- Imugene Limited (ASX:IMU) has announced that the crucial clinical endpoint of Progression Free Survival (PFS) has been met in the Phase 2 trial of HER-Vaxx.
- The final PFS read-out is likely to be released within months.
- Imugene sees a significant market opportunity for HER-Vaxx, which is targeting patients with metastatic gastric cancer that over-express the HER-2/neu receptor.
Marking a significant breakthrough, Imugene Limited (ASX:IMU) has achieved a clinical milestone for its cancer immunotherapy, HER-Vaxx, which is in Phase 2 gastric cancer clinical trial. Imugene has recently informed that the second clinical endpoint for Phase 2 HER-Vaxx study, i.e., Progression Free Survival (PFS) has now been met.
In January this year, the Company completed the recruitment of patients to the Phase 2 HER-Vaxx clinical trial following the Independent Data Monitoring Committee (IDMC) review of interim analysis safety and efficacy data from the study.
Clinical Trial Milestone for HER-Vaxx
As per Imugene, the crucial clinical endpoint of PFS has been met in the Phase 2 trial after the occurrence of a statistically significant required number of PFS events. The Company added that the data from these 24 PFS events will now be evaluated, with the final PFS readout anticipated within months.
Progression-Free Survival and Overall Survival (OS) are the two crucial clinical endpoints of the Phase 2 study.
Last year, the interim data from the Phase 2 study of HER-Vaxx showed positive Overall Survival with a Hazard Ratio of 0.418. The interim analysis found the median OS as 14.2 months for patients receiving HER-Vaxx in combination with chemotherapy, as opposed to 8.8 months for patients treated with chemotherapy alone.
All in all, the interim data suggested that the treatment with HER-Vaxx is effective & well tolerated, with an overall survival benefit that is better than standard-of-care chemotherapy alone.
Why is HER-Vaxx Trial Targeting HER-2 Positive Gastric Cancer?
Imugene’s Phase 2 HER-Vaxx study is designed to measure the immune response, safety, and efficacy in 36 patients with metastatic gastric cancer that over-express the HER-2/neu receptor. The Company chose HER-2 positive gastric cancer for the study as this type of cancer is not nearly as well served as breast cancer.
In the case of gastric cancer, there is a slightly lower number of patients who are HER-2 positive, and these patients have less access to the approved therapies. However, the disease is much more severe than breast cancer, offering a substantial market opportunity for Imugene’s HER-Vaxx.
The Company selected specific regions to conduct the Phase 2 clinical trial of HER-Vaxx due to the prevailing factors of higher rates of gastric cancer, access, and reimbursement of the standard of care.
The trial is being conducted at various sites across India and Eastern Europe, where clinicians face difficulty in accessing already approved antibody treatments like Herceptin® and Perjeta®.
As of 1:33 PM AEST, Imugene shares are trading at AUD 0.190.