ABBV-706 / AbbVie - LARVOL DELTA

Seizure-related homolog 6 (SEZ6) expression and ctDNA methylation profiles in patients with high-grade neuroendocrine carcinomas (NECs)/neuroendocrine tumors (NETs) from a phase 1 study of ABBV-706 in advanced solid tumors. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05599984 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Circulating tumor DNA • Clinical • Metastases • P1 data • CNS Disorders • Endocrine Cancer • Epilepsy • Neuroendocrine Tumor • Oncology • Solid Tumor • SEZ6

Safety and efficacy of ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate, in high-grade neuroendocrine neoplasms. (ASCO 2025) - P1 | "Clinical Trial Registration Number: NCT05599984 The abstract will be released to the public on May 22, 2025 at 5:00 PM EDT"

Clinical • CNS Disorders • Endocrine Cancer • Epilepsy • Neuroendocrine Tumor • Oncology • Solid Tumor • SEZ6

M23-385: Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=350 | Recruiting | Sponsor: AbbVie | Trial completion date: May 2027 ➔ Nov 2027 | Trial primary completion date: Oct 2025 ➔ Nov 2027

Adverse events • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • EGFR • SEZ6

First-in-human study of ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors (AIOM 2024) - P1 | " Ph1, open-label, DE and dose-expansion study(NCT05599984) of ABBV-706(IV, 1.3–3.5mg/kg doses, Q3W, 21d cycles) as monotherapy or in combination with budigalimab(anti-PD1 inhibitor), carboplatin or cisplatin. ABBV-706 demonstrated manageable safety profile with promising efficacy in SCLC and NENs. Further evaluation of ABBV-706 is ongoing."

Clinical • IO biomarker • Metastases • P1 data • Anemia • Brain Cancer • CNS Disorders • CNS Tumor • Endocrine Cancer • Epilepsy • Fatigue • Glioma • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Lung Cancer • Malignant Glioma • Neuroendocrine Tumor • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • SEZ6

Prevalence and Prognostic Impact of SEZ6 Expression in a Real-World Cohort of Patients with Small-Cell Lung Cancer (IASLC-WCLC 2024) - P1 | "Standard-of-care (SOC) treatment consisted of first-line platinum-based chemotherapy with or without immune checkpoint inhibitors and second-line topotecan/irinotecan or lurbinectedin. Although the sample size was small and the study was limited to a single site, these data support SEZ6 as a potential ADC-targetable biomarker in SCLC. This real-world SCLC cohort could also be used as a borrowed control for the phase 1 single-arm study being conducted in patients with SCLC treated with ABBV-706 to help identify novel predictive biomarkers and interpret the outcomes from the study."

Clinical • IO biomarker • Real-world • Real-world evidence • CNS Disorders • Epilepsy • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • ASCL1 • NEUROD1 • SEZ6

First-in-human study of ABBV-706, a seizure-related homolog protein 6 (SEZ6)–targeting antibody-drug conjugate (ADC), in patients (pts) with advanced solid tumors. (ASCO 2024) - P1 | " Phase 1, open-label, multicenter, DE and dose-expansion study (NCT05599984) of ABBV-706 as monotherapy or in combination with budigalimab (a programmed cell death 1 inhibitor), carboplatin, or cisplatin. ABBV-706 demonstrated a manageable safety profile with promising efficacy in SCLC and NENs. Further evaluation of ABBV-706 is ongoing."

Clinical • Metastases • P1 data • Anemia • Brain Cancer • CNS Disorders • CNS Tumor • Endocrine Cancer • Epilepsy • Fatigue • Gastrointestinal Disorder • Glioma • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Lung Cancer • Neuroendocrine Tumor • Neutropenia • Oncology • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Thrombocytopenia • SEZ6

