Nivolumab, Chemotherapy Combination Significantly Improve Overall Survival in Patients With Bladder Cancer

The combination of nivolumab (Opdivo) with cisplatin-based chemotherapy followed by nivolumab monotherapy significantly benefitted overall survival (OS) and progression-free survival (PFS) when used as a first-line treatment for patients with unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy, according to the results of the CheckMate -901 sub-study.

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This is the first trial to demonstrate that an immunotherapy-based combination has statistically significant survival benefits compared to standard of care (SoC) chemotherapy.

“Nivolumab with cisplatin-based chemotherapy is the first immunotherapy-based combination to improve both OS and PFS in patients with previously untreated unresectable or metastatic urothelial carcinoma who are eligible for cisplatin-based chemotherapy,” said Dana Walker, MD, MSCE, vice president, global program lead, genitourinary cancers, Bristol Myers Squibb, in the press release.

The benefits are spread across a wide range of genitourinary cancers, including advanced renal cell carcinoma, and resectable muscle-invasive urothelial carcinoma, Walker explained. Urothelial carcinoma is the most common type of bladder cancer, accounting for 90% of bladder cancer cases. This type of cancer can manifest in the bladder, ureters, and renal pelvis.

Most patients are diagnosed at an early stage and treated with surgery; however, approximately half of patients will experience recurrence, and up to 25% will develop metastases. Chemotherapy is SoC for metastatic disease but has short durability and second-line treatments are limited.

The phase 3 CheckMate -901 is a randomized and open-label primary study evaluating nivolumab plus ipilimumab (Yervoy) versus chemotherapy (cisplatin- or carboplatin-based) monotherapy for patients with previously untreated, unresectable, or metastatic urothelial cancer.

OS and PFS outcomes are based on the results of a sub study within CheckMate -901, which included 608 patients with untreated unresectable or metastatic urothelial cancer. Investigators randomized patients to receive a combination of nivolumab (360 mg) and chemotherapy administered every 3 weeks or SoC chemotherapy alone.

The combination shows a consistent safety profile to what was observed in previous clinical trials. The most common adverse events (AEs) associated with nivolumab were rash, fatigue, musculoskeletal pain, and pruritus, and serious grade 3 and 4 AEs in fewer than 5% of patients were abdominal pain, hyponatremia, and increased aspartate aminotransferase and lipase.

Nivolumab is the first programmed death-1 (PD-1) immune checkpoint inhibitor to be granted regulatory approval. Designed to capitalize on the patient’s own immune system to fight cancer, it has received regulatory approval in more than 65 countries.

Nivolumab and nivolumab-based combinations are also showing incredible survival benefits across tumor types, including melanoma and advanced renal cell carcinoma.

“We are encouraged by these positive results and remain steadfast in our commitment to bringing new solutions to patients with high unmet needs,” Walker said in the press release.

Reference

Briston Myers Squibb. 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. News Release. July 11, 2023. Accessed on July 12, 2023. https://news.bms.com/news/corporate-financial/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