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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.

A broad coalition is calling for Congress to ensure that Medicaid patients are guaranteed coverage to participate in potentially life-saving clinical trials.

In a letter (PDF) to Congressional leaders, the coalition urged Congress to include the bipartisan Clinical Treatment Act in a healthcare extenders package, which is expected to pass this spring.

The letter was signed by leaders of 106 organizations representing patients, providers, medical researchers, survivors, and families. It urged lawmakers to include H.R. 913 in the upcoming “must-pass” healthcare extenders package to ensure clinical trial coverage for Medicaid patients.

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Organizations backing the bill include the Association for Clinical Oncology, the American Medical Association, the American Heart Association and the American Cancer Society Cancer Action Network. 

The legislation, introduced by Rep. Ben Ray Luján (D-NM) and Rep. Gus Bilirakis (R-FL), would ensure states cover routine care costs of participation in an approved clinical trial for Medicaid enrollees with life-threatening conditions. It currently has 28 cosponsors from both political parties.

In the letter, the organizations noted that Medicaid insures nearly one-fifth of the U.S. population and is the only major payer that is not required by federal law to cover routine costs, such as physician visits and laboratory tests, associated with participating in a clinical trial.

Only 11 states require their Medicaid programs to cover the costs, leaving as many as 42.2 million Medicaid patients potentially without coverage.

“Importantly, clinical trials often provide patients with the best—perhaps only—treatment options for their condition,” the organizations wrote. “Without the guarantee of coverage, however, many Medicaid beneficiaries do not have the latest technological and scientific advancements as a treatment option.”

Coverage would have little to no impact on the overall cost of care to Medicaid programs, they said. The cost of any investigative device or drug would continue to be covered by the clinical trial sponsor. Routine costs only include the non-experimental costs of treating a patient who is participating in a clinical trial. These are part of standard care and would be incurred whether or not a patient participates in a clinical trial.

“Without fair coverage, patients with Medicaid are being excluded from potentially life-saving clinical trials. This is a simple fix and one that should be addressed by Congress as soon as possible,” said Monica Bertagnolli, M.D., chair of the Association for Clinical Oncology, an affiliated professional organization of the American Society of Clinical Oncology.

The organizations hope to get the legislation included as part of a package of health program extenders that Congress must fund before current funding expires May 22.

The supporters of the legislation said the bill would also improve the quality of clinical research and reduce health disparities as Medicaid insures a large portion of people from under-represented minority and ethnic groups who are not well represented in clinical trial enrollment.