In a first-in-human phase I/II clinical trial conducted by the Epigenetic Therapy Dream Team, a novel epigenetic therapy called SGI-110 has shown promise as a new treatment option for patients with an early form of leukemia, myelodysplastic syndrome, and those with acute myelogenous leukemia.
Aaron Cohen, a 77-year-old acute myeloid leukemia patient, received SGI-110 through the Epigenetic Dream Team clinical trial. “I’ve had a good life, and if this was what God wanted I was OK with it,” Cohen said of his diagnosis. “I was in the process of tidying everything up in my life when I went on the trial. Now my outcome looks wonderful and my outlook on life has changed. I can’t thank the doctors enough. For me, this drug has been a lifesaver.”
In its first three years of funding, this Dream Team initiated five clinical trials. These have yielded impressive results for early-stage clinical trials, with vigorous clinical responses with minimal toxicities observed for several patients. They have also identified a novel therapeutic approach that has the potential to change the face of therapy for tens of thousands of cancer patients. The Dream Team is currently in the final stages of designing later-stage trials to validate this novel treatment strategy.
The potential new therapeutic approach is to treat patients with an epigenetic therapy, or a combination of two epigenetic therapies, and then with a conventional chemotherapy or an experimental immunotherapy.
The idea for this unique approach came from observations from one of the phase I/II clinical trials conducted by the Epigenetic Dream Team that suggested that epigenetic therapies can make patients’ tumors more sensitive to subsequent treatments. Specifically, these data showed that a substantial number of patients with recurrent, metastatic, non–small cell lung cancer who did not respond to treatment with the combination epigenetic therapy being tested in the trials, did respond dramatically to subsequent chemotherapy or experimental immunotherapy. The responses observed were far more extensive and durable than expected for patients with advanced, non–small cell lung cancer who had not benefited from previous treatments. Therefore, epigenetic therapy may be used to sensitize cancers for subsequent therapies.