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Highlights
- Imugene launches Australian site for azer-cel CAR T-cell therapy trial.
- Sydney’s Royal Prince Alfred Hospital to lead DLBCL patient recruitment.
- New phase targets better access and outcomes for lymphoma patients.
Imugene Ltd (ASX:IMU) has launched the first Australian site for its Phase 1b clinical trial of azer-cel (azercabtagene zapreleucel), expanding its innovative allogeneic CAR T-cell therapy program. This trial focuses on treating relapsed or refractory diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin’s lymphoma that currently lacks effective treatment options for many patients. The Royal Prince Alfred Hospital in Sydney will lead recruitment efforts, beginning in November 2024, marking Australia’s only active allogeneic CAR T-cell trial for DLBCL.
The opening of this trial site represents a significant milestone in providing Australian patients with access to cutting-edge treatments. Azer-cel, developed by Imugene, offers a potential lifeline to patients needing alternative therapies, especially those who have relapsed after conventional treatments. Imugene’s CEO, Leslie Chong, expressed pride in bringing this pioneering trial to Australia, stating that it is the first of five planned sites aimed at accelerating enrolment and improving outcomes for patients facing this challenging form of blood cancer.
DLBCL is a serious condition, affecting approximately 80,500 individuals worldwide each year, with around 30,000 new cases reported in the United States alone. For many patients, standard treatments, including autologous CAR T-cell therapies targeting the CD19 protein, have shown limited effectiveness, often resulting in relapse. Azer-cel stands out as an “off-the-shelf” allogeneic CAR T-cell therapy, designed to provide a faster and more accessible solution compared to autologous therapies, which require complex and time-intensive cell harvesting from patients.
Recent data from Imugene’s US trial sites indicate promising results, with three patients achieving complete responses, two of whom were treated with azer-cel in combination with lymphodepletion chemotherapy and interleukin-2 (IL-2). These patients demonstrated durable responses, extending beyond 90 to 120 days, highlighting the potential of azer-cel to offer meaningful benefits for those with limited treatment choices. The combination therapy has shown significant clinical activity and durability, raising hopes for a potential breakthrough in DLBCL treatment.
Unlike traditional CAR T-cell therapies, which rely on a patient's cells, azer-cel utilizes donor T-cells, simplifying the treatment process and reducing logistical challenges. This approach not only shortens wait times but also addresses the high demand for accessible cancer therapies. Safety data from both the US and Australian trials further support azer-cel’s safety profile, making it a promising therapeutic option in the landscape of blood cancer treatment.
As Imugene advances this critical trial phase in Australia, azer-cel's innovative design positions it as a promising therapy for DLBCL patients, offering new hope in addressing unmet treatment needs.
