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NewsAbbVie's Temab-A scores two FDA breakthrough therapy designations — one for previously treated EGFR wild-type nonsquamous NSCLC and another (in combo with bevacizumab) for refractory metastatic colorectal cancer. The c-Met–directed antibody-drug conjugate showed strong response rates across both tumor types in early-phase trials, signaling its potential as a multi-cancer treatment option.
AbbVie's telisotuzumab adizutecan (Temab-A; ABBV-400), a c-Met–directed antibody-drug conjugate (ADC) with a topoisomerase 1 inhibitor payload, has received two FDA breakthrough therapy designations. The first is for monotherapy in previously treated, c-Met–expressing, EGFR wild-type nonsquamous non–small cell lung cancer (NSCLC) after platinum chemotherapy and anti–PD-(L)1 therapy. The second is for Temab-A in combination with bevacizumab in refractory metastatic colorectal cancer (mCRC) after prior fluoropyrimidine, irinotecan, oxaliplatin, and anti-VEGF therapy.
Both designations were supported by data from the phase 1 study M21-404. In NSCLC, Temab-A delivered strong results across multiple patient subgroups, including those with EGFR mutations and brain metastases. In mCRC, the combination outperformed standard-of-care TAS-102 plus bevacizumab on progression-free survival in biomarker-unselected patients.
By the Numbers:
Why it matters: Temab-A's dual breakthrough designations highlight c-Met as a compelling target across multiple solid tumors. For patients with limited options after standard therapies, this ADC could represent a meaningful new treatment avenue — and the ongoing phase 3 AndroMETa-CRC trial will be key to confirming its promise.
