Bladder cancer is highly prevalent in the developed world and is the sixth most common cancer diagnosis.

The average five-year survival rate in the US is 77%, but this number drops to 5% for patients with metastatic disease.

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Urothelial carcinoma (UC) is the most predominant subtype, making up 90% of bladder cancer cases.

The last decade saw no new developments in the management of advanced and metastatic UCs (mUCs), with platinum-based therapies being the standard of care (SOC) in the first line, followed by the introduction of Merck’s Bavencio for maintenance therapy.

This paradigm has since changed with the introduction of immunotherapies, although many UC cases are progressive and have poor prognosis following immunotherapy treatment with a median overall survival (OS) of only 7.3 months.

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The EV-302 trial assessed Pfizer’s Padcev, an antibody-drug conjugate, in combination with Merck’s Keytruda in the treatment of 886 patients who had UC and were treatment-naive.

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The trial compared this combination against well-established chemotherapy gemcitabine in combination with either cisplatin or carboplatin.

Recently published results from the trial demonstrated that the Padcev-treated group significantly improved both progression-free survival (PFS) and OS compared to the chemotherapy control arm, by 6.2 and 15.4 months, respectively (P<0.001).

The Padcev arm also had a lower incidence of treatment-related adverse events (AEs) that were grade three or higher when compared to the chemotherapy arm (55.9% versus 69.5%).

These impressive results have enabled the Padcev-Keytruda combination to become the SOC for the first-line treatment of mUCs.

Trailing Pfizer’s monumental success, Bristol Myers Squibb’s Opdivo also received US Food and Drug Administration (FDA) approval for the first-line treatment of mUCs following the CHECKMATE-901 clinical trial results.

The trial recruited 608 patients and demonstrated solid clinical improvements for patients receiving Opdivo and gemcitabine-cisplatin compared to gemcitabine-cisplatin alone.

The Opdivo combo improved the 12-month PFS by 12.4%. The OS was also improved in the Opdivo arm, with a hazard ratio of 0.78 (P=0.02).

However, grade three AEs were higher in the Opdivo group, with 61.8% experiencing grade three events compared to 51.7% in the control arm.

Leading data and analytics company GlobalData analyst consensus forecasts predict total global sales of Padcev to reach $5.7bn by 2030 while Opdivo’s total sales will be at $8.5bn, falling significantly from 2029’s predicted $11.5bn due to biosimilar erosion.

Padcev and Keytruda will encompass a large share of the mUC market due to their dramatic improvement in OS, as well as their relatively improved safety profile compared to Opdivo alongside chemotherapy.

Although the clinical success of Padcev, Keytruda, and Opdivo is reassuring, there remains a significant unmet need in subsequent lines of therapy, particularly with patients who see disease progression despite immunotherapy treatment.

While there is little room in the first-line market for UCs, subsequent treatment lines are rife with opportunity.

Johnson & Johnson’s Balversa, a fibroblast growth factor receptor kinase inhibitor, received FDA approval for patients with FGFR3 gene alterations following one line of prior systemic therapy.

This label also specifies that patients should receive programmed cell death protein 1 (PD-1) or PD-L1 inhibitors prior to therapies.

The approval follows results from the THOR study, which assessed 351 patients who had one prior treatment and were anti-PD-L1 treatment-naive.

Balversa was compared against Keytruda and showed relatively even results with the well-established immunotherapy.

OS was 10.9 months versus 11.1 months for Balversa and Keytruda, respectively, with no significant difference between the two arms.

Ultimately while Padcev and Keytruda see broad application as the new SOC in the first line, Balversa may see promising results in subsequent lines of therapy, leaving little room for Opdivo to contest the market.