Genmab and BioNTech announced the initial data from the phase II GCT1046-04 trial, which evaluated the efficacy of acasunlimab (DuoBody-PD-L1x4-1BB), an investigational bispecific antibody also known as GEN1046/BNT311.
Acasunlimab is an investigational bispecific antibody, which aims to elicit an antitumor response through conditional activation of 4-1BB on T cells and natural killer (NK) cells, which is stringently based on simultaneous binding of the PD-L1 arm.
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The GCT1046-04 clinical trial is an open-label study evaluating the safety and efficacy of acasunlimab in patients with relapsed/refractory mNSCLC.
The randomised trial assessed the acasunlimab both as a monotherapy and in combination with pembrolizumab, in patients with PD-L1-positive metastatic non-small cell lung cancer (mNSCLC) who had progressed after one or more previous anti-PD(L)1 containing treatments.
The trial showed an overall survival rate of 69% over 12 months, a median overall survival of 17.5 months, and an overall response rate of 30% in patients treated with the combination therapy every six weeks.
It involved 113 patients across three arms, with the objective response analysis conducted for 62 centrally confirmed PD-L1-positive efficacy-evaluable patients.
In the Phase II study, Arm A, which involved acasunlimab monotherapy, showed a median overall survival of 5.5 months, a 50% disease control rate, and a 31% overall response rate.
Arm B, which combined acasunlimab with pembrolizumab every three weeks, resulted in an 8.6-month median overall survival, a 59% disease control rate, and a 21% overall response rate.
With the combination administered every six weeks, Arm C demonstrated the most significant outcomes, including the 17.5-month median overall survival, a 75% disease control rate, and a 30% overall response rate.
The anti-tumor activity was observed across various patient subgroups and the adverse events reported were consistent with the known safety profiles of the individual drugs.
Genmab executive vice-president and chief development officer Judith Klimovsky said: “The initial results of acasunlimab in combination with pembrolizumab administered every six weeks suggest a potential meaningful impact on patients with metastatic non-small cell lung cancer.
“We will continue to evaluate these data to inform further development of acasunlimab including a planned Phase III trial as we remain committed to investigating acasunlimab as a potential treatment option.”
Last year, Genmab and Seagen reported additional positive results from the Phase III clinical trial of Tivdak for the treatment of recurrent or metastatic cervical cancer.
