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Study of autologous dendritic cell therapy targeting Mucin 1 as a treatment for the maintenance of ovarian cancer patients in remission
  1. J Goh1,
  2. J Mason2,
  3. J Chan3,
  4. M Moradi4,
  5. J Berek5,
  6. B Beningno6,
  7. L Mileshkin7,
  8. F Recio8,
  9. N Tchabo9,
  10. E Rossi10,
  11. P Eisenberg11,
  12. P Rose12,
  13. P Mitchell13,
  14. J Young14,
  15. M Matos15,
  16. A Secord16,
  17. M Davy17,
  18. S Gargosky18 and
  19. H Gray19
  1. Aff1 grid.413313.70000000404067034Greenslopes Brisbane QLD Australia
  2. Aff2 ScrippsCC La Jolla CA USA
  3. Aff3 grid.266102.10000000122976811UCSF San Francisco CA USA
  4. Aff4 NYDT New York NY USA
  5. Aff5 grid.414123.1000000040450875XStanford Palo Alto CA USA
  6. Aff6 grid.416555.60000000403715941Northside Atlanta GA USA
  7. Aff7 PMCC MELBOURNE VIC Australia
  8. Aff8 CollResGrp Boca Raton FL USA
  9. Aff9 MorristownMC Morristown NJ USA
  10. Aff10 grid.257413.60000 0001 2287 3919IndianaUni Indianapolis IN USA
  11. Aff11 MarinCC Greenbrae CA USA
  12. Aff12 ClevelandClin Cleveland OH USA
  13. Aff13 Austin Melbourne VIC Australia
  14. Aff14 grid.259828.c0000000121893475MUSC Charelston NC USA
  15. Aff15 GoldCoast Southport QLD Australia
  16. Aff16 DukeUMC Durham NC USA
  17. Aff17 grid.416075.10000000403671221RAH Adelaide SA Australia
  18. Aff18 PrimaBioMed Sydney NSW Australia
  19. Aff19 UniWashington Seattle WA USA

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Meeting abstracts

CVac is an autologous cellular therapy targeted to elicit a T cell response to tumors that over-express mucin 1. CAN-003 is a randomized, open-label, Phase 2 trial evaluating the safety and efficacy of CVac given as a single agent to epithelial ovarian cancer (EOC) patients who are in complete remission (CR) following first or second-line chemotherapy. Patients were eligible if they had stage III or IV EOC and obtained a complete response to standard first or second line platinum/ taxane based chemotherapy. The first 7 patients received CVac to allow evaluation of manufacturing in the US and for safety evaluation. Patients were randomized to CVac therapy or standard of care (SOC). Patients in the active group were treated with up to 10 doses of CVac, 4 weekly for 7 doses, and 8 weekly for 3 doses. The trial is closed to enrolment and completes in 2013. 63 patients were enrolled into the trial; 42 were in 1st remission (age 55.7+/- 9.2 y) and 21 were in 2nd remission (age 56.8+/-9.0 y). 60 were Caucasian, 1 African American and 2 Asian. 36 treated patients and 27 OSC (data until Dec 12 2013). 10 SAEs were reported in total. 7 SAEs in CVac patients and 3 SAEs were reported in SOC; none were unexpected and only one (abdominal pain) was classified as possibly-related to CVac. Interim analysis has shown positive trends in PFS; as of 17 August 2012, the median PFS for days on study as 365 d for CVac, 421 d for non-randomized CVac, and 321 d for OSC. Updated PFS data will be presented at the meeting. Overall survival data is being collected and will be presented at the meeting. As expected, assessment of anti-mucin-1 responses have indicated no humoral response, however, interim immune monitoring results show a T cell response that is mucin 1-specific after 3 CVac doses. No mucin 1 response was observed in normal healthy volunteers nor untreated patients. The complete T-cell responses analysis throughout the course of CVac treatment will be presented at the meeting. In conclusion, study data show that immunotherapy with CVac is well tolerated. Immunological outcomes are consistent with the mechanism of action and the interim trends are encouraging for PFS.