Johnson & Johnson Highlights Multiple Blood Cancer Trial Data At ASCO Presentation

Johnson & Johnson JNJ shared data from several cancer studies at the 2025 American Society of Clinical Oncology (ASCO) annual meeting on Tuesday.

Here’s that the New Brunswick, New Jersey-based company released.

Phase 3 AMPLITUDE Study

Johnson & Johnson released promising Phase 3 results from the AMPLITUDE study evaluating niraparib combined with abiraterone acetate plus prednisone (AAP) in metastatic castration-sensitive prostate cancer (mCSPC) patients with homologous recombination repair (HRR) genetic alterations, including BRCA mutations.

Key findings:

• The study met its primary endpoint of radiographic progression-free survival (rPFS) among 696 patients.
• Patients with BRCA mutations (n=191) saw the strongest benefit:
  • Median rPFS was not reached vs. 26 months for placebo group
  • 48% reduced risk of radiographic progression or death
• All HRR-altered patients also benefited:
  • Median rPFS not reached vs. 29.5 months for placebo
  • 37% reduced risk of progression or death
• Symptomatic progression was significantly reduced:
  • 56% reduction in BRCA patients
  • 50% reduction in HRR patients
• Early overall survival (OS) data shows a positive trend:
  • 25% reduced risk of death in BRCA patients
  • 21% reduction in HRR patients
  • OS data still maturing

In summary, the combination therapy significantly delays disease progression and shows encouraging early signs of extending survival in genetically selected mCSPC patients.

JNJ-79635322 Phase 1 Study

Johnson & Johnson released initial Phase 1 results of JNJ-79635322 for relapsed or refractory multiple myeloma.

The overall response rate (ORR) among the 36 patients who received the recommended phase 2 dose (RP2D) was 86.1%. In the 27 patients who were naive to BCMA and GPRC5D-directed therapies, the ORR was 100% at the RP2D.

Phase 1b/2 CARTITUDE-1 Study

The company also revealed new long-term follow-up data from the Phase 1b/2 CARTITUDE-1 study demonstrating 33% (n=32) of patients in the study (n=97) with relapsed or refractory multiple myeloma (RRMM) treated with CARVYKTI (ciltacabtagene autoleucel; cilta-cel) achieved PFS of five years or more with a single infusion and no maintenance or subsequent anti-myeloma therapy.

A subset of 12 patients who underwent serial evaluations at a single site remained minimal residual disease (MRD) negative and imaging negative throughout five years of post-treatment follow-up.

At a median follow-up of 61.3 months, the median OS was 60.7 months.

With longer follow-up, the safety profile in CARTITUDE-1 was consistent with the known safety profile of CARVYKTI, with no new safety signals observed.

There were two newly reported second primary malignancies (both solid tumors) and no new Parkinsonism events or cranial nerve palsies.

Phase 3 PERSEUS and Phase 3 CEPHEUS Studies

Johnson & Johnson highlighted data from two studies of DARZALEX FASPRO (daratumumab and hyaluronidase-fihj)-based quadruplet regimen demonstrated deep and sustained MRD negativity rates and improved long-term progression-free survival (PFS) in patients with newly diagnosed multiple myeloma, regardless of transplant status.

Phase 3 PERSEUS Study

New analysis from the Phase 3 PERSEUS study shows the addition of DARZALEX FASPRO to bortezomib, lenalidomide and dexamethasone (D-VRd), followed by an investigational maintenance regimen of DARZALEX FASPRO with lenalidomide (D-R), led to improved and deepened rates of overall and sustained MRD negativity, defined as no cancer cells detected within 100,000 bone marrow cells for at least 24 months, compared to VRd induction and consolidation with R maintenance.

More than half of patients who received the DARZALEX FASPRO-based regimen achieved sustained MRD negativity for 24 or more months, and more than two-thirds of patients achieved sustained MRD negativity at 12 months, showing 95.3% PFS at 48 months.

Phase 3 CEPHEUS Study

The post-hoc analysis of the Phase 3 CEPHEUS study focused exclusively on transplant-ineligible patients, showing that DARZALEX FASPROto VRd significantly deepens response and prolongs PFS compared to VRd alone.

Data from the Phase 3 CEPHEUS study show 60% overall MRD negativity and improved PFS with DARZALEX FASPRO in transplant-ineligible newly diagnosed patients.

Price Action: JNJ stock is down 0.62% at $154.40 at the last check on Tuesday.

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