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Turning Point Gets FDA IND Clearance to Start Elzovantinib, Aumolertinib Lung Cancer Trial

NEW YORK – Turning Point Therapeutics on Thursday said it will start a Phase Ib/II trial mid-year to evaluate its MET-targeting agent elzovantinib with EQRx's third-generation EGFR inhibitor aumolertinib in patients with EGFR-mutated and MET-amplified advanced non-small cell lung cancer.

San Diego-based Turning Point can begin the SHIELD-2 study now that the US Food and Drug Administration has accepted its investigational new drug application for the combination in this indication. The trial will involve advanced NSCLC patients who have EGFR mutations and MET amplifications in their tumors and have progressed on treatment with the EGFR inhibitor osimertinib (AstraZeneca's Tagrisso).

Turning Point and Cambridge, Massachusetts-based EQRx announced last year they planned to study the elzovantinib-aumolertinib combination in this subgroup of advanced NSCLC patients. The companies estimate that up to 20 percent of NSCLC patients with EGFR-mutated tumors become resistant to first-line EGFR inhibitor treatments after acquiring MET amplifications.

Preclinical research suggests that the combination of a MET and EGFR inhibitor may overcome resistance mechanisms that emerge with EGFR treatment. In the planned Phase Ib/II trial, the companies will assess the safety, tolerability, and preliminary efficacy of the elzovantinib-aumolertinib regimen.

Aumolertinib is already approved in China as a first-line treatment for EGFR-mutated NSCLC and a second-line therapy for NSCLC with T790M resistance mutations. At the 40th Annual JP Morgan Healthcare Conference last week, EQRx discussed plans to start a three-arm trial this year comparing single-agent aumolertinib versus aumolertinib plus chemotherapy versus osimertinib. Turning Point is also conducting a Phase I trial of elzovantinib in patients with advanced or metastatic solid tumors with MET alterations.