Jounce Therapeutics (JNCE) Reports Results from Pre-Planned Data Review of INNATE Phase 2 Trial of JTX-8064 and Pimivalimab
Jounce Therapeutics, Inc. (Nasdaq: NASDAQ:), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, today announced that patients from the INNATE Phase 2 trial in the ovarian cancer combination cohort with platinum resistant ovarian cancer are experiencing deep and durable responses based on a pre-planned informal data review.
The INNATE trial evaluates JTX-8064 as a monotherapy and in combination with the PD-1 inhibitor pimivalimab in patients with advanced solid tumors. JTX-8064, is a humanized IgG4 monoclonal antibody designed to specifically bind to the macrophage receptor Leukocyte Immunoglobulin Like Receptor B2 (LILRB2/ILT4), inhibiting LILRB2 binding with its ligands which may result in reprogramming immune-suppressive macrophages to enhance anti-tumor immunity.
A data review was conducted on March 15, 2023 to assess the potential to achieve proof-of-concept (POC) in the ovarian cancer combination cohort of the INNATE trial. In this cohort, 35 patients with third- and fourth-line platinum resistant ovarian cancer were treated with JTX-8064 and Jounce’s PD-1 inhibitor, pimivalimab. There were five RECIST 1.1 responders, four of which are confirmed, with all five patients remaining on study for over six months with continued tumor reduction over time. The remaining 30 patients have discontinued treatment. Upon confirmation of a fifth confirmed partial response (PR), the ovarian combination cohort would meet Jounce internal criteria for POC, based on a statistically meaningful improvement over the benchmark of pembrolizumab alone in the analogous setting. In patients with one to six prior lines of therapy for ovarian cancer, pembrolizumab monotherapy demonstrated a response rate of 8.5%, with duration of response of 10.2 months. Two of the five responders in INNATE have a PD-L1 score of zero, indicating a low likelihood of response to a PD-1 inhibitor. The combination was well tolerated with
Ovarian Cancer Combination Cohort Responders
|Subject||PD-L1(CPS)||ResponseAssessment||When was uPRdemonstrated||Current status|
|1||55%||cPR||Wk 9||-82.8% (wk 45)|
|2||15%||cPR||Wk 18||-66.4% (wk 36)|
|3||5%||cPR||Wk 18||-87.6% (wk 27)|
|4||0%||cPR||Wk 18||-78.26% (wk 27)|
|5||0%||uPR||Wk 27||-40% (wk 27)|
Ovarian Combination Cohort Target Lesion % Change from Baseline over Time
“Following this analysis, we are pleased to…
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