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• W2600590954 abstract "4040^ Background: GVAX is composed of GM-CSF-secreting allogeneic pancreas cancer cell lines and administered with low-dose cyclophosphamide (CY) to inhibit regulatory T cells. In prior studies, GVAX induced mesothelin-specific T cell responses that correlated with survival. CRS-207 is a live-attenuated Listeria monocytogenes engineered to express human mesothelin. CRS-207 stimulates potent innate and adaptive immunity and has shown synergy with GVAX in mouse tumor models. Anecdotal survival benefit was observed in the CRS-207 phase I study in patients who received prior GVAX. Methods: Patients were enrolled with metastatic pancreatic ductal adenocarcinoma (PDA) who received or refused ≥ 1 prior chemotherapy, had ECOG ≤ 1 and adequate organ function. Patients were randomized 2:1 to receive 2 doses of CY/GVAX followed by 4 doses of CRS-207 (Arm A) or 6 doses of CY/GVAX (Arm B) every 3 weeks. Clinically stable patients were offered additional 20-week courses. The primary endpoint was comparison of OS between treatment arms. Secondary endpoints were to evaluate safety, clinical and immune responses. Results: 90 patients were treated (Arm A: 61, Arm B: 29). As of Jan 2013, 27 patients completed 1 course (A: 24, B: 3) and 17 patients (A: 15, B: 2) initiated a 2 nd course. Median age was 63. Median number of prior regimens was 3. No treatment-related serious adverse events (SAEs) or unexpected toxicities were observed. The most frequent Grade (G) 3/4 related toxicities were fever, lymphopenia, hypophosphatemia, elevated liver enzymes, and fatigue following CRS-207 in <5% of subjects. Of 51 patients evaluated post-treatment, 34% had stable disease in Arm A vs. 19% in Arm B. OS for all patients treated was 6 months in Arm A vs. 3.4 months in Arm B (two-sided, p=0.0114). Conclusions: Combined CY/GVAX pancreas and CRS-207 was generally well-tolerated with no treatment-related SAEs or unexpected G3/4 toxicities. The significant difference in OS between treatment arms met the criteria for early stopping. This indicates that the combination immunotherapy may extend OS for metastatic PDA patients with minimal toxicity and should continue to be developed as an effective therapy. Clinical trial information: NCT01417000." @default.
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• W2600590954 date "2013-05-20" @default.
• W2600590954 modified "2023-10-17" @default.
• W2600590954 title "Interim safety and efficacy analysis of a phase II, randomized study of GVAX pancreas and CRS-207 immunotherapy in patients with metastatic pancreatic cancer." @default.
• W2600590954 doi "https://doi.org/10.1200/jco.2013.31.15_suppl.4040" @default.
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