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news.Study confirmed the safety of CDX-011 at the pre-defined maximum dose level in six patients
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Celldex Therapeutics (Celldex) has reported positive results from a Phase 2 study of CDX-011 (formerly CR011-vcMMAE), in patients with heavily pre-treated, locally advanced or metastatic breast cancers.
Reportedly, the primary efficacy endpoint for the study has been met with significant antitumor activity in patients whose tumors express the target GPNMB. In addition, positive results were seen in patients with triple-negative disease, where treatment options are relatively limited due to lack of hormone receptor or HER2-neu expression.
CDX-011 is the first candidate from the company’s antibody-drug conjugate (ADC) platform, which utilises fully human monoclonal antibodies to deliver the potent cellular toxin, MMAE, directly to tumor cells by targeting GPNMB.
The Phase 2 study investigated the safety, tolerability and efficacy of CDX-011 in locally advanced or metastatic breast cancer patients who were heavily pre-treated (median of seven prior regimens). The study confirmed the safety of CDX-011 at the pre-defined maximum dose level (1.88mg/kg) in six patients.
In the study, an additional 28 patients were enrolled as an expanded Phase 2 cohort (for a total of 34 treated patients at 1.88mg/kg, the Phase 2 dose) to evaluate the progression-free survival (PFS) rate at 12 weeks. As previously seen in melanoma patients, the 1.88mg/kg dose was well tolerated in this patient population.
The primary activity endpoint, which called for at least 20% patients in the Phase 2 study portion to be progression-free at twelve weeks, has been met. To date, 35% evaluable patients are without progression of disease at 12 weeks.
In addition, at the Phase 2 dose level, 13% evaluable patients achieved confirmed or unconfirmed Partial Responses (PR), while 60% evaluable patients with measurable disease experienced some reduction in tumor size.
GPNMB expression was identified in 71% of analysed tumor samples and treatment with CDX-011 was associated with improved outcomes in all activity parameters in patients whose tumors expressed GPNMB. However, patients who received the Phase 2 dose and whose tumors expressed GPNMB 29%, had confirmed Partial Responses, 71% had decreases in tumor size, and all seven achieved at least stable disease with duration from 17.3 to 26.9 weeks.