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The CR is still a CR even after 18 months, and 8 females remain alive with longest over 40 months since treatment.
Highlights from Dr. Leath’s presentation include:
A 38% (n = 19/50) 12-month survival rate in second- and third-line PRmCC treated with axalimogene filolisbac, representing a 52% improvement over the expected 12-month milestone survival rate of 24.5%
Eight patients remain alive as of January 31, 2017 (Range 12.02 – 40.6 months)
Disease control (complete response, partial response, or stable disease) was achieved in 32% of patients based on investigator assessment of best response
A durable complete response in a patient with PRmCC previously treated with chemotherapy and bevacizumab remains ongoing at 18.5 months
Results compare favorably to GOG Study 227C of bevacizumab, which demonstrated a 12-month milestone overall survival (OS) rate of 30% in a similar patient population which subsequently supported regulatory approval in first-line treatment in combination with chemotherapy in 2014
Consistent with its immunotherapy mechanism of action, axalimogene filolisbac demonstrated a promising plateau in the survival curve, indicating potential long-term clinical benefit for a subset of patients with PRmCC
Axalimogene filolisbac was generally well-tolerated, with primarily infusion-associated, low grade, transient TRAEs (≥30%), such as fatigue, chills, anemia, nausea and fever
Only 2 patients experienced grade 4 TRAEs
Advaxis plans to initiate a global, phase 3 randomized registration study in patients with metastatic cervical cancer later this year.
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