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In Brief This Week: Telix Pharmaceuticals, Grail, Byondis, CStone Pharmaceuticals

NEW YORK – Telix Pharmaceuticals said this week that it has dosed the final kidney cancer patient in its Phase III pivotal study for its PET imaging agent TLX250-CDx (89Zr-DFO-girentuximab). The trial, dubbed ZIRCON, is evaluating the imaging agent for renal cell carcinoma patients. The study has dosed 300 patients to date, which according to Telix exceeds the target enrollment of 252 patients. Beyond ZIRCON, Telix is also using TLX250-CDx in a Phase II kidney cancer radiopharmaceutical clinical trial dubbed STARLITE 2 as a way to visualize carbonic anhydrase IX (CA9)-expressing tumors on PET scans prior to enrolling patients and throughout the trial. 

Multi-state health system Mercy said this week that it has partnered with Grail to make the firm's cancer early detection blood test, Galleri, available to patients across its centers in the southern and southwestern US, joining several other health systems and managed care organizations. The firm stressed that Galleri — a methylation-based assay designed to detect epigenetic patterns in circulating cell-free DNA that are associated with more than 50 types of cancer — is recommended specifically for adults with an elevated risk for cancer and available by prescription only. Customers will have to pay out of pocket for the test, which is not yet covered by insurance, but Mercy said it will "work with patients who qualify for but are unable to pay the total cost of the test." Interested patients can contact Mercy to see if they are eligible and connect with a "care navigator" to aid them in the test ordering process. 

Byondis said that the US Food and Drug Administration has accepted its biologics license application for trastuzumab duocarmazine (SYD985) in patients with HER2-positive unresectable locally advanced or metastatic breast cancer. The drug received fast track designation in 2018 based on Phase I data in heavily pretreated patients with HER2-positive metastatic breast cancer. The FDA is expected to make a decision on the application by May 12, 2023. 

CStone Pharmaceuticals this week said that regulators in Hong Kong have approved Gavreto (pralsetinib) as a treatment for RET fusion-positive metastatic non-small cell lung cancer. Regulators approved the drug based on data from the Phase I/II ARROW study, in which 79 percent of 68 treatment-naïve patients and 62 percent of 126 previously treated patients responded to treatment.

Suzhou, China-based CStone has an exclusive collaboration and license agreement with Blueprint Medicines to develop and commercialize Gavreto in the greater China region, including mainland China, Hong Kong, and Taiwan. Gavreto is already approved in mainland China for RET fusion-positive NSCLC. The drug is also available in the US for metastatic RET fusion-positive NSCLC, advanced RET-mutant medullary thyroid cancer, and metastatic RET fusion-positive thyroid cancer that requires systemic therapy and is radioactive iodine-refractory.

In Brief This Week is a selection of news items that may be of interest to our readers but had not previously appeared in Precision Oncology News.