Texas-based artificial intelligence (AI) oncology firm, Lantern Pharma, has dosed the first patient from Taiwan in a Phase II trial of LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC).
The first enrollment and dosing of the first patient in Taiwan marks the extension of the company’s HARMONIC trial into Asia for the first time. The Phase II HARMONIC trial (NCT03786692) has already been dosing patients in the US, with plans to soon enroll patients in Japan.
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Research published in the Journal of Thoracic Oncology in 2019 found that in Taiwan, more than half of all new lung cancer cases (53%) turned out to be in never-smokers.
Panna Sharma, President and CEO of Lantern Pharma, said: “The enrollment of our first patient in Taiwan marks another important milestone in the expansion of our HARMONIC trial. The extremely high proportion of never-smoker lung cancer patients in Taiwan makes this region important for accelerating our enrollment with the objective of addressing a critical unmet need in a population where this disease has an outsized impact.”
The Taiwan initiation follows preliminary results from the trial’s initial safety lead-in cohort, which demonstrated an 86% clinical benefit rate and 43% objective response rate among the first seven patients. The HARMONIC trial will examine LP-300 in combination with two chemotherapies, carboplatin and pemetrexed.
In the previous lead-in cohort of seven patients, six patients experienced clinical benefits from the combination of LP-300 alongside chemotherapy while one patient experienced progressive disease. Of those who saw medical benefit from the treatment, three showed partial responses with an average tumour size reduction of 51%. Three others saw disease stability with an average tumour size reduction of 13%.
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By GlobalDataDesigned using the company’s own proprietary AI-driven platform, RADR, LP-300 is designed as a disulfide small molecule and an investigational new drug candidate for NSCLC patients who have never smoked and whose cancer has progressed despite receiving treatment with tyrosine kinase inhibitors (TKIs).
Reggie Ewesuedo, vice president of clinical development at Lantern Pharma said: “The initiation of patient dosing in Taiwan demonstrates the continued momentum of our Asia expansion strategy. With active screening now occurring at multiple sites across both Japan and Taiwan, we expect to see accelerated enrollment in the trial. The enthusiasm we’ve seen from clinical collaborators in Taiwan reflects the significant need for new therapeutic options for never-smoker NSCLC patients in this region.”
The news follows after the 11th Annual Clinical Trials in Oncology conference in Munich where sponsors and research organisations were urged to listen to patients and take careful considerations on what clinical trials demand from their day-to-day lives.
