telisotuzumab adizutecan (ABBV-400) / AbbVie - LARVOL DELTA

AndroMETa-CRC-064: A Study Assessing Adverse Events and Disease Activity of Intravenously (IV) Infused Telisotuzumab Adizutecan in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer (clinicaltrials.gov) - P2 | N=74 | Active, not recruiting | Sponsor: AbbVie | Phase classification: P3 ➔ P2

Adverse events • Monotherapy • Phase classification • Colorectal Cancer • Oncology • Solid Tumor • TOP1

A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers (clinicaltrials.gov) - P2 | N=168 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Biliary Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Telisotuzumab adizutecan for metastatic colorectal cancer: a c-MET-targeted antibody-drug conjugate with a topoisomerase inhibitor payload. (PubMed, Expert Opin Investig Drugs) - "By exploiting c-MET surface expression rather than signaling dependency, Temab-A provided preliminary clinical activity across a broad population, including a clinically meaningful subgroup with c-MET overexpression. The ongoing phase 3 AndroMETa-CRC-560 trial will determine whether Temab-A plus bevacizumab can become a new therapeutic option for mCRC."

Journal • Review • Colorectal Cancer • Oncology • Solid Tumor • MET

A Study to Assess Adverse Events and Change in Disease Activity With Treatment Combinations With Telisotuzumab Adizutecan in Adults Participants With Pancreatobiliary Cancers (clinicaltrials.gov) - P2 | N=168 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2 trial • Biliary Cancer • Oncology • Pancreatic Cancer • Solid Tumor

Telisotuzumab Adizutecan and PD-1 Inhibitor in Untreated Advanced Non-Squamous Non-Small Cell Lung Cancer: A Phase 1b/2 Study (IASLC-WCLC 2026) - P1, P1/2 | "Budigalimab is an investigational programmed cell death receptor 1 (PD-1) inhibitor with a mechanism of action similar to the approved pembrolizumab in these patients...In Part 2, 240 patients will be randomized 1:1:1 to receive selected doses of Temab-A + pembrolizumab or standard-of-care treatment (pembrolizumab + pemetrexed + investigator's choice of carboplatin or cisplatin), followed by pembrolizumab + pemetrexed for up to ~33 months...Additional secondary endpoints are subgroup analyses of ORR, PFS, OS, DOR, and DCR by PD-L1 and c-Met expression and history of brain metastases. Exploratory efficacy endpoints include intracranial OR, PFS and DOR by BICR, and patient-reported outcomes."

First-in-human • IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PD-L1

Telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with fluorouracil, leucovorin, and budigalimab in locally advanced/metastatic gastric, gastroesophageal junction, or esophageal adenocarcinoma (a/m GEA). (ASCO 2025) - P1, P2 | "Treatment is administered until disease progression, intolerable toxicity, or other discontinuation criteria are met. Either archived formalin-fixed paraffin-embedded tissue or a fresh biopsy is required for biomarker research that will include evaluation of c-Met protein expression and MET genomic alterations."

Combination therapy • IO biomarker • Metastases • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor • HER-2 • MET • PD-L1

Telisotuzumab adizutecan plus bevacizumab vs trifluridine and tipiracil plus bevacizumab in refractory metastatic colorectal cancer: A phase 3 study (ESMO 2026) - No abstract available

Metastases • P3 data • Colorectal Cancer • Oncology • Solid Tumor

Long-term follow-up of Telisotuzumab Adizutecan (ABBV-400, Temab-A) in combination with bevacizumab (Bev) vs standard of care (SOC) in patients (pts) with 3L+ colorectal cancer (CRC): Updated results of a phase 1 study (ESMO 2026) - No abstract available

Clinical • Combination therapy • P1 data • Colorectal Cancer • Oncology • Solid Tumor

Phase 2 randomized study evaluating safety, efficacy, and optimal dose of ABBV-400 in combination with fluorouracil, folinic acid, and bevacizumab in previously treated patients with metastatic colorectal cancer. (ASCO 2024) - P2 | "ABBV-400 is a c-Met–directed antibody-drug conjugate composed of the monoclonal antibody telisotuzumab conjugated to a potent topoisomerase 1 inhibitor payload...In stage 2, patients are randomized to up to 4 ABBV-400 dose cohorts (2 with Q2W and 2 with Q4W ABBV-400 schedule; all in combination with Q2W 5-FU, FA, and bev) and a comparator cohort (irinotecan [180 mg/m 2 ] + 5-FU [400 mg/m 2 bolus and 2400 mg/m 2 infusion] + FA [200 mg/m 2 ] + bev [5 mg/kg]; all Q2W). Patients are treated until progression, unacceptable toxicity, or other discontinuation criteria are met. Enrollment was initiated in November 2023, with 3 patients enrolled as of January 4, 2024."

