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
Project | Company | Trial | Regimen | Setting | Comparator | Primary endpoint | Nº of patients | Expected readout |
---|---|---|---|---|---|---|---|---|
Abecma (Car-T) | BMS/ 2seventy bio | Karmma-9 | Revlimid maintenance | Suboptimal response to ASCT | Revlimid maintenance | PFS | 618 | March 2031 (ct.gov), 2027 as indicated by BMS |
Carvykti (Car-T) | J&J (partnership with Legend Biotech) | Cartitude-5 | VRd induction | Not considered for ASCT | VRd + Rd | PFS | 650 | June 2026, enrollment completion expected by YE2023 |
Carvykti (Car-T) | Janssen (partnership with Legend Biotech) | Cartitude-6 | DVRd induction + Revlimid maintenance | ASCT-eligible | DVRd induction + ASCT + DVRd consolidation & Revlimid maintenance | PFS + sustained MRD-ve CR | 750 | June 2033 |
Elrexfio (bispecific) | Pfizer | Magnetismm-7 | Monotherapy | After ASCT (MRD+ve or -ve) | Revlimid maintenance | PFS | 760 | August 2027 |
Elrexfio (bispecific) | Pfizer | Magnetismm-6 | Darzalex + Revlimid | Transplant-ineligible | DRd | PFS + sustained MRD-ve CR | 966 | March 2028 |
Tecvayli (bispecific) | J&J | Majestec-4 | Revlimid maintenance | After ASCT | Revlimid maintenance | PFS | 1,572 | April 2028 |
Tecvayli (bispecific) | J&J | Majestec-7 | Darzalex + Revlimid | Transplant-ineligible | DRd | PFS + sustained MRD-ve CR | 1,590 | May 2029 |
Source: OncologyPipeline.
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