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Turning Point Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Combination of Elzovantinib and Aumolertinib in EGFR Mutant Met-Amplified Non-Small Cell Lung Cancer

Excerpt from the Press Release:

SAN DIEGO, Jan. 20, 2022 (GLOBE NEWSWIRE) — Turning Point Therapeutics, Inc. (NASDAQ: TPTX), a precision oncology company developing next-generation therapies that target genetic drivers of cancer, today announced that the company has received clearance from the FDA for the company’s Investigational New Drug (IND) application for the combination of elzovantinib and aumolertinib in EGFR mutant MET-amplified advanced non-small cell lung cancer (NSCLC). The company expects to initiate the Phase 1b/2 SHIELD-2 combination study in mid-2022.

Aumolertinib is EQRx’s third generation EGFR inhibitor which is approved in China for first line treatment of EGFR mutant NSCLC and second line treatment of T790M+ EGFR mutant NSCLC. The combination of elzovantinib and aumolertinib will be studied in this Phase 1b/2 trial in patients with EGFR mutant MET-amplified advanced NSCLC who have progressed following treatment with osimertinib. The study will evaluate the safety, tolerability and preliminary efficacy of the combination regimen.

Preclinical data suggest the combination of MET and EGFR inhibition has the potential to increase anti-tumor activity based on complementary mechanisms. It is estimated that 15 to 20% of patients who progress on a first-line EGFR inhibitor develop MET amplification as the basis of acquired resistance.

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