Novel agent demonstrated tolerability, clinical response in patients with advanced NSCLC
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CHICAGO — For patients with advanced non-small cell lung cancer who showed an inadequate response to front-line immunotherapy checkpoint inhibitors and chemotherapy, the addition of CAN-2409 was well-tolerated.
The preliminary clinical data of CAN-2409, a replication-deficient adenoviral gene construct that delivers the thymidine kinase gene, was presented at ASCO Annual Meeting.
“I think one of greatest unmet needs in patients with — or in the management of patients with — metastatic non-small cell lung cancer is what to do in the second line after patients have failed to respond to the frontline immunotherapy or chemoimmunotherapy. We’ve seen some interesting trials being presented already at this meeting evaluating combination approaches to immunotherapy in this setting,” Charu Aggarwal, MD, MPH, Leslye M. Heisler associate professor for lung cancer excellence at University of Pennsylvania’s Abramson Cancer Center, told Healio. “What we are demonstrating is that we can come in with an immunotherapeutic mechanism to increase the response rate to their pre-existing backbone, be it maintenance pembrolizumab or maintenance methotrexate and pembrolizumab, with simple intratumoral (IT) injection of cytotoxic immunotherapy.”
According to the abstract, delivery of CAN-2409 via monotherapy IT followed by oral valacyclovir is safe among patients with NSCLC.
The open-label phase 2 clinical trial evaluated the safety and clinical activity of IT CAN-2409 combined with immunotherapy checkpoint inhibitors and chemotherapy for advanced NSCLC. Patients were split among three cohorts, as determined by response to immunotherapy checkpoint inhibitors at time of enrollment. According to the data chart, two patients enrolled in cohort 1 had stable disease, 20 patients in cohort 2 had progressive disease and six patients in cohort 3 had refractory disease.
The data cutoff for the preliminary analyses was Jan. 10, 2022, and included 28 patients who received one or more doses of CAN-2409; 22 patients were alive and six had died due to disease. Moreover, 14 patients were RECIST evaluable and received two doses of CAN-2409. Of these 14, clinical response was detected in four patients.
“We are demonstrating stabilization of disease in a vast majority of patients, but interestingly we are also observing partial responses in patients who may have failed to respond to initial immunotherapy, suggesting that this technology is able to reinvigorate immune response,” Aggarwal said.