DNV3 / Zhejiang Shimai - LARVOL DELTA

Efficacy and safety of DNV3 combined with toripalimab andchemotherapy in advanced melanoma: an open-labelinvestigator-initiated clinical trial (SITC 2025) - "Background Despite the transformative role of immune checkpoint inhibitors in advanced melanoma, anti-PD-(L)1-refractory patients face limited treatment options.Methods This investigator-initiated trial assessed a novel quadruplet regimen combining DNV3 (anti-LAG-3), toripalimab (anti-PD-1), and chemotherapy (nab-paclitaxel/cisplatin) in 27 Asian patients with unresectable/metastatic melanoma (77.8%[21/27] anti-PD-[L]1-pretreated and 22.2%[6/27] treatment-naïve mucosal melanoma; subtypes: 13 mucosal, 6 acral, 5 cutaneous, 3 unknown primary melanoma).Results The regimen achieved a 44.4% overall response rate (ORR), with robust activity in anti-PD-(L)1-resistant subgroups (42.9% ORR, 7.36-month median PFS). Immune-related toxicities (grade 3-4, 22.2%) were manageable without fatal events.Conclusions These results demonstrate that LAG-3/PD-1 dual blockade with chemotherapy exhibits encouraging efficacy in refractory melanoma, particularly for anti-PD-(L)1-resistant and..."

Clinical • Metastases • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

DNV3 plus toripalimab and chemotherapy in advanced melanoma: An update on an open-label investigator-initiated trial (ESMO 2025) - "Methods Eligible patients (ECOG PS 0-1) received nab-paclitaxel (initial dose 260 mg/m 2 , reduced to 200 mg/m 2 ), cisplatin (25 mg/m 2 ), DNV3 (3 mg/kg), and toripalimab (240 mg) every 3 weeks for 6 cycles, followed by maintenance immunotherapy. Conclusions This study demonstrates preliminary tolerability and efficacy of DNV3 combined with toripalimab and chemotherapy in advanced melanoma, particularly in mucosal melanoma and liver metastases. Legal entity responsible for the study The authors."

Clinical • Metastases • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor

Safety and efficacy analysis of DNV3 plus toripalimab and chemotherapy in advanced melanoma: An open-label investigator-initiated trial. (ASCO 2025) - P=N/A | "The dosages for chemotherapy (albumin-bound paclitaxel at 260 mg/m² on Day 1 and cisplatin at 25 mg/m² on Days 1 to 3 for the first 6 cycles) and DNV3 (administered at 3 mg/kg) were based on body surface area and weight, while Toripalimab was given at a fixed dose of 240 mg. The study provided preliminary evidence of the tolerability and potential efficacy of the combination of DNV3 plus Toripalimab with chemotherapy in patients with advanced melanoma, particularly in those with mucosal melanoma and liver metastases."

Clinical • IO biomarker • Metastases • Cutaneous Melanoma • Infectious Disease • Melanoma • Mucosal Melanoma • Oncology • Solid Tumor • LAG3

An Open-label, Multicenter, Dose-Escalation and Expansion Phase I/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetic Characteristics and Preliminary Efficacy of DNV3 in Combination with toripalimab in Patients with Relapsed/Metastatic Cutaneous Rare Neoplasm (ChiCTR) - P1/2 | N=105 | Completed | Sponsor: Zhejiang Cancer Hospital; Zhejiang Cancer Hospital

New P1/2 trial • Oncology • Skin Cancer • CTLA4 • PD-1 • PD-L1

An open-label, multicenter Phase 2 single-arm, study to assessing the efficacy and safety of DNV3 in combination with toripalimab and chemotherapy in patients with locally advanced unresectable or metastatic melanoma following failure of prior treatment with immune checkpoint inhibitors (ChiCTR) - P2 | N=60 | Not yet recruiting | Sponsor: Fujian Cancer Hospital; Fujian Cancer Hospital

Checkpoint inhibition • Combination therapy • Metastases • New P2 trial • Melanoma • Oncology • Solid Tumor • BRAF