Showed that immunotherapy given both before and after lung cancer surgery lengthens survival.
KEYNOTE-671, trial NCT03425643 sponsored by Merck and reported in 2023, showed that pembrolizumab given both before and after surgery for resectable stage II to IIIB non-small-cell lung cancer lengthens survival. It randomised 797 patients to neoadjuvant pembrolizumab plus chemotherapy followed by adjuvant pembrolizumab, or placebo, met its primary endpoints of event-free survival and overall survival, and led to FDA approval of the perioperative regimen in October 2023, the first such regimen with a survival benefit. OnCo links it to the perioperative term and to Heather A. Wakelee and Tina Cascone, and its findings are consistent with CheckMate 816, AEGEAN, CheckMate 77T and NEOTORCH. Whether the adjuvant phase adds to neoadjuvant treatment alone has never been tested head to head, which is the trial's main unanswered question. Pembrolizumab has its own page.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
797 enrolled.
Step lines join published landmark estimates; the true curve between them is not shown.
Curves show the trial population; they are not a prediction for any one person.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | Pembrolizumab + chemotherapy → pembrolizumab | 397 | 47.2 months | 0.59 (0.48 to 0.72) | - | link |
| Placebo + chemotherapy → placebo | 400 | 18.3 months | ||||
| Overall survival at 36 monthsprimary | Pembrolizumab arm | - | 71.3% | 0.72 (0.56 to 0.93) | 0.005 | link |
| Placebo arm | - | 64% |
A second publication from the KEYNOTE-671 trial, later than the first and described in its title as an update or longer-term analysis. Read it with the primary publication linked from the trial page; the record was linked automatically and its figures have not been checked by hand.
This is the paper Europe PMC returns for registry id NCT03425643 with the most citations, so it is the natural first reading for anyone following the KEYNOTE-671 trial. Read the abstract above alongside the trial page and the registry entry; the record was linked automatically and its figures have not been checked by hand.
Shares Tina Cascone, KEYNOTE-091 (PEARLS), A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer, A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer.
Shares Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer, A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer, Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer.
Shares Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer, Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer, Lung cancer (all types).
Shares Perioperative Pembrolizumab for Early-Stage Non-Small-Cell Lung Cancer, Neoadjuvant / adjuvant / perioperative, Resectable stage I to III non-small-cell lung cancer, Lung cancer (all types).
Shares Resectable stage I to III non-small-cell lung cancer, Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors.
Shares Resectable stage I to III non-small-cell lung cancer, Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors.
Shares Resectable stage I to III non-small-cell lung cancer, Merck & Co. (MSD), Pembrolizumab, Immune checkpoint inhibitors.
Shares KEYNOTE-091 (PEARLS), Resectable stage I to III non-small-cell lung cancer, Lung cancer (all types), Immune checkpoint inhibitors.