Phase II Kidney Cancer Therapy Study from Telix Approved by US FDA

Telix Pharmaceuticals Limited announces that the US FDA has accepted the Investigational New Drug Application (“IND”) to undertake a clinical study of the Company’s investigational kidney cancer therapy, TLX250 (¹⁷⁷Lu-DOTA-girentuximab).

The STARLITE 2 study is a single arm, investigator-led Phase II study in patients with advanced clear cell renal cell carcinoma (ccRCC), the most common and aggressive form of kidney cancer. TLX250 targets carbonic anhydrase IX (CA9), a protein that is highly expressed in patients that are likely to demonstrate a more limited response to cancer immunotherapy. The study will evaluate TLX250-delivered radiation as an immune system “primer” in combination with the anti-PD-12 immunotherapy Opdivo 3 (nivolumab). The primary endpoint is to determine the efficacy of combining immunotherapy with TLX250 as assessed by the number of tumors responding to the Telix therapy versus the current standard of care alone. The study is expected to enroll 29 patients.

Principal Investigator for the STARLITE 2 study, Darren R. Feldman, MD, medical oncologist at Memorial Sloan Kettering Cancer Center (New York) said, “Each year 76,000 Americans will be diagnosed with kidney cancer, therefore it is important we continue to explore new treatment options. The selective targeting of TLX250 to CA9 delivers radiation therapy directly to ccRCC tumors. Combining this innovative approach with anti-PD-1/PD-L1 therapy could enhance existing immune-based treatments.” 

Telix Chief Medical Officer, Dr. Colin Hayward added, “The introduction of immunotherapy agents has improved the outlook for patients with advanced clear cell renal cancer, but most patients eventually progress. This therapy, along with patient selection and treatment response assessment with our CA9-targeting imaging agent TLX250-CDx may potentially offer a new paradigm of more accurate staging and personalized treatment for kidney cancer patients through a “theranostic” approach.”