Update on CheckMate -901 trial evaluating Opdivo + Yervoy as first-line treatment for metastatic urothelial carcinoma
Update on CheckMate -901 trial evaluating Opdivo + Yervoy as first-line treatment for unresectable or metastatic urothelial carcinoma (bladder cancer).
Bristol Myers Squibb announced the Phase III CheckMate -901 trial, comparing Opdivo (nivolumab) plus Yervoy (ipilimumab) to standard-of-care chemotherapy as a first-line treatment for patients with untreated unresectable or metastatic urothelial carcinoma, did not meet the primary endpoint of overall survival (OS) in patients whose tumor cells express PD-L1 greater than 1% at final analysis.
The company remains blinded to the data, and an independent Data Monitoring Committee recommended that the trial continue to assess other primary and secondary endpoints. No new safety signals were observed at the time of the analysis.
The CheckMate -901 trial is also assessing Opdivo plus Yervoy in patients with unresectable or metastatic urothelial carcinoma who are ineligible for cisplatin-based chemotherapy. Additionally, a sub-study of CheckMate -901 with pivotal intent is evaluating Opdivo in combination with chemotherapy versus chemotherapy alone in patients who are eligible for cisplatin-based chemotherapy. The CheckMate -901 primary study and sub-study are ongoing, and the company will report results for these additional components of the study when available.
Opdivo plus Yervoy-based combinations have shown significant improvements in OS in six Phase III clinical trials in five tumors to date: non-small cell lung cancer, metastatic melanoma, advanced renal cell carcinoma, malignant pleural mesothelioma and esophageal squamous cell carcinoma. In addition, Opdivo has shown clinical benefit in second-line metastatic urothelial carcinoma and adjuvant muscle-invasive urothelial carcinoma.
About CheckMate -901 : CheckMate -901 is a Phase III, randomized, open-label trial evaluating Opdivo in combination with Yervoy (primary study) or Opdivo in combination with chemotherapy (sub-study) compared to standard-of-care chemotherapy alone, in patients with untreated unresectable or metastatic urothelial cancer. In the primary study, a total of 707 patients were randomized to receive either Opdivo (1 mg/kg) plus Yervoy (3 mg/kg) every three weeks for four cycles, followed by Opdivo (480 mg) every four weeks for a maximum of two years, or chemotherapy (gemcitabine-cisplatin or gemcitabine-carboplatin) every three weeks for six cycles. The primary endpoints of the primary study are overall survival (OS) in patients who are ineligible for cisplatin-based chemotherapy and OS in patients with tumor cell PD-L1 expression greater than 1%. Key secondary endpoints include OS in all randomized patients, progression-free survival (PFS) and safety outcomes.
A sub-study of CheckMate -901 is evaluating Opdivo in combination with chemotherapy versus chemotherapy alone in patients who are eligible for cisplatin-based chemotherapy.
The OS outcomes for patients whose tumor cells express PD-L1 greater than 1% are based on the final efficacy analysis for this endpoint of the CheckMate -901 primary study; the other parts of the study are ongoing.
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