Among patients with advanced non-small cell lung cancer (NSCLC), real-world overall survival (OS) outcomes with immunotherapy are largely consistent with OS outcomes in randomized clinical trials (RCTs) of immunotherapy, according to a meta-analysis.

However, OS outcomes vary for more vulnerable patients, who are often excluded from RCTs, researchers noted. These findings were published in Lung Cancer.

The researchers conducted a meta-analysis of real-world observational studies to compare the efficacy of immunotherapy-based regimens in previously treated patients with advanced or recurrent NSCLC.

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The meta-analysis encompassed 66 studies and a total of 57,016 patients. The researchers grouped the treatments patients received into the following categories:

  • Nivolumab monotherapy, as 46 of the studies included a nivolumab-specific study arm
  • Other immune checkpoint inhibitors (ICIs), which consisted of unspecified ICIs or mixed ICIs (nivolumab, pembrolizumab, atezolizumab, and durvalumab)
  • Non-immunotherapy comparator treatments.

The median OS ranged from 4.2 months to 17 months in the nivolumab group, from 4.6 months to 29.6 months in the mixed/unspecified ICIs group, and from 1.1 months to 29.3 months in the non-immunotherapy group.

The pooled 1-year OS rate was 45.6% in the nivolumab group, 43.9% in the mixed/unspecified ICI group, and 30.2% in the non-immunotherapy group. The pooled 2-year OS rates were 28.0%, 20.4%, and 23.9%, respectively.

Results by Subgroups

The researchers also analyzed patients in the nivolumab group by age (elderly vs non-elderly), Eastern Cooperative Oncology Group performance status (ECOG PS), and the presence of metastases in the liver or central nervous system (CNS).

Pooled 2-year OS rates could not be calculated for all nivolumab subgroups, and the researchers did not perform any subgroup analyses for the mixed/unspecified ICI group or the non-immunotherapy group due to insufficient numbers.

The researchers found that OS outcomes with nivolumab did not differ by age, but patients with poor ECOG PS had worse OS. The pooled 1-year OS rate with nivolumab was 39.6% in patients age 75 or older and 43.2% in patients younger than 75 years. The pooled 1-year OS rate was 27.1% in patients with an ECOG PS of 2 or higher and 51.6% in patients with an ECOG PS less than 2.

Outcomes with nivolumab did not differ according to the presence or absence of CNS metastasis, but patients with liver metastases had worse outcomes. The pooled 1-year OS rate with nivolumab was 41.9% in patients with CNS metastasis and 40.0% in patients without it. The pooled 1-year OS rate was 23.8% in patients with liver metastasis and 43.4% in patients without it.

“These results provide evidence complementary to RCT-based findings on the survival benefits of immunotherapy in pretreated advanced NSCLC patients,” the researchers wrote. “While further research is needed for particular subgroups (eg, those with liver metastases and autoimmune diseases), the findings can be used by oncologists and patients to inform therapeutic decision-making.”

Disclosures: This research was supported by Bristol Myers Squibb. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.


Juarez-Garcia A, Sharma R, Hunger M, et al. Real-world effectiveness of immunotherapies in pre-treated, advanced non-small cell lung cancer patients: A systematic literature review. Lung Cancer. Published online March 9, 2022. doi: