A clinical trial led by researchers at the Medical University of South Carolina (MUSC) will test a new combination of two immunotherapy drugs in people with non-small cell lung cancer (NSCLC) — the most common type of lung cancer (LC) — to determine if the combination is safe and if it can kick-start an anti-cancer response in those with more advanced stages of disease. The trial is now enrolling participants.
The initial part of this Phase 1b/2 study, “ALT-803 plus Nivolumab in Patients with Pretreated, Advanced or Metastatic Non-Small Cell Lung Cancer,” will evaluate the safety and dosing tolerability of the checkpoint inhibitor nivolumab in addition to the immune stimulator ALT-803. The second part will look at the response rate to treatment, defined as best response recorded from the therapy’s start until disease progression or recurrence.
“While recently approved immunotherapies are extremely exciting and better than chemotherapy for second-line therapy, about 80 percent of patients will not respond. By combining two kinds of immunotherapy, we feel we have designed a treatment that is very promising to extend the remarkable benefit experienced by some patients to a larger percentage of people with advanced lung cancer,” John Wrangle, M.D., a medical oncologist at MUSC and the study’s main investigator, said in a press release.
ALT-803, a drug developed by Altor Bioscience, is based on a discovery made by Mark Rubinstein, PhD, a cancer immunologist at MUSC, when he was a post-doctorate fellow at the Scripps Research Institute. Dr. Rubinstein cooperated in the trial’s design. Nivolumab is a U.S. Food and Drug Administration-approved treatment for patients with advanced non-small cell lung cancer (both squamous and non-squamous).
“Scientists know that for many kinds of cancers, there are immune cells inside tumors,” Dr. Rubinstein said. “The problem is, the tumors come up with ways to keep the immune cells from fighting off the cancer, creating what doctors call checkpoints. That’s where checkpoint inhibitors such as the drug nivolumab come in. They block those checkpoints, helping the immune cells fight the cancer. For about 5 percent of the people who get this drug, it’s highly effective, getting rid of their tumors.”
But, he added, “many patients don’t yet benefit from this therapy. To improve its effectiveness, we’re testing the addition of a powerful immune stimulation factor, ALT-803, to the checkpoint blocker.”
More information on this study, expected to finish in December 2018, is available at its clinical trial.gov (NCT02523469) site. People wanting enrollment information can also call Amanda Gilbert at 843-792-8795.