KEYNOTE-867: A Phase III, Randomized, Double-Blind Study of Stereotactic Body Radiotherapy With Pembrolizumab for Unresected Stage I or II Non–Small Cell Lung Cancer
Salma K. Jabbour, Szabolcs Sótér, Michael Eaton, Gabriella Gálffy, Dariusz Kowalski, Akito Hata, Augusto Valdivia, Nikolaj Frost, Evgeny Levchenko, Mariana Monteiro, Anoop Haridass, Myriam Bouchard, Ki Hyeong Lee, Myung-Ju Ahn, Brett G.M. Hughes, André Durham, Yan Xu, Ayman Samkari, Andrew Song, Andreas PircherPurpose
Stereotactic body radiotherapy (SBRT) is standard of care for inoperable stage I or II non–small cell lung cancer (NSCLC). KEYNOTE-867 (ClinicalTrials.gov identifier:
Methods
Adults with untreated, stage I or II (T1 to limited T3, N0, M0) NSCLC (AJCC 8 th edition) that was inoperable, or adults who refused surgery, were randomly assigned 1:1 to thoracic SBRT to primary tumors for ≤2 weeks concomitantly with pembrolizumab 200 mg or placebo once every 3 weeks for ≤17 cycles. The primary end point was event-free survival (EFS) by blinded independent central review.
Results
A total of 448 participants were randomly assigned to SBRT plus pembrolizumab (n = 227) or SBRT plus placebo (n = 221). The median time from random assignment to the data cutoff date (June 11, 2024) for the prespecified first interim analysis was 20.6 (range, 1.3-56.8) months. The median EFS (95% CI) was 31.2 (22.5 to 39.1) months and 28.3 (19.8 to 33.1) months for the pembrolizumab and placebo arms, respectively (hazard ratio, 0.92 [95% CI, 0.69 to 1.24];
Conclusion
The addition of pembrolizumab to SBRT did not improve EFS and was associated with a higher incidence of treatment-related AEs compared with SBRT alone in participants with inoperable stage I or II NSCLC. Based on the benefit-risk profile, the KEYNOTE-867 trial was prematurely stopped, and all study treatment was discontinued.