Pembrolizumab Wins FDA Approval in Operable Lung Cancer

The FDA approved pembrolizumab (Keytruda) on Monday in combination with platinum-based chemotherapy for the perioperative treatment of resectable non-small cell lung cancer (NSCLC).

Approval was based on improved event-free survival (EFS) and overall survival (OS) in patients with stage II-IIIB (N2) NSCLC, as demonstrated in the KEYNOTE-671 trial.

In the phase III study of nearly 800 previously untreated patients, median EFS was not reached among patients randomized to pembrolizumab plus neoadjuvant chemotherapy plus pembrolizumab alone after surgery, as compared with 17 months for patients assigned to receive placebo in place of the checkpoint inhibitor (HR 0.58, 95% CI 0.46-0.72, P<0.0001).

Median OS, meanwhile, was also not reached in the pembrolizumab arm versus 52.4 months in the placebo arm (HR 0.72, 95% CI 0.56-0.93, P=0.0103).

“There remains a need for treatment options to improve outcomes for patients with earlier stages of non-small cell lung cancer,” principal investigator Heather Wakelee, MD, of Stanford University in Palo Alto, California, said in a statement from drugmaker Merck.

“This important milestone has the potential to change the current treatment paradigm for resectable non-small cell lung cancer that is greater than four centimeters or has lymph node involvement, by offering an immunotherapy-based regimen that has demonstrated statistically significant improvements in overall survival and event-free survival compared to a placebo and chemotherapy regimen,” she added.

Of note, the survival improvement was demonstrated despite a higher number of patients in the pembrolizumab arm being unable to undergo surgery following neoadjuvant therapy due to adverse events (6% vs 4.3% in the placebo arm). These patients were also more likely to have surgery delayed (3.1% vs 2.5%, respectively).

According to the full prescribing information, common adverse events (≥20% of patients) in KEYNOTE-671 included nausea and vomiting, fatigue, neutropenia, anemia, constipation, decreased appetite, decreased white blood cell counts, musculoskeletal pain, rash, cough, diarrhea, and dyspnea.

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