LP-300 Shows Promise in Treating Advanced Lung Cancer in Never Smokers

Microscopic image of non-small cell lung cancer - Generated with Google Gemini AI

Findings from a primary analysis of the phase 2 Harmonic trial (NCT05456256) of the investigational new drug candidate and disulfide small molecule LP-300 (Tavocept, BNP7787, DImesna) with carboplatin and pemetrexed for the treatment of non–small cell lung cancer (NSCLC) in never smokers showed positive results, including a clinical benefit rate (CBR) of 86% and an objective response rate (ORR) of 43%.¹

“Preliminary results indicate that this LP-300 triplet regimen is active against advanced NSCLC with actionable alterations and there were no unexpected adverse events. Also, the early HARMONIC patient data indicates that the adverse events appear to be primarily due to chemotherapy and not the study drug,” said Janakiraman Subramanian, MD, director of thoracic oncology at Inova Schar Cancer Institute, in a press release.

The safety lead-in portion of the phase 2 study enrolled 7 patients. Of these, 3 patients achieved a partial response and 3 had stable disease. In the patients who achieved a partial response, there was an average of 51% reduction in tumor size, and in those with stable disease, there was an average 13% reduction in tumor size. One patient has remained on the study treatment for 14 months with a 57% reduction in tumor size.

Additionally, there were no dose-limiting toxicities, safety concerns, or serious treatment-related adverse events reported.

Randomization of the study is ongoing, and the study will continue to assess for progression-free survival (PFS) and overall survival (OS).

About the Phase 2 HARMONIC Study

HARMONIC is enrolling patients with NSCLC that are never smokers and have relapsed following treatment with tyrosine kinase inhibitors (TKIs). Patients are being randomized to receive carboplatin and pemetrexed with or without LP-300 in 21-day cycles. Patients will complete 4 to 6 cycles of study treatment, and then have the option to remain on pemetrexed maintenance therapy.²

The study’s primary end points are PFS and OS, and secondary end points include ORR, duration of response, CBR, and safety.

Patients with inoperable stage III or IV NSCLC with actionable genomic alterations who have experienced progression on or after TKIs and have an ECOG performance status of 0 or 1 are eligible for participation in the study. Additionally, patients must have adequate bone marrow and hepatic functions, and if a patient has central nervous system metastases, they must be stable and controlled.

The study is enrolling in 8 locations in California, Pennsylvania, Texas, and Virginia, and has an estimated completion date of May 2025.

REFERENCES:

1. Lantern Pharma announces positive clinical update from ongoing phase 2 Harmonic™ clinical trial for never smokers with advanced NSCLC, including an 86% clinical benefit rate in the initial patient cohort. News release. Lantern Pharma. August 5, 2024. Accessed August 6, 2024. https://tinyurl.com/589m5jyx

2. A study of LP-300 with carboplatin and pemetrexed in never smokers with advanced lung adenocarcinoma (HARMONIC). ClinicalTrials.gov. Updated July 8, 2024. Accessed August 6, 2024. https://clinicaltrials.gov/study/NCT05456256