Last year inESMOAt the meeting, Regeneron presented targetedMUC16/CD3Dual AntibodyubamatamabPhase I Clinical Data of Monotherapy for Recurrent Ovarian Cancer in China. 42 Name Acceptance ≥1 Subtotal dose ≥20 mg ubamatamabAmong the treated patients, overall achieved14%（6/42) Overall Response Rate (ORR). In patients without visceral metastases (exploratory subgroup),ORRIncrease to21%（6/29), inMUC16In patients with high-expression tumors,ORR Increase to31%（4/13）。
In this year'sESMOAt the meeting, Regeneron will presentMUC16/CD3Double AntibodyubamatamabUnitedPD-1AntibodyCemiplimabPhase I clinical data.The clinical design is3+3Clinical dose-escalation study,MUC16/CD3Dual-antibody therapy has been adopted and launched.CD3The Same Strategy for Bispecific Antibodies — Low-Dose Priming Before Full-Dose Administration to EliminateCRSSide effects, full-dose administration is1-450mg 。PD-1The amount of antibody used is350mg，Q3W, administered intravenously, and inMUC16/CD3Day of Dual Antibody Administration29-36The sky began to administer the drug. The dose escalation group was enrolled.35Patient, with29Patients received more than1Dose ofPD-1Antibody Therapy (Cemiplimab), these patients had received an average of5Line Therapy (1-10）。Patients received an average of11Week'sMUC16/CD3Dual-antibody therapy and12Week'sPD-1After treatment, the most commonTEAEIs pain (82.9%) andCRS（68.6%,All are1-2Level),3Side effects of grade and above are mainly anemia, pain, and neutropenia.In terms of efficacy,MUC16/CD3Dual Antibody Administration10-250mgIn dose-escalation patients,ORRFor18.2%（95%
CI:5.2-40.3), medianDoRFor8.3Months (4.2enot estimable). According to the currently disclosed data, the bispecific antibody combinationPD-1Monoclonal antibodies did notThere is a significant improvement in efficacy, and further analysis can be conducted after detailed data is disclosed.In view ofMUC16/CD3While seeing some efficacy along with safety, Regeneron has already initiated2Phase Clinical Study.2The phase clinical design is as follows: the monotherapy group has two dose groups, 250mg and 800mg, with a dosing frequency of Q3W. The combination therapy group uses a bispecific antibody.250mg IV Q3W+PD-1。
In the development of bispecific antibody drugs, although Regeneron is not as dominant as Roche and Johnson & Johnson, it is following its own unique path based on solid theoretical exploration. Compared with Roche and Johnson & Johnson's deep cultivation in hematological tumors, Regeneron focuses more on...Solid tumors: Regeneron is currently exploring various bispecific antibody therapies for the treatment of solid tumors.As the leader in CD28 bispecific antibodies, Regeneron is also exploring different treatment modalities, including combinations with PD-1 and CD3 bispecific antibodies. They have conducted in-depth research on the mechanisms of action of these combinations. Preliminary clinical results have already demonstrated the effectiveness of these mechanisms. In the foreseeable future, Regeneron is expected to advance more combination therapies into clinical trials, which may bring revolutionary changes to the treatment of solid tumors.
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