2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.111 (Poster) Phase 2a Intratumoral Large Surface Area Microparticle Paclitaxel in Stage 3/4 Lung Cancer

PP01.111 (Poster) Phase 2a Intratumoral Large Surface Area Microparticle Paclitaxel in Stage 3/4 Lung Cancer

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A study conducted at multiple clinical trial sites investigated the safety and efficacy of Large Surface Area Microparticle Paclitaxel (LSAM-PTX) in patients with non-resectable stage 3/4 lung cancer. LSAM-PTX is designed for intratumoral (IT) injection, providing a depot of paclitaxel in the tumor while limiting systemic exposure. The trial included subjects receiving up to three monthly IT injections of LSAM-PTX in combination with standard of care therapies. The subjects were followed for up to 1 year for preliminary efficacy and 6 months for safety.<br /><br />Some key findings from the study include:<br />- LSAM-PTX was well tolerated with low systemic paclitaxel exposure and no apparent accumulation.<br />- Immunophenotyping of peripheral blood showed no significant changes in lymphocyte concentrations. However, there were increases in proliferating CD4 and CD8 T cells in subjects on concurrent immunotherapy, reductions in Tregs, and reductions in MDSCs.<br />- Disease Control Rate at 3 and 6 months was 80% and 86%, respectively.<br />- Overall Survival at 3, 6, and 12 months post-treatment initiation was 71%, 47%, and 25%.<br />- The trial has some limitations including a single-arm design and a heterogeneous mix of tumor subtypes and concurrent therapies.<br /><br />The study suggests that LSAM-PTX is safe and well tolerated when used in combination with various concurrent therapies for non-resectable lung cancer. It also indicates potential immunomodulatory effects of LSAM-PTX. However, further research is needed, including a randomized controlled trial, to confirm its efficacy.

Asset Subtitle

Hiren Mehta

Keywords

LSAM-PTX

clinical trial

safety

efficacy

non-resectable lung cancer

intratumoral injection

systemic exposure

standard of care

immunophenotyping

disease control rate