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

Telisotuzumab adizutecan (Temab-A, ABBV-400), a novel c-Met antibody-drug conjugate, in Asian patients (pts) with advanced CRC: Results of a phase I study (ESMO Asia 2025) - P1 | "Temab-A monotherapy had encouraging efficacy in AS pts with CRC with comparable responses to OVR pts. No new safety signals were observed vs OVR pts."

Clinical • Metastases • P1 data • Oncology • Solid Tumor • MET

Exposure-response analyses from a randomized dose optimization study of telisotuzumab adizutecan (Temab-A) in combination with bevacizumab in patients with metastatic colorectal cancer (mCRC). (ASCO-GI 2026) - P1 | "Clinical Trial Registration Number: NCT05029882 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Clinical • Combination therapy • Metastases • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

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) - P2 | "Funded by AbbVie Inc Clinical Trial Registration Number: NCT07023289 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

Circulating tumor DNA • Clinical • Monotherapy • P2 data • Colorectal Cancer • Gastrointestinal Cancer • Oncology • Solid Tumor

A phase 2 randomized study of telisotuzumab adizutecan (ABBV-400, Temab-A) in combination with standard of care (SOC) in patients with metastatic colorectal cancer. (ASCO-GI 2026) - P2 | "Funded by AbbVie Inc Clinical Trial Registration Number: NCT06820463 The full, final text of this abstract will be available on Jan 05 at 05:00 PM EST."

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

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

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

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

A phase 2 randomized study of telisotuzumab adizutecan (ABBV-400, Temab-A) in combination with standard of care (SOC) in patients with metastatic colorectal cancer [WITHDRAWN] (ESMO 2025) - No abstract available

Clinical • Combination therapy • Metastases • P2 data • Colorectal Cancer • Oncology • Solid Tumor

Combination with bevacizumab (Bev) in Colorectal Cancer (CRC) (AbbVie Press Release) - "In biomarker unselected patients with advanced CRC who have received three or more prior lines of therapy (NCT05029882), treatment with 2.4 mg/kg dose of Temab-A plus Bev (n=30) achieved an objective response rate (ORR) of 26.7% compared to an ORR of 0% with trifluridine/tipiracil with Bev (the current standard of care (SOC), n = 20).1 Grade ≥3 treatment emergent adverse events (TEAEs) occurred in 67% and 65% of patients, respectively."

P1 data • Colorectal Cancer

Monotherapy in MET-Amplified Solid Tumors (AbbVie Press Release) - "Among 100 patients with advanced MET-amplified solid tumors, including non-small cell lung cancer (NSCLC) (n=29), CRC (n=22), gastroesophageal adenocarcinoma (GEA) (n=14), and 16 other tumor types (n=35) who had progressed after SOC treatment (NCT05029882), Temab-A monotherapy achieved an ORR of 46% across all dose levels and tumor types with higher responses observed in patients with NSCLC (69%) and GEA (71%). The most common grade ≥3 TEAEs were anemia (40%) and neutropenia (34%)."

P1 data • Colorectal Cancer • Gastroesophageal Junction Adenocarcinoma • Non Small Cell Lung Cancer

Monotherapy in Pancreatic Ductal Adenocarcinoma (PDAC) (AbbVie Press Release) - "Among 42 biomarker unselected patients with advanced/metastatic PDAC who experienced disease progression while receiving or after completing their first-line (1L) therapy (NCT06084481), Temab-A demonstrated an ORR of 24% overall and 40% in patients who received first-line gemcitabine-nab-paclitaxel treatment. Grade ≥3 TEAEs occurring in ≥10% of all patients were anemia (38%) and neutropenia (21%)."

P1 data • Pancreatic Ductal Adenocarcinoma

A Study to Assess Adverse Events and Change in Disease Activity in Participants 12 Years of Age or Older With Locally Advanced or Metastatic Solid Tumors That Harbor MET Amplification Receiving Intravenously Infused Telisotuzumab Adizutecan (clinicaltrials.gov) - P2 | N=125 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2 trial • Solid Tumor

MET Alterations in Cancer and MET-Targeted Therapy: Detection Strategies, Treatment Efficacy, and Emerging Technologies. (PubMed, Target Oncol) - "This review summarizes the frequency of MET alterations across different cancer types and the clinical validation of MET alterations in MET-targeted therapies, offering a detailed comparison of objective response rates (ORR) for therapies including crizotinib, capmatinib, tepotinib, savolitinib, telisotuzumab vedotin, telisotuzumab adizutecan, and amivantamab. Additionally, emerging technologies such as circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) analyses have been investigated for their potential to improve MET alterations detection. This review also highlights studies that demonstrate the potential of MET ctDNA and CTC analyses to predict treatment responses and identify resistance mechanisms in MET-targeted therapies."

