ASCO meeting is leading venue for oncology clinical trial presentations.
June 7, 2021 - Morristown, NJ – Atlantic Health System Cancer Care physicians are lead or co-authors of seven original studies to be presented and published at the 2021 ASCO Annual Meeting, held virtually June 4-8. The ASCO annual meeting is the world’s leading venue for presenting original clinical research on cancer.
“Atlantic Health System Cancer Care is one of the nation’s most innovative cancer programs, with access to many clinical trials that are generally only available at major academic medical centers,” said Eric Whitman, MD, medical director, Atlantic Health System Cancer Care, founding director of the Atlantic Melanoma Center and interim chief research officer, Atlantic Health System. “These novel clinical trials offer more treatment options for our patients, and enable us to provide early access to these promising therapies.”
The studies cover some of the most exciting areas of cancer research today, including a therapy that “supercharges” patients’ immune T cells to fight Stage IV melanoma; an investigational vaccine for patients whose prostate cancer has recurred; a type of CAR T-cell therapy for lymphoma, which harnesses patients’ immune systems to attack their cancers, and the first clinical trial of an investigational therapy that targets proteins involved in advanced solid tumors and lymphoma.
Studies presented at the ASCO meeting are co-authored by Dr. Whitman, whose study is being presented orally; Angela Alistar, MD, medical director of GI medical oncology and the Breakthrough Treatment Center at Morristown Medical Center, who is lead author on one of four studies; Mohamad Cherry, MD, medical director of hematology for Atlantic Health System, and Morristown Medical Center urologic oncologist Sandip Prasad, MD.
See below for links to the study abstracts, which are now “live,” and brief descriptions of the studies:
Lifileucel (LN-144), a cryopreserved autologous tumor infiltrating lymphocyte (TIL) therapy in patients with advanced melanoma: Evaluation of impact of prior anti-PD-1 therapy.
Dr. Whitman
June 6, 8 – 11 a.m.
Dr. Whitman and colleagues will present the first reported long-term data on Cohort 2 of 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. Participants in this arm of the study were given a second generation infusion product. 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 and American Association for Cancer Research (AACR) 2021. Dr. Whitman is the only New Jersey-based author of these study results. NCT02360579
A phase 1, multicenter, open-label, dose-escalation, safety, pharmacodynamic, pharmacokinetic study of Q702 with a cohort expansion at the RP2D in patients with advanced solid tumors.
Dr. Alistar, lead author; poster
Available starting June 4, 9 a.m.
Dr. Alistar and colleagues will discuss a newly opened study that will test Q702, a novel immune checkpoint inhibitor—a drug that blocks certain proteins from protecting tumors from immune attack—in patients whose advanced solid tumors (tumors that do not contain liquids) have not responded to current standard-of-care treatments and need new therapeutic options. In preclinical studies, Q702 has been shown to block receptors on three proteins that suppress immune system activity, and to activate tumor-killing T cells. The study, which will look at the drug’s efficacy, safety and mode of action, is sponsored by Qurient Co. Ltd. Atlantic Health System Cancer Care is one of four centers in the U.S., and the only on the East Coast, to participate in this study. NCT04648254
First-time in-human study of VMD-928, an oral allosteric TrkA selective inhibitor targeting TrkA protein overexpression, in patients with solid tumors or lymphoma.
Dr. Alistar; poster
Available starting June 4, 9 a.m.
This phase 1 study looked at the safety and tolerability of VMD-928 for adults with advanced solid tumors and lymphoma who were already heavily pretreated with other drugs, and helped determine the recommended dose for a phase 2 clinical trial. VMD-928 is the first oral small molecule selective inhibitor of the cancer-promoting TrkA protein which acts as a “glue” that sticks two TrkA proteins together and inhibits their functioning. Dr. Alistar and colleagues showed some stabilization of disease and relatively minor adverse events. The researchers have established the ideal VMD-928 dose and are recruiting patients who have been screened for TrkA biomarkers to help determine efficacy in a number of difficult-to-treat cancer types. Atlantic Health System Cancer Care is the only New Jersey site for this clinical trial. The study is funded by VM Oncology. NCT03556228
BDB001, an intravenously administered toll-like receptor 7 and 8 (TLR7/8) agonist, in combination with pembrolizumab in advanced solid tumors: Phase 1 safety and efficacy results.
