- Imugene Limited (ASX:IMU) has recently released the secondary efficacy endpoint PFS data for its HER-Vaxx immunotherapy.
- The Company’s PFS Hazard Ratio was comparable to the landmark Roche/Genentech registrational ToGA study.
- Imugene has further planned two company sponsored Phase 2 trials and one Investigator Sponsored Study with HER-Vaxx in early & late-stage gastric cancer.
The clinical stage immuno-oncology player Imugene Limited (ASX:IMU) has recently released the secondary efficacy endpoint PFS (progression free survival) data for its HER-Vaxx immunotherapy. HER-Vaxx is Imugene’s B-cell activating immunotherapy, which has been designed for treating HER-2/neu overexpressing tumours, like pancreatic, ovarian, gastric, breast, and lung cancers.
The HER-Vaxx immunotherapy is formed from multiple B cell epitopes derived from the extracellular domain of HER-2/neu receptor. In pre-clinical, Phase 1 and Phase 2 studies, HER-Vaxx has been shown to encourage a potent polyclonal antibody response to a validated and well-known cancer target - HER-2/neu.
Progression Free Survival data
Imugene informed that the centrally reviewed secondary PFS endpoint was designed with a specified 1-sided false positive probability of 0.10. The analysis demonstrated a HR (hazard ratio) of 0.719 with a 1-sided p-value of 0.266 between the HER-Vaxx plus SOC (standard of care) chemotherapy treatment arm relative to the SOC chemotherapy control arm.
The Company highlighted that there was no variation in safety between the two treatment arms, demonstrating HER-Vaxx does not add toxicity to the standard of care chemotherapy. The detailed safety analysis will be undertaken once the trial is completed.
The Company’s PFS Hazard Ratio was comparable to the landmark Roche/Genentech registrational ToGA study (PFS HR of 0.71). The ToGA study also examined the effect of Herceptin plus chemotherapy against SOC chemotherapy alone in advanced HER-2+ gastric cancer.
About HER-Vaxx Phase 2 gastric cancer trial
Imugene is progressing with an open-label Phase 2 gastric cancer trial designed to assess the efficacy, immune response, and safety in metastatic gastric cancer overexpressing the HER-2 protein.
In the HERIZON Phase 2 study, the patients are randomised into two arms of either standard chemotherapy alone or HER-Vaxx plus standard chemotherapy. The study is being conducted in countries with limited access to trastuzumab in Asia and Eastern Europe.
The primary endpoint of the study is overall survival, with progression-free survival by independent central review and safety as secondary endpoints. The immune related endpoints of the study include values and changes from randomization in humoral and cellular immunogenicity data. Imugene has enrolled 36 patients for the study, with 24 patients achieving a PFS event in this signal generating trial.
Imugene is waiting for the events needed for Overall Survival (OS) evaluation and will subsequently analyse all data comprising final PFS, OS, safety, and immune responses. Based on the recent PFS results, Imugene has further planned two company sponsored Phase 2 trials and one Investigator Sponsored Study with HER-Vaxx in early & late-stage gastric cancer.
Imugene shares are trading at AU$0.395 as of 12:04 PM AEST.