AbbVie Launches Phase 2/3 Trial of Next-Generation cMET ADC ABBV-400 in EGFR-Mutant NSCLC

▎Armstrong

On September 4, 2025, AbbVie registered a Phase 2/3 clinical trial on Clinicaltrials.gov for the new-generation cMET ADC drug ABBV-400 in treating locally advanced or recurrent EGFR-mutant non-small cell lung cancer.

This Phase 2/3 clinical trial plans to enroll 430 patients with locally advanced or recurrent EGFR-mutated non-small cell lung cancer and is expected to be completed by 2031.

In May this year, AbbVie announced that the FDA granted accelerated approval for its cMET ADC new drug Telisotuzumab Vedotin to be marketed for the treatment of previously treated patients with advanced non-small cell lung cancer (NSCLC) who have high expression of the cMET protein. The brand name is Emrelis.

ABBV-400 is a next-generation cMET ADC that uses TOPO1i as its payload. The indication for colorectal cancer has advanced to Phase III clinical trials, while indications for gastric cancer, non-small cell lung cancer, and others are also being pursued.

At last year's ESMO conference, AbbVie Inc. presented Phase I clinical trial data for ABBV-400 in treating non-squamous EGFR wild-type NSCLC, with an ORR of 43.8%.

Summary

In recent years, AbbVie has been making continuous efforts in the ADC field. It first acquired Immunogen for $10.1 billion to obtain FRα ADC, securing a leading position in the ovarian cancer field. Then, its self-developed products gradually entered the harvest period, covering non-small cell lung cancer and small cell lung cancer from cMET to SEZ6, and have already occupied a place in the entire lung cancer field.