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Ref Type Abstract
PMID
Authors Kartik Sehgal, Jesus Corral Jaime, Steven Francis Powell, Cesar Augusto Perez, Elisa Fontana, Ed Kingsley, Federico Longo Munoz, … SHOW ALL … , and Solange Peters
Title Sigvotatug vedotin (SV), an investigational integrin beta-6 (IB6)–directed antibody‒drug conjugate (ADC), and pembrolizumab combination therapy: Initial results from an ongoing phase 1 study (SGNB6A-001).
Journal Vol Issue Date Pages Journal Short Title
Journal of Clinical Oncology 43 no. 16_suppl May 28, 2025 3010 J Clin Oncol
URL https://ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.3010
Abstract Text Background: IB6, a tumor-associated membrane protein, is overexpressed in many solid tumors, including non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC). SV, an IB6-directed ADC, demonstrated encouraging antitumor activity and manageable safety as a monotherapy in patients (pts) with advanced NSCLC in SGNB6A-001, an ongoing phase 1 study (Peters, ASCO 2024). Due to immunogenic cell death induction and innate immune system activation, SV activity may be enhanced when combined with pembrolizumab (P; SV+P). We report initial results of SV+P in pts with advanced solid tumors. Methods: SGNB6A-001 (NCT04389632) is an open-label, multicenter, dose-escalation and dose-expansion phase 1 study evaluating the safety, pharmacokinetics (PK), and antitumor activity of SV. Part C is evaluating safety of SV+P in pts with advanced solid tumors; part D is currently enrolling to evaluate SV+P in treatment-naive pts with locally advanced, unresectable, or metastatic NSCLC and HNSCC. Pts receive SV 1.8 mg/kg by adjusted ideal body weight IV Q2W and P 400 mg IV Q6W. Primary endpoint is safety; secondary endpoints include efficacy and PK. Results reported here are from parts C and D. Results: As of Nov 26, 2024, 31 pts received ≥1 dose of SV+P in parts C and D (19 NSCLC, 11 HNSCC, and 1 esophageal); median (95% CI) follow-up was 2.9 (1.6-5.0) months, and 26 pts remain on treatment. Median (range) age was 65 (34-80) years, 61% were male, and 52% had ECOG PS 0. Of pts with NSCLC, 12 (63%) had non-squamous tumors and 11 (58%) had tumors with PD-L1 TPS ≥1. All pts with HNSCC had tumors with PD-L1 CPS ≥1. Any-grade (Gr) and Gr ≥3 treatment-emergent adverse events (TEAEs) occurred in 87% and 35% of pts, respectively. Most common TEAEs are shown in the Table. Any-Gr and Gr ≥3 immune-mediated TEAEs occurred in 61% and 10% of pts, respectively. Pneumonitis/interstitial lung disease occurred in 3 pts (9.7%), with no Gr ≥3 events. Renal TEAEs led to discontinuation of both SV and P in 2 pts (6%); 3 other pts discontinued treatment (1 progressive disease, 2 consent withdrawal). There were no treatment-related deaths. In 7 efficacy-evaluable pts with TPS≥1 NSCLC, 1 confirmed (c) complete response (CR), 1 c partial response (PR), and 2 PRs pending confirmation were observed (ORR 57%; cORR 29%). In 8 efficacy-evaluable pts with 1L HNSCC, 2 cCR and 1 cPR were observed (cORR 37.5%). Conclusions: SV+P demonstrated manageable safety and encouraging preliminary efficacy. These data support the ongoing phase 3 Be6A-Lung-02 study (NCT06758401) comparing SV+P vs P as first-line treatment for pts with PD-L1 high (TPS≥50) advanced NSCLC. Clinical trial information: NCT04389632.

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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
CD274 positive head and neck squamous cell carcinoma predicted - sensitive Pembrolizumab + SGN-B6A Phase I Actionable In a Phase I trial (SGNB6A-001), SGN-B6A and Keytruda (pembrolizumab) combination treatment demonstrated safety and activity in patients with CD274 (PD-L1)-positive (CPS >=1) head and neck squamous cell carcinoma, resulting in a confirmed overall response rate of 37.5% (3/8) with 2 confirmed complete response and 1 confirmed partial response (J Clin Oncol 2025 43: 16_suppl, 3122; NCT04389632). detail...
CD274 positive lung non-small cell carcinoma predicted - sensitive Pembrolizumab + SGN-B6A Phase I Actionable In a Phase I trial (SGNB6A-001), SGN-B6A and Keytruda (pembrolizumab) combination treatment demonstrated safety and activity in patients with CD274 (PD-L1)-positive (CPS >=1) non-small cell lung cancer, resulting in an overall response rate of 57% (4/7) with 1 confirmed complete response, 1 confirmed partial response, and 2 partial responses pending confirmation (J Clin Oncol 2025 43: 16_suppl, 3122; NCT04389632). detail...