Advaxis Presents Updated Data from Ongoing ADXS-503 Phase 1/2 Lung Cancer Trial at the 2020 Society for Immunotherapy of Cancer (SITC) Annual Meeting
Disease control rate of 67% and overall response rate of 17% in first six evaluable patients with immediate prior progression on KEYTRUDA®
Biomarker data confirms on-mechanism activation of innate and adaptive immune responses to ADXS-503
ADXS-503 appeared safe and well tolerated as a monotherapy and in combination with KEYTRUDA®
The data presented across three cohorts; Part A monotherapy, Part B combination with KEYTRUDA® and Part C combination with KEYTRUDA® in the first line setting for patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy, together, demonstrate that ADXS-503 was safe and well tolerated, and may restore or enhance sensitivity to checkpoint inhibitors as an off-the-shelf, neoantigen immunotherapy.
“The results observed thus far in Part B of this study, with ADXS-503 added to KEYTRUDA® without intervening treatment or a change in the checkpoint inhibitor at the time of progression on KEYTRUDA®, provide encouraging proof-of-concept that ADXS-503 may re-sensitize or enhance the response to KEYTRUDA®,” said
Key presentation highlights:
Poster presentation titled, “Phase 1/2 Study of an Off-the-Shelf, Multi-Neoantigen Vector (ADXS-503) Alone and in Combination with Pembrolizumab in Subjects with Metastatic Non-Small Cell
- ADXS-503 alone (Part A) and in combination with Pembrolizumab (Part B-DL1 and Part C) appeared safe and tolerable.
- There were no added toxicities from combining ADXS-503 with Pembrolizumab
- In Part A, ADXS-503 alone achieved stable disease in 50% (n=6) of heavily pre-treated patients including prior treatment with checkpoint inhibitors in all but one patient
- In Part B, the overall response rate (17%) and disease control rate (67%) (n=6) suggest that adding on ADXS-503 after immediate prior progression on Pembrolizumab may re-sensitize or enhance response to Pembrolizumab
- The first two patients treated in the Part B that had achieved SD and PR have now lasted 10 months
- In Part B, one patient with squamous histology also achieved stable disease, suggesting this regimen may be broadly applicable across NSCLC
- Biomarker data from 9 patients to date, 6 from Part A and 3 from Part B, show:
- Activation of cytotoxic- and/or memory-CD8+ T cells in patients treated with monotherapy and in combination therapy
- 100% efficient priming by ADXS-503 with generation of CD8+ T cells against neoantigens in the vector as well as antigen spreading observed
- Patients with known KRAS mutations in tumor samples have achieved stable disease in the study, including KRAS G12D in 2 out of 6 patients in Part A and KRAS G12V in 1 out of 3 in Part B DL1. Mutational analysis is ongoing across all patients.
The Phase 1/2 clinical trial of ADXS-503 is seeking to establish the recommended dose, safety, tolerability and clinical activity of ADXS-503 administered alone and in combination with a KEYTRUDA® in approximately 50 patients with NSCLC, in at least five sites across the
ADXS-HOT is a program that leverages the Company’s proprietary Lm technology to target hotspot mutations that commonly occur in specific cancer types. ADXS-HOT drug candidates are designed to target acquired shared or “public” mutations in tumor driver genes along with other proprietary cancer-testes and oncofetal tumor-associated antigens that also commonly occur in specific cancer types. ADXS-HOT drug candidates are an off-the-shelf treatment, designed to potentially treat all patients with a specific cancer type, without the need for pretreatment biomarker testing, DNA sequencing or diagnostic testing.
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KEYTRUDA® is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of
Source: Advaxis, Inc.