A new multiple myeloma race heats up

Qilu’s upcoming phase 3 trial of its GPRC5D T-cell engager QLS32015, recently unveiled on clinicaltrials.gov, only serves to highlight the fact that Chinese biotechs continue to fight in a field from which western rivals appear to have walked away. The study, to be conducted exclusively in China, will assess QLS32015 in multiple myeloma patients who have undergone at least three prior lines of therapy, and is the only phase 3 not involving Johnson & Johnson’s Talvey.Talvey has FDA accelerated approval for fifth-line multiple myeloma, and is also in various pivotal trials with, for example, the MonumenTAL-6 second-line trial expected to complete next year. Following Roche’s discontinuation of forimtamig last year, Chia Tai and Leads Biolabs are the only firms with GPRC5D T-cell engager programmes in early clinical trials, according to OncologyPipeline.Qilu’s phase 3 will test QLS32015 monotherapy against investigator’s choice of Pomalyst plus dexamethasone (Pd), or Xpovio plus dexamethasone (Sd), in patients who have previously progressed on an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 MAb. TrispecificsMeanwhile, the attention in the west has shifted to BCMA x GPRC5D-targeting T-cell engagers. The multiple myeloma leader, J&J, is also active in this space with JNJ-79635322, which produced promising early data at ASCO this year. But J&J could face competition: AbbVie signed a deal with Simcere last January covering SIM0500; Mabworks released early data at ASH last year from a phase 1/2 trial of its contender MBS314; and Innovent’s phase 1/2 trial of IBI3003 is due to be completed next year.Qilu has also mimicked J&J and started a clinical trial evaluating its own anti-BCMA x GPRC5D T-cell engager programme, QLS4131. Beyond T-cell engagers, Bristol Myers Squibb has a GPRC5D targeted Car-T, arlocabtagene autoleucel, in phase 3 development. Its Quintessential trial, in patients with relapsed/refractory multiple myeloma who have received at least three prior lines of therapy, is expected to report results in 2026. The company is also developing a BCMA x GPRC5D Car-T therapy, BMS-986453.  GPRC5D T-cell engagers ProjectCompanyStatusMonospecifics against GPRC5DTalveyJ&JFDA accelerated approval 2023 for 5th-line MM; Monumental-3 and -6 phase 3 trials (due 2026)QLS32015QiluChina-only phase 3 trial (to start Oct 2025)LBL-034Nanjing Leads BiolabsPhase 2 trial in r/r multiple myelomaTQB2029Chia Tai TianqingPhase 1 in multiple myelomaBispecifics against BCMA x GPRC5DJNJ-79635322J&JPhase 1 in r/r multiple myeloma and AL amyloidosisSIM0500AbbVie/ SimcerePhase 1 in r/r multiple myelomaMBS314MabworksPhase 1/2 in r/r multiple myelomaIBI3003InnoventPhase 1/2 in r/r multiple myelomaQLS4131QiluPhase 1 in r/r multiple myelomaSource: OncologyPipeline.