Key Findings
The FDA has granted Breakthrough Therapy Designations to telisotuzumab adizutecan (Temab-A, also known as ABBV-400) for two specific indications: metastatic colorectal cancer (mCRC) and non-small cell lung cancer (NSCLC). For mCRC, the designation applies to Temab-A used in combination with bevacizumab (Avastin) for adults with refractory disease previously treated with fluoropyrimidine-, irinotecan-, and oxaliplatin-based chemotherapy, anti-VEGF antibodies, and anti-EGFR antibodies where appropriate. For NSCLC, the designation applies to Temab-A monotherapy in adults with locally advanced or metastatic, EGFR wild-type, non-squamous NSCLC whose tumors express c-Met and who have previously received platinum-based chemotherapy and an anti-PD-(L)1 antibody.
Technical Details
Temab-A is a humanized ADC designed to target the c-Met protein on cancer cell surfaces. It utilizes a cleavable linker to deliver a topoisomerase 1 inhibitor payload directly to target cells, aiming to minimize damage to healthy tissue compared to traditional chemotherapy. Clinical data from the phase 1 M21-404 study in 122 patients with BRAF wild-type, microsatellite-stable mCRC showed:
- Objective response rate: 15.6%
- Disease control rate: 74.6%
- Median progression-free survival: 4.6 months
- Median overall survival: 10.4 months
- Median response duration: 5.9 months
Side effects were primarily gastrointestinal and hematologic; 10% of patients discontinued treatment due to side effects, and 3% died from treatment-related causes.
Background and Outlook
In NSCLC, AbbVie is conducting the phase 1b/2 M24-536 trial to evaluate Temab-A as a monotherapy and in combination with a PD-1 inhibitor as a potential chemotherapy-free first-line option for advanced non-squamous NSCLC without actionable genetic mutations. Additionally, Temab-A is being tested in EGFR-mutated NSCLC, including combinations with osimertinib (Tagrisso). Beyond these indications, the drug is under evaluation in phase 2/3 and phase 3 trials for pancreatic ductal adenocarcinoma, ovarian cancer, gastroesophageal adenocarcinoma, and head and neck squamous cell carcinoma.
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