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Pembro Plus Chemo Fails to Show Efficacy Benefit in TKI-Resistant, EGFR-Mutated, Metastatic Nonsquamous NSCLC (KEYNOTE-789)

*June 2023*

Key Points:

  • KEYNOTE-789 did not show a significant improvement in PFS or OS with the addition of pembrolizumab to chemotherapy in patients with TKI-resistant EGFR-mutated metastatic nonsquamous NSCLC.
  • There remains a need for more effective treatment strategies for patients with EGFR-mutated NSCLC.

An analysis from the randomized, phase 3 KEYNOTE-789 trial did not show a significant efficacy benefit with the addition of pembrolizumab to chemotherapy in patients with tyrosine kinase inhibitor (TKI)-resistant, EGFR-mutated metastatic nonsquamous non–small cell lung cancer (NSCLC). The findings were presented during the 2023 ASCO Annual Meeting by James Chih-Hsin Yang, MD, PhD, of National Taiwan University Hospital and National Taiwan University Cancer Center, in Taipei, Taiwan (LBA9000).

Although there was a trend toward improved progression-free survival (PFS; HR 0.80; P = .0122) and improved overall survival (OS; HR 0.84; P = .0362) with pembrolizumab versus placebo, the difference did not meet the prespecified statistical boundaries. Based on these findings, “we cannot recommend adding pembrolizumab to chemotherapy in this scenario,” Dr. Yang said.

Study Discussant Jonathan W. Riess, MD, MS, of the University of California, Davis, agreed and said that new strategies are needed to improve responses to immunotherapy in patients with EGFR-mutated lung cancer.

“There is likely a population of EGFR-mutated lung cancer that benefits from immunotherapy in some way,” he noted, adding that “we need to do a better job of identifying…and targeting that population.” Read more.