Johnson & Johnson
Medical Device R&D and Manufacturer
Following the announcement of bispecific antibodies last monthTecvayliAndCD38Monoclonal AntibodyDarzalexJohnson & Johnson Reports Another Success with Strong Positive Data from Combination Therapy for Multiple Myeloma——Its3Phase Clinical TrialMajesTEC-9The results showed,TecvayliMonotherapy Shows Excellence in Specific Refractory Multiple Myeloma Patients, Significantly Reducing Risk of Disease Progression or Death Compared to Standard Treatment, Offering New Therapeutic Options for These Patients.
Single-agent efficacy stuns, targets multi-drug resistant population
MajesTEC-9The trial focused on those who have received1-3Patients with multiple myeloma undergoing line therapy, who generally face a treatment bottleneck: all participants had previously received anti-CD38Monoclonal antibodies and lenalidomide (Revlimid) Treatment, among which85%CorrectCD38Refractory to inhibitors,79%Resistant to lenalidomide,90%The group whose first-line treatment has recently been ineffective falls under the category of high unmet clinical needs.
In the trial,TecvayliMonotherapy vs. Standard Treatment Regimen (including Pomalidomide+Bortezomib+DexamethasonePVdPlan, or Carfilzomib+DexamethasoneKdPlan) Head-to-head comparison launched. The results showed that this bispecificBCMATargetedCD3 TCell Adaptors Exhibit Overwhelming Advantages:
Reduced compared to standard treatment71%The risk of disease progression or death;
Reduce simultaneously40%The risk of death;
This result is based on the confirmation of a pre-specified interim analysis. The full data will be announced at subsequent major medical conferences and simultaneously submitted to global health regulatory authorities.
Professor at the Winship Cancer Institute of Emory UniversityRoberto MinaThe doctor said:“MajesTEC-9The results further confirmed thatTecvayliThe transformative potential of this immunotherapy regimen in the early stages of multiple myeloma treatment will benefit all eligible patients, including refractory cases commonly seen in community healthcare institutions.”
Combined Therapy Has Already Shown Its Power, Dual-Line Data Establishes Core Position
The success of this monotherapy trial is an important extension based on the impressive data from earlier combination therapy. Previously announced3PeriodMajesTEC-3In the trial,TecvayliAndDarzalexCombination therapy shows equally impressive results in second-line multiple myeloma patients:
MoreDarzalexCombined with Dexamethasone+Pomalidomide/Standard combination regimen of bortezomib, reduce54%The risk of death;
The trial did not reach the median overall survival period of the two groups (OS), but the experimental group3YearOSAs high as83%, significantly better than the control group's65%；
The risk of disease progression or death was significantly reduced.83%。
Roberto MinaDr. emphasized,MajesTEC-3AndMajesTEC-9The positive results jointly laid the foundation forTecvayliThe core position——Make it become“Key therapeutic drugs that can be selected after the patient's first recurrence”。
Layout of Multi-Dimensional Joint Solutions Targets a Larger Treatment Market
As a milestone drug,TecvayliIn2022Year obtained in the United StatesFDAApproved for fourth-line treatment of multiple myeloma, becoming the world's first marketedBCMATargeted BispecificTCell Engager; In the same year, the European Medicines Agency approved it for third-line treatment, offering a new therapeutic direction for advanced patients.
At present, Johnson & Johnson is actively expandingTecvayliTreatment scenarios, exploring more combination therapy options, including those with the company2023Another bispecific antibody approved in the yearTalveyCombined use, in order to cover a wider patient population.
It is worth noting that,TecvayliKnown potential side effects exist, including cytokine release syndrome and neurotoxicity, with a black box warning on its drug label, and it can only be obtained through“Risk Assessment and Mitigation Strategies (REMS）”Monitoring Plan Acquisition to Ensure Medication Safety.
Multiple myeloma is characterized by a high recurrence rate. Despite significant advancements in treatment options in recent years,CD38Patients who are refractory to inhibitors and lenalidomide still lack effective therapies with good tolerance, which also presents aTecvayliProvided a broad market space.
As part of Johnson & Johnson's oncology pipeline“Cash Cow”，DarzalexHas shown steady performance since its listing ten years ago,2024Annual sales reached117Billion US dollars,2025Sales in the first three quarters of the year have reached104billion dollars, with the whole year expected to achieve another outstanding performance.
AndTecvayliThe market performance was equally impressive,2024Annual sales volume is5.49Billion US dollars,2025The first three quarters of the year have quickly climbed to4.94billion dollars, and with the expansion of indications and the accumulation of clinical data, it is expected to become the next core growth engine for Johnson & Johnson's oncology sector.
Source:fierce biotech
