6 November 2014
CVAC DEMONSTRATES OVERALL SURVIVAL BENEFIT
IN SECOND REMISSION OVARIAN CANCER
Overall Survival data from the CAN-003 trial continues to show benefit for second remission ovarian cancer patients ("second remission patients") using CVac
Half of standard of care second remission patients survived past 25.53 months; more than half of CVac treated patients still alive after 36 months
Data to be included in Poster presentation at SITC Annual Conference
SYDNEY, AUSTRALIA - Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD) ("Prima" or the "Company") is pleased to announce that CVacTM has demonstrated a clinically meaningful improvement in Overall Survival ("OS") over standard of care ("SOC") in second remission ovarian cancer patients in the CAN-003 protocol.
In second remission patients (n=20) from CAN-003, the median for SOC patients was 25.53 months, which is consistent with current literature. By comparison, for patients treated with CVac a median has still not yet been reached after 36 months (current hazard ratio=0.17 (95%CI: 0.02, 1.44); p=0.07). This implies at least a 10 month median survival advantage for second remission patients treated with CVac.
This means second remission patients treated with CVac are living significantly longer and are 83% less likely to die compared with SOC patients. This follows the very positive Progression Free Survival ("PFS") data for second remission patients from CAN-003 announced in May 2014.
For first remission patients, the interim data demonstrates a slightly positive trend in CVac patients with no median reached yet in the CVac or SOC group. This confirms Prima’s previous decision to focus further clinical development on second remission patients.
Lucy Turnbull, Chair of Prima BioMed commented:
"This data is a strong confirmation that CVac could considerably extend the progression free period and the overall length of life in second remission patients with ovarian cancer. CVac has an excellent safety and tolerability profile that also supports a potentially high quality of life given its very limited side effects."
Marc Voigt, Prima’s Chief Executive Officer said: "This data is extremely encouraging and further supports the positive overall survival trend we presented earlier this year for second remission patients. Whilst we had anticipated the OS data for second remission patients to be mature enough for final analysis by the end of this calendar year, given the better than expected results Prima BioMed Ltd, Level 7, 151 Macquarie Street, Sydney NSW 2000 Phone: +61 2 9276 1224 Fax: +61 2 9276 1284 www.primabiomed.com.au ABN: 90 009 237 889
with the median for CVac patients still not yet reached, we will continue to monitor the second remission CAN-003 patients and look forward to updating the market on their progress."
The interim OS data from CAN-003 for second remission patients will be included in a poster presentation (Poster Number P85) entitled "Trial evaluating overall survival in epithelial ovarian cancer (EOC) patients in second remission with an autologous dendritic cell therapy targeting mucin 1" at the 29th Annual Meeting of the Society for Immunotherapy of Cancer ("SITC") on 8 November 2014 by Prima’s Chief Technical Officer, Sharron Gargosky.
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