Merck's Keytruda scores key NICE sign-off for first-line NSCLC indication

Another day, another win for Keytruda.

On Friday, when England’s National Institute for Health and Care Excellence signed off on Merck’s megablockbuster for another indication, it represented a key breakthrough in the treatment of lung cancer—not just another in a long line of label expansions for the versatile drug.

NICE recommended Keytruda in combination with chemotherapies carboplatin and paclitaxel as an option for untreated metastatic squamous non-small-cell lung cancer. With the nod, Keytruda becomes the first immunotherapy to score NICE's backing in a first-line (1L) setting for this type of NSCLC, regardless of PD-L1 expression, when combined with chemotherapy.

With 48,000 new cases per year, lung cancer is the third most common form of cancer in the U.K and is the top cause of cancer deaths. Only 16% of those diagnosed survive for five or more years. Because symptoms rarely appear in the early stages, roughly 75% of people are diagnosed when the cancer has spread beyond the lungs. Roughly 80% of those with lung cancer have the NSCLC type.

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“(This) is a major breakthrough for this subtype of lung cancer which until now has had few treatment options, poor prognosis and relatively little positive research compared to other forms of lung cancer,” Toby Talbot, oncologist at Royal Cornwall Hospital, said in a release. “This treatment offers the hope of enhanced life expectancy compared to previous standard treatments.”

The approval is based on results from the Keynote 407 trial of 559 adults. Those who received Keytruda and chemotherpy lived a median 15.9 months, compared to 11.3 months for those on chemo alone, leading to a 36% reduction in the risk of death. NICE also was presented with subsequent evidence that found that after follow-up of 14.3 months, Keytruda and chemo patients had an overall survival of 17.1 months versus 11.6 months for those on chemo alone.

“We understand how devastating a lung cancer diagnosis is. That is why we welcome this treatment option,” Lorraine Dallas, the director of prevention information and support at the Roy Castle Lung Cancer Foundation, said in a release. “Having ways to manage their cancer and maintain their quality of life in the face of uncertainty is valuable.”  

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After its original FDA green light for advanced melanoma in 2014, Keytruda has gained 37 additional approvals and seen its sales skyrocket to $14.4 billion in 2020. Through three quarters of 2021, the treatment generated sales of $12.6 billion, which put it on track to reach $17 billion for the year.