Opdivo-Based Regimen Becomes First Immune Therapy to Demonstrate Significant Benefit Over Cisplatin Chemotherapy in First-Line UC Treatment

ShanghaiOctober 20, 2023PR Newswire -- Bristol-Myers Squibb recently announced the first published data from the Phase III clinical study CheckMate -901. According to an assessment by the Blinded Independent Central Review Committee (BICR), compared with standard cisplatin-based chemotherapy, Opdivo (nivolumab) combined with cisplatin-based chemotherapy followed by Opdivo monotherapy as a first-line treatment for cisplatin-tolerant patients with unresectable or metastatic urothelial carcinoma showed significant and clinically meaningful improvements in both primary endpoints of overall survival (OS) and progression-free survival (PFS).

Data with a median follow-up of approximately 33 months showed,OpdivoCombination with cisplatin-based chemotherapy regimens reduced the risk of patient death by 22%, with a median OS of 21.7 months, compared to 18.9 months in the chemotherapy-alone group (Hazard Ratio [HR] 0.78; 95% Confidence Interval [CI]: 0.63 to 0.96; P=0.0171). In the 12-month and 24-month analyses, patients receiving upfront...OpdivoThe OS rates for patients receiving a combination of cisplatin-based chemotherapy were 70.2% and 46.9%, respectively, while the OS rates for patients receiving chemotherapy alone were 62.7% and 40.7%, respectively. Among those receivingOpdivoIn patients receiving combination therapy, the risk of death or disease progression was reduced by 28%, with a median PFS of 7.9 months, compared to 7.6 months in the chemotherapy-only group (HR 0.72; 95% CI: 0.59 to 0.88; P=0.0012). The 12-month and 24-month PFS rates were 34.2% and 23.5%, respectively, versus 21.8% and 9.6% in the chemotherapy-only group.OpdivoThe combination chemotherapy regimen based on cisplatin was well tolerated, consistent with the known safety data of its components. No new safety signals were observed.

Moreover, in exploratory analyses, the objective response rate (ORR) was approximately 15% higher in the Opdivo plus cisplatin-based therapy group compared to the chemotherapy-alone group (57.6% vs. 43.1%), with nearly double the number of patients achieving complete response (CR; 21.7% vs. 11.8%). The Opdivo plus cisplatin-based chemotherapy regimen demonstrated longer response duration, with a median duration of complete response almost three times that of the chemotherapy-alone group (37.1 months vs. 13.2 months).

These data will be disclosed for the first time at the Presidential Symposium of the 2023 European Society for Medical Oncology (ESMO) Annual Meeting, held from 10:30 AM to 12:15 PM Eastern Standard Time (EST) on October 22, 2023 / 4:30 PM to 6:15 PM Central European Time (CET) (Abstract #LBA7).

"In the first-line treatment of patients with metastatic urothelial carcinoma, chemotherapy alone has shown limited durability of response, which has long been a major challenge in treating this difficult-to-treat disease."Michiel S. van der Hejiden, MD, Department of Medical Oncology, Netherlands Cancer Institute (NCI, Amsterdam, the Netherlands)"Nivolumab combined with a cisplatin-based chemotherapy regimen brings a significant survival benefit, which is a major achievement because, compared to the standard cisplatin-based chemotherapy, this is the first combination of chemotherapy and immunotherapy to show substantial improvement, offering new hope for patients with urothelial carcinoma. These data not only have the potential to change clinical practice but also could revolutionize the treatment model for cisplatin-tolerant patients."

"Until now, for patients with unresectable or metastatic urothelial carcinoma who are cisplatin-ineligible, there has been a persistent lack of effective first-line treatment options based on immunotherapy. Today, we are proud to see that the results of CheckMate -901 indicate that Opdivo in combination with cisplatin-based chemotherapy can bring hope and survival benefits to these patients."Dana Walker, M.D., Vice President of Bristol-Myers Squibb and Head of Genitourinary Oncology Development Program"The results of the CheckMate -901 study reinforce our existing research findings and further confirm that treatment regimens based on Opdivo can improve overall survival across multiple tumor types, including genitourinary cancers. In the coming months, we look forward to discussing these findings with health authorities around the world. We are also very excited about the possibility of providing a new, clinically needed treatment option for patients with urothelial carcinoma."

Bristol-Myers Squibb sincerely thanks all the patients and researchers who participated in the CheckMate -901 clinical study.

OpdivoAndOpdivoThe combination therapy based on it has shown significant improvement in OS in Phase III clinical trials across multiple tumor fields, including metastatic urothelial carcinoma, advanced renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, metastatic melanoma, and esophageal squamous cell carcinoma, etc.