Tuesday September 1, 2020 0 comments
BOULDER and SAN CARLOS, Calif. -- Addario Lung Cancer Medical Institute (ALCMI) and Biodesix, Inc. today announced they will begin an observational study to prospectively evaluate the clinical utility of biomarkers, including the proteomic Primary Immune Response (PIR) test, for front-line non-small cell lung cancer (NSCLC) patients receiving immunotherapy with and without the addition of systemic platinum-based chemotherapy who have high expression of program death ligand-1 (PD-L1) on their tumor cells.
Biodesix is a leader in lung cancer diagnostic solutions, and has developed a serum-based proteomic test, Primary Immune Response (PIR) that, in retrospective studies, identified a pre-treatment immune profile that predicts response to anti-PD-1 therapy.
California-based ALCMI is a patient-founded, not-for-profit global research consortium dedicated to catalyzing and accelerating the discovery, development, and delivery of new and more effective treatment options for lung cancer patients.
Together, they aim to enroll 390 advanced-stage, non-squamous NSCLC patients with ≥50 percent expression of PD-L1 at leading cancer institutions in the U.S.
“Immunotherapy has revolutionized our treatment of lung cancer patients,” said Dr. Mary Jo Fidler, Rush University Medical Center.
“Many patients, especially those with high expression of the associated PD-L1 marker, prefer a non-chemotherapy treatment option. Clinical experience, however, suggests that this may not be the best therapy for all of these patients.”
Adding systemic chemotherapy (carboplatin and pemetrexed) to pembrolizumab, an FDA-approved triplet immunotherapy regimen (Langer Lancet Oncol. 2016) independent of PD-L1 status, may be a way to mitigate rapidly progressive disease in high PD-L1 expressers receiving pembrolizumab monotherapy.
However, applying the triplet combination to all patients with PD-L1 ≥50 percent may expose them to increased side effects and cost of therapy without additional benefit.
“ALCMI is dedicated to improving overall survival for all lung cancer patients in the most targeted way possible,” said Tony Addario, ALCMI chair and CEO.
“This study reflects that commitment and will drive the pursuit of new and better care options for patients with NSCLC.”
In a study presented at the European Society for Medical Oncology, the Biodesix PIR test demonstrated utility in retrospectively classifying second-line NSCLC patients treated with nivolumab by overall survival.
The immunotherapy resistant subgroup in the test demonstrated activation in the complement, acute phase, extra-cellular matrix and wound healing pathways.
The proteomic test classification is independent of PD-L1 status and uses mass spectrometry in combination with machine learning to analyze circulating proteins in blood.
“We know that immunotherapy by itself does not work for everyone,” said Scott Hutton, CEO of Biodesix.
“With the physical and financial toxicity associated with these therapies, a biomarker that can predict survival or early death would be critical in determining the best therapeutic regimen for lung cancer patients.”