Genmab is advancing two pivotal clinical trials testing its experimental bispecific antibody acasunlimab in combination therapies for advanced lung cancer and melanoma, representing potential breakthrough treatments for patients with limited therapeutic options.
Phase 3 Lung Cancer Trial Shows Promise
The Danish biotechnology company launched a Phase 3 trial titled "ABBIL1TY NSCLC-06" on November 25, 2024, evaluating acasunlimab combined with pembrolizumab versus standard chemotherapy docetaxel in patients with PD-L1 positive metastatic non-small cell lung cancer (NSCLC). The study targets patients who have progressed after treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy, representing a challenging patient population with significant unmet medical needs.
The trial employs a randomized, open-label, parallel assignment design where participants receive either the experimental combination of acasunlimab and pembrolizumab administered every six weeks, or docetaxel given every three weeks. The study's primary goal focuses on treatment efficacy, with both researchers and participants aware of which treatment is being administered.
Melanoma Study Targets Relapsed Patients
Concurrently, Genmab is conducting a Phase 2 study called "ABBIL1TY MELANOMA-07" examining acasunlimab as both monotherapy and in combination with pembrolizumab for patients with relapsed/refractory, unresectable locally advanced or metastatic cutaneous melanoma. The study specifically enrolls patients whose disease progressed on or after treatment with a checkpoint inhibitor.
This randomized, open-label Phase 2 trial began recruiting in July 2025, following a parallel intervention model where participants receive biological treatments administered via intravenous infusion. The study aims to evaluate both the effectiveness and safety of acasunlimab targeting specific proteins involved in tumor growth.
Market Implications and Investment Considerations
The outcomes of both trials could significantly impact Genmab's market position and stock performance. Successful results from either study might establish new, more effective treatment options for challenging cancer types, potentially enhancing the company's competitive standing in the oncology market.
The lung cancer trial is particularly significant given the large patient population affected by NSCLC and the limited options available for patients who have progressed after standard treatments. Similarly, the melanoma study addresses an important unmet need for patients with advanced disease who have exhausted checkpoint inhibitor therapies.
Both studies remain ongoing, with primary completion and estimated overall completion dates yet to be announced for the lung cancer trial. The melanoma study's progression through recruitment represents a critical milestone in advancing acasunlimab's clinical development program across multiple cancer indications.
