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Lantheus Announces First Patient Dosed in Phase 2 Clinical Trial of NM-01 to Monitor PD-L1 Expression in Non-Small Cell Lung Cancer (NSCLC) Patients
NM-01 is a novel technetium-99m SPECT imaging agent currently being developed for the assessment of PD-L1 expression in cancer cells NORTH BILLERICA, Mass.,
About this update from Lantheus Holdings, Inc.
[{"type":"text","content":"NM-01 is a novel technetium-99m SPECT imaging agent currently being developed for the assessment of PD-L1 expression in cancer cells\nNORTH BILLERICA, Mass., May 13, 2022 (GLOBE NEWSWIRE) -- Lantheus Holdings, Inc. (“the Company”) (NASDAQ: LNTH), an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics and artificial intelligence solutions to Find, Fight and Follow serious medical conditions, today announced the first patient has been dosed in a Phase 2 trial evaluating NM-01, its proprietary technetium 99m SPECT imaging agent used to assess PD-L1 expression in cancer cells, for its potential to identify patients who will respond to checkpoint inhibitor therapies. The PELICAN trial (NCT04992715) is an open-label, single-arm trial in non-small cell lung cancer (NSCLC) patients. The primary endpoint is the assessment of PD-L1 expression in primary tumor and metastatic lesions by NM-01 compared to immunohistochemistry. Other objectives will look at quantifying intra- and inter-tumoral heterogeneity of PD-L1 expression by NM-01, as well as establishing correlation with other diagnostic procedures. The trial is being conducted by Lantheus’ partner NanoMab Technology Limited (NanoMab) at King’s College London. Lantheus licensed NM-01 from NanoMab in 2019. “While checkpoint inhibitor therapies targeting PD1 or PD-L1 have improved the prognosis for NSCLC patients, there are often unpredictable outcomes with these therapies for patients,” said Gary Cook, MD, King’s College London, and principal investigator of the trial. “PELICAN will help us determine if NM-01 can aid in selecting responders to checkpoint inhibitor therapies, thereby getting the right treatments to the right patients while sparing non-responders from unnecessary side-effects, procedures and costs.” Current assessment of PD-L1 expression is performed on tumor biopsy samples using immunohistochemistry. Discrepancies in checkpoint inhibitor treatment response have highlighted potential deficiencies in the current method of evaluating PD-L1 expression in a clinical setting. Immunohistochemical assessment of tumor samples obtained by needle biopsy is often unable to capture the heterogeneity and dynamic nature of PD-L1 expression within the tumor and its microenvironment. NM-01, an imaging agent targeting PD-L1 re...