In patients with measurable disease
who received Verzenio plus an AI (n=267), an objective response rate of 55.
Objective response rate in patients with measurable disease
More than half of women with measurable disease
taking LEE011 plus letrozole saw their tumor size shrink by at least 30% (overall response rate (ORR) in patients with measurable disease
= 53% vs 37%, p=0.
This triple combination study is assessing the safety and effectiveness of the company's DPX-Survivac, along with Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) enzyme inhibitor, epacadostat, and low-dose cyclophosphamide in patients with recurrent ovarian cancer who have measurable disease
Twenty patients had measurable disease
, with a median of 1 prior chemotherapy regimens and a median PSA of 255.
A complete remission (CR) was defined as the disappearance of all measurable disease
(lymph node 11 g/dl, white blood cell (WBC) >1.
In addition, about half had measurable disease
, and 25% had visceral metastases, indicating mCRPC with a poor prognosis.
Eligible patients must have been treated initially with surgery, had a response to first-line platinum- and taxane-based therapy, and have relapsed as defined by the presence of measurable disease
Marek stressed the need for objective, measurable disease
markers in diagnosis and disease progression, as well as in research studies.
One patient with CLL had more than a 50 percent reduction in measurable disease
, but no improvement in disease markers in the blood.
This Phase 2 trial will also measure the direct effect of OGX-427 on PSA levels, time to progression by PSA or measurable disease
, numbers of circulating tumor cells (CTCs) and other relevant secondary endpoints.
Those with measurable disease
only within a previous radiation therapy port must have demonstrated clear evidence of progression prior to study entry.