Clinical trial treatment at Sanford granted FDA approval

Sanford Health was one of several major cancer centers that participated in a groundbreaking clinical trial testing the combination of chemotherapy with immunotherapy for first-line treatment of advanced non-small cell lung cancer.

The treatment – using Keytruda, also known as pembrolizumab, in combination with pemetrexed and carboplatin – recently was granted FDA-approval through the accelerated approval program. The Keynote-021 trial enrolled 123 patients with locally advanced or metastatic non-squamous NSCLC, according to a news release from Merck, which manufactures the drug.

Key findings from the study that led to approval included nearly twice as many patients responding to the new immunotherapy combination versus standard chemotherapy (55 percent compared to 29 percent) and a longer duration of disease control.  Sanford offered the trial to participants in Sioux Falls and Fargo. The study was available at 24 other major cancer centers in the United States and Taiwan. Steven Powell, M.D in Sioux Falls and Amit Panwalkar, M.D. were principal investigators on the trial. Both are medical oncologists.

“This is the new standard of care for the majority of patients with advanced lung cancer,” said Dr. Steven Powell with Sanford Health. “Our clinical trials program allowed us to bring this cutting edge option to our patients long before the FDA approval.”

Lung cancer is the No. 1 cancer killer in the United States, causing one in four cancer deaths, according to the American Cancer Society.

Sanford Health and Sanford Research continue to work toward finding innovative therapies for cancer treatment.  With active research in the laboratory and through clinical trials, Sanford offers novel treatment options for many types of cancer

Updated results from the Keynote-021 trial will be presented at the American Society of Clinical Oncology conference in June. The ongoing Keynote-189 study is further evaluating this approach and was also offered at Sanford.

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