NEW YORK – Telix Pharmaceuticals said on Wednesday that the first patient with advanced renal cancer has received its radiopharmaceutical TLX250 in a Phase II trial.
The patient received treatment at Memorial Sloan Kettering Cancer Center within the STARLITE 2 trial, in which Telix is evaluating TLX250 (177Lu-DOTA-girentuximab) plus Bristol Myers Squibb's immunotherapy Opdivo (nivolumab). The Melbourne, Australia-based firm will enroll about 30 clear-cell renal cell carcinoma patients who have progressed on immunotherapy.
The radiopharmaceutical is designed to deliver a cancer-killing radioisotope — in this case lutetium-177 — directly to cells that express the protein carbonic anhydrase IX (CA9). Telix is betting that by combining TLX250 with the checkpoint inhibitor Opdivo, the targeted radiation will prime patients' immunotherapy-resistant tumors and make them responsive.
In the trial, Telix will use its investigational imaging agent TLX250-CDx (89Zr-DFO-girentuximab) to visualize CA9-expressing cancers on PET scans prior to enrolling patients and throughout the trial. Telix is currently evaluating TLX250-CDx as a diagnostic agent for kidney cancer in its Phase III ZIRCON trial. Recently, the firm began the Phase II OPALESCENCE trial to evaluate it for breast cancer patients, too.
The primary goals of the STARLITE-2 study are to determine the safety and preliminary efficacy of the targeted radiopharmaceutical and Opdivo combo. Investigators will determine the best dose of the drug as well as track patients' overall response rates.