Adjuvant Pembrolizumab Expands Options for Patients with Resected Stage IB-IIIA NSCLC

Luis Paz-Ares, MD, PhD, highlight adverse events to monitor with pembrolizumab in this setting as well as its role in the treatment landscape.

Luis Paz-Ares, MD, PhD

Luis Paz-Ares, MD, PhD

As pembrolizumab (Keytruda) tacks on an indication for the adjuvant treatment of patients with stage IB, II, or IIIA non–small cell lung cancer (NSCLC) following resection and platinum-based chemotherapy, immunotherapeutic options now cover a broader array of patients with thoracic malignancies, according to Luis Paz-Ares, MD, PhD.1

Data from the phase 3 KEYNOTE-091 (NCT02504372) trial supported the approval. Findings from the trial demonstrated a disease-free survival (DFS) of 58.7 months (95% CI, 39.2-not reached [NR]) in patients who received pembrolizumab (n = 506) vs 34.9 months (95% CI, 28.6-NR) in patients (n = 504) who received placebo (HR, 0.73; 95% CI, 0.60-0.89).1

“It is good news for our patients [and] physicians to have another opportunity of treatment for NSCLC,” Paz-Ares said. “In addition to that, this is the first approval covering patients regardless of PD-L1 expression and it’s also widespread in terms of the stage. From that point of view, this is covering a clear unmet need for our patients.”

In an interview with OncLive®, Paz-Ares, chair of the Medical Oncology Department at the Hospital Universitario 12 de Octubre, an associate professor at the Universidad Complutense de Madrid, and head of the Lung Cancer Unit at the National Oncology Research Center in Spain, highlighted adverse events (AEs) to monitor with pembrolizumab in this setting as well as its role in the treatment landscape.

What were some of the key efficacy findings from the KEYNOTE-091 trial?

At the time of the second interim analysis, we have shown a significant improvement in [DFS] compared with the placebo arm.

It’s important that the benefit was pretty consistent across the different study subsets. There were some differences. The benefit was not that clear for patients who didn’t receive adjuvant chemotherapy, those were approximately 15% of the patients in this trial. [Additionally], patients with squamous histology did not seem to have the same magnitude of benefit, there was some overlapping on the confidence interval.

The other relevant part of the results was their safety profile and that was favorable. [It was] very consistent with the safety profile known in stage IV disease and that consisted mainly of some immunological AEs.

What AEs were of note in this trial?

There was an increase in the number of AEs, particularly [grade] 3 to 5—those were 34% on the pembrolizumab arm compared with 26% on the placebo arm. If we focus on treatment-related AEs that led to death the numbers were low, 0.7% on the pembrolizumab arm, which means 4 patients. The number of patients who required discontinuation of the treatment due to AEs was 20% in the pembrolizumab arm compared with 6% in the placebo arm.

In terms of general AEs, there were no major differences between the 2 arms [in] weight increase, pruritus, asthenia, diarrhea, coughing, and so on. But, [regarding] immune-mediated AEs…there were some differences, particularly higher incidence of hypothyroidism and hyperthyroidism, pneumonitis, skin rash, colitis, and some other immune-related AEs. It’s important [that], for most of the cases, AEs were mild to moderate and there were very few severe AEs.

I don’t think there is a particular profile of patients that are at risk apart from patients who were not included in the trial, such as those with known immune-related diseases [and] autoimmune diseases.

How do you see this agent fitting into the treatment landscape for patients with NSCLC?

Pembrolizumab is going to represent a potential alternative for the adjuvant treatment of patients with resected NSCLC. Typically for those patients we use adjuvant chemotherapy and now we have the results of 2 trials showing atezolizumab [Tecentriq] and pembrolizumab’s impact on the outcomes of patients.

Pembrolizumab offers an opportunity for patients [with] stage IB to stage III [disease], regardless [of] PD-L1 expression. That is complementary to the label of atezolizumab, which was only indicated for patients with stage II and III [disease] if they express PD-L1 in at least 1% of the cells. From that perspective, it is a complementary alternative that extends the opportunity for adjuvant treatment in our patients.


FDA approves pembrolizumab as adjuvant treatment for non-small cell lung cancer. FDA. January 26, 2023. Accessed March 14, 2023.

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