NEW YORK – Applied Pharmaceutical Science on Sunday said that the US Food and Drug Administration has accepted an investigational new drug application for its next-generation selective RET inhibitor APS03118, which the company hopes to advance in the clinic this year for advanced RET-altered solid tumors as well as for patients who are resistant to first-generation RET inhibitors.
Applied Pharmaceutical Science, located in Beijing and Philadelphia, also has a clinical application pending with China's National Medical Products Administration for APS03118. If that application goes through, the company will launch a multi-center clinical trial in the US, China, and Australia in Q2 2022.
The FDA has already approved two RET inhibitors, selpercatinib (Eli Lilly's Retevmo) and pralsetinib, (Blueprint Medicines' Gavreto) for advanced RET fusion-positive non-small cell lung cancer patients, as well as for certain advanced medullary thyroid cancer patients with RET mutations and advanced thyroid cancer patients with RET fusions who require systemic therapy and are refractory to radioactive iodine therapy.
In preclinical studies, APS03118 has demonstrated activity against a range of RET fusions and mutations such as RET gatekeeper V804M/L/E and solvent frontier G810R/S/C mutations, which can make tumors resistant to selective RET inhibitors. Applied Pharmaceutical Science's drug has also shown activity against brain tumors in animal models, suggesting it might be distinct from other drugs in its class in its ability to treat brain metastases.