First-in-Class! FDA Approves Bristol Myers Squibb’s First-Line Combination Therapy for Bladder Cancer

Mar 08, 2024 07:48 CST Updated 07:48

Bristol-Myers Squibb

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▎WuXiEdited by Kant Content Team

Bristol Myers Squibb Company announced today that the U.S. FDA has approved its重磅 PD-1 inhibitor Opdivo in combination with cisplatin and gemcitabine as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma (UC), the most common type of bladder cancer. The press release noted,This is the first-line combination therapy that uses immunotherapy and chemotherapy simultaneously for treating this patient population.

This approval is based on the results of the CheckMate-901 trial, in which, at a median follow-up of approximately 33 months, compared with cisplatin and gemcitabine aloneOpdivo, when used in combination with cisplatin and gemcitabine, reduces the risk of patient death by 22%.，The median overall survival (OS) in the Opdivo combination therapy group was 21.7 months, compared to 18.9 months in the cisplatin + gemcitabine group (HR=0.78; 95% CI: 0.63, 0.96; p=0.0171). Patients receiving Opdivo in combination with cisplatin and gemcitabineThe risk of disease progression or death was reduced by 28%., the median progression-free survival (PFS) was 7.9 months, and the PFS for the cisplatin plus gemcitabine group was 7.6 months (HR=0.72; 95% CI: 0.59, 0.88; p=0.0012).

Moreover, in the exploratory analysis, the objective response rate (ORR) was 57.6% (n=175, 95% CI: 51.8, 63.2) in the Opdivo combination therapy group and 43.1% (n=131, 95% CI: 37.5, 48.9) in the control group. The complete response (CR) rate and partial response (PR) rate were 22% (n=66) and 36% (n=109), respectively, in the Opdivo combination therapy group, compared to 12% (n=36) and 31% (n=95), respectively, in the control group.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses by utilizing the body's own immune system to fight cancer.The FDA has previously approved Opdivo for adjuvant treatment of adult UC patients who are at high risk of recurrence after undergoing radical resection for UC; the FDA also approved Opdivo for the treatment of adult patients with locally advanced or metastatic UC whose disease progresses during or after platinum-containing chemotherapy, or those who experience disease progression within 12 months following platinum-based neoadjuvant or adjuvant therapy.

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References:

[1] U.S. Food and Drug Administration Approves Opdivo ® (nivolumab), in Combination with Cisplatin and Gemcitabine, for First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma. Retrieved March 7, 2024, from https://news.bms.com/news/details/2024/U.S.-Food-and-Drug-Administration-Approves-Opdivo--nivolumab-in-Combination-with-Cisplatin-and-Gemcitabine-for-First-Line-Treatment-of-Adult-Patients-with-Unresectable-or-Metastatic-Urothelial-Carcinoma/default.aspx

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