Monday, June 4, 2012 (Last Updated: 06/05/2012)MONDAY, June 4 (HealthDay News) -- The anti-programmed death (PD)-1 monoclonal antibody BMS-936558 is active in patients with melanoma, non-small-cell lung cancer (NSCLC), and renal cell cancer that has progressed despite standard therapy, according to a study published online June 2 in the New England Journal of Medicine to coincide with presentation at the annual meeting of the American Society of Clinical Oncology, held from June 1 to 5 in Chicago.
Suzanne Louise Topalian, M.D., from the Johns Hopkins University School of Medicine in Baltimore, and colleagues conducted a phase I trial involving 296 patients to assess the activity and safety of BMS-936558. Patients had melanoma, NSCLC, colorectal, prostate, and renal cell cancer that had progressed in spite of receiving standard therapies.
The researchers found that objective responses (complete or partial) were seen for 28 percent of patients with melanoma, 27 percent with renal cell cancer, and 18 percent with NSCLC. Many of the responses were ongoing for more than one year. Grade 3 or 4 drug-related adverse events were seen in 14 percent of patients and included pneumonitis, vitiligo, hypophysitis, hepatitis, colitis, and thyroiditis. In immunohistochemical analysis of pretreatment biopsies from 42 patients, 36 percent of patients with tumors that were positive for the protein PD-L1 achieved an objective response, whereas no patients with tumors negative for PD-L1 achieved an objective response.
"It's exciting to see this degree of antitumor activity from a single agent among patients with a range of cancers that had progressed despite standard therapies," Topalian said in a statement. "We were especially surprised to see activity in nearly 20 percent of patients with lung cancer, who are historically unresponsive to immune-based therapies."
Several authors disclosed financial ties to pharmaceutical companies, including Bristol-Myers Squibb, which manufactures BMS-936558.
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