Clinical • Combination therapy • Metastases • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • BRAF • EGFR • MET

Phase 1b/2 study evaluating telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with budigalimab in patients (pts) with advanced non-squamous (NSQ) non-small cell lung cancer (NSCLC) with no prior treatment for advanced disease and no actionable genomic alterations. (ASCO 2025) - P1, P1/2 | "Pts are randomized 1:1:1:1 to Temab-A at 1 of 2 doses determined in part 1 + budigalimab, to budigalimab + CT, or to SOC (pembrolizumab + CT) arms...Treatment continues until disease progression, intolerable toxicity, or other discontinuation criteria are met. The first dosing of the first patient enrolled is planned in March 2025."

Clinical • Combination therapy • IO biomarker • Metastases • P1/2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET • PD-L1

Telisotuzumab adizutecan (ABBV-400; Temab-A) in combination with bevacizumab (Bev) vs standard of care (SOC) in patients (pts) with 3L+ colorectal cancer (CRC): Dose expansion results of a phase I study (ESMO 2025) - P1 | "Methods Unselected pts with advanced CRC were enrolled in 2 parts: (1) Safety lead-in: pts received escalating doses of Temab-A at 1.6 (n=7) or 2.4 (n=8) mg/kg (2.0 mg/kg backfill [n=5]) + Bev 7.5 mg/kg Q3W; (2) Dose optimization: pts were randomized to Temab-A 2.0 (n=23) or 2.4 (n=22) mg/kg + Bev 7.5 mg/kg Q3W, or trifluridine/tipiracil (TAS-102) 35 mg/m 2 days 1–5 and 8–12 Q4W + Bev 5.0 mg/kg (n=21) Q2W (SOC). c, confirmed; CI, confidence interval; DCR, disease control rate; DCR12, DCR at 12 weeks; ORR, objective response rate. Conclusions Temab-A at 2.4 mg/kg + Bev had manageable safety and promising efficacy compared with the SOC in 3L+ pts with CRC."

Clinical • Combination therapy • P1 data • Colorectal Cancer • Oncology • Solid Tumor • MET

First-in-human study of ABBV-400, a novel c-Met–targeting antibody-drug conjugate, in advanced solid tumors: Results in colorectal cancer. (ASCO 2024) - P1 | "The antibody-drug conjugate ABBV-400 comprises c-Met–targeting antibody telisotuzumab conjugated to a novel topoisomerase 1 inhibitor payload. ABBV-400 at 2.4 and 3.0 mg/kg Q3W has a tolerable and manageable safety profile, with promising antitumor activity. Long-term tolerability appears improved at 2.4 relative to 3.0 mg/kg, with higher relative dose intensity and generally lower TEAEs. The study is also evaluating ABBV-400 with bevacizumab in pts with CRC."

Metastases • P1 data • Anemia • Colorectal Cancer • Fatigue • Gastrointestinal Cancer • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • Thrombocytopenia • MET

A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=990 | Recruiting | Sponsor: AbbVie | N=700 ➔ 990

Enrollment change • Colorectal Cancer • Oncology • Solid Tumor

AbbVie to Present New Data at WCLC 2026 Showcasing Innovation Across Lung Cancer Pipeline (AbbVie Press Release) - "Additionally, new data and updates from AbbVie's telisotuzumab adizutecan (Temab-A) and ABBV-706 programs across NSCLC and small cell lung cancer (SCLC) to be shared."

Clinical data • Non Small Cell Lung Cancer • Small Cell Lung Cancer

Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Select Advanced Solid Tumor Indications Receiving Intravenous (IV) ABBV-400 (clinicaltrials.gov) - P1 | N=325 | Recruiting | Sponsor: AbbVie | Active, not recruiting ➔ Recruiting

Adverse events • Enrollment open • Platinum resistant • Biliary Cancer • Biliary Tract Cancer • Breast Cancer • Epithelial Ovarian Cancer • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Head and Neck Cancer • Hepatocellular Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer • HER-2 • TOP1

Phase I basket study of telisotuzumab adizutecan (ABBV-400; Temab-A), a c-Met protein-targeting antibody-drug conjugate: Results from patients (pts) with pancreatic ductal adenocarcinoma (PDAC) (ESMO 2025) - P1 | "Table: 2214MO Outcome Overall (N=42 ‡ ) 1L FOLFIRINOX (n=26) 1L gem– nab -paclitaxel (n=15) Best overall response,* ,† n (%) CR 0 0 0 PR 10 (24) 4 (15) 6 (40) SD 24 (57) 17 (65) 6 (40) PD 4 (10) 2 (8) 2 (13) NE/Not assessed 4 (10) 3 (12) 1 (7) ORR,* ,† n (%) 10 (24) 4 (15) 6 (40) CBR,* ,† n (%) 34 (81) 21 (81) 12 (80) Median PFS, mo [95% CI] 5.3 [4.0, 6.8] 5.0 [3.6, 6.2] 6.8 [2.4, NE] *Confirmed responses...CBR, clinical benefit rate; CR, complete response; NE, not estimable; PD, progressive disease; PFS, progression-free survival; PR, partial response; SD, stable disease. Conclusions Temab-A had a manageable safety profile in pts with advanced PDAC and promising efficacy, especially in pts who received 1L gemcitabine– nab -paclitaxel."

