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Benzinga
Benzinga
Technology
Vandana Singh

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

FDA

The FDA has signed off Turning Point Therapeutics Inc's (NASDAQ: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 (NASDAQ: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.
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