Patients receiving nivolumab plus cisplatin-based chemotherapy lived longer than patients treated with standard chemotherapy alone.
Adding nivolumab (Opdivo) to cisplatin-based chemotherapy in the first-line setting significantly extended overall survival (OS) compared with standard chemotherapy alone in cisplatin-eligible patients with unresectable or metastatic urothelial carcinoma.1
The findings, which come from a sub-study of the phase 3 CheckMate-901 trial, showed that the combination of nivolumab and chemotherapy also led to a significant improvement in progression-free survival (PFS) vs chemotherapy alone. The results were announced in a press release from Bristol Myers Squibb (BMS), the developer of nivolumab.
The sub-study included 608 cisplatin-eligible patients with advanced urothelial carcinoma who were randomized to either the combination of nivolumab (360 mg) and cisplatin-based chemotherapy, or the control arm of standard-of-care frontline cisplatin-based combinations. The primary end points of OS and PFS were assessed by Blinded Independent Central Review.
There were no new safety signals that emerged compared with the established safety profiles of the individual treatments.
No specific data were shared in the press release; BMS plans to share the data at a medical meeting and discuss the results with health regulatory authorities.
“Today’s news is yet another example of the power of immunotherapy combinations to transform outcomes for patients with cancer. Opdivo with cisplatin-based chemotherapy is the first immunotherapy-based combination to improve both overall survival and progression-free survival in patients with previously untreated unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy, reinforcing the benefits of Opdivo-based treatments seen across a variety of genitourinary cancers, including durable survival in advanced renal cell carcinoma and a reduced risk of recurrence in resectable muscle-invasive urothelial carcinoma,” Dana Walker, MD, MSCE, vice president, global program lead, genitourinary cancers, Bristol Myers Squibb, stated in the press release.1
“We are encouraged by these positive results and remain steadfast in our commitment to bringing new solutions to patients with high unmet needs. We thank the patients, investigators and all site personnel involved in the CheckMate -901 trial,” added Walker.
The overall phase 3 CheckMate-901 trial included 707 patients with unresectable or metastatic urothelial carcinoma who were randomized to the first-line combination of nivolumab plus ipilimumab (Yervoy), or the control arm of standard chemotherapy.2
In the immunotherapy arm, patients received nivolumab at 1 mg/kg and ipilimumab at 3 mg/kg every 3 weeks for 4 cycles, followed by nivolumab at 480 mg every 4 weeks for up to 2 years. In the control arm, patients received standard chemotherapy consisting of either gemcitabine/cisplatin or gemcitabine/carboplatin every 3 weeks for 6 cycles.
Previously reported results showed that in patents whose tumor cells had PD-L1 expression levels of at least 1%, the combination of nivolumab plus ipilimumab did not improve OS vs standard chemotherapy, missing the primary end point.2
1. Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy Shows Overall Survival and Progression-Free Survival Benefit for Cisplatin-Eligible Patients with Unresectable or Metastatic Urothelial Carcinoma in the Phase 3 CheckMate -901 Trial. Published online and accessed July 11, 2023. https://investors.bms.com/iframes/press-releases/press-release-details/2023/Opdivo-nivolumab-in-Combination-with-Cisplatin-Based-Chemotherapy-Shows-Overall-Survival-and-Progression-Free-Survival-Benefit-for-Cisplatin-Eligible-Patients-with-Unresectable-or-Metastatic-Urothelial-Carcinoma-in-the-Phase-3-CheckMate--901-Trial/default.aspx
2. Bristol Myers Squibb Provides Update on CheckMate -901 Trial Evaluating Opdivo (nivolumab) Plus Yervoy (ipilimumab) as First-Line Treatment for Patients with Unresectable or Metastatic Urothelial Carcinoma. Published online May 16, 2022. Accessed May 18, 2022. https://bit.ly/38v7Mzn