Merck & Co.'s Keytruda wins EU nod for sixth lung cancer use

2024-03-28

临床结果上市批准临床3期免疫疗法

Merck & Co. said Thursday that the European Commission approved its immunotherapy Keytruda (pembrolizumab) for patients diagnosed with resectable non-small-cell lung cancer (NSCLC) at high risk of recurrence, regardless of PD-L1 expression. The approval marks the first time an anti-PD-1/L1 therapy has been cleared in Europe for this patient population based on positive overall survival (OS) results.

Specifically, the indication is for Keytruda to be paired with platinum-containing chemotherapy in the neoadjuvant setting, then continued as monotherapy after surgical resection. The FDA cleared Keytruda for a similar use last October (see - Spotlight On: Where Keytruda will slot into the perioperative lung cancer arena).

The EU filing, recently issued a positive opinion by the bloc's Committee for Medicinal Products for Human Use (CHMP), was supported by results from the 797-patient Phase III KEYNOTE-671 trial.

Adding Keytruda to neoadjuvant chemotherapy ahead of surgery, followed by Keytruda as a single agent in the adjuvant setting, reduced the risk of death by a significant 28% in resectable stage II, IIIA or IIIB NSCLC patients, compared to placebo plus chemotherapy in the neoadjuvant setting followed by placebo after surgical resection.

Median OS was not reached among those who received Keytruda, and was 52.4 months in the comparator group. The Keytruda-based regimen also improved event-free survival (EFS), lowering the risk of disease recurrence, progression or death by 41%, compared to the chemotherapy-placebo. With a median EFS of 47.2 months, the Keytruda regimen outperformed the chemotherapy-placebo arm by nearly 2.5 years.

Last October, EU regulators also authorised Keytruda as a monotherapy for the adjuvant treatment of NSCLC patients at high risk of recurrence following complete resection and platinum-based chemotherapy.

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