Opdivo by Bristol Myers Shows Positive Results in Phase 3 Trial for Bladder Cancer Patients

According to the results of a late-stage clinical trial, Opdivo, an immunotherapy developed by Bristol Myers Squibb, has demonstrated the ability to improve survival in patients with a specific type of bladder cancer when used in combination with chemotherapy.

In comparison to standard-of-care chemotherapy, the drug not only achieved the primary goal of extending overall survival but also prevented disease progression in patients undergoing treatment.

Furthermore, when compared to chemotherapy alone, the combination of Opdivo and chemotherapy proved to be more effective in suppressing tumor progression.

The study focused on patients with urothelial carcinoma who were eligible for standard-of-care cisplatin-based chemotherapy, which is a type of platinum-based chemotherapy.

This success for Bristol Myers Squibb comes after the failure of the CheckMate-901 trial, which found that the combination of Opdivo and Yervoy, a CTLA-4 inhibitor also developed by Bristol Myers Squibb, did not work in bladder cancer patients. Particularly for patients whose tumors expressed the PD-L1 biomarker, the treatment was notably ineffective.

Although Opdivo is one of Bristol Myers Squibb’s top-selling treatments, with Refinitiv and analysts predicting sales exceeding $8 billion this year, the introduction of Merck’s rival drug Keytruda has led to a decline in sales in recent years.

Bristol Myers Squibb may face further competition from Merck due to its new phase 3 EV-302 trial, which combines Keytruda with Padcev, an antibody-drug conjugate developed by Astellas and Seagen. The study aims to evaluate the Keytruda-Padcev regimen as a first-line treatment for bladder cancer, regardless of the patient’s eligibility for cisplatin. Results from the study have not yet been made public but are expected to be announced later this year.

Leerink Partners analysts have projected estimated peak sales of $5 billion for Padcev in front-line bladder cancer treatment across the U.S. and Europe. Additionally, the combined regimen has received accelerated approval from the Food and Drug Administration for first-line, cisplatin-ineligible bladder cancer.

Previously, a combination of Keytruda and chemotherapy failed to significantly outperform chemotherapy alone as a treatment, leading to restrictions on the drug’s approval for only a specific subset of patients.

In addition to these promising late-stage results, Bristol Myers Squibb may challenge Merck’s dominance in bladder cancer by competing with Merck KGaA. Currently, Merck’s Bavencio serves as a standard maintenance therapy for patients who have responded to initial platinum-based chemotherapy. Bavencio acts as a single agent after chemotherapy, while the new study suggests the use of the Opdivo-chemo combination as an initial treatment, followed by Opdivo monotherapy as an alternative regimen.

Opdivo was initially approved by the FDA in 2014 and later, in 2017, received approval as a treatment for certain types of bladder cancer. It has since been recognized as a follow-up treatment for patients at risk of bladder cancer recurrence after radical resection.

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