(National Cancer Institute)
1 June 2015. A late-stage clinical trial shows an engineered antibody that harnesses the immune system increases the survival time of people with a common form of lung cancer compared to standard chemotherapy. The study of the drug nivolumab, marketed as Opdivo by Bristol-Myers Squibb, was reported yesterday at the annual meeting of American Society of Clinical Oncology and in the New England Journal of Medicine.
Participants in the trial were individuals with squamous cell non–small-cell lung cancer who had not responded to earlier chemotherapy. Worldwide, lung cancer causes some 1.6 million deaths, according to World Health Organization. Non-small cell lung cancer is the most common form of lung cancer, accounting for about 85 percent of all cases. American Cancer Society estimates more than 221,000 new cases of lung cancer will be diagnosed in the U.S. during 2015, affecting somewhat more men than women, leading to 158,000 deaths.
Nivolumab is an antibody that limits a protein called programmed cell death-1 or PD-1 that prevents activation of T-cells in the immune system, which in turn encourages progression of tumors. Bristol-Myers Squibb is testing its nivolumab drug Opdivo as a single therapy or in combination with other drugs against a number of solid tumor cancers in more than 50 clinical studies.
This clinical trial — conducted in the U.S., Europe, and Latin America — tested Opdivo against the chemotherapy drug docetaxel, considered the standard of care for treating non-small-cell lung cancer and other solid tumor cancers. The 272 participants, people who did not respond to earlier chemotherapy treatments, were randomly divided to receive Opdivo infusions every 2 weeks or docetaxel infusions every 3 weeks. The trial looked primarily at overall survival rates and times, but also for response rates to the respective drugs and progression-free survival time, as well as risk of death, measured by a hazard ratio.
The results show after 1 year, individuals receiving Opdivo had a median survival time of 9.2 months and an overall survival rate of 42 percent, compared to 6 months survival time and 24 percent survival rate for docetaxel recipients. Some 20 percent of participants receiving Opdivo responded completely or in part to treatments, compared to 9 percent for those receiving docetaxel. Likewise, Opdivo recipients had a a 41 percent lower risk of death, and somewhat longer median progression-free survival time (3.5 months) compared to docetaxel patients (2.8 months).
Bristol-Myers Squibb also reported on a similar clinical trial where the combination of Opdivo and another of its immunotherapy drugs Yervoy had a longer progression-free survival time than Yervoy alone among people with advanced untreated melanoma. In addition, participants receiving Opdivo alone had a longer progression-free survival time than those receiving Yervoy alone.
The company reported as well that the U.S. Food and Drug Administration accepted its biologics license application — request to review the therapy for marketing approval — for the combination of Opdivo and Yervoy to treat advanced untreated melanoma, and granted an expedited process for the review. That review is expected to be completed by 30 September 2015.
Read more:
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- Cancer Biotech Raising $147 Million in IPO
- Novartis, Aduro Biotech Partner on Cancer Immunotherapy
- Bristol-Myers Squibb Acquires Biotech Cancer Therapies
- Lung Cancer Antibody Given FDA Breakthrough Tag
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