TLX66 Meets Study Objectives in Patients with AL Amyloidosis

Melbourne (Australia) and Southampton (United Kingdom) – 25 May 2021. Telix announces bone marrow conditioning investigational candidate TLX66 has met study objectives, demonstrating the initial safety profile in patients with AL amyloidosis.

Telix is pleased to announce that the Company’s bone marrow conditioning investigational candidate TLX66 (⁹⁰Y-besilesomab) has met study objectives, demonstrating the initial safety profile in patients with Systemic Amyloid Light Chain Amyloidosis (AL amyloidosis).

The TRALA trial (Targeted Radiotherapy for AL Amyloidosis) is a Phase I/IIa trial to evaluate the safety and toxicity of TLX66 as the sole bone marrow conditioning agent prior to autologous hematopoietic stem cell transplantation (HSCT) in patients with AL amyloidosis. The TRALA trial was sponsored by the University of Southampton Hospital in Southampton, U.K. and run across four centres: Southampton, University College Hospital London, Royal Free Hospital London and Queen Elizabeth Hospital Birmingham. All study data were reviewed by the trial’s Independent Data Monitoring Committee (IDMC).

In total, nine patients with AL amyloidosis were enrolled into the TRALA trial and received TLX66 as the sole bone marrow conditioning agent prior to undergoing autologous HSCT. TLX66 demonstrated a favourable safety profile and was well tolerated in all nine patients, each of whom completed the trial. All patients (100%) were successfully engrafted following bone marrow conditioning with TLX66 and autologous HSCT without any chemotherapy. Disease response as measured by fall in clonal free light chains (FLC) was seen in seven out of the nine patients, with two complete responses (CR) and five partial responses (PR) within the first 100 days post-transplant. In two of the patients achieving PR, the clonal FLC continued to fall, with one patient achieving CR subsequently with no further treatment. In addition, reduction in the measurable malignant plasma cells in the bone marrow was seen in six of eight evaluable patients. All patients remain alive at a median follow-up of 31 months (range 14 – 57 months).

Telix Chief Medical Officer Dr. Colin Hayward said, “The results from the TRALA trial indicate that TLX66 may offer a new approach to bone marrow conditioning in patients who could benefit from HSCT such as those with AL amyloidosis, providing new hope to patients with this rare disease and with few effective treatment options. TLX66 was well-tolerated, enabling successful engraftment of the patients’ own transplanted stem cells without the need for toxic chemotherapy. With all patients remaining alive, and most not requiring further therapy, we believe these data support taking TLX66 forward into a pivotal registration program in this rare disease indication.”

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