Pembrolizumab/Chemo Earns European Approval in Resectable NSCLC

The European Medicine Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on the approval of pembrolizumab/chemotherapy for patients with resectable NSCLC in February 2024.

The European Commission has approved neoadjuvant pembrolizumab (Keytruda) plus platinum-based chemotherapy followed by adjuvant pembrolizumab monotherapy for adult patients with resectable non–small cell lung cancer (NSCLC) who are at high risk of recurrence, according to a press release from Merck, the developers of pembrolizumab.¹

Supporting data for the approval came from the phase 3 KEYNOTE-671 trial (NCT03425643). After a median follow-up of 29.8 months (range, 0.4-62.0), pembrolizumab plus chemotherapy reduced the risk of death by 28% compared with placebo plus chemotherapy (HR, 0.72; 95% CI, 0.56-0.93; P = .00517). The median overall survival (OS) was not reached (NR; 95% CI, NR-NR) with the pembrolizumab combination vs 52.4 months (95% CI, 45.7-NR) in the placebo arm.

Treatment with pembrolizumab plus chemotherapy yielded a 41% reduction in the risk of disease recurrence, progression, or death compared with placebo plus chemotherapy (HR, 0.59; 95% CI, 0.48-0.72). The median event-free survival (EFS) was 47.2 months (95% CI, 32.9-NR) with pembrolizumab/chemotherapy and 18.3 months (95% CI, 14.8-22.1) with placebo/chemotherapy.

“Despite the clinical advances for patients with metastatic lung cancer, lung cancer continues to be the leading cause of cancer death in Europe, reinforcing the need to treat these patients in earlier stages of their disease, where we may have the most impact,” Solange Peters, MD, PhD, chair of the medical oncology and thoracic malignancies department, Centre Hospitalier Universitaire Vaudois, Lausanne, Switzerland, said in the press release.¹ “The approval of this [pembrolizumab]-based regimen is an important milestone for patients diagnosed with resectable [NSCLC] at high risk of recurrence, regardless of PD-L1 expression, providing a new option for these patients that has shown, through the results of the phase 3 KEYNOTE-671 trial, the potential to help extend their lives.”

In the KEYNOTE-671 trial, 797 patients were randomly assigned to receive pembrolizumab at 200 mg intravenously every 3 weeks or matched placebo plus chemotherapy for up to 4 cycles as neoadjuvant treatment before surgery. Following surgery, patients received pembrolizumab or placebo every 3 weeks for a maximum of 13 cycles.

The trial’s primary end points were EFS and OS. Secondary end points included pathologic complete response and major pathologic response.

The European Medicine Agency’s Committee for Medicinal Products for Human Use issued a positive opinion on the approval of pembrolizumab/chemotherapy for patients with resectable NSCLC in February 2024.² Additionally, the FDA previously approved pembrolizumab plus chemotherapy for this patient population in October 2023 based on findings from the KEYNOTE-671 trial.³

References

1. European Commission approves Merck’s KEYTRUDA® (pembrolizumab) plus chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for resectable non-small cell lung cancer (NSCLC) at high risk of recurrence in adults. News release. Merck. March 28, 2024. Accessed March 28, 2024. https://tinyurl.com/mtxusy2m
2. Merck receives positive EU CHMP opinion for KEYTRUDA® (pembrolizumab) in combination with chemotherapy as neoadjuvant treatment, then continued as monotherapy as adjuvant treatment, for the treatment of resectable NSCLC at high risk of recurrence. News release. Merck. February 23, 2024. Accessed March 28, 2024. http://tinyurl.com/2cx5k39a
3. FDA approves neoadjuvant/ adjuvant pembrolizumab for resectable non-small cell lung cancer. News release. FDA. October 16, 2023. Accessed March 28, 2024. https://bit.ly/3M3hfyi