Dr. Alistar; poster discussion
Available starting June 4, 9 a.m.
Dr. Alistar and colleagues will report on a phase 1 study of BDB001, an immune modulator that showed a robust immune system response against cancer in an earlier study. The current study combines BDB001 with pembrolizumab (Keytruda), a monoclonal antibody immunotherapy, against advanced solid tumors. The treatment was well tolerated and adverse events were mild to moderate. Twenty-nine percent of study participants treated with the highest dosing levels of BDB001 showed durable treatment responses and pharmacodynamic analyses (study of the drug’s biochemical and physiologic effects) showed they had robust increases in interferon gamma and interferon inducible protein-10, both of which stimulate immune responses against cancer. Atlantic Health System Cancer Care is the only study site in the Northeast. The study is sponsored by Seven and Eight Biopharmaceuticals Inc. NCT03486301
Selection of the recommended phase 2 dose (RP2D) for subcutaneous nemvaleukin alfa: ARTISTRY-2.
Dr. Alistar; poster
Available starting June 4, 9 a.m.
ARTISTRY-2 is an ongoing phase 1/2 clinical trial of nemvaleukin alpha, a novel engineered cytokine (protein involved in cell signaling) that binds to receptors that activate certain types of immune cells to function as a cancer immunotherapy. The results being reported at ASCO look at nemvaleukin given every seven days or every 21 days during a six-week period followed by a combination with pembrolizumab for 21 days, for patients with advanced solid tumors. In an analysis of subjects’ response to nemvaleukin before starting the pembrolizumab treatment period, the researchers determined the optimal dose for toxicity-free treatment. They also found that the drug had a systemic effect, and activated the immune system cells that attack tumors, and was able to stabilize disease in a significant number of participants. The researchers are now enrolling participants in the phase 2 trial. Atlantic Health System Cancer Care is the only study site in New Jersey. This study is sponsored by Alkermes, Inc. NCT03861793
Outreach: Preliminary safety and efficacy results from a phase 2 study of lisocabtagene maraleucel (liso-cel) in the nonuniversity setting.
Dr. Cherry; publication only
Concerns about adverse events related to CAR T-cell therapy have resulted in this therapy being given primarily on an inpatient basis. OUTREACH evaluates safety and efficacy of liso-cel (Breyanzi)—a type of CAR T-cell treatment—for patients with relapsing/remitting large B-cell lymphoma, across inpatient and outpatient settings at non-university medical centers. Dr. Cherry and colleagues gave participants infusions of equal doses of CD8+ and CD4+ cells to test for potential negative reactions, such as an excessive immune response or infection. Both inpatients and outpatients had similar safety results. Of patients who could be evaluated for therapeutic efficacy, inpatients had 50% complete response and outpatients had 61% complete response. The team will present results from longer term follow up at a future scientific meeting. This study is sponsored by the Bristol-Myers Squibb Company. NCT03744676
First-in-human, phase I study of PF-06753512, a vaccine-based immunotherapy regimen (PrCa VBIR), in biochemical relapse (BCR) and metastatic castration-resistant prostate cancer (mCRPC).
Dr. Prasad; poster
Available starting June 4, 9 a.m.
Vaccines targeting prostate cancer antigen—a protein that is on the surface of cancer cells—may be viable approaches to treating relapsed and metastatic prostate cancer, when combined with immune checkpoint inhibitors. Dr. Prasad and colleagues tested this first-in-human vaccine with these patients, breaking them up into three different treatment groups, each with its own treatment schedule and therapeutic combination. A number of patients had durable responses to the treatment, and the researchers concluded that the vaccine has a manageable safety profile. The vaccine appears to stimulate antigen-specific immunity and results in noticeable antitumor activity, particularly in cancers that grow due to the hormone androgen. Atlantic Health System Cancer Care is the only study site in New Jersey. This study is sponsored by Pfizer. NCT02616185For information on current Atlantic Health System Cancer Care clinical trials, go to: www.atlantichealth.org/research.
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 18,000 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 five health systems in the region.
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.