NICE gives Keytruda parity with Opdivo for adjuvant melanoma

After three years of availability via the Cancer Drugs Fund (CDF), MSD's checkpoint inhibitor Keytruda has now been approved for routine NHS use after surgery for people with melanoma to prevent the cancer returning.

PD-1 inhibitor Keytruda (pembrolizumab) has been recommended by NICE for adjuvant treatment of adults with stage 3 melanoma that has spread to the lymph nodes, aiming to remove any cancer left behind after surgery.

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

MSD – known as Merck & Co in North America – said the upgrade to routine NHS commissioning "follows a successful period of monitoring and patient access."

The move puts MSD back on level pegging with Bristol-Myers Squibb, whose PD-1 inhibitor Opdivo (nivolumab) was moved from the CDF to routine NHS use in February. Both companies have promised to provide their drugs to the NHS at a confidential discount.

The change in status is an endorsement of Keytruda's clinical profile as an adjuvant melanoma treatment, a use that was approved by regulators on the back of the phase 2 KEYNOTE‑054 trial which showed that it reduced the risk of disease recurrence or death by 44% compared to placebo.

Since then, MSD has also claimed approval in the US for Keytruda as adjuvant treatment of adults and children aged over 12 with stage 2b or 2c melanoma based on the KEYNOTE-716 trial, which showed a 35% reduction in disease recurrence or death versus placebo. Use in stage 2 melanoma isn't approved yet in Europe.

The new status for Keytruda has been welcomed by patient organisation Melanoma Focus, which said that fear of recurrence is "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."

"It is a mark of how far we have come in treatment in recent years that we can now substantially improve survival and significantly reduce those fears," said the group's chief executive Susanna Daniels.

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