EMPOWER-Lung1: First-Line Cemiplimab Use in PD-L1–High Advanced NSCLC

Highlighting data from the EMPOWER-Lung1 trial, Marina Chiara Garassino, MD, considers the role of first-line cemiplimab in managing PD-L1–high metastatic NSCLC.

Case: A 72-Year-Old With Advanced NSCLC Cancer

Initial presentation

  • KD is a 72 y/o female who presents to her primary care physician complaining of fatigue and a persistent cough.
    • PMH:
      • Hyperlipidemia (controlled)
      • Anxiety (controlled)
      • COPD (controlled)
    • SMH: quit smoking 3 years ago and enjoys social drinking with her family
    • FH: she lives alone but her kids and grandkids live nearby

Clinical workup

  • Current Labs:
    • CBC panel: Normal
    • Liver function/Renal function: Normal
  • PD-L1: 85%
  • ECOG 1
  • Molecular testing: (-) EGFR, ALK, ROS1
  • CT scan of the head and neck showed a 5cm nodule in the right upper lobe of lung
    • CT guided biopsy of the upper lobe confirms non-squamous cell carcinoma
  • Abdominal CT scan shows liver metastases
  • Diagnosis consistent with Stage IV non-small cell lung adenocarcinoma


Marina Chiara Garassino, MD: EMPOWER-Lung 1 randomized patients to receive cemiplimab [Libtayo] alone or chemotherapy. The key eligibility criteria of the trial were very similar to the KEYNOTE-024 trial. The patients had to have a PD-L1 of more than 50%, and EGFR, ALK, and ROS had to be excluded. One difference with the KEYNOTE-024 trial was that patients could be enrolled independently by their smoking habits. In EMPOWER-Lung 1, the patients were all smokers. The other difference was that patients who had brain metastases, who were stable and untreated with steroids, were included. The results for the brain metastases were important because we’re always discussing if there is a benefit for brain metastases. In results that were recently presented, we saw that the patients who were treated with cemiplimab did better compared with those treated with chemotherapy with these kinds of brain alterations. Basically, the trial was very similar to the KEYNOTE-024 trial. There were also more patients with squamous histology compared with the KEYNOTE-021 trial, and this was clearly related to the fact that this trial was enriched by patients who smoked in the past or were active smokers.

The results of the adverse events of EMPOWER-Lung 1 were numerically slightly different from the CheckMate 24. We have more experience now, so I consider the adverse effects to be the same in both clinical trials. What I suggest for the clinical practice is a clear assessment of the patient’s autoimmunity from the beginning. It’s important to check that initially. For example, it’s important to have a TSH [thyroid-stimulating hormone] from the beginning. It’s important to have cortisol from the beginning. We want to assess a baseline of all possible autoimmunity that we can observe in the patients.

Then I suggest to continually monitor the adverse events and educate the patients. Patients must be aware that some adverse effects can arrive and can appear. They should immediately refer and reach out to the doctors as soon as they see, for example, a particular fatigue. Sometimes we believe it’s the fatigue associated with the cancer treatment, but this fatigue can also present in hypothyroidism. We can underestimate how adverse effects can, if corrected, improve the quality of life of patients.

I suggest doing a very good assessment when you start the immunotherapy to check all the possible adverse effects and autoimmunity in the beginning. Anytime they do a new treatment, assess the toxicity and test for TSH, which is the hypothyroidism, or all the disturbances of the thyroid that are the most represented adverse effects in these patients. We should educate the patients to report shortness of breath that isn’t the same shortness of breath that they had before, because this can represent pneumonitis and must be treated with other drugs, not with antibiotics.

More or less, all the adverse effects are the same. We shouldn’t just think that if we see fewer events, that’s because the treatment is less toxic. There are some adverse effects that are very similar and very common to all the immune checkpoint inhibitors. We should have exactly the same approach for all of them.

Transcript edited for clarity.

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