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

Vandana Singh
·1 min read

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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