Advaxis announced the final 18-month survival data from Lm-LLO-E7-15, a Phase 2 study evaluating the safety and efficacy of ADXS-HPV (1×109 cfu) (ADXS11-001) with and without cisplatin (40 mg/m2, weekly x 5) in 110 patients with recurrent cervical cancer.

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ADXS-HPV is an immunotherapy designed to target cells expressing the HPV gene E7. Expression of the E7 gene from high-risk HPV variants is responsible for the transformation of infected cells into dysplastic and malignant tissues. Eliminating these cells can eliminate the dysplasia or malignancy.

Lm-LLO-E7-15 was a randomized Phase 2 study conducted in 110 women with recurrent cervical cancer. All patients were treated previously with chemotherapy, radiotherapy, or both; and had an ECOG performance status of 0–2. 

Patients also received Naprosyn as premedication and ampicillin post-infusion. Efficacy was determined from overall survival and scans taken at baseline and at 3, 6, 9 12, and 18 months after treatment began. The primary endpoint of the study is overall survival.

The final 18-month survival data are 28% (31/110) and the final 12-month survival was 36% (39/110). The median overall survival was approximately 8.5 months. Patients that completed the study will continue to be followed for survival. 

Survival results were not significantly different between treatment groups with or without cisplatin chemotherapy or who had previous therapy comprised of a combination of chemotherapy and radiation, radiation alone, or chemotherapy alone.

The tumor response rate was 11% with 6 complete responses and 6 partial responses/110 patients and was similar in both treatment groups per RECIST 1.1 criteria. Stable disease >3 months was observed in 35 additional patients, for a disease control rate of 43% (47/110). 

Average duration of response after 12 month minimum follow-up was 10.5 months for both treatment groups. In those patients treated with ADXS-HPV alone who had stable disease, the average duration of response was 6 months compared to 4.1 months in patients treated with ADXS-HPV plus cisplatin. 

Activity was observed against all high risk HPV strains detected, including 16, 18, 31, 33, and 45.

Subset analyses showed that the addition of cisplatin to ADXS-HPV did not significantly improve survival or tumor response; and survival and tumor response were equally strong in patients with aggressive disease (defined as recurrence ≤2 years from initial diagnosis) vs. non-aggressive disease (defined as recurrence >2 years from initial diagnosis).

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