NICE backs bladder cancer duo that can double survival

A new treatment regimen for advanced bladder cancer combining MSD's Keytruda with Astellas' Padcev has been given the green light for NHS use in England and Wales.

Reimbursement authority NICE has backed the use of the two drugs as a first-line option for patients living with urothelial cancer (UC) – the most common form of bladder cancer – which has spread to other parts of the body or cannot be completely removed by surgery.

The combination of PD-1 inhibitor Keytruda with Nectin-4-directed antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) becomes an alternative to chemotherapy for this type of cancer and has been described by oncologists as a 'practice-changing' regimen for this type of cancer.

Five-year survival rates with chemotherapy have remained stubbornly low at around 12%, but Padcev/Keytruda looks set to improve on that. In the EV-302 trial, the combination almost doubled the time to disease progression or death to 12.5 months from 6.3 months compared to platinum-based chemo, with a median overall survival (OS) of 31.5 months versus 16.1 months.

NICE's final draft guidance (PDF) means that more than three-quarters (77%) of people diagnosed with metastatic UC in England, who are currently eligible for chemo, can now be offered Padcev/Keytruda.

Patient organisation Action Bladder Cancer said the decision is "welcome news for a badly neglected group of patients" who have not seen any significant advance in treatment for decades. It also pointed out that, unlike chemo, the new regimen is generally well-tolerated, which "has a direct effect on quality of life, both for the patient and also for their loved ones."

MSD said that around 10,000 people are diagnosed with bladder cancer each year in the UK, excluding Wales, and it is the 11th most common cancer in the UK. It is estimated that 1,250 people a year could benefit from the treatment.

NICE's recommendation is the second this year for a new therapy for advanced bladder cancer, coming after it backed NHS use of Johnson & Johnson's oral drug Balversa (erdafitinib) for adults with metastatic or unresectable FGFR-altered UC who have previously received at least one line of therapy containing a PD1/PD-L1 inhibitor.

Earlier this month, Astellas and Pfizer – which has rights to Padcev in the US and some other markets – also reported the results of the EV-303 study, which showed that neoadjuvant/adjuvant use of Padcev/Keytruda combination improved overall survival when used before and after surgery in patients with early-stage bladder cancer who were not eligible for cisplatin chemotherapy.