4-5) Women diagnosed with triple negative disease tend to be of younger age (34% were 18-29 years of age), lower socioeconomic status, and are more obese when compared to hormone positive tumors (ER/PR+, HER2 negative).
The purpose was to assess the differences in survival and stage at diagnosis among hormone positive (ER/PR positive), HER2 positive, Triple Positive (ER/PR/ HER2 + and ER/HER2 +), and Triple Negative disease (ER/PR/ HER2 negative) in a 12 year period.
Seventy two percent of the patients were hormone positive (ER/PR positive), while 14% of the population was diagnosed with triple negative disease (Table I).
In patients with triple negative disease
, 5 of 7 (71%) analysed samples expressed GPNMB, 7 of 9 (78%) evaluable patients had tumour shrinkage, and the median PFS for these patients was 17.
Progression free and overall survival benefits were demonstrated in the subgroup of patients with triple negative disease that also highly expressed GPNMB, and strong trends towards benefits were seen in all patients with high GPNMB expression.
Phase 2b EMERGE Final Survival Results: Survival Benefit of CDX-011 is Greatest in Patients with Triple Negative Disease that Highly Expresses (25%) GPNMB and All Patients with High GPNMB Expression*
Based on these data, the Company believes CDX-011 has significant promise as a targeted therapy for patients with breast cancer and high expression of GPNMB, and especially for those with triple negative disease.
Together, patients with 25% GPNMB expression levels and patients with triple negative disease account for more than 35% of the total breast cancer patient population and we believe CDX-011 could play a vital role as a much needed treatment option for these patients.
We continue to explore ABRAXANE's utility to treat breast cancer with an emphasis on the more difficult-to-treat sub-groups such as triple negative disease
," said Patrick Soon-Shiong, M.
The results in triple negative disease
are especially encouraging," said Anthony Marucci, President and Chief Executive Officer of Celldex Therapeutics.
We are very encouraged to see such positive results in patients with triple negative disease - or those with advanced, refractory and heavily pre-treated breast cancers -- where there is a clear unmet medical need.
In patients with triple negative disease, 5 of 7 (71%) analyzed samples expressed GPNMB, 7 of 9 (78%) evaluable patients had tumor shrinkage, and the median PFS for these patients was 17.