Merck Launches 15th Global Phase III Trial of Lurbinectedin in Combination with Pembrolizumab for First-Line Maintenance Treatment of Cervical Cancer

Oct 15, 2025 15:18 CST Updated 15:18

MSD

Pharmaceutical R&D and Manufacturer

On October 14 local time, MSD registered aPhase III Clinical Study of Luskansatuzumab in Combination with Pembrolizumab for First-Line Maintenance Therapy in Cervical Cancer（MK-2870-036）. This isReedKesintuzumab InitiatedItem 15International Phase III Clinical Trial.

Source:ClinicalTrials Official Website

MK-2870-036 Is a randomized, open-label, multi-center Phase III clinical study designed to evaluateLukansatuzumab in combination with Pembrolizumab(With or without bevacizumab)AsFirst-line maintenance treatment for patients with persistent, recurrent, or newly diagnosed metastatic cervical cancer with PD-L1 CPS greater than or equal to 1Efficacy and safety.

The study consists of two parts and is planned to include1023 subjectsPart 1,Eligible subjects will be assigned to receiveLukansatuzumab + Pembrolizumab+ BevacizumabTreatment. Part 2,All subjects received standard induction therapy. Eligible subjects without disease progression will begin maintenance therapy and be randomized to receivePembrolizumabOrLukansatuzumab+ PembrolizumabTreatment. All participants in the second part of the maintenance treatment may also receive bevacizumab treatment based on the investigator's judgment.

Part 1 The primary endpoint isOnce or multiple timesAdverse Event (AE) Number of subjects,Number of subjects who discontinued study treatment due to adverse events.The primary endpoint of Part 2 isBICR According toRECIST 1.1AssessmentProgression-Free Survival（PFS）、Overall Survival（OS）。

The study is expected to begin on November 18, 2025, and be completed on October 29, 2031.

Lukansatuzumab is a product developed by Kelun Biotech.TargetedTROP2 ADC Drug, composed of the humanized monoclonal antibody Sacituzumab, an enzymatically cleavable Linker, and the novel topoisomerase I inhibitor T030 conjugate, with a drug-to-antibody ratio（DAR）An average of up to 7.4.

In May 2022, Kelun-Biotech signed a cooperation agreement with MSD, granting the latter exclusive rights to develop, use, manufacture, and commercialize Lukansatuzumab outside of Greater China, with a total transaction amount nearing$1.4 billion。

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