AbbVie’s antibody drug conjugate (ADC) Temab-A (telisotuzumab adizutecan) has demonstrated promising results in a Phase I trial in patients with lung cancer, as the ADC modality continues to take centre stage at this year’s American Society of Clinical Oncology (ASCO) meeting.

AbbVie’s candidate, dubbed internally as ABBV-400, achieved an overall response rate (ORR) of 63% in patients with advanced EGFR (epidermal growth factor receptor)-mutated, non-squamous (NSQ) non-small cell lung cancer (NSCLC). The drug has already demonstrated positive data in patients with wildtype EGFR.

Patients enrolled in the trial were those who had progressed after platinum-based chemotherapy doublet and tyrosine kinase inhibitor(s) (TKIs). Temab-A was administered every three weeks. Patients were initially enrolled at 3 mg/kg, which was later reduced to 2.4 mg/kg.

Immunotherapies currently on market are generally not recommended as first-line treatments for patients with EGFR mutation. Daiichi Sankyo and AstraZeneca’s Enhertu (trastuzumab deruxtecan), the only ADC approved for NSCLC, previously demonstrated an objective response rate (ORR) of 49%. Enhurtu, however, is approved for HER2-mutant NSCLC, making direct comparisons difficult.

AbbVie presented results from its Phase I trial (NCT05029882) at the 2025 ASCO Annual Meeting, taking place from 30 May to 3 June in Chicago, Illinois. The trial is enrolling around 500 adults with NSCLC, gastroesophageal adenocarcinoma, colorectal cancer (CRC) or advanced solid tumours.

Data from the 41 patients enrolled demonstrated a median duration of response at 9.8 months and a median progression-free survival of 10.9 months. These figures were irrespective of c-Met expression, a protein found in NSCLC. Temab-A works by targeting c-Met and delivering a topoisomerase 1 inhibitor payload.

Treatment emergent adverse events occurred in all patients, the most common being haematologic and gastrointestinal side effects. More serious events, those grade 3 and higher, occurred in 78% of patients. As with other ADCs, interstitial lung disease was observed – Temab-A generated a rate of 7% of this respiratory complication in participants.

“Data demonstrate a manageable safety profile, promising anti-tumour activity … and are supportive of further exploration of this novel ADC in this setting,” Dr. Nivedita Aanur, NSCLC clinical lead at AbbVie, told Pharmaceutical Technology.

Nearly 85% of lung cancers are NSCLC, with initial treatment for patients with EGFR mutations including targeted therapy and/or chemotherapy. According to a GlobalData report, the global NSCLC market, valued at $30.7bn in 2021, is set to grow to $45.4bn by 2031.