Nuvectis Pharma Initiated Phase 1b Study Of NXP900 In Combination With Astrazeneca's Tagrisso (Osimertinib) In Patients With EGFRmut+ NSCLC

NXP900 Phase 1b Clinical Program

The Phase 1b program was initiated with the NXP900 single agent (monotherapy) study following the successful completion of a Phase 1a dose escalation study in patients with advanced solid tumors and a clinical drug-drug interaction study in healthy volunteers.

The ongoing single agent study evaluates the safety and clinical activity of NXP900 in patients with specific genetic alterations selected based on their characteristics as either direct or dependent targets of NXP900, and the tumor types were selected based on the prevalence of the relevant genetic alterations and supporting scientific data. Today marks the commencement of the first combination study of NXP900 as part of the Phase 1b program.

Phase 1b of NXP900 in Combination with Osimertinib in Patients with EGFRmut+ NSCLC

Eligible patients for this study include those with unresectable, metastatic or locally advanced EGFRmut+ NSCLC who have been previously treated with, and had a response to, osimertinib in the first or second line setting as a single agent or in combination with chemotherapy. Patients whose tumors harbor mutations in the EGFR domain that are known to cause resistance to osimertinib, or who have other known oncogenic drivers other than EGFR mutation are not eligible.

Ron Bentsur, Chairman and Chief Executive Officer of Nuvectis commented, "We are pleased to announce the initiation of the NXP900 plus osimertinib combination study, as we continue to advance the NXP900 clinical program and unlock NXP900's promising therapeutic potential." Mr. Bentsur added, "The clinical benefit and improved outcomes afforded by osimertinib to patients with EGFRmut+ NSCLC are well known, and we believe, based on extensive medical and scientific literature and proof of concept experiments done by us and others, that a combination with NXP900 has the potential to extend these benefits in patients who acquired resistance to osimertinib, using an all oral combination of osimertinib and NXP900." Mr. Bentsur concluded, "We expect 2026 to be an exciting year with multiple data readouts from both the single agent and combination studies, and we look forward to providing updates from the program throughout the year."