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Atlantic Health System Physicians Co-Author 5 Studies, Presented at American Association for Cancer Research (AACR) Annual Meeting

Atlantic Health System Cancer Care physicians are co-authors of five original studies presented at this year’s AACR Annual Meeting, held virtually April 10-15 and May 17-21. The AACR meeting is one of the world’s premier scientific gatherings of cancer specialists and researchers.

“Atlantic Health System Cancer Care is extremely proud of its role, helping to lead these studies alongside some of the world’s best-known cancer researchers,” said Eric Whitman, MD, medical director, Atlantic Health System Cancer Care and director of the Atlantic Melanoma Center. “Our physicians conduct the most innovative research and provide world-class care seldom found outside of major academic medical centers. These innovative clinical trials offer more treatment options for patients, both in our area and in some cases, around the world.”

Studies presented at the AACR meeting were co-authored by Dr. Whitman; Missak Haigentz, MD, chair of hematology/oncology at Morristown Medical Center, medical director of hematology/oncology for Atlantic Health System and principal investigator, Atlantic Health Cancer Consortium NCORP; and Angela Alistar, MD, medical director of GI medical oncology and the Breakthrough Treatment Center at Morristown Medical Center. See below for links to the study abstracts, which are now live, and brief descriptions of the studies:

CT008 – Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced (unresectable or metastatic) melanoma: durable duration of response at 28 month follow up

Dr. Whitman; presentation

Dr. Whitman and colleagues presented 28-month follow-up data on the ongoing global phase 2, multicenter clinical trial of a new type of investigational cancer treatment known as lifileucel (LN-144) for advanced (Stage IV) melanoma. Lifileucel is a TIL (tumor infiltrating lymphocyte) therapy, in which the patient’s own immune system cells are removed from his/her tumor, treated with an immune booster and then infused back into the patient, along with a medication that stimulates the immune system. All participants in the study have metastatic melanoma that has progressed despite prior treatment with other therapies, including anti-PD-1 (checkpoint inhibitor) immunotherapy and BRAF/MEK inhibitor targeted therapy. At 28 months, lifileucel therapy has shown an overall response rate (ORR) of 36.4%. The study, which is ongoing, is sponsored by Iovance Biotherapeutics. Dr. Whitman and co-investigators presented earlier results at ASCO 2020. (NCT02360579CT201)

Early report of a phase I/II study of human placental hematopoietic stem cell derived natural killer cells (CYNK-001) for the treatment of adults with COVID-19 (NCT04365101)

Dr. Whitman; e-poster

Dr. Whitman and colleagues published interim phase 1 results from the first study to evaluate the safety and efficacy of CYNK-001 (Celularity, Inc.) to treat patients with SARS-CoV-2 (the virus that causes COVID-19). The investigational drug was previously only tested against various types of cancer. CYNK-001 is the only cryopreserved, allogeneic, off-the-shelf, natural killer (NK) cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various blood cancers, solid tumors, and infectious disease. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity (specialized immunity to certain disease causing agents). CYNK-001 has been shown to be toxic to various types of cancer cells and secretes immune-modulating cell-signaling proteins (cytokines) when they reach their target. Patients with moderate to severe COVID-19 not requiring intensive care or mechanical ventilation were enrolled in this study. Infusions of CYNK-001 were generally well tolerated, and three of four patients showed improvement in oxygenation, lung inflammation and medical imaging findings. Phase 1 is still ongoing. Once it is complete, a randomized, phase 2 clinical trial will test the efficacy of this therapy for SARS-CoV-2 against the best available therapy.

1671 – Evaluation of total PD-1 expression using multi-color flow cytometry in metastatic non-small Cell lung cancer patients treated with multi-neoantigen vector (ADXS-503) alone and in combination of pembrolizumab to assess T-cell & T-cell memory subset

Dr. Haigentz; e-poster

Dr. Haigentz and colleagues tested novel laboratory assays developed by Precision for Medicine to be used as biomarkers in Advaxis clinical trials of ADXS-503 alone and in combination with pembrolizumab (Keytruda) for metastatic non-small cell lung cancer. ADXS-503 is a new type of investigational cancer drug that targets “hotspot” mutations that commonly occur in specific cancer types. Pembrolizumab is an immunotherapy that targets the PD-1 pathway, which protects cancer cells from immune attack. It is commonly used to treat this type of lung cancer. The researchers used the lab assays to examine frozen blood cells from individuals treated with the two-drug combination and those treated with ADXS-503 alone, in order to detect freestanding PD-1 proteins and PD-1 proteins bound to pembrolizumab. The assays were effective at detecting PD-1 on various immune T cells. Dr. Haigentz and colleagues state that the assays will help in the evaluation of total PD-1 expression in T cells when PD-1 blocking immunotherapies are used. These results may also support the combination of ADXS-503 with PD-1 focused therapies that could lead to more effective cancer immunotherapies.

