Findings from a randomised phase III study indicate that PD-1 immunotherapy is an effective treatment option for patients with non-squamous, non-small cell lung cancer (NSCLC).

Among patients with advanced disease that worsened after receiving platinum-based chemotherapy, those treated with nivolumab lived on average three months longer than those treated with docetaxel chemotherapy.

“This is the first phase III study to show that immunotherapy is effective against non-
squamous cell NSCLC, and appears to be particularly active in patients with PD-L1-
positive tumours,” said lead study author Luis Paz-Ares, MD, PhD, a professor of medicine at Hospital Universitario 12 de Octubre in Madrid, Spain.

“While nivolumab appears to be more potent against this most common lung cancer, it is important to note that it is also far easier on patients compared to the standard second-line treatment, docetaxel.”

Lung cancer is the most common cancer worldwide, with more than 1.8 million new cases diagnosed in 2012.

It is also the leading cause of cancer deaths in the United States. 

NSCLC is the most common form of lung cancer, accounting for 85% of all lung cancers.

More than two-thirds of those are non-squamous cell cancers.

The study randomly assigned 582 patients with advanced non-squamous NSCLC to treatment with nivolumab or docetaxel.

Response rates were higher in the nivolumab group compared to the docetaxel group (19.2% vs. 12.4%).

Responses also lasted significantly longer in the nivolumab group (17.1 months vs. 5.6 months, on average).

The median overall survival was 12.2 months in the nivolumab group compared to 9.4 months in the docetaxel group.

Of note, in the subgroup of patients with high levels of PD-L1 in their tumour (≥1% cells), the median survival with nivolumab exceeded 17 months as compared to 9 months for those treated with docetaxel.

Nivolumab was well tolerated overall, with only one in 10 patients experiencing serious side effects, compared to more than half of patients in the docetaxel arm.

There was one treatment-related death in the docetaxel arm and none in the nivolumab arm.

Due to toxic side effects, 4.9% patients stopped nivolumab, and 14.9% patients stopped docetaxel.

Nearly half of the patients who stopped treatment subsequently received systemic therapy.

The researchers pointed out that patients with higher levels of the biomarker PD-L1 experienced the greatest degree of benefit from nivolumab.

Overall, patients who received nivolumab had a 27% lower risk of death compared to those who received docetaxel.

However, the subgroup of patients with the high levels of PD-L1 had a 41- 60% reduction in risk of death, which was not observed in cases of low or undetectable PD- L1 levels.

Earlier this year, the FDA approved nivolumab as a second-line treatment for advanced squamous NSCLC.

However, nivolumab is not yet available for patients with lung cancer in Europe.

Dr Paz-Ares stated that nivolumab could potentially become a new standard therapy for patients with previously treated NSCLC.

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Source: ASCO