Adjuvant Pembrolizumab Approval Adds to Prevention of Recurrent NSCLC

An expert from Yale School of Medicine discusses how the approval of adjuvant pembrolizumab expands treatment to include patients with IB, II, III, and IIIA resected, early-stage, non–small cell lung cancer regardless of PD-L1 expression.

The approval of adjuvant pembrolizumab in resected non–small cell lung cancer (NSCLC) achieves the goal of moving the best agents forward to earlier lines of treatment, according to Roy S. Herbst, MD, PhD.

In an interview with CancerNetwork®, Herbst, Ensign Professor of Medicine and Professor of Pharmacology at Yale School of Medicine, as well as chief of medical oncology at Yale Cancer Center and Smilow Cancer Hospital in New Haven, Connecticut, spoke about the FDA approval of adjuvant pembrolizumab for resected early-stage NSCLC.1

The approval of pembrolizumab was supported by data from the phase 3 KEYNOTE-091/EORTC-1416-LCG/ETOP-8-15-PEARLS trial (NCT02504372), in which the agent yielded a median disease-free survival of 58.7 months (95% CI, 39.2-not reached [NR]) among patients with resected NSCLC compared with 34.9 months (95% CI, 28.6-NR) among those receiving placebo (HR, 0.73; 95% CI, 0.60-0.89).2

Herbst also discussed how the approval not only expands adjuvant treatment to patients with stag IB to IIIA disease but also to those who don’t have a PD-L1 expression.


Lung cancer is such a common disease. We’re doing more and more screenings, so we’re finding disease early before it spreads outside the lung. But even when we resect [a tumor], there can be as much as a 70% to 80% chance that it will come back. What this approval means is that now adjuvant therapy with pembrolizumab—one of the most used immunotherapy drugs—can be used in all [disease] stages: IB, II, III, and IIIA regardless of PD-L1 status; it doesn’t matter what the biomarker shows.

The good news is that this [approval] gives physicians another option to offer their patients to keep the cancer from coming back once the patients have had the maximum surgery, the maximum chemotherapy, and now they’re getting immunotherapy.

The data are quite exciting. There was a hazard ratio of 0.73; that translates to a 27% decrease in recurrence of lung cancer in the patients who got pembrolizumab vs those who did not. This is now something to offer patients. There already was another drug approved in this setting, atezolizumab [Tecentriq], but only for stage II and III [disease] and only for patients who were PD-L1–positive.

This [approval] now broadens to allow for patients who don’t have any PD-L1 [expression] which will be quite a few. It also allows used in stage IB [disease] which includes tumors greater than 4 cm with no nodes.

[This is] a drug that we very commonly use in first-line metastatic or advanced disease, with chemotherapy, [and] in the second-line setting. And now, we are using it here in the earliest disease setting. That has always been the goal: to take the best drugs and move them earlier in disease, this way more patients will live longer having been treated for lung cancer.


  1. FDA approves pembrolizumab as adjuvant treatment for non–small cell lung cancer. News release. FDA. January 26, 2022. Accessed February 1, 2023.
  2. O’Brien M, Paz-Ares L, Jha N, et al. EORTC-1416-LCG/ETOP 8-15 – PEARLS/KEYNOTE-091 study of pembrolizumab versus placebo for completely resected early-stage non-small cell lung cancer (NSCLC): outcomes in subgroups related to surgery, disease burden, and adjuvant chemotherapy use. J Clin Oncol. 2022;40(suppl 16):8512-8512. doi:10.1200/JCO.2022.40.16_suppl.8512
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