Clinical • P1 data • Pan tumor • Oncology • Pancreatic Cancer • Pancreatic Ductal Adenocarcinoma • MET

A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants Previously Treated, EGFR Wildtype, Locally Advanced/Metastatic Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P3 | N=660 | Not yet recruiting | Sponsor: AbbVie

New P3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Overall survival (OS) analysis of telisotuzumab adizutecan in patients (pts) with nonsquamous non-small cell lung cancer (NSQ NSCLC): Phase 1 first-in-human study (ESMO 2026) - No abstract available

Clinical • First-in-human • P1 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Telisotuzumab adizutecan (Temab-A) for EGFR-mutated (mut) nonsquamous non-small cell lung cancer (NSQ NSCLC): post hoc analysis from a Phase 1 first-in-human (FIH) study in patients (pts) with brain metastases (BMs) (ESMO 2026) - No abstract available

Clinical • First-in-human • P1 data • Retrospective data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

Telisotuzumab adizutecan (ABBV-400; Temab-A) in patients with MET-amplified (MET-amp) advanced solid tumors: Results from a phase I study (ESMO 2025) - P1 | "Table: 918O All pts with MET -amp tumors 1.6 mg/kg n=18 2.0 mg/kg n=8 2.4 mg/kg n=34 3.0 mg/kg n=39 Total ∗ N=100 Grade ≥3 AE, n (%) 10 (56) 4 (50) 24 (71) 33 (85) 72 (72) Gastrointestinal AEs, n (%) 14 (78) 5 (63) 27 (79) 29 (74) 75 (75) Grade ≥3 1 (6) 0 0 2 (5) 3 (3) Hematologic AE, n (%) 9 (50) 3 (38) 25 (74) 34 (87) 72 (72) Grade ≥3 5 (28) 3 (38) 19 (56) 28 (72) 56 (56) cORR, n (%) 7 (39) 3 (38) 16 (47) 20 (51) 46 (46) cCBR, n (%) 12 (67) 5 (63) 27 (79) 33 (85) 78 (78) *Includes 1 pt treated at 4 mg/kg.AE, adverse event; c, confirmed; CBR, clinical benefit rate; ORR, objective response rate. Conclusions Temab-A monotherapy had a manageable safety profile and encouraging efficacy in pts with diverse MET- amp advanced solid tumors."

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Dose optimization and exposure-response analyses to support optimal dose of ABBV-400, a novel C-met–targeting antibody drug conjugate, in patients with metastatic colorectal cancer (mCRC). (ASCO 2024) - P1 | "Population PK, E-R for efficacy and safety and RDI analyses and totality of clinical data supported the selection of 2.4 mg/kg Q3W as optimal ABBV-400 monotherapy dose for further study in mCRC patients. 1. Sharma M, et al."

Clinical • Metastases • Anemia • Colorectal Cancer • Gastrointestinal Cancer • Hematological Disorders • Neutropenia • Oncology • Solid Tumor • Thrombocytopenia • MET • TOP1

Has Colorectal Cancer (c-)Met Its Match With Telisotuzumab Adizutecan? (PubMed, J Clin Oncol) - No abstract available

Journal • Colorectal Cancer • Oncology • Solid Tumor

ABBV-400, a c-Met protein-targeting antibody-drug conjugate (ADC), in patients (Pts) with advanced EGFR wildtype (WT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase I study (ESMO 2024) - P1 | "ABBV-400 is an ADC composed of the c-Met–targeting mAb telisotuzumab conjugated to a novel topoisomerase 1 inhibitor payload. ABBV-400 has a tolerable safety profile and antitumor activity in pts with NSQ EGFR WT NSCLC, warranting further investigation. Evaluation of ABBV-400 in other NSCLC subtypes is ongoing. Table: 1257MO Preliminary efficacya aTime-to-event endpoints (PFS, DOR, OS) are immature.bConfirmed responses.CBR, clinical benefit rate; CR, complete response; NE, not estimated; NSQ, non-squamous; ORR, objective response rate; PD, progressive disease; PR, partial response; SD, stable disease"

Clinical • Metastases • P1 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

A phase 2 randomized study comparing telisotuzumab adizutecan monotherapy with standard of care in patients with post-adjuvant circulating tumor DNA-positive colorectal cancer. (ASCO-GI 2026) - P1, P2 | "Study follow-up will occur every 3 mos for the first 2 yrs and every 6 mos for the 3 yrs thereafter. The Table shows study objectives and endpoints."

Circulating tumor DNA • Clinical • Monotherapy • P2 data • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor • MET • TOP1

ABBV-400, a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced gastric/gastroesophageal junction adenocarcinoma (GEA): Results from a phase I study (ESMO 2024) - P1 | "ABBV-400 is an ADC consisting of the c-Met–targeting mAb telisotuzumab conjugated to a novel topoisomerase 1 inhibitor payload. ABBV-400 demonstrated a tolerable safety profile and antitumor activity in pts with advanced GEA, warranting additional study in future clinical trials."

Clinical • Metastases • P1 data • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • Solid Tumor • MET