Medical Partners Open Phase I Trial Center to Improve Access, Novel Drug Development

Angela Alistar, MD

Atlantic Health System of Morristown New Jersey and Translational Genomics Research Institute (TGen) of Arizona have opened a center dedicated to phase I clinical trials in cancer and improving access for patients with limited coverage. With the Breakthrough Treatment Center, Atlantic Health and TGen aim to develop novel precision medicine therapies for patients who have not responded to standard treatments.

The center, based in Morristown, formally began operating in March and is an offshoot of the Breakthrough Oncology Accelerator (BOA), a care delivery and financial model produced through the partnership of Atlantic Health, TGen, and Origin Commercial Ventures, of Wilmington, North Carolina, that is designed to expand patient access to critical but historically cost-prohibitive agents.

Advances in genomics, immune-oncology, and other therapies have proceeded at a rapid pace. The inability of the healthcare system and insurance companies to keep up translates to a financial infrastructure that is incompatible with modern cancer care, officials for Atlantic Health, TGen, and Origin said. The BOA is the partners’ effort to make treatment not only more widely available but also more affordable.

Through the BOA, Atlantic Health System, T Gen, and Origin Commercial Ventures have collaboratively opened early and late-phase studies at Atlantic Health that, beyond Atlantic, are available only at a select few centers around the world.

“Some of these trials are only offered to a handful of patients in the United States,” said Trisha O’Keefe, PhD, RN, president of Morristown Medical Center, where the Breakthrough Treatment Center is based. “With the opening of our Breakthrough Treatment Center, patients receiving phase I clinical research therapy now have the unique opportunity to be treated in a private space and we have the opportunity to offer hope to our patients with even the most difficult-to-treat cancers.”

TGen is a nonprofit affiliate of City of Hope, Duarte, California, that is working to improve precision medicine by developing understanding of the genetic components of diseases including cancer. Atlantic Health includes 6 medical centers covering a broad geographic area in New Jersey.

Coupling Atlantic Health System’s cancer care with TGen’s medical research, the Breakthrough Treatment Center will support the BOA’s goal of facilitating clinical investigation into genomics-driven and immune-oncology targeted therapies while broadening the number of highly specific studies available to patients who have failed the standard of care (SOC) and are therefore in need of subsequent treatment options.

“We’re a unique center,” Mohamad Cherry, MD, medical director, hematology, Atlantic Health System, said in an interview with OncologyLive®. Many patients do not have access to advanced therapies and this center will make it easier for them, he said.

“Many of these studies are not [open elsewhere] in New Jersey or surrounding states, so patients have to travel long distances to get something similar. We want patients to reach out to us and ask about [our] studies before they travel to other places.”

The Breakthrough Treatment Center is presently recruiting patients for 12 phase I studies across disease types. Angela Alistar, MD, medical director, for gastrointestinal medical oncology at Morristown Medical Center, said the trial ADXS-NEO (NCT03265080) is one of the center’s most exciting state-of-the-art clinical offerings.

The safety and efficacy study is enrolling patients with advanced or metastatic tumors. Patients (N = 48) will receive investigational ADXS-NEO either alone or in combination with SOC pembrolizumab (Keytruda). ADXS-NEO, a live, attenuated listeria monocytogenes immunotherapy, uses personalized antigen delivery based on whole-exome sequencing of a patient’s tumor. This approach helps a patient’s immune system recognize and respond to the mutation-derived neoantigens specific to the patient’s tumor.1,2

“This is as exciting as it gets in immunotherapy,” Alistar said. “Not all tumor types respond well to the SOC drugs, and we know now that immunotherapy by itself is not sufficient for the treatment of many tumors, so we continue to conduct research to find new ways to make tumors visible to the immune system. I know that our patients are [interested] to hear that we can create a vaccine based on their tumor profiles; that really is the future of oncology.”

The Breakthrough Treatment Center will support early stage trials beyond the 12 that Atlantic Health and TGen have announced. One of these will be a first-in-human infusion study for patients who have relapsed/refractory acute myelogenous leukemia or myelodysplastic syndromes (MDS). That this trial is being conducted in approximately 10 centers across the nation is evidence of the Breakthrough Treatment Center‘s commitment to exploring novel therapies, Cherry said. “This [conveys] the importance of the center, because we were selected to run this study,” he said.

He added that patients with acute leukemia and high-grade MDS typically have poor prognoses after failing standard chemotherapy. “There is unmet need. These patients need more [options],” Cherry said. A representative from Atlantic Health said that more details about this phase I initiative will be available in coming weeks.

Beyond phase I studies, the center’s investigative efforts also include several phase II and phase III trials. Presently, the center is home to 33 phase II studies and 31 phase III studies in a range of cancer types, spanning breast, brain, anal, head and neck, leukemia/myelodysplastic syndromes, lymphoma/multiple myeloma, pancreatic, colorectal, lung, and prostate. Atlantic Health System and TGen aim to open a total of 100 studies across phases by March 2020.

“Instead of a generalized approach to cancer care, we have designed a multidisciplinary specialty approach focused on tumor specific care,” O’Keefe said. “This focus on research is one part of our unrelenting commitment to creating a national model for cancer care, right here in our backyard.”

The BOA is partly a product of the growing interest in immunotherapy and targeted therapy, which have burgeoned with rapid advances in investigation over the past decade. “Research institutes and smaller biotech firms, where much of the translational research on these breakthrough therapies occurs, have never seen such fertile ground,” according to a release issued by the BOA.3 At the same time, newer treatments for cancer are becoming so costly that payers have not kept up with negotiations for payment rates with health systems. One of the stated goals of the BOA is to develop additional models of affordability so that patients can access costly breakthrough treatments. Another is to develop models of access to cancer care that can be replicated by other health systems.

In August 2019, Atlantic Health was named a National Community Oncology Research Program (NCORP) by the National Cancer Institute (NCI). The program allows participating health centers to develop and implement programs for cancer screening and prevention, and care delivery, as well as treatment studies. A goal that is strongly emphasized in NCORP is the inclusion of minority and ethnic populations, particularly populations that face greater challenges in obtaining cutting-edge cancer care. Specific goals are to increase adult and pediatric participation in the NCI and National Clinical Trials Network clinical trials. Collection of tissue samples to support advances in genomics and molecularly targeted therapies is also part of the initiative.

Health systems in New Jersey that are a part of the Atlantic Health NCORP include CentraState Healthcare System of Freehold; Holy Name Medical Center, Teaneck; Hunterdon Healthcare, Raritan; St. Joseph’s Health, of Paterson; and Saint Peter’s Healthcare System, New Brunswick.

References

1. Preliminary data from phase 1 study evaluating ADXS-NEO suggest rapid immunogenicity and clinical activity [press release]. Princeton, NJ: Advaxis, Inc.; March 29, 2019. https://ir.advaxis.com/press-release/preliminary-data-phase-1-study-evaluating-adxs-neo-suggest-rapid-immunogenicity-and/ Accessed September 25, 2019.
2. New immune data from ongoing ADXS-NEO phase 1 study support clinical potential for neoantigen-directed immunotherapies [press release]. Princeton, NJ: Advaxis, Inc.; July 15, 2019.
3. New Jersey’s first Natinoal Cancer Institute community oncology research program (NCORP) awarded to Atlantic Health cancer consortium [news release]. Morristown, NJ: Atlantic Health System; August 22, 2019. www.prnewswire.com/news-releases/new-jerseys-first-national-cancer-institute-community-oncology-research-program-ncorp-awarded-to-atlantic-health-cancer-consortium-300905989.html.