Advaxis’ ADXS-503 (HOT Lung) Demonstrates Pronounced and Sustained Tumor Control in Ongoing Phase 1/2 Lung Cancer Trial
Disease control rate of 67% in first six evaluable patients who had progressed on KEYTRUDA
Approximate 50% improvement in disease control rate versus the rates reported in other checkpoint rechallenge studies
Durable, sustained tumor control of over 43 and 33 weeks observed in first two evaluable patients
Key data updates for the first 6 evaluable patients who have received ADXS-503 as an add-on therapy immediately following progression with KEYTRUDA®, include:
- Disease control rate of 67% (4/6 patients) and overall response rate of 17% (1/6 patients) achieved after immediate prior progression on KEYTRUDA® with previous best responses of stable disease
- Sustained clinical benefit with the first two treated patients remaining on treatment for over 43 and 33 weeks
- Updated and new patient level data for the four patients with observed disease control, all of whom remain on study, include:
° Previously reported partial response (PR) with 60% tumor reduction seen on 8-week scan and sustained at 33-week scan in an elderly patient with non-squamous NSCLC who had received Pembrolizumab for approximately 30 months with a best overall response (BOR) of stable disease
° Previously reported stable disease (SD) with a 25% reduction in target lesion sustained at 43-week scan in an elderly patient with non-squamous NSCLC who had received Pembrolizumab for ~32 months with a BOR of stable disease.
° Stable disease (SD) confirmed on 13 week-scan in a patient with squamous NSCLC who had received Pembrolizumab for approximately 15 months with a BOR of stable disease
° Stable disease (SD) on 6 week-scan in a patient with non-squamous NSCLC who had received Pembrolizumab for approximately 14 months, including combination therapy with chemotherapy in the beginning
“I am highly encouraged by these data which suggest that treatment with ADXS-503 has the potential to re-sensitize or enhance response to KEYTRUDA®, even in patients with immediate prior progression on treatment,” said Dr. Andres Gutierrez, Chief Medical Officer of Advaxis. “Other checkpoint inhibitor rechallenge studies have reported disease control rates of approximately 45 percent, with these studies typically including bridging therapy, a change in checkpoint inhibitor, or an interruption in treatment of varying intervals. The 67% disease control rate demonstrated thus far in this ongoing study represents an impressive 50 percent improvement versus the disease control rate observed in other studies in similar settings. This improvement in the setting of uninterrupted treatment on KEYTRUDA® is promising and suggests that ADXS-503 may be capable of re-stimulating the immune system to drive clinically meaningful benefit. The sustained durability of responses is also noteworthy, and I look forward to the continued evaluation of ADXS-503 in additional patients as we advance through the efficacy expansion phase of the study.”
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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Source: Advaxis, Inc.