NICE okays Merck’s Keytruda, giving it parity with Opdivo for adjuvant melanoma

UNITED KINGDOM – Merk & Co’s checkpoint inhibitor Keytruda, which has been available for three years through the Cancer Drugs Fund (CDF), has now been approved for routine NHS use after surgery for people with melanoma to prevent the cancer from returning.

National Institute for Health and Care Excellence (NICE) has recommended the PD-1 inhibitor Keytruda (pembrolizumab) for adjuvant treatment of adults with stage 3 melanoma that has spread to the lymph nodes, with the goal of removing any cancer left behind after surgery.

Since November 2018, Keytruda has been available for this use through the CDF, which provides interim access to drugs while additional data on their efficacy and safety is gathered

Merck & Co. stated that the transition to routine NHS commissioning “follows a successful period of monitoring and patient access.”

The move brings Merck & Co back into line with Bristol-Myers Squibb, whose PD-1 inhibitor Opdivo (nivolumab) was approved for routine NHS use in February. Both companies have promised to give the NHS a confidential discount on their drugs.

The change in status is an endorsement of Keytruda’s clinical profile as an adjuvant melanoma treatment, a use approved by regulators based on the phase 2 KEYNOTE054 trial, which demonstrated that it reduced the risk of disease recurrence or death by 44% compared to placebo.

Merck has since claimed approval in the United States for Keytruda as adjuvant treatment for adults and children over the age of 12 with stage 2b or 2c melanoma based on the KEYNOTE-716 trial, which demonstrated a 35% reduction in disease recurrence or death versus placebo. In Europe, use in stage 2 melanoma is not yet approved.

Melanoma Focus, a patient organization, has welcomed Keytruda’s new status, stating that fear of recurrence is a major concern.

A huge emotional burden for patients and families and in particular for the growing population of melanoma patients who are diagnosed at a younger age.”

Moving checkpoint inhibitors further up the treatment pathway, into adjuvant and neoadjuvant (pre-surgery) lines of therapy, is a key goal for their developers, with the goal of increasing the patient population eligible for treatment and improving the chances of a good clinical outcome.

Since receiving FDA approval for advanced melanoma in 2014, Keytruda has received 37 additional approvals, with sales shot up to US$14.4 billion by 2020.

Through the first three quarters of 2021, the treatment generated US$12.6 billion in sales, putting it on track to reach US$17 billion for the year, Fiercepharma reports.

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