Innovative Center Focuses on Phase I Trials

Angela Alistar, MD

Medical Director

Gastrointestinal Medical Oncology

Morristown Medical Center

A partnership between a healthcare system in Morristown, New Jersey, and a genomics research institute in Phoenix, Arizona, has led to the opening of a center dedicated to offering phase I cancer trials in community settings and improving access for patients with limited coverage.

The goal of Atlantic Health System and Translational Genomics Research Institute’s (TGen) collaboration: to develop novel precision medicine therapies for patients who have not responded to standard treatments.

The Breakthrough Treatment Center formally began operating in March. An offshoot of the Breakthrough Oncology Accelerator (BOA), a care delivery and financial model produced through the partnership of Atlantic Health System, TGen, and Origin Commercial Ventures of Wilmington, North Carolina, the center 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 healthcare systems and insurance companies to keep up translates to a financial infrastructure that is incompatible with modern cancer care, officials for Atlantic Health System, TGen, and Origin said. The BOA is the partners’ effort to make treatment both more widely available and more affordable.

Through the BOA, Atlantic Health System, TGen, and Origin have collaboratively opened early- and late-phase studies at Atlantic Health System that are available at just a few other select centers around the world.

“Some of these trials are only offered to a handful of patients in the United States,” said Trish O’Keefe, PhD, RN, president of Morristown Medical Center, where the new 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, a nonprofit affiliate of City of Hope in Duarte, California, is working to improve precision medicine by developing understanding of the genetic components of diseases including cancer. Atlantic Health System 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 in need of subsequent treatment options.

“We’re a unique center,” Mohamad Cherry, MD, medical director of hematology at Atlantic Health System, said in an interview with OncologyLive^®. “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 (Table). Angela Alistar, MD, medical director of 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 offering.

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 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 System and TGen have announced. One will be a first-in-human infusion study for patients who have relapsed/refractory acute myeloid leukemia or myelodysplastic syndromes (MDS). The trial is being conducted in approximately 10 centers nationwide, which 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. More details about this phase I initiative will be available in coming weeks, according to an Atlantic Health System representative.

The center’s investigative efforts also include several phase II and III trials. Presently, the center is home to 33 phase II and 31 phase III studies in a range of cancer types, spanning breast, brain, anal, head and neck, leukemia/MDS, 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.”

Table. Phase I Clinical Trials at Atlantic Health System's Breakthrough Treatment Center

In August 2019, Atlantic Health System was named a National Cancer Institute (NCI) Community Oncology Research Program (NCORP). The program allows participating health centers to develop and implement programs for cancer screening and prevention, care delivery, and treatment studies. One goal strongly emphasized in NCORP: the inclusion of minority and ethnic populations, particularly populations that face greater challenges in obtaining cutting-edge cancer care. Specific goals involve increasing adult and pediatric participation in the NCI and National Clinical Trials Network studies. Collecting 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 System NCORP include CentraState Healthcare System, Freehold; Holy Name Medical Center, Teaneck; Hunterdon Healthcare, Raritan; St. Joseph’s Health, 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. 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. biospace.com/article/releases/new-immune-data-from-ongoing- adxs-neo-phase-1-study-support-clinical-potential-for-neoantigen- directed-immunotherapies/.
3. New Jersey’s first National Cancer Institute community oncology research program (NCORP) awarded to Atlantic Health cancer consortium [news release]. Morristown, NJ: Atlantic Health System; August 22, 2019. prnewswire.com/news-releases/new-jerseys- first-national-cancer-institute-community-oncology-research- program-ncorp-awarded-to-atlantic-health-cancer-consortium- 300905989.html.

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 BOA’s stated goals involves developing additional models of affordability so that patients can access costly breakthrough treatments. Another is to develop models of access to cancer care that other health systems can replicate.