The following article features coverage from the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.

An analysis of data from 8 clinical trials showed that immunotherapy plus chemotherapy improved survival over immunotherapy alone in patients with advanced non-small cell lung cancer (NSCLC).

The analysis was presented by Oladimeji Akinboro, MD, of the US Food and Drug Administration (FDA) in Silver Spring, Maryland, at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting.

The pooled analysis included data from 8 randomized controlled trials evaluating anti-PD-L1 immunotherapy alone, chemotherapy-immunotherapy combinations, and chemotherapy alone for the first-line treatment of patients with advanced NSCLC. The trials were used to support FDA approvals.

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The analysis included a total of 2108 patients with NSCLC whose PD-L1 scores ranged from 1% to 49%. At baseline, 51% of patients were younger than 65 years, and 12% were age 75 or older.

Most patients were men (67%), White (79%), current or former smokers (85%), and had an Eastern Cooperative Oncology Group performance status of 1 or higher (65%).

At a median follow-up of 12.1 months, patients receiving immunotherapy and chemotherapy (n = 639) had longer progression-free survival (PFS) and overall survival (OS) compared with patients who received immunotherapy alone (n = 529).

The median PFS was 7.7 months for chemotherapy plus immunotherapy and 4.2 months for immunotherapy alone (hazard ratio [HR], 0.60; 95% CI, 0.48-0.76). The median OS was 21.4 months and 14.5 months, respectively (HR, 0.68; 95% CI, 0.52-0.90). 

However, survival outcomes were similar between the treatment groups for patients age 75 and older.

“Although the overall survival results we have presented should reflect the composite net benefit of drug efficacy and safety, these results are not prescriptive and not intended to regulate the practice of oncology,” Dr Akinboro noted. “We believe that patient-level treatment decisions should be made between patients and their oncologists.”

“These results are exploratory and hypothesis-generating,” he continued. “Nonetheless, they question the use of IO [immunotherapy]-only regimens as control arms in randomized controlled trials of patients with non-small cell lung cancer with PD-L1 scores of 1% to 49% and suggest that the preferred control arms in such trials would be chemo-IO regimens.”

Dr Akinboro said he and his colleagues plan to conduct comparative pooled safety analyses of chemotherapy-immunotherapy and immunotherapy-only regimens. The team plans to identify indicators of tolerability by subgroups, including older adults, patients with KRAS mutations, and racial and ethnic minorities.  

Disclosures: One study author declared affiliations with AstraZeneca. Please see the original reference for a full list of the authors’ disclosures.

Read more of Cancer Therapy Advisor’s coverage of the 2021 ASCO Annual Meeting by visiting the conference page.


Akinboro O, Vallejo JJ, Mishra-Kalyani PS, et al. Outcomes of anti-PD-(L1) therapy in combination with chemotherapy versus immunotherapy (IO) alone for first-line (1L) treatment of advanced non-small cell lung cancer (NSCLC) with PD-L1 score 1-49%: FDA pooled analysis. J Clin Oncol. 2021;39:(suppl 15; abstr 9001). doi:10.1200/JCO.2021.39.15_suppl.9001