Clinical Trials

Date: 2018-10-12

Type of information: Presentation of results at a congress

phase: 2

Announcement: presentation of results at the European Society for Medical Oncology (ESMO) 2016 Congress

Company: Immune Design (USA - MA)

Product: CMB305 and atezolizumab

Action mechanism:

immunotherapy product/monoclonal antibody/immune checkpoint inhibitor/TLR4 agonist
Atezolizumab is a monoclonal antibody designed to make cancer cells more vulnerable to the body’s immune system by interfering with the immune checkpoint PD-L1. PD-L1 is found on the surface of cells in tumours and is believed to act as a “stop sign,” preventing the immune system from destroying cancer cells. By inhibiting PD-L1, atezolizumab may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.
CMB305 is a prime-boost vaccine approach against NY-ESO-1-expressing tumors, designed to generate an integrated, anti-NY-ESO-1 immune response in vivo via a targeted, specific interaction with dendritic cells, a mechanism of action Immune Design believes differs from traditional cancer vaccines. CMB305 is being evaluated in soft tissue sarcoma patients in ongoing Phase 1 monotherapy and 2 combination studies.

Disease: soft tissue sarcoma, locally advanced, relapsed, or metastatic NY-ESO-1+ synovial sarcoma or myxoid/round-cell liposarcoma.

Therapeutic area: Cancer - Oncology

Country:

Trial details:

The fully enrolled trial is evaluating the safety, immunogenicity and efficacy of CMB305 in combination with atezolizumab, or atezolizumab alone, in a total of 88 patients with locally advanced, relapsed, or metastatic NY-ESO-1⁺ synovial sarcoma or myxoid/round-cell liposarcoma.
The trial is being conducted pursuant to a clinical collaboration with Genentech.

Latest news:

• On October 11, 2018, Immune Design announced program updates CMB305 cancer vaccine program in development for the treatment of cancer. Based on a recent review of the CMB305 program, including an early analysis of the ongoing Phase 2 study that showed the combination of CMB305 and Tecentriq® (atezolizumab) is not likely to show a survival benefit in relapsed synovial sarcoma patients, the company has decided to discontinue the SYNOVATE trial. Immune Design will seek external collaborations to explore the continued development of CMB305 in sarcoma.
• On August 30, 2017, Immune Design announced topline data from its interim analysis of the ongoing, randomized Phase 2 trial evaluating CMB305 in combination with atezolizumab (Tecentriq®) or atezolizumab alone in 88 soft tissue sarcoma patients. The data have been presented in a poster discussion session at the European Society of Medical Oncology (ESMO) 2017 Congress.

Data to be presented at ESMO build upon those data on the first 36 patients summarized in the abstract, and include a greater number of patients enrolled.

Clinical Benefit: Data from the larger patient population show that patients receiving CMB305 and atezolizumab experienced greater clinical benefit in the form of Disease Control Rate (including objective responses), Progression Free Survival and Time to Next Treatment than those receiving atezolizumab alone.
Immune Response: Patients who received the combination of CMB305 and atezolizumab demonstrated an increased frequency of induced immune responses to NY-ESO-1, including NY-ESO-1-specific T cells, NY-ESO-1 antibodies, and antigen spreading, in comparison to patients who received atezolizumab alone
Biomarkers: In an exploratory analysis, a trend towards improved overall survival was observed in patients in the CMB305 and atezolizumab combination arm who had pre-existing and treatment-induced anti-NY-ESO-1 immunity, compared to the atezolizumab alone arm. Pre-treatment tumor biopsy analysis showed negligible levels of PD-L1 expression.
Safety: No new safety signals have been observed in either arm.
Immune Design intends to present survival data in 2018 once all patients have at least one year of follow up.