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Keytruda gains NICE clearance in first line bladder cancer

MSD extends advantage in immunotherapy with Cancer Drugs Fund clearance


MSD is extending Keytruda’s advantage over rival immunotherapy treatments in England and Wales, with NICE approving its extended use in bladder cancer.

Cost effectiveness watchdog NICE issued a Final Appraisal Determination (FAD) on Friday, recommending MSD’s treatment within the cancer drugs fund (CDF) for untreated locally advanced or metastatic urothelial carcinoma in adults when cisplatin-containing chemotherapy is unsuitable.

This makes it the first and only immunotherapy recommended by NICE on the CDF for both cisplatin ineligible and prior platinum-containing chemotherapy treated bladder cancer patients.

This adds to Keytruda’s existing NICE approval in melanoma and second line and first line PD-L1 positive non-small cell lung cancer (NSCLC).

Keytruda costs £2,630 per 100 mg vial in the UK (excluding VAT), however MSD has once again struck a confidential discount on its price with NHS England.

The recommendation states that Keytruda’s use should be stopped at two years of uninterrupted treatment, or earlier in the event of disease progression, and stresses that the NHS should follow the conditions in the managed access agreement.

The decision puts MSD’s drug ahead of its nearest rivals in bladder cancer, Roche and its immunotherapy Tecentriq, which gained NICE approval in December for use in the CDF in bladder cancer patients for whom cisplatin-based chemo is unsuitable.

Meanwhile NICE rejected Bristol-Myers Squibb’s Opdivo in second line bladder cancer last year, and the company is attempting to get this decision reversed with an updated value proposal.

Pembrolizumab is already the only immunotherapy that has been recommended by NICE for inclusion in the CDF for urothelial cancer patients who have failed on platinum containing chemotherapy.

Andrew Winterbottom, Founder and CEO of Fight Bladder Cancer, said his  organisation was “absolutely delighted” with the news.

“A cisplatin-containing chemotherapy is usually the first line of treatment for people with late stage bladder cancer, but many patients may not be suitable due to underlying clinical parameters. If people can’t tolerate it, there aren’t many options left. It is very exciting to see breakthroughs like this, where new treatments are likely to offer meaningful objective response for a number of patients receiving treatment and it is generally well tolerated - a major change in clinical practice.”

MSD’s KEYNOTE-052 trial submitted to support the NICE submission is early stage and not mature, however  - hence why NICE has once again used the ‘managed entry’ system of the CDF.

MSD’s KEYNOTE-052 is an ongoing phase 2, single-arm trial which included 370 patients who had not had chemotherapy for advanced or metastatic urothelial cancer and for whom cisplatin was considered ineligible.

The primary efficacy outcome measure was Objective Response Rate (ORR) and this was all patients was 29 % in all 310 patients, and 47% in those with PD-L1-expression cutoff of 10%.

Results from a median duration of follow-up of 9.5 months showed that median overall survival for pembrolizumab was 11.0 months and median progression-free survival was 2.3 months. If MSD’s studies show these figures translate into longer overall survival, Keytruda is likely to gain approval for routine use on the NHS once its CDF status expires.

While the bladder cancer approval is good news for MSD, immunotherapy continues to hold surprises as companies extend into new tumour types.

NICE has begun a review of Keytruda in another setting -  previously treated oesophageal or gastro-oesophageal junction cancer, for which the firm hasn’t yet secured EMA approval.  However trial data in December from KEYNOTE-61 in these patients showed the drug failed to meet its primary endpoint of overall survival.

Article by
Andrew McConaghie

30th April 2018

From: Regulatory



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