T-cell therapy combination K drug in PD-L1 positive r/r DLBCL patients ORR up to 86%!

IMV is a clinical phase biopharmaceutical company dedicated to innovative immunotherapy.
recently, the company announced that its new T-cell therapy DPX-Survivac combined with Mercadon anti-PD-1 therapy Keytruda (Corida, generic name pembrolizumab, Pabliju monoantigen) to treat PD-L1-positive recurrence/refragortic large B-cell lymphoma (r/r DLBCL) patients with up to 86% objective remission (ORR).
results will be presented at the 35th annual meeting of the Society for Cancer Immunotherapy (SITC) on November 9-14.
DPX-Survivac, based on the survivin peptide segment and made up of IMV Proprietary Delivery Platform (DPX), produces a continuous cytotoxic T-cell response for cancer cells with survivin peptides on the cell surface.
this "no-release" platform can be made with peptide antigens to induce a targeted, robust and long-lasting immune response.
The preparation uses freeze-dried to remove all moisture, and the active drug ingredient uses a simple reconstruction procedure that completely dissolves in the oil, arrives in the body after injection and programmes the immune cells, providing more scale and duration of the immune response than other targeted cell therapies in the body.
DPX-Survivac is a nanoscale oil that, after injection, can be ingested by antigen-presented cells (APC) to activate and activate T cells in the lymph nodes, which then migrate to the tumor site, infesting the tumor, identifying cancer cells, and destroying cancer cells.
the SPiReL study group were patients with cancer cell expression survivin (survival) relapse or recurring (r/r), incurable DLBCL.
the study, all clinical responses observed were related to the expression of PD-L1 biomarkers.
to date, all clinical responses observed in the study were in PD-L1-positive subjects, with PD-L1 plus cells scoring ≥10 percent in the tumor area.
in the PD-L1-negative population (n-11), all subjects experienced an ongoing disease (PD; n-9) or a stable disease (SD;n=2) and no benefits were observed.
differences between the two groups are statistically significant and suggest that PD-L1 has the potential to become a predictive biomarker and auxiliary diagnosis of T-cell therapy in combination with Keytruda therapy for DLBCL to identify and recruit patients most likely to have a therapeutic response.
18 pre-treatment samples from patients in the SPiReL study were available for biomarker analysis as of the data deadline reported by the SITC.
39% (7/18) of the participants showed positive for PD-L1 before treatment.
the main findings of this population include: (1) disease control rate (DCR) of 100%, DCR defined as: stable disease (SD), complete or partial remission (CR or PR) ;(2) objective remission rate of 86% (6/7), 3 cases of complete remission (CR), 3 cases of partial remission (PR).
DPX-Survivac mechanism PD-L1 pathr regulates T-cell response, allowing tumors to evade immune system monitoring.
the expression of PD-L1 and the prognostic relationship between various cancers has been widely studied and has been shown to be a predictive biomarker for PD-1/PD-L1 path-checkpoint inhibitor therapy in a variety of tumor types.
in DLBCL, PD-L1 was expressed in 26%-75% of patients and was generally associated with poor prognosis and shorter survival.
checkpoint inhibitors such as Keytruda and Opdivo have not yet been approved in DLBCL and have limited activity in PD-L1-positive patients.
DPX-Survivac is a leading candidate in IMV's new class of immunotherapy, a patented nanoscale oil that is made up of five unique HLA restrictive peptides (HLA-A1, A2, A2, A3, A24, B7) from vistoprin proteins (survivin) and is designed to produce targeted and persistent cancer cell damage in the body, and has been shown to be safe in all clinical studies to date.
survivin has been recognized by the U.S. National Cancer Institute (NCI) as a promising tumor-related antigen that is widely overexpressed in most cancers and plays an important role in fighting cell death, supporting tumor-related angiogenesis, and improving resistance to chemotherapy.
IMV has identified more than 20 tumor adaptations in which survivin can be targeted by DPX-Survivac.
previously, DPX-Survivac had been granted fast-track eligibility (FTD) by the FDA for the treatment of advanced ovarian cancer, and ODD for ovarian cancer by the FDA and the European Medicines Agency (EMA).
source: IMV's T Cell Therapy Solutions 86% Objective Response Rate in With Merck's Keytruda? in PD-L1 Positive Patients with r/r DLBCL