FDA Clears IND Application for LB2102 in Extensive-Stage SCLC

By Michael Vlessides, MD /alert Contributor

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The FDA has cleared Legend Biotech’s Investigational New Drug application for LB2102, an autologous chimeric antigen receptor T-cell therapy for the treatment of adult patients with extensive stage small-cell lung cancer.

The investigational agent is designed to selectively target delta-like ligand 3, which is highly restricted to several malignancies, including SCLC, large-cell neuroendocrine carcinoma, some prostate cancers, and certain other neuroendocrine tumors. In previous research, delta-like ligand 3 has also been linked to various other cancer activities, including tumor growth, invasion, and migration.

The efficacy of LB2102 will soon be assessed in a phase-1, first-in-human, open-label clinical study. That investigation will determine the safety and preliminary efficacy of LB2102 in patients with extensive-stage SCLC and large-cell neuroendocrine carcinoma, and also determine the recommended dose of LB2102 for further phase-2 research.

SCLC is among the most aggressive forms of lung cancer, accounting for as much as 15 percent of all cases in the United States. What’s more, the disease becomes markedly more difficult to treat once it has spread and becomes extensive-stage SCLC. Indeed, between 60 and 70 percent of SCLC patients are diagnosed with metastatic disease.

“On average, only seven percent of patients with SCLC are alive five years after receiving their diagnosis,” Lida Pacaud, MD, Vice-President of Clinical Development at Legend Biotech said in a statement. “We are eagerly awaiting the start of this phase-1 trial, and we hope that the study will provide much-needed insight into the potential of this investigational CAR-T therapy.”

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Disclosures: Pacaud is an employee of Legend Biotech.

Photo Credit: Getty Images. 

 

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