Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been approved by the European Commission (EC) in combination with cisplatin and gemcitabine as a first-line treatment in adult patients with unresectable or metastatic urothelial carcinoma (UC).
The approval marks Opdivo in combination with chemotherapy as the first concurrent immunotherapy-chemotherapy approved for this patient population in the EU.
Accounting for approximately 90% of all bladder cancer cases, the ninth most common cancer globally, UC most frequently occurs in the cells that line the inside of the bladder but can also occur in other parts of the urinary tract, such as the ureters and renal pelvis.
The EC’s decision “is a major step forward for this patient population,” said BMS’ vice president and global programme lead, gastrointestinal and genitourinary cancers, Dana Walker.
The regulator’s decision was based on results from the CheckMate-901 trial, which has been evaluating Opdivo in combination with cisplatin and gemcitabine or Opdivo in combination with Yervoy (ipilimumab) followed by Opdivo monotherapy compared to standard-of-care chemotherapy alone in patients with untreated, unresectable or metastatic UC.
Presented at the European Society of Medical Oncology Congress 2023, results showed that Opdivo in combination with cisplatin and gemcitabine followed by Opdivo monotherapy demonstrated statistically significant and clinically meaningful improvement in the primary efficacy endpoints of overall survival and progression-free survival, compared to chemotherapy alone.
In addition, the safety profile was consistent, with no new safety concerns identified.
Walker added: “With [the] approval by the EC, we’re pleased to be able to offer Opdivo concurrently with chemotherapy to eligible patients with unresectable or metastatic UC.”
Already approved in more than 65 countries, including the US, EU, Japan and China, Opdivo is a PD-1 immune checkpoint inhibitor that works to utilise the body’s own immune system to help restore an anti-tumour immune response.
Opdivo is also approved to treat ten different cancer indications in the EU, including non-small cell lung cancer, melanoma and oesophageal squamous cell carcinoma.
In March, BMS announced that Opdivo had been approved by the US Food and Drug Administration to treat a subset of patients with UC based on results from the CheckMate-901 trial.