Miami, FL - Researchers at Sylvester Comprehensive Cancer Center are pioneering new treatment strategies for rare and aggressive gynecologic neuroendocrine carcinomas (NEC). Drs. Aman Chauhan and Abdulrahman Sinno are collaborating on a phase 1 clinical trial to test a novel combination of immunotherapies for patients with gynecological and other neuroendocrine cancers who have exhausted conventional treatment options. This initiative addresses a critical unmet need for patients with these rare and deadly cancers.
The Challenge of Gynecologic Neuroendocrine Carcinoma
Gynecological NEC is a rare malignancy, affecting approximately one in 100,000 individuals. It is characterized by its aggressive nature and rapid spread, leading to poor outcomes. Current treatment options, primarily chemotherapies, have shown limited success, leaving patients with advanced NEC with a median survival of just one year to 18 months.
"When it’s advanced, most patients don’t survive for more than a year, year-and-a-half," said Dr. Chauhan, an associate professor in the Division of Medical Oncology at the University of Miami Miller School of Medicine. "And a lot of our patients with gynecological neuroendocrine cancer are young patients with families. So, we are really taking up the challenge to try to fight this cancer and the breakthroughs will come through research."
Leveraging Expertise in Theranostics
As South Florida's only National Cancer Institute (NCI)-designated cancer center, Sylvester is uniquely positioned to manage and study NEC cancers. The center's expertise in theranostics and neuroendocrine cancers is being leveraged to improve outcomes for women with these rare gynecologic malignancies.
"We found a window here where we’re able to leverage the expertise that’s available within our cancer center in theranostics and in other areas that are specific to neuroendocrine cancers to improve outcomes for women with these rare gynecologic malignancies," said Dr. Sinno, an associate professor in the Division of Gynecological Oncology at the Miller School.
A Novel Immunotherapy Combination
The investigator-initiated phase 1 clinical trial, expected to open for enrollment in the coming months, will evaluate a novel immunotherapy combination for patients with NEC cancers. The trial builds upon the current standard of care, which involves initial treatment with chemotherapy followed by immunotherapy. However, for patients who do not respond well to these treatments, alternative strategies are needed.
The trial will introduce an oncolytic virus, a virus that selectively infects and destroys high-grade neuroendocrine cancer cells, in combination with conventional immunotherapy drugs. Preclinical data have demonstrated "deep, durable responses" with this approach, regardless of the tumor's location.
"We inject the virus directly into the tumor, where it grows and divides and thrives, and then eventually kills the cancer cell, because they literally explode. The virus eats it up from the inside," Dr. Chauhan explained.
The oncolytic virus not only directly kills cancer cells but also provokes an immune system response, making the tumor "visible" to the immune system and enhancing its ability to target and eliminate the cancer.
Access to Cutting-Edge Treatments
Sylvester is also participating in an industry-sponsored clinical trial for gynecologic NEC cancer treatment, testing a DLL3 BiTE (bispecific T-cell engager) immunotherapy drug. This drug has shown promising results in treating NEC cancer of the lung, leading to FDA approval for small-cell lung cancer even before the completion of a phase 3 trial. Sylvester is one of the few centers in the country with access to this trial for patients with newly diagnosed gynecological high-grade neuroendocrine cancer.
"I’m very happy to say we are one of the very few centers in the country that has access to that drug trial. So, if you have newly diagnosed gynecological high-grade neuroendocrine cancer, we can consider you for that DLL3 BiTE antibody drug trial," said Dr. Chauhan.
These research efforts offer hope for improved treatments and outcomes for patients with these rare and aggressive cancers. Sylvester will be the only site in the United States that will have access to this combination of conventional immunotherapy drugs and the novel oncolytic virus drug.
