Dr Kim on the HARMONIC Trial of LP-300 in Advanced Lung Cancer

Edward S. Kim, MD, MBA, physician-in-chief at City of Hope Orange County and vice physician-in-chief at City of Hope National Medical Center, discusses the investigation of LP-300 plus chemotherapy in the phase 2 HARMONIC trial (NCT05456256) in patients with advanced lung adenocarcinoma.

The ongoing open-label, randomized study is evaluating the addition of LP-300 to standard-of-care carboplatin plus pemetrexed vs carboplatin plus pemetrexed alone in patients with advanced lung adenocarcinoma who were never smokers. The design of the study stemmed from results a prior phase 3 trial (DMS32212R; NCT00966914), and it will further explore the efficacy of LP-300 in this subset of patients, Kim begins. In that phase 3 study, never-smoker patients who received LP-300 plus cisplatin and paclitaxel experienced a 2-year survival rate of 63%, compared with 28% for patients in this subgroup treated with chemotherapy alone (HR, 0.519; P = .0462). 

HARMONIC is expected to enroll 90 patients who will be randomly assigned in a 2:1 fashion, Kim says. Notably, patients are required to have non–small cell lung cancer (NSCLC) with an actionable genomic alteration, Kim continues. The study is including patients who received prior systemic treatment with TKIs for NSCLC and experienced disease progression, unacceptable TKI-related adverse effects, or intolerance.

After patients complete 6 cycles of carboplatin and pemetrexed with or without LP-300, both arms will have the option to receive pemetrexed maintenance. Additionally, blood and biopsy specimens will be collected throughout the trial to monitor any changes on biomarkers, Kim says.

The goal of the study is to better understand if LP-300 can enhance the chemotherapy regimen in a setting where there is an unmet need for patients who received prior targeted therapy, Kim concludes.