A new type of immunotherapy treatment for metastatic non-small cell lung cancer (NSCLC) is being tested by Missak Haigentz, Jr., MD, medical director of hematology and oncology for Atlantic Health System.
Early results appear promising in this phase 1/2 clinical trial of ADXS-503 being developed by Advaxis, Inc., a new type of cancer therapy which targets "hotspot" mutations that commonly occur in specific cancer types, both by itself and in combination with immunotherapy Keytruda® (pembrolizumab), which is commonly used to treat this type of lung cancer.
Dr. Haigentz and colleagues published early results of this study in conjunction with ASCO 2020, the world's premier scientific meeting for clinical research in oncology. Princeton-based Advaxis, ADXS-503's manufacturer and the study's sponsor, reported additional results following submission of the ASCO research summary.
Atlantic Health System's Carol G. Simon Cancer Center at Morristown Medical Center and Overlook Medical Center are the only sites in New Jersey for this study.
"I find these results very encouraging, although they are early," said Dr. Haigentz, who also serves as principal investigator for the Atlantic Health Cancer Consortium, the only New Jersey-based National Cancer Institute Community Oncology Research Program (NCORP). "New treatments are urgently needed for this form of cancer."
Advaxis reported 16-week results of the first patients dosed in Part B of this study, which is designed for NSCLC patients whose cancer has progressed despite treatment with pembrolizumab. Among their findings were that the first two patients whose cancer had previously progressed while on pembrolizumab alone had tumors that stopped growing or were reduced in size while on the two-drug combination.
One patient's tumor had reduced by 25% after 16 weeks of combination therapy. The second patient achieved a partial response with a nearly 60% reduction of the lung tumor burden. Responses to combination treatment of patients whose cancer had spread while on pembrolizumab immediately before starting the clinical trial suggest ADXS-503 may re-sensitize or enhance response to pembrolizumab.
Examination of biomarkers (molecular indicators of disease) showed activation of two types of immune system T cells, which are known to fight cancer cells, with new CD8+ T cells generated in all seven patients evaluated. Both as a standalone treatment and in combination with pembrolizumab, ADXS-503 appeared safe and well tolerated with no toxicities at the dosage given.
Based on the latest data, the company has decided to expand the study.
We are excited with the outcomes in these very early stages of the evaluation of the combination therapy ADXS-503 + pembrolizumab in patients failing pembrolizumab as a potential new therapeutic option for patients failing a checkpoint inhibitor."
Andres A. Gutierrez , MD, PhD, Chief Medical Officer and EVP, Advaxis, Inc.,Atlantic Health System
"Based on our promising early results, we are planning to expand Part B to further characterize the potential clinical benefit in patients, as well as the opening of Part C, as a first-line therapy next month."
ADXS-503 is part of Advaxis' ADXS-HOT cancer immunotherapy program, which uses the company's proprietary Lm technology (listeria monocytogenes bacteria) to target hotspot cellular mutations by mimicking infection and redirecting the immune system's response against the cancer.
Pembrolizumab is an anti-PD-1 (anti-programmed death receptor-1) immunotherapy known as a checkpoint inhibitor. These drugs inactivate "checkpoints" on certain immune cells in order to stimulate an immune response against the cancer.
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