Nuvectis Pharma Starts Phase 1b Study Testing NXP900 Plus Osimertinib In Non-Small Cell Lung Cancer

Nuvectis Pharma, Inc., a clinical-stage biopharmaceutical company focused on developing precision medicines for serious unmet medical needs in oncology, has announced the initiation of a Phase 1b study evaluating its oral small molecule candidate NXP900 in combination with osimertinib in patients with EGFR-mutated non-small cell lung cancer (NSCLC). NXP900 is a potent inhibitor of SRC and YES1 kinases, pathways known to drive resistance to EGFR inhibitor therapy in EGFR-mutated NSCLC. Osimertinib (Tagrisso®), marketed by AstraZeneca, is a third-generation EGFR inhibitor widely used either alone or in combination with chemotherapy in first- or later-line settings for patients with EGFR-mutated NSCLC.

The Phase 1b program follows 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 of NXP900 evaluates safety and clinical activity in patients selected based on specific genetic alterations targeted by NXP900. Tumor types were chosen according to the prevalence of these genetic alterations and supporting scientific data. The current Phase 1b study marks the first time NXP900 is being evaluated in combination with osimertinib.

The combination study will enroll patients with unresectable, metastatic, or locally advanced EGFR-mutated NSCLC who have previously received osimertinib and experienced a response, either as a single agent or in combination with chemotherapy. Patients whose tumors harbor mutations known to cause resistance to osimertinib, or who have other oncogenic drivers besides EGFR, are not eligible for participation.

Ron Bentsur, Chairman and CEO of Nuvectis, stated that the initiation of the NXP900 and osimertinib combination study represents an important step in advancing the NXP900 clinical program and exploring its therapeutic potential. He highlighted that while osimertinib has already demonstrated significant clinical benefit in EGFR-mutated NSCLC, combining it with NXP900 may help extend these benefits in patients who develop resistance. The all-oral combination approach offers a potentially convenient and effective strategy to overcome resistance mechanisms.

Mr. Bentsur also noted that 2026 is expected to be a pivotal year for the NXP900 program, with multiple data readouts anticipated from both the single-agent and combination studies, and the company looks forward to providing updates on clinical progress throughout the year.