Immunotherapy with Opdivo plus cisplatin-based chemotherapy improved overall survival and progression-free survival in patients with unresectable or metastatic urothelial carcinoma.
Preliminary findings from a substudy demonstrated that Opdivo (nivolumab) plus cisplatin-based chemotherapy provided significant survival benefits in patients with unresectable or metastatic urothelial carcinoma, a type of bladder cancer.
In particular, patients with unresectable or metastatic urothelial carcinoma treated with Opdivo plus cisplatin-based chemotherapy obtained significant benefits in overall survival (the time from treatment when a patient with cancer is still alive) and progression-free survival (the time during and after treatment when a patient with cancer lives with the disease without worsening) compared with those treated with chemotherapy alone, according to a press release from Bristol Myers Squibb, the manufacturer of Opdivo. These findings were based on a substudy of the phase 3 CheckMate-901 trial.
“Today’s news is yet another example of the power of immunotherapy combinations to transform outcomes for patients with cancer,” Dr. Dana Walker, vice president, global program lead, genitourinary cancers at Bristol Myers Squibb, said in the release. “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.”
In addition, researchers conducting this study noted a tolerable safety profile with Opdivo plus cisplatin-based chemotherapy with no new side effects observed, according to the release.
The substudy of the CheckMate-901 trial is comparing Opdivo plus cisplatin-based chemotherapy with chemotherapy alone in 608 patients with untreated, unresectable or metastatic urothelial carcinoma who are eligible for treatment with cisplatin. Patients were randomly assigned either 360 milligrams of Opdivo plus chemotherapy every three weeks or chemotherapy alone. The main areas of focus for the substudy were overall survival and progression-free survival.
This substudy is part of a primary trial — CheckMate-901 — assessing Opdivo plus Yervoy (ipilimumab) with chemotherapy versus chemotherapy alone, and is still ongoing, according to the release. Researchers aim to enroll an estimated 1,290 patients with previously untreated, unresectable or metastatic urothelial carcinoma, with an estimated study completion date of July 15, 2025, as noted in its ClinicalTrials.gov listing.
Urothelial carcinoma accounts for most bladder cancer cases — 90%, according to the release — and typically originates in cells that line the inside of the bladder. This disease may also originate in other areas within the urinary tract including the renal pelvis and ureters.
Although the majority of patients receive a urothelial carcinoma diagnosis at an early stage, nearly 50% of patients who undergo surgery may experience recurrence or progression within two to three years after undergoing the procedure, according to the release.
Twenty to 25% of patients may also develop metastatic disease, which represents a challenge regarding treatment since responses are not that durable in the first-line setting.
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