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Immutep Announced Clinical Development Update for its First-in-Class LAG-3 Antigen Presenting Cell Activator Candidate Eftilagimod Alpha

Immutep Limited (ASX: IMM; NASDAQ: IMMP) provides a clinical development update for its first-in-class LAG-3 antigenpresenting cell (APC) activator product candidate, eftilagimod alpha ("efti").

Benzinga · 09/14/2022 05:05
Immutep Limited ((ASX: IMM, NASDAQ:IMMP) provides a clinical development update for its first-in-class LAG-3 antigenpresenting cell (APC) activator product candidate, eftilagimod alpha ("efti"). Immutep CEO Marc Voigt said: "Efti is an innovative LAG-3-based clinical candidate with broad therapeutic potential supported by encouraging activity and well-tolerated safety in multiple Phase II trials in solid tumor indications including NSCLC, HNSCC and MBC. Recent data from TACTI-002, a frontline, PD-L1 all-comer trial in NSCLC, demonstrated that efti in combination with anti-PD-1 therapy delivered a clinical benefit in patients across all levels of PD-L1 expression, including patients with negative PD-L1. Based on this compelling data, coupled with the large market opportunity and high unmet need for more durable and tolerable options, our late-stage clinical development efforts will focus on frontline NSCLC in combination with anti-PD-1 therapy. We look forward to providing additional clinical data in 1L NSCLC later this year. Regulatory interactions and late-stage planning to evaluate efti in MBC, another attractive opportunity for efti, will also continue." Late-Stage Efti Clinical Development Updates Pathway in Lung Cancer (anti-PD-1 combination with or without chemo) Immutep is prioritising 1L NSCLC in terms of late-stage clinical strategy, based on compelling data, coupled with the large market opportunity and continued high unmet need for more durable and tolerable options. In combination with top selling drug in oncology, Keytruda®, efti has been delivering strong results, especially in patients known to respond less than optimally/sub-optimally to anti-PD-1 treatment (e.g. patients with negative orlow PD-L1 expression levels). Immutep's next steps in NSCLC will be shaped by the maturing TACTI002 data, with additional data expected in Q4 2022 and feedback from regulatory authorities. Initial results from Immutep's ongoing INSIGHT-003 trial evaluating efti in combination with anti-PD-1 therapy and chemotherapy are also expected in Q4 2022. These results may help to further inform the design of our late-stage trial in 1L NSCLC. Pathway in Head and Neck Cancer (anti-PD-1 combination) Currently, 47/154 patients (approximately 30%) have been recruited into Immutep's ongoing randomised Phase IIb TACTI-003 trial in 1L HNSCC. Recruitment is accelerating as further sites have been activated. The trial is being conducted in collaboration with Merck & Co., Inc., Rahway, NJ, USA (known as "MSD" outside the United States and Canada). Efti in 1L HNSCC has Fast Track designation by the FDA, which provides Immutep with access to more frequent meetings and communications with the FDA, and potentially enables Rolling Review of a Biologic License Application. In addition, Fast Track designation may provide Accelerated Approval and Priority Review if relevant criteria are met, for efti in HNSCC. Pathway in Breast Cancer (chemo combination) Immutep will continue with preparations for future clinical development in MBC, including engagement with the regulators, Contract Research Organisations and other stakeholders, each of which are progressing. Efti has shown encouraging clinical data in combination with chemotherapy in this indication, including statistically significant improvements in overall survival (OS) across several pre-defined subgroups. As such, MBC remains an attractive opportunity for efti.