CT174 – Phase II study of avelumab and trastuzumab with FOLFOX chemotherapy in previously untreated HER2-amplified metastatic gastroesophageal adenocarcinoma

Dr. Alistar; e-poster

In a phase 2 study, Dr. Alistar and colleagues tested a combination of avelumab, trastuzumab and FOLFOX with patients with previously untreated metastatic gastric and gastric cancer that overexpresses the HER2 gene. Avelumab (Bavencio) is a monoclonal antibody immunotherapy known as an anti-PD-L1 therapy or immune checkpoint inhibitor, while trastuzumab (Herceptin) is also a monoclonal antibody that targets HER2 receptors. FOLFOX is a standard combination of chemotherapeutic drugs. The researchers added avelumab to the standard trastuzumab and FOLFOX regimen for these types of cancer. Study investigators showed that this combination therapy generated anti-tumor activity and compared favorably to previous studies of trastuzumab and chemotherapy. Dr. Alistar and colleagues are excited about the potential for adding checkpoint inhibitors to the chemotherapy/trastuzumab combination for these types of advanced gastrointestinal cancers. Some patients in the study were still being treated at the time the research abstract was submitted to the AACR. Additional lab-based studies are now underway. Atlantic Health System Cancer Care is the only cancer program in New Jersey involved in this study. (NCT03783936)

CT177 – A multi-center phase 2a trial of the CXCR4 inhibitor motixafortide (BL-8040) (M) in combination with pembrolizumab (P) and chemotherapy (C), in patients with metastatic pancreatic adenocarcinoma (mPDAC)

Dr. Alistar; e-poster

To date, physicians have been unable to improve the health of people with metastatic pancreatic adenocarcinoma, the most common type of pancreatic cancer, with checkpoint inhibitor immunotherapy. Preclinical research has shown that the inhibition of the CXCR4 protein helps makes cancer cells more accessible to checkpoint inhibitors. In the second cohort of phase 2a COMBAT clinical trial, Dr. Alistar and colleagues tested BioLineRx Ltd.’s CXCR4 inhibitor BL-8040 in combination with checkpoint inhibitor pembrolizumab (Keytruda) and a type of chemotherapy against this Stage IV cancer. The study had encouraging results, with a confirmed objective response rate of 13.2%, 5.6 month median duration of benefit from the treatment, overall survival average of 6.5 months and progression free survival of four months. The investigators concluded that the therapeutic combination should be tested against this late-stage cancer in a randomized clinical trial. (NCT02826486)

For information on current Atlantic Health System Cancer Care clinical trials, go to: www.atlantichealth.org/research. To learn more about the 2021 AACR Annual Meeting, go to: https://www.aacr.org/meeting/aacr-annual-meeting-2021/.

About Atlantic Health System Cancer Care

Atlantic Health System Cancer Care offers an unparalleled network of cancer specialists and resources for more than 70,500 patients annually through its flagship Carol G. Simon Cancer Center at Morristown and Overlook medical centers, as well as its comprehensive oncology programs at Chilton, Hackettstown and Newton medical centers. With more than 250 cancer specialists and medical professionals, all five hospitals and Atlantic Medical Group have been recognized nationally for their role in advancing the fight against cancer. Atlantic Health System Cancer Care is the lead affiliate of Atlantic Health Cancer Consortium (AHCC) – the only New Jersey-based National Cancer Institute (NCI) Community Oncology Research Program (NCORP). Atlantic Health System is affiliated with the Translational Genomics Research Institute (TGen) of Phoenix, Arizona, and together they have created the Breakthrough Oncology Accelerator, a pioneering research and clinical collaboration designed to improve patient access to the most innovative and sophisticated therapies for cancer.

About Atlantic Health System

Atlantic Health System is at the forefront of medicine, setting standards for quality health care in New Jersey, Pennsylvania and the New York metropolitan area. Powered by a workforce of more than 17,000 team members and 4,800 affiliated physicians dedicated to building healthier communities, Atlantic Health System serves more than half of the state of New Jersey including 11 counties and 4.9 million people. The not-for-profit system offers more than 400 sites of care, including seven hospitals: Morristown Medical Center in Morristown, NJ, Overlook Medical Center in Summit, NJ, Newton Medical Center in Newton NJ, Chilton Medical Center in Pompton Plains, NJ, Hackettstown Medical Center in Hackettstown, NJ, Goryeb Children’s Hospital in Morristown, NJ, and Atlantic Rehabilitation Institute in Madison, NJ.

Atlantic Medical Group, comprised of 1,000 physicians and advanced practice providers, represents one of the largest multi-specialty practices in New Jersey and joins Atlantic Accountable Care Organization and Optimus Healthcare Partners as part of Atlantic Alliance, a Clinically Integrated Network of more than 2,500 health care providers throughout northern and central NJ.

Atlantic Health System provides care for the full continuum of health care needs through 16 urgent care centers, Atlantic Visiting Nurse and Atlantic Anywhere Virtual Visits. Facilitating the connection between these services on both land and air is the transportation fleet of Atlantic Mobile Health.

Atlantic Health System leads the Healthcare Transformation Consortium, a partnership of seven regional hospitals and health systems dedicated to improving access and affordability and is a founding member of the PIER Consortium – Partners in Innovation, Education, and Research – a streamlined clinical trial system that will expand access to groundbreaking research across seven health systems in New Jersey.

Atlantic Health System has a medical school affiliation with Thomas Jefferson University and is home to the regional campus of the Sidney Kimmel Medical College at Morristown and Overlook Medical Centers and is the official health care partner of the New York Jets.