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Bristol joins the BCMA first-line multiple myeloma race

The phase 3 Karmma-9 trial has now been posted on clinicaltrials.gov, and is set to start patient recruitment imminently. The study will evaluate Bristol Myers Squibb/2seventy bio's BCMA-specific Car-T therapy Abecma plus maintenance Revlimid versus maintenance Revlimid alone in newly diagnosed multiple myeloma with suboptimal response after autologous stem cell transplant, in approximately 618 patients. The primary endpoint is PFS. Bristol stated earlier this month that data readout was expected as early as 2027. Johnson & Johnson/Legend's Carvykti leads the BCMA race in first-line multiple myeloma, with the Cartitude-5 trial expected to complete enrolment by the year end. Cartitude-6 in transplant-eligible patients is to start recruitment next month. Pfizer and J&J are also conducting two phase 3 trials each for their respective BCMA T-cell engagers, elranatamab and teclistamab. Meanwshile, GSK's antibody-drug conjugate Blenrep failed in phase 3 in the third-line plus setting, so initiation of the planned first-line Dreamm-10 trial is up in the air. Topline data in the second-line setting are expected by the year end. 

 

BCMA Phase 3 development program in first-line multiple myeloma

ProjectCompanyTrialRegimenSettingComparatorPrimary endpointNº of patientsExpected readout
Abecma (Car-T)BMS/ 2seventy bioKarmma-9Revlimid maintenanceSuboptimal response to ASCTRevlimid maintenancePFS618March 2031 (ct.gov), 2027 as indicated by BMS
Carvykti (Car-T)J&J (partnership with Legend Biotech)Cartitude-5VRd inductionNot considered for ASCTVRd + RdPFS650June 2026, enrollment completion expected by YE2023
Carvykti (Car-T)Janssen (partnership with Legend Biotech)Cartitude-6DVRd induction + Revlimid maintenanceASCT-eligibleDVRd induction + ASCT + DVRd consolidation & Revlimid maintenancePFS + sustained MRD-ve CR750June 2033
Elrexfio (bispecific)PfizerMagnetismm-7MonotherapyAfter ASCT (MRD+ve or -ve)Revlimid maintenancePFS760August 2027
Elrexfio (bispecific)PfizerMagnetismm-6Darzalex + RevlimidTransplant-ineligibleDRdPFS + sustained MRD-ve CR966March 2028
Tecvayli (bispecific)J&JMajestec-4Revlimid maintenanceAfter ASCTRevlimid maintenancePFS1,572April 2028
Tecvayli (bispecific)J&JMajestec-7Darzalex + RevlimidTransplant-ineligibleDRdPFS + sustained MRD-ve CR1,590May 2029

Source: OncologyPipeline.