India Pharma Outlook Team | Thursday, 14 September 2023
InnoCare Pharma has received IND approval to conduct a clinical trial in China of ICP-189, a novel SHP2 (Src Homology 2 domain containing protein tyrosine phosphatase) allosteric inhibitor, in combination with furmonertinib, a highly brain-penetrant, broadly active mutation-selective EGFR (epidermal growth factor receptor) inhibitor. InnoCare and ArriVent announced a clinical research agreement in mid-July to explore the anti-tumor effectiveness and safety of ICP-189 in combination with furmonertinib in patients with advanced non-small cell lung cancer (NSCLC).
ArriVent is testing furmonertinib in patients with advanced or metastatic NSCLC who have EGFR or HER2 mutations, including exon 20 insertion mutations and other rare EGFR mutations. It is approved in China as a first-line treatment for adults with locally advanced or metastatic NSCL C with EGFR exon 19 insertion (19DEL) or exon 21 (L858R) substitution mutations, and is being developed for additional indications in collaboration with Shanghai Allist Pharmaceuticals Co. Ltd, who discovered furmonertinib. The dosage was increased up to 120 mg in the dose escalation study with no DLT detected and a favorable PK and safety profile demonstrated. ICP-189 monotherapy demonstrated preliminary efficacy. In the 20 mg dosage cohort, one patient with cervical cancer obtained a verified partial response.