ASCO Report 2015: Immunotherapy nivolumab improves survival in squamous-non-small cell lung cancer

by Bruce Sylvester: In a Phase III trial comparing standard docetaxel chemotherapy with immunotherapy nivolumab, researchers reported that subjects with squamous-non-small cell lung cancer treated with nivolumab lived an average of 3.2 months longer than those receiving the standard chemotherapy. And, at one year, the immunotherapy cohort achieved nearly double the survival rate (42 percent) of the chemotherapy cohort (24 percent).

The findings were released simultaneously in the May 31 issue of the New England Journal of Medicine and at the American Society for Clinical Oncology 2015 annual meeting.

“This solidifies immunotherapy as a treatment option in lung cancer,” said investigator Julie Brahmer, M.D., director of the Thoracic Oncology Program at the Johns Hopkins Kimmel Cancer Center. “In the 20 years that I’ve been in practice, I consider this a major milestone,” she added.

ASCO lung cancer expert commentator, Gregory A. Masters, MD, attending physician at the Helen F. Graham Cancer Center and Associate Professor at the Thomas Jefferson University Medical School in Philadelphia, added, “Even five years ago, an effective immunotherapy for lung cancer was largely considered impossible. Today, we have such a treatment, and it surpasses the standard therapy both in terms of efficacy and patient quality of life.”

The investigators enrolled 272 subjects with advanced, squamous non-small cell lung cancer whose disease had progressed despite initial chemotherapy. They randomized 135 subjects to nivolumab and 137 subjects to docetaxel. Both drugs were administered intravenously.

They found that median overall survival of nivolumab-treated subjects was 9.2 months, compared with six months for docetaxel-treated subjects.

At one year, 57 of nivolumab-treated subjects (42 percent) were alive, compared with 33 docetaxel-treated subjects (24 percent).

Approximately 27 subjects (20 percent) treated with nivolumab were responsive to treatment, while 12 subjects (8.8 percent) treated with docetaxel responded.

Median disease-progression free survival was 3.5 months for nivolumab-treated subjects and 2.8 months for docetaxel-treated subjects. Brahmer noted that the modest increase in median survival time with immunotherapy could be misleading in terms of overall effect of such treatment. “Patients who respond to immunotherapy tend to continue their responses for long durations, and these lengthier responses are cut off in calculations of median overall survival,” she says.

Nivolumab treatment reduced the relative risk of dying from lung cancer by 41 percent when compared with docetaxel treatment.

Notably, a higher rate of the most severe side effects occurred among subjects taking docetaxel (55 percent) than among those taking nivolumab (6.9 percent). Immunotherapy can produce severe side effects, and it’s important to be vigilant in efforts to manage them. However, it is less toxic than chemotherapy,” said Brahmer.

Nivolumab (Opdivo ®) was approved in March of 2015 by the U.S. Food and Drug for the treatment patients whose lung cancer progressed, despite standard chemotherapy.

Bristol Myers Squibb funded the study