Abstract 2219
Background
Racotumomab is an anti-idiotype vaccine, a mirror image of N-Glycolylneuraminic acid (NeuGcGM3), which mimics this ganglioside and triggers an immune response in various tumors. In this study we investigated the prognostic significance of tissue NeuGcGM3 expression level and prognostic as well as predictive value of circulating tumor cell count monitoring in patients on Racotumomab treatment.
Methods
Out of 48 patients characterized, 40 were non-small cell lung cancer (NSCLC), 12 stage III and 28 stage IV. 19 Adenocarcinoma and 21 Squamous Ca. 2 were small cell lung cancer (SCLC) and 6 with other carcinomas. Male/Female ratio was 3.36(37/11) and median age was 63 (31-84). All patients received Racotumomab as switch maintenance after chemotherapy. 7 PD-L1 (+) Pts also received check point inhibitors on progression. Expression of NeuGcGM3 was detected with 14F7 monoclonal antibody IHC staining and graded as 0,1+,2+ or 3+ according to intensity. Circulating tumor cell (CTC) count was monitored using Cell Sorter throughout the treatment course, before starting Racotumomab and every 3 months or on clinical progression.
Results
NeuGcGM3 IHC were performed 25 out of 48 patients whose paraffin blocks were available. 9 Patients had strong (3+), 12 had (2+) and 4 patients had (1+) NeuGcGM3 staining intensity. There was no statistically significant difference in the mean overall survival of the patients according to IHC staining level (1+) mean OS:55.3 months, (2+) mean OS:40.9 months, and (3+) OS:39.0 months. In 14 Patients, circulating tumor cell count was monitored from the blood and correlated well with clinical outcomes in 11 out of 14 patients (%78.5). Significant reduction of the CTC counts was compatible with clinical response whereas increased CTC counts were early messengers for clinical progression.
Conclusions
This study revealed that any grade of NeuGcGM3 positivity in the tumor tissue is adequate to select a patient for Racotumomab treatment regardless of the IHC intensity. We also concluded that CTC monitoring in patients receiving immunotherapy is a good predictive and prognostic tool.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Necdet Uskent.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.
Resources from the same session
5368 - Durvalumab and Paclitaxel Combination for treatment of metastatic triple negative breast cancer is safe with very promising efficacy
Presenter: Hazem Ghebeh
Session: Poster Display session 3
Resources:
Abstract
1520 - A prospective cohort study on the pharmacokinetics of nivolumab in metastatic non-small cell lung cancer, melanoma, and renal cell cancer patients
Presenter: Daan Hurkmans
Session: Poster Display session 3
Resources:
Abstract
1603 - Safety and clinical activity of subcutaneously (SC) administered anti-PD-1 antibody PF-06801591 in phase I dose-expansion cohorts of locally advanced or metastatic non-small-cell lung cancer (NSCLC) and urothelial carcinoma (UC)
Presenter: Byoung Cho
Session: Poster Display session 3
Resources:
Abstract
3922 - Development of the Functional Assessment of Cancer Therapy-Immune Checkpoint Modulator (FACT-ICM): A scale to measure quality of life in cancer patients treated with ICMs
Presenter: Aaron Hansen
Session: Poster Display session 3
Resources:
Abstract
2408 - Immune checkpoint inhibitors (ICIs) as “chemotherapy (Ctx) sensitization” strategy in advanced solid tumors
Presenter: Francisco Javier Ros Montana
Session: Poster Display session 3
Resources:
Abstract
3612 - Validation of progression-free survival (PFS) as surrogate endpoint in randomised trials of immune checkpoint inhibitors in advanced solid cancers
Presenter: Peey Sei Kok
Session: Poster Display session 3
Resources:
Abstract
3827 - Pharmacokinetic (PK) analysis of weight-based and fixed dose cemiplimab in patients (pts) with advanced malignancies
Presenter: Michael Migden
Session: Poster Display session 3
Resources:
Abstract
2120 - A burst of highly differentiated CD4 TL identifies a subset of fast progressors, and correlates with hyperprogressive disease in NSCLC patients treated with ICI
Presenter: Hugo Arasanz
Session: Poster Display session 3
Resources:
Abstract
4254 - Nivolumab treatment in advanced non-small cell lung cancer (aNSCLC): a French nationwide retrospective cohort (UNIVOC Study)
Presenter: Christos Chouaid
Session: Poster Display session 3
Resources:
Abstract
1084 - Dissociated responses in patients with metastatic solid tumors treated with immunotherapy
Presenter: Pauline Vaflard
Session: Poster Display session 3
Resources:
Abstract