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Research from Rutgers Cancer Institute of New Jersey shows administering the immunotherapy drug pembrolizumab together with chemotherapy given at the same time as radiation treatment (chemoradiation) is safe and tolerable as a first-line therapy for patients with stage 3 non-small cell lung cancer (NSCLC). The work, stemming from a multi-center phase 1 clinical trial led by Rutgers Cancer Institute, is published in the February 20 online edition of JAMA Oncology.

“Locally advanced NSCLC accounts for 20 to 25 percent of all new diagnoses of NSCLC, with five-year overall survival rates of between 25 to 30 percent when standard therapy is given. Current standard treatment in which an immunotherapy drug is administered after chemoradiaton offers a 57 percent progression-free survival rate compared to 43.5 percent when chemoradiation is given alone. Our team wanted to examine the safety and tolerability of the immunotherapy drug pembrolizumab when administered concurrently with chemoradiation, as we’ve learned from first-line treatment of stage 4 disease that we see better patient outcomes the earlier immunotherapy is given,” shares Rutgers Cancer Institute radiation oncologist Salma Jabbour, MD, who is the lead and corresponding author of the current work.

Typically, the human body’s immune system recognizes abnormal cells in the body and destroys them. Cancer cells frequently create proteins (PD-L1, programmed cell death ligand-1) on the cell surface that act as signals to turn off this part of the immune system. Pembrolizumab is a drug approved by the Food and Drug Administration to treat melanoma and other forms of cancer that targets PD-1 receptors, which act as a signaling ‘switch.’ Pembrolizumab blocks this action and turns the ‘switch’ back on, allowing the immune system to recognize cancer cells as foreign and attack them.

For a 27 month period between 2016 and 2018, 23 participants were enrolled (52 percent were women; median age 69 years). Five cohorts evaluating different timing and dosing of pembrolizumab combined with chemotherapy (carboplatin and paclitaxel weekly) and definitive radiation therapy (60 Gy in 2 Gy/day x 30 fractions) for unresectable, locally advanced, stage 3 disease were examined. Median follow-up time was 16 months.

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Results show the combined treatment is feasible and well tolerated with a 12-month progression-free survival of 69.7 percent. Clinical benefit accounted for 94.6 percent at a median of 12.6 months. Of 19 evaluable patients (those who received 2 or more cycles of pembrolizumab) for response, the best response to therapy was a partial response seen in 73.7 percent, followed by 15.8 percent with a complete response, and 5.3 percent with stable disease. Local progression occurred in one patient, and of the six who developed metastatic disease, the median time to metastatic disease was 14.7 months. While there was an increased rate of pneumonitis, the authors note that patients with this form of lung inflammation responded to high-dose steroid treatment.

This study demonstrates that the combination of immunotherapy with chemoradiation has the potential to improve cure rates for patients with stage 3 non-small cell lung cancer.”

Dr. Salma Jabbour, professor of radiation oncology at Rutgers Robert Wood Johnson Medical School

Given the risk of pneumonitis when pembrolizumab is given with chemoradiation, the authors note further evaluation of the treatment combination through clinical trials is warranted, where careful radiation design to limit key lung parameters and biomarkers can be implemented. They add study limitations include the small sample size and limited follow-up duration.

Source:

Rutgers Cancer Institute of New Jersey

Journal reference:

Jabbour, S.K, et al. (2020) Phase 1 Trial of Pembrolizumab Administered Concurrently With Chemoradiotherapy for Locally Advanced Non–Small Cell Lung Cancer. JAMA Oncology. doi.org/10.1001/jamaoncol.2019.6731.

The Cancer Prevention and Research Institute of Texas (CPRIT) has awarded new grants totaling $1.8 million to two University of Texas at Dallas scientists for their research related to lung and kidney cancers.

The Individual Investigator Awards are among 55 new grants totaling more than $78 million that the institute announced Feb. 19. To date, CPRIT has awarded $2.49 billion in grants to Texas research institutions and organizations through its academic research, prevention and product development research programs.

With the latest grants to the researchers in the School of Natural Sciences and Mathematics, UT Dallas has received nearly $18.5 million from CPRIT to support cancer studies.

CPRIT continues to be an important source of funding for efforts aimed at the prevention and treatment of cancer. The institute's ongoing support of basic research allows UT Dallas scientists to make important contributions toward the fundamental understanding of disease and the improvement of outcomes for cancer patients."

Dr. Joseph Pancrazio, vice president for research and professor of bioengineering at UT Dallas

Dr. Li Zhang, professor of biological sciences and the Cecil H. and Ida Green Distinguished Chair in Systems Biology Science, received $900,000 for lung cancer research. In previous studies, Zhang and her colleagues discovered that cells of the most common type of lung cancer — non-small cell lung cancer — consume substantially more oxygen than normal cells. The lung cancer cells also outpace their normal counterparts in synthesizing a critical chemical called heme, which helps transport and store oxygen. These elevated levels of oxygen and heme fuel tumor growth and progression.

With the new CPRIT grant, Zhang will use advanced imaging techniques in animal models to investigate whether drugs that target heme synthesis and uptake can be a successful strategy for suppressing lung tumors and improving the effectiveness of chemotherapy, radiotherapy and immunotherapy.

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Zhang previously received a CPRIT grant of $900,000 in 2015.

Dr. Jie Zheng, professor of chemistry and biochemistry and the Cecil H. and Ida Green Professor in Systems Biology Science, also received $900,000 for his research, which is aimed at improving the accuracy of computerized tomography (CT)- and fluorescence-guided kidney cancer surgery.

With more kidney cancers being diagnosed in the early stage, partial kidney removal is becoming an increasingly important treatment, in particular for those patients who have poor kidney function or cancer in both kidneys. In current clinical settings, CT is used first to noninvasively localize and stage kidney cancers, followed by fluorescence imaging of normal renal tissue to guide surgery. However, due to the limitations of current contrast agents, no significant improvement in reducing positive margin rates in kidney cancer surgery has been achieved, Zheng said.

Zheng's project will focus on developing a single material, based on gold nanoparticles, that can achieve high contrast in both CT and fluorescence imaging of kidney cancers. His approach takes advantage of the unique physiological microenvironment associated with kidney cancer in a way that allows the tumor margins to be more accurately differentiated during surgical removal. His nanoparticles also have the potential to effectively and selectively deliver anti-cancer drugs to tumors that cannot be treated surgically.

Zheng received three previous CPRIT grants in 2011, 2014 and 2016 totaling nearly $2.4 million.

Source:

University of Texas at Dallas