomized patients. The primary endpoints of the sub-study include OS and PFS.

The results of this sub-study showed that for patients with unresectable or metastatic UC who are eligible for cisplatin-based chemotherapy, compared with standard treatment (cisplatin-based chemotherapy) as first-line therapy, Opdivo combined with chemotherapy followed by Opdivo monotherapy demonstrated statistically significant benefits in OS and PFS. The combination of Opdivo and chemotherapy as first-line treatment for urothelial carcinoma showed good safety and tolerability, with no new safety signals identified. BMS stated that it will discuss these results with regulatory authorities.

As early as May 16, 2022, BMS announced the primary study results, showing that compared with chemotherapy, Opdivo combined with Yervoy failed to improve OS in patients with tumor cell PD-L1 expression ≥1%. However, the data had not been unblinded at that time, and the Independent Data Monitoring Committee (IDMC) recommended that the trial continue to evaluate other primary and secondary endpoints. In this press release, BMS stated that the primary study is still ongoing.

In addition to resectable or metastatic urothelial carcinoma, Opdivo and Opdivo combination therapies have demonstrated significant OS improvements in Phase III clinical trials across multiple tumors, including advanced renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, metastatic melanoma, and esophageal squamous cell carcinoma.

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