Although the U.S. Food and Drug Administration approved Opdivo (nivolumab) for lung cancer, researchers continue to test variations of the drug to improve the outcome for cancer patients. Now, researchers are conducting a clinical trial combining the drug with another anti-cancer agent to see if two drugs work better than one.
Researchers from the Medical University of South Carolina have opened a Phase IB/II clinical trial with Opdivo, a drug that has already shown “spectacular results” for treating lung cancer patients, to assess whether a longer survival can be achieved with patients when ALT-803 is added to nivolumab.
Opdivo, developed by Bristol-Myers Squibb, works by blocking the PD-L1 protein and activating the immune system, leading it to attack and kill cancer cells. ALT-803, being developed by Altor BioScience Corporation, is an immune stimulation drug.
Keytruda, another immunotherapy drug that blocks PD-L1, has been shown to be effective in fighting pleural mesothelioma, a signature cancer of asbestos. The chance for survival and an improved quality of life increase for mesothelioma and lung cancer patients when they receive targeted therapy, such as the PD-L1 blockers.
By combining these two forms of immunotherapy drugs, the researchers are hoping to deliver a one-two punch to the cancer cells. Opdivo throws the first punch as the checkpoint inhibitor by breaking through the roadblocks put up by tumor cells allowing the immune cells to fight the cancer. ALT-803 then delivers the follow-up punch by providing a boost in the form of extra stimulation to the immune system, increasing the body’s natural defense mechanism.
“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,” said John Wrangle, M.D., medical oncologist and principal investigator of the trial, in a Jan. 12 press release from MUSC.
The researchers hope to enroll 91 patients in the clinical trial that will be conducted at the Medical University of South Carolina in Charleston, SC. The trial is open to lung cancer patients who have experienced disease recurrence or progression during or after prior platinum chemotherapy.
“Instead of simply cutting the brake cables of the immune cells using only a checkpoint blocker, we are also adding fuel in the form of ALT-803 so the immune cells will have optimal stimulation and ability to kill tumor cells,” said Mark Rubinstein, Ph.D., who made a discovery that led to the development of the drug.
Nearly 3,000 Americans are diagnosed with mesothelioma each year. Although survival is often less than 18 months, continued breakthroughs with immunotherapy have given many hope that long-term survival is possible.
For more information about the trial see ClinicalTrials.gov.