FDA Clears Turning Point's IND For Elzovantinib + Aumolertinib Combo Regime In Lung Cancer Setting

The FDA has signed off Turning Point Therapeutics Inc's TPTX Investigational New Drug (IND) application for elzovantinib + aumolertinib combo therapy 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 Inc's EQRX third-generation EGFR inhibitor approved in China for first-line treatment of EGFR mutant NSCLC and second-line treatment of T790M+ EGFR mutant NSCLC. 
• Related: Turning Point Reveals Early Repotrectinib Data In NTRK+ Advanced Solid Tumors.
• The combination of elzovantinib and aumolertinib will be studied in this Phase 1b/2 trial in patients who have progressed following treatment with osimertinib. 
• The study will evaluate the combination regimen's safety, tolerability, and preliminary efficacy.
• Preclinical data suggest that the combination of MET and EGFR inhibition can increase anti-tumor activity based on complementary mechanisms.
• Price Action: TPTX shares are up 6.60% at $38.95 during the market session on the last check Thursday.