AbbVie Showcases Robust Solid Tumor Pipeline at ASCO 2024 with New Data from Its Innovative Antibody-Drug Conjugate (ADC) Platform (PRNewswire) - P1 | N=350 | NCT05599984 | Sponsor: AbbVie | "...Early data from the monotherapy dose escalation part of a first-in-human study of ABBV-706, a potential best-in-class SEZ6 directed ADC, will be presented at an oral presentation. The data demonstrate that among a total of 48 efficacy-evaluable patients (23 SCLC and 25 NEN), the overall confirmed objective response rate was 43.8%. Within the SCLC group, the confirmed objective response rate was 60.9%. Among all the 53 enrolled patients at the time of data cut-off, the most common ≥3 TEAEs were neutropenia (42%), anemia (42%), and leukopenia (28%). The ongoing study (NCT05599984) is evaluating ABBV-706 as monotherapy or in combination...in patients with advanced solid tumors, including SCLC and other NENs. Additional data will be presented at the meeting."

P1 data • Neuroendocrine Tumor • Small Cell Lung Cancer

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=350 | Recruiting | Sponsor: AbbVie | Trial completion date: Oct 2025 ➔ May 2027

Adverse events • Combination therapy • Metastases • Monotherapy • Trial completion date • Brain Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • EGFR • SEZ6

ABBV-706 is a novel SEZ6-targeted topoisomerase 1 inhibitor ADC for SCLC and other neuroendocrine cancers (AACR 2024) - P1 | "Furthermore, Top1i inhibition is an effective mechanism of action in SCLC with topotecan approved in 2L, although significant toxicity limits broad utility. As such, we hypothesized that a SEZ6-Top1i ADC would enable effective Top1 inhibition in tumor cells and reduce toxicity relative to ABBV-011 or systemic chemotherapy, driving increased therapeutic benefit...In addition, ABBV-706 had activity in the setting of resistance to cisplatin/etoposide (1L SoC in SCLC), in combination with cisplatin, and in SEZ6-expressing neuroendocrine liver and cervical PDX models...ABBV-706 shows promise as an agent for the treatment of SCLC and other difficult to treat SEZ6 expressing neuroendocrine tumors. ABBV-706 has completed dose escalation, and dose expansion is currently ongoing in a Phase 1 FIH clinical study (NCT05599984)."

Endocrine Cancer • Lung Cancer • Neuroendocrine Tumor • Non Small Cell Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SEZ6 • TOP1

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=350 | Recruiting | Sponsor: AbbVie | Trial completion date: Dec 2026 ➔ Oct 2025 | Trial primary completion date: Dec 2026 ➔ Oct 2025

Adverse events • Combination therapy • Metastases • Monotherapy • Trial completion date • Trial primary completion date • Brain Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • EGFR • SEZ6

Phase 1 Study of ABBV-706, Anti-Sez6 Antibody-Drug Conjugate, in Adults With Advanced Solid Tumors (JSMO 2024) - No abstract available

Clinical • Metastases • P1 data • Oncology • Solid Tumor • SEZ6

Phase I study of ABBV-706, an anti-SEZ6 antibody-drug conjugate, alone or in combination in adults with advanced solid tumors (ESMO 2023) - P1 | "The study will evaluate the preliminary safety, tolerability, pharmacokinetics (PK), and antitumor activity of ABBV-706 as monotherapy and in combination with budigalimab (a PD-1 inhibitor), carboplatin, or cisplatin, and determine the recommended phase 2 dose (RP2D) of ABBV-706. Tumor tissue submission for retrospective SEZ6 expression analysis is required. The study began in December 2022 and enrollment is ongoing."

Clinical • IO biomarker • Metastases • P1 data • Brain Cancer • CNS Tumor • Endocrine Cancer • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • SEZ6

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=350 | Recruiting | Sponsor: AbbVie | Not yet recruiting ➔ Recruiting

Adverse events • Combination therapy • Enrollment open • Monotherapy • Brain Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • EGFR

Study to Evaluate Adverse Events, Change in Disease Activity, and How ABBV-706 Moves Through the Body When Intravenously (IV) Infused Alone or in Combination With IV Infused Budigalimab, Cisplatin, or Carboplatin in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1 | N=350 | Not yet recruiting | Sponsor: AbbVie

Adverse events • Combination therapy • Monotherapy • New P1 trial • Brain Cancer • Glioblastoma • Lung Cancer • Non Small Cell Lung Cancer • Oligodendroglioma • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • EGFR