The UK’s National Institute for Health and Care Excellence (NICE) has recommended a new combination regimen in metastatic urothelial carcinoma (mUC) for use by the National Health Service (NHS).
This means that patients across the UK will now have access to a dual-pronged, targeted treatment approach, which combines Astellas Pharma and Pfizer’s antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) with MSD’s Keytruda (pembrolizumab).
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Padcev and Keytruda were made available to patients through the signing of commercial deals between NHS England and both Astellas and MSD. These agreements brought prices of the drug down, allowing NICE to deem the treatment “cost-effective”.
The combination was approved as a therapeutic regimen by the US Food and Drug Administration (FDA) in December 2023, which the European Commission (EC) and Medicines and Healthcare products Regulatory Agency (MHRA) echoed, giving the two drugs the go-ahead in September and October 2024, respectively.
Padcev-Keytruda is now the standard of care (SoC) in first-line mUC treatment due to the positive results of the Phase III EV-302 trial (NCT04223856), which found that the cancer-fighting duo could reduce the risk of disease progression or death by 55%.
Following its introduction to the bladder cancer market, the combination will join Bristol Myers Squibb’s (BMS) blockbuster PD-1 blocker Opdivo (nivolumab), which is available through the NHS as an adjuvant treatment to surgery for high-risk, muscle-invasive bladder cancer (MIBC) in chemotherapy-ineligible patients.
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By GlobalDataIn the US, the drug is generally prescribed in MIBC patients alongside cisplatin and gemcitabine for first-line treatment of MIBC. However, a report by GlobalData predicts that Padcev-Keytruda will absorb a significant proportion of Opdivo’s market share moving forward.
This will likely be driven by the results of the Phase III EV-303/KEYNOTE-905 trial (NCT03924895), which found that the combination extended survival in cisplatin-ineligible patients – an effect that was observed before and after surgical cystectomy.
The combination’s strong efficacy profile only further bolsters the current success of Keytruda, which has dominated the oncology market – so much so that it was the best-selling drug of 2024, raking in $29.5bn for MSD. In the short term, analysts at GlobalData forecast that the drug’s sales will continue to climb, peaking at $35.7bn in 2027.
However, sky-high sales of the PD-1 inhibitor may soon crash back down to earth, as the key US patents covering its exclusivity are set to expire in 2028. Following this, Keytruda will face significant competition from generics, with GlobalData’s analysts predicting that income from the drug will drop by 53% to $16.7bn in 2031.
To try and curb this impact, MSD has developed a subcutaneous form of Keytruda, which is currently under regulatory review with the FDA. The regulator is expected to make a final decision on the drug by 23 September 2025.
Meanwhile, the longer-term growth outlook for Padcev is positive, as GlobalData’s analysts forecast that the drug’s sales are set to bring in $6.3bn by 2031. Pfizer and Astellas are also conducting trials to widen Padcev’s potential, with 27 clinical trials currently exploring the drug’s efficacy in bladder and urinary tract cancers.
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