NASDAQ:LTRN
Lantern Pharma, Inc. (NASDAQ:LTRN) provided a clinical update to its Phase II Harmonic trial highlighting that six of seven patients experienced clinical benefit from LP-300 combination treatment. Of these patients comprising the lead-in cohort, three showed partial response (PR) and three others exhibit stable disease (SD). Average tumor size reduction for the partial responders was 51% and for those with stable disease, 13%. These results produce a clinical benefit1 and disease control2 rate of 86% and an objective response rate (ORR) of 43%.
Safety was another strong point for Harmonic. A preliminary analysis found no safety concerns, dose limiting toxicities or treatment related serious adverse events. The most common adverse events were a decrease in white blood cell count and thrombocytopenia. Patients in this first stage of the trial were never smoker NSCLC patients who had failed on previous tyrosine kinase inhibitor (TKI) therapy. These individuals received treatment with LP-300 along with carboplatin and pemetrexed.
These results compare favorably to historical responses to other combination studies that measure an investigational drug with pemetrexed and carboplatin in non-small cell lung cancer (NSCLC) patients who have relapsed following TKI therapy.
Other highlights from the trial include a 57% reduction in tumor size for a patient that has been enrolled in the study for 14 months. The seventh patient that did not achieve a PR or SD experienced progressive disease. Investigators observed that the patients with low to intermediate tumor mutation burden were most responsive to LP-300 combination therapy.
A second stage of the trial is planned following the favorable safety profile generated in the first stage. The trial is now in the randomization and expansion phase where 80 additional patients will be placed in the LP-300 + SoC or SoC arms of treatment. Results from this portion of the study will be provided when 30 clinical events have been observed. If the data are supportive, Lantern will consider applying for a Breakthrough Therapy designation. Lantern is scheduled to report second quarter results on August 8th after the close and will be available to answer questions related to the interim update during the webinar following the release.
SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR.
DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.
________________________
1. Clinical Benefit Rate (CBR) is the percentage of patients who had a complete response, partial response, or had stable disease for 6 months or more. This is the proportion of patients who received a benefit from the intervention.
2. Disease control rate (DCR) is the proportion of patients who, according to internationally recognized criteria for alleviating evaluation, achieve tumor relief (PR+CR) and stable disease (SD) after treatment and can maintain for the minimum duration requirement.
3. Passaro, A. et al. Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. Annals of Oncology. October 2023.
4. Arter, Z.L., Nagasaka, M. The Nail in the Coffin?: Examining the KEYNOTE-789 Clinical Trial’s Impact. Lung cancer. January 2024.
5. Mok, T. et al. Nivolumab Plus Chemotherapy in Epidermal Growth Factor Receptor–Mutated Metastatic Non–Small-Cell Lung Cancer After Disease Progression on Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors: Final Results of CheckMate 722. Thoracic Oncology. January 2024.
6. Yu, H. et al. HERTHENA-Lung01, a Phase II Trial of Patritumab Deruxtecan (HER3-DXd) in Epidermal Growth Factor Receptor–Mutated Non–Small-Cell Lung Cancer After Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and Platinum-Based Chemotherapy. Thoracic Oncology. September 2023.
