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Results

Of 36 patients randomized (19 treated with IMU-131 plus chemotherapy and 17 with chemotherapy alone), 32 patients had a survival event (15 and 17 respectively). Analysis showed a 42% survival benefit for patients treated with IMU-131 plus chemotherapy compared to chemotherapy alone. This translated into an overall survival HR of 0.580 (80% 2-sided CI: 0.362, 0.927) with a statistically significant p-value of 0.066 (alpha 0.10). The median OS for patients receiving IMU-131 plus chemotherapy was 13.9 months, compared to 8.3 months in patients treated with chemotherapy alone. There was no difference in safety between the two treatment arms, indicating IMU-131 does not add toxicity to chemotherapy. IMU-131 induced persistent HER2 specific antibodies. Additional data on response and biomarker evaluation is pending.

Conclusions

These results demonstrate that active immunization with the B-lymphocyte stimulating HER2 vaccine, IMU-131 (HER-Vaxx), may provide treatment benefits consistent with traditional monoclonal antibodies with a corresponding adaptive immune response without added toxicity