Merck & Co – known as MSD outside the US and Canada – has announced that the European Commission (EC) has approved its anti-PD-1 therapy Keytruda (pembrolizumab) for expanded lung cancer use.
The decision, which specifically applies to adults with resectable non-small cell lung cancer (NSCLC) at high risk of recurrence, means that Keytruda can now be used in combination with platinum-containing chemotherapy as a neoadjuvant treatment and then continued as a monotherapy in the adjuvant setting.
Lung cancer is the leading cause of cancer death worldwide and NSCLC accounts for approximately 80% of all lung cancer cases.
Merck outlined that the approval marks the sixth lung cancer indication in Europe for Keytruda, which works by increasing the ability of the body’s immune system to help detect and fight tumour cells.
The EC’s latest approval on the therapy follows a recent recommendation from the European Medicines Agency’s human medicines committee and was supported by positive results from the phase 3 KEYNOTE-671 trial.
At a median follow-up of 29.8 months, the Keytruda regimen significantly improved overall survival, reducing the risk of death by 28% versus placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection, regardless of PD-L1 expression.
For patients who received the Keytruda-based regimen, median overall survival was not reached, compared with 52.4 months for those in the chemotherapy/placebo group.
The Keytruda regimen was also shown to improve event-free survival, reducing the risk of disease recurrence, progression or death by 41% compared to chemotherapy/placebo therapy.
Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, said the approval “demonstrates [the company’s] continued progress to advance treatments in earlier stages of lung cancer”.
She continued: “We are eager to build on this momentum as we plan to seek additional approvals of this regimen around the world and to work together with the cancer community to help drive earlier diagnosis of lung cancer, an urgent need.”
The approval comes just two days after Merck’s Winrevair (sotatercept-csrk) was approved by the US Food and Drug Administration to treat adults with pulmonary arterial hypertension (PAH), a rare and progressive disorder in which the blood vessels in the lungs thicken and narrow.
Winrevair, which is now the first FDA-approved activin signalling inhibitor therapy for PAH, has been indicated to increase exercise capacity, improve World Health Organization functional class and reduce the risk of clinical worsening events.