Journal • Review • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Study to Assess Adverse Events and Change in Disease Activity of Intravenous (IV) Telisotuzumab Adizutecan Compared to Standard of Care in Adult Participants With Locally Advanced or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=430 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2/3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=694 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Enrollment open • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (clinicaltrials.gov) - P2 | N=140 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Circulating tumor DNA • Enrollment open • Monotherapy • Colorectal Cancer • Oncology • Solid Tumor

AndroMETa-CRC-064: A Study Assessing Adverse Events and Disease Activity When Comparing Intravenously (IV) Infused ABBV-400 to Trifluridine and Tipiracil (LONSURF) Oral Tablets Plus IV Infused Bevacizumab in Adult Participants With c-Met Protein Above Cutoff Level Above Refractory Metastatic Colorectal Cancer (clinicaltrials.gov) - P3 | N=460 | Recruiting | Sponsor: AbbVie | Trial completion date: Apr 2029 ➔ Oct 2028 | Trial primary completion date: Apr 2029 ➔ Oct 2028

Adverse events • Monotherapy • Trial completion date • Trial primary completion date • Colorectal Cancer • Oncology • Solid Tumor • TOP1

M21-404: Study to Assess Adverse Events and Change in Disease Activity in Adult Participants With Advanced Solid Tumors Receiving Intravenous (IV) ABBV-400 as Monotherapy and in Combination With IV Bevacizumab (clinicaltrials.gov) - P1 | N=520 | Active, not recruiting | Sponsor: AbbVie | Trial completion date: Nov 2025 ➔ Nov 2027 | Trial primary completion date: Nov 2025 ➔ Nov 2027

Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Lung Cancer • Lung Non-Small Cell Squamous Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

A Study to Assess Adverse Events and Change in Disease Activity in Adult Participants Receiving Intravenously Infused Telisotuzumab Adizutecan Alone or With Standard of Care in Participants With Post Adjuvant Circulating Tumor DNA Positive Colorectal Cancer and No Radiographic Evidence of Disease (clinicaltrials.gov) - P2 | N=140 | Not yet recruiting | Sponsor: AbbVie

Adverse events • Circulating tumor DNA • Monotherapy • New P2 trial • Colorectal Cancer • Oncology • Solid Tumor

Telisotuzumab adizutecan (ABBV-400; Temab-A) monotherapy vs trifluridine/tipiracil plus bevacizumab in patients with refractory metastatic colorectal cancer with increased c-Met protein expression: An open-label, randomized, phase 3 trial. (ASCO 2025) - P1, P3 | "Patient eligibility includes age ≥18 years, confirmed c-Met expression of 3+ in ≥10% of tumor cells, metastatic adenocarcinoma of the colon/rectum, measurable disease per RECIST v1.1, ECOG performance status 0–1, prior treatment with a fluoropyrimidine (eg, 5-FU or capecitabine), oxaliplatin, irinotecan, and an anti-VEGF antibody (unless locally not approved) or an anti-EGFR antibody if indicated, and appropriate targeted therapy or immunotherapy if targetable mutations present (eg, BRAF V600E or HER2) or MSI-H/dMMR. Prior treatment with regorafenib and/or fruquintinib is permitted, but no prior treatment with trifluridine/tipiracil Study-specific c-Met protein expression IHC cutoff is defined as 3+ intensity in ≥10% of tumor cells...Safety evaluations include adverse event monitoring, vital sign measurements, ECG variables, and clinical laboratory testing. Enrollment began in December 2024."

Clinical • IO biomarker • Metastases • Monotherapy • P3 data • Colon Adenocarcinoma • Colon Cancer • Colorectal Adenocarcinoma • Colorectal Cancer • Microsatellite Instability • Oncology • Solid Tumor • BRAF • HER-2 • MET • MSI

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

A Study to Assess Adverse Events, Change in Disease Activity of Intravenous Telisotuzumab Adizutecan in Combination With Osimertinib as First-Line Treatment in Adult Participants With Locally Advanced Unresectable or Metastatic EGFR-Mutated Non-Squamous Non-Small Cell Lung Cancer (clinicaltrials.gov) - P2/3 | N=694 | Not yet recruiting | Sponsor: AbbVie

Adverse events • New P2/3 trial • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

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), a c-Met protein–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced EGFR-mutated (MT) non-squamous (NSQ) non-small cell lung cancer (NSCLC): Results from a phase 1 study. (ASCO 2025) - P1 | "Temab-A has a manageable safety profile with promising clinical activity in pts with 3L+ NSQ EGFR MT NSCLC, meriting further investigation. aConfirmed responses. P, probability."

Clinical • Metastases • P1 data • Anemia • Interstitial Lung Disease • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Solid Tumor • EGFR • MET

An oral presentation on investigational telisotuzumab adizutecan (ABBV-400, Temab-A), a next-generation, c-Met directed antibody-drug conjugate (ADC) with a novel topoisomerase 1 inhibitor (Top1i) payload, will showcase (PRNewswire) - P1 | N=520 | NCT05029882 | Sponsor: AbbVie | "Preliminary safety and efficacy results in 41 patients with pre-treated, advanced epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) from the dose expansion part of a Phase 1 study (NCT05029882). Patients received a median of 3 prior lines of therapies and 93% of patients had prior anti-EGFR treatment. The objective response rate (ORR) was 63%. High ORR was observed regardless of c-Met protein expression levels. At the time of data cut-off, 54% of responders experienced a ≥6 months duration of response (DoR). The most common any-grade TEAEs in ≥30% of patients were anemia (63%), nausea (61%), vomiting (37%), decreased appetite (34%), and neutropenia (34%). Additional data with 4 months follow-up will be presented at ASCO."

P1 data • Lung Non-Squamous Non-Small Cell Cancer