Clinical Trials

In a recent study, patients who took Keytruda before and after surgery had better results than those who only had surgery.

As doctors weigh various immunotherapy strategies for the treatment of early-stage non-small cell lung cancer (NSCLC), Merck & Co. has now unveiled new data that it hopes can establish Keytruda, used both before and after surgery, as a new standard of care.

Using Keytruda around surgery reduced the risk of disease recurrence, progression or death by 42% in patients with resectable stage 2 to 3b NSCLC, according to data to be presented at the American Society of Clinical Oncology’s (ASCO) annual meeting.

Keytruda mounted that event-free survival (EFS) benefit during an interim analysis of the KEYNOTE-671 trial. In the study, the PD-1 inhibitor is being used on top of neoadjuvant chemo before surgery and then as a single-agent adjuvant therapy after surgery. It’s being pitted against neoadjuvant chemo alone followed by resection and placebo. The continuous use of a treatment before and after surgery is known as a perioperative regimen.

We anticipate that this will be a really major addition to treatment standards for patients with early-stage lung cancer. – Eliav Barr, M.D., chief medical officer at Merck Research Laboratories, said in an interview with Fierce Pharma ahead of the data release.

Based on the phase 3 data, Merck is seeking FDA approval for Keytruda as a perioperative treatment in early lung cancer. It’s slated to receive a decision from the agency by October 16.

KEYNOTE-671 adds to a stable of positive immunotherapy readouts in early NSCLC, potentially complicating doctors’ treatment choices. Speaking with analysts with SVB Securities, two cancer experts described the landscape as “messy” because of the various approaches.

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