ESMO Congress 2023 | OncologyPRO

Abstract 1490P

Background

Tumor necrosis factor (TNF-α) has anticancer activity. Tumors neutralize TNF-α by shedding excess soluble TNF receptors (sTNF-Rs) in the tumor microenvironment preventing TNF-α from binding to tumor membrane bound sTNF-Rs, triggering cell death pathways. Removal of sTNF-Rs via apheresis liberates the anticancer effects of TNF-α alone or with anticancer agents.

Methods

Protocol CP7-008 [NCT04690686] evaluated LW-02 Column Immunopheresis® (‘LW-02 CI’) in advanced (Stages IIIB/IV) squamous or adenocarcinoma NSCLC patients (pts), who progressed 1or 2 line(s) of treatment (1^st-line with a platinum salt). Sixteen (16) pts were assigned to 1 of 3 arms to receive LW-02 CI 3x/week: with atezolizumab (Arm 1, n=7), with paclitaxel (Arm 2, n=3) or as monotherapy (Arm 3, n=6; pts progressed 2 lines, or 1 but not suitable for Arm 1) for 16 weeks. Clinically stable and/or objectively improved pts could receive extended therapy.

Results

Safety and tumor burden changes were evaluated in two groups—pts that had at least 1 LW-02 CI treatment (‘ITT’) and pts treated ≥4 weeks (≥4 wks). Pts’ tumor burden was assessed via RECIST 1.1 (or iRECIST if appropriate). After 644 LW-02 CI procedures, 373 AEs (including 22 SAEs) were reported; 18 AEs (14.8%), including 3 SAEs (13.6%), had a causal relationship to treatment with the LW-02 Column. All were Grades 1 or 2, except for 2 Grade 3 SAEs. All resolved, and none required treatment discontinuation. For tumor burden, the best overall response was stable disease (11 pts), durable for ≥8 wks. Other endpoints were duration of treatment (DoT), overall survival (OS), disease control rate (DCR) and progression free survival (PFS). The results are summarized for both groups below.

Table: 1490P

Median DoT, OS, DCR and PFS

Endpoint (mos)	Overall	Arm 1	Arm 2	Arm 3
ITT	≥4 wks	ITT	≥4 wks	ITT	≥4 wks	ITT	≥4 wks
DoT	4.1	4.7	4.3	4.7	5.4	5.4	3.0	3.5
OS	9.9	11.1	16.5	17.0	9.5	9.5	7.7	10.2
PFS	4.1	5.2	4.0	4.0	7.7	7.7	5.5	5.8
DCR %	68.8	84.6	57.1	80.0	100.0	100.0	66.7	80.0

Conclusions

LW-02 CI alone or combined with chemo- or immunotherapy appears safe with clear anticancer efficacy signals in treating advanced NSCLC. These results, when compared with data from existing therapies, warrant further investigation.

Clinical trial identification

NCT04690686.

Editorial acknowledgement

Legal entity responsible for the study

Immunicom Inc.

Funding

Immunicom Inc.

Disclosure

M. Bozkurt, D. Gökhan, M. Teomete: Financial Interests, Institutional, Principal Investigator: Immunicom Inc.. C. Turam: Financial Interests, Institutional, Coordinating PI: Immunicom Inc.. L. Florin: Financial Interests, Institutional, Member of Board of Directors: Immunicom. A. Ostrowski: Financial Interests, Institutional, Officer, Employee: Immunicom. R. Segal, V. Manax: Financial Interests, Institutional, Member of Board of Directors: Immunicom.