Paz Vellanki, Vice President of Clinical Development, Oncology at Precision for Medicine, shared on LinkedIn:
“The FDA has granted two Breakthrough Therapy Designations to AbbVie’s telisotuzumab adizutecan (Temab-A), an investigational c-Met-directed antibody-drug conjugate, in colorectal cancer and non-small cell lung cancer.
The designations cover two different development strategies:
- Metastatic colorectal cancer: Temab-A in combination with bevacizumab for patients who have received multiple prior therapies.
- NSCLC: Temab-A as monotherapy for patients with locally advanced or metastatic, EGFR wild-type, c-Met protein-expressing, non-squamous disease following platinum-based chemotherapy and anti-PD-(L)1 therapy.Both designations were based primarily on data from the first-in-human Phase 1 M21-404 study.
I’ll be following how target expression informs patient selection, which populations benefit, and the evidence supporting Temab-A alone or in combination.
Temab-A remains investigational, and later-stage studies will help clarify how these strategies translate into clinical benefit.
You can also read: Telisotuzumab Adizutecan (Temab-A) Earns FDA Breakthrough Therapy Designation in c-Met–Expressing NSCLC
