Adding chemotherapy to immunotherapy may improve some outcomes, but not others, in patients with advanced non-small cell lung cancer (NSCLC) whose tumors have higher expression of programmed death ligand 1 (PD-L1), a pooled analysis presented at the 2022 ASCO Annual Meeting suggested.
According to presenter Oladimeji Akinboro, MD, MPH, of the Center for Drug Evaluation and Research, U.S. Food and Drug Administration in Silver Spring, Maryland, these findings “reinforce and emphasize the importance of shared decision making between patients and their oncologists.”
The pooled analysis used data from studies of patients with advanced NSCLC and a PD-L1 tumor proportion score of 50% or higher treated in the first-line setting with either combination chemotherapy and immunotherapy, or immunotherapy alone. A total of 3189 patients were included.
The chemo-immunotherapy arm included patients from 6 studies: KEYNOTE-021 (pembrolizumab plus chemotherapy), KEYNOTE-189 (pembrolizumab plus chemotherapy), KEYNOTE-407 (pembrolizumab plus chemotherapy), IMpower150 (atezolizumab plus bevacizumab plus chemotherapy), IMpower130 (atezolizumab plus chemotherapy), and CheckMate-9LA (nivolumab plus ipilimumab plus chemotherapy).
The immunotherapy-only arm likewise included patients from 6 studies: CheckMate 026 (nivolumab), KEYNOTE-024 (pembrolizumab), KEYNOTE-042 (pembrolizumab), IMpower110 (atezolizumab), CheckMate 227 (nivolumab plus ipilimumab), and EMPOWER-Lung 1 (cemiplimab).
Results showed a median overall survival (OS) of 25.0 months for chemo-immunotherapy vs 20.9 months for immunotherapy alone (hazard ratio, 0.82; 95% CI, 0.62-1.08).
Median progression-free survival (PFS) was 9.6 months for chemo-immunotherapy compared with 7.1 months for immunotherapy alone (hazard ratio, 0.69; 95% CI, 0.55-0.87). The overall response rate (ORR) was 61% with chemo-immunotherapy compared with 43% for immunotherapy alone (odds ratio, 1.2; 95% CI, 1.1-1.3).
A subgroup analysis indicated that most patients tended to do better with chemo-immunotherapy. However, those aged 75 years and older appeared to have better outcomes with immunotherapy-only regimens.
Dr Akinboro emphasized that the results are hypothesis generating only and pointed out that the analyses do not explain the lack of concordance between OS and either PFS or ORR. Additionally, notable differences exist between clinical trial populations and real-world patients.
“In patients with NSCLC with PD-L1 of 50% or higher, our analysis suggests that there may be no difference in OS for chemo-immunotherapy versus immunotherapy alone, though there may be a slight numerical advantage in favor of chemo-immunotherapy,” Dr Akinboro said. “Observed differences in PFS and ORR that appear to favor chemo-immunotherapy must be interpreted within the context of the OS results and within the context of the exploratory nature of this analysis.”
Disclosure: One study author declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Akinboro O, Vallejo JJ, Nakajima EC, et al. Outcomes of anti-PD-(L)1 therapy with or without chemotherapy (chemo) for first-line (1L) treatment of advanced non-small cell lung cancer (NSCLC) with PD-L1 score ≥50%: FDA pooled analysis. Presented at ASCO 2022; June 3-7, 2022. Abstract 9000.