Oncology news archive

73 percent reduction in risk of disease progression or death seen with CARVYKTI® in the CARTITUDE-4 study in a subset of patients who had early relapse after initial multiple myeloma therapy1

88 percent of transplant-eligible patients achieved a complete response or better, and 47 percent of patients sustained MRD-negativity for longer than one year with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based induction, consolidation and maintenance regimens in the Phase 3 PERSEUS study 7.5 years median overall survival achieved with DARZALEX®-based regimen in Phase 3 MAIA final analysis is the longest reported in patients ineligible for transplant

Significantly lower infusion-related reactions seen with subcutaneous amivantamab compared with intravenous administration in new Phase 2 data

New MajesTEC-1 data show a median duration of response of 24 months, with responses deepening, including in patients who switched to biweekly dosing1 Separate analyses from the MajesTEC-1 and OPTec studies are the first to underscore the opportunity for outpatient administration of TECVAYLI®

New formulation showed non-inferiority to intravenous administration in fourth positive Phase 3 study in RYBREVANT® clinical program Longer overall survival, progression-free survival and duration of response shown with subcutaneous amivantamab; featured in Best of ASCO 2024 RYBREVANT® marketing application submitted to European Medicines Agency based on PALOMA-3 study

Investigational chemotherapy-free regimen of RYBREVANT® plus lazertinib addresses a significant unmet need as most patients with EGFR-mutated NSCLC have high-risk disease Landmark Phase 3 MARIPOSA data featured in an oral presentation at ASCO

PALOMA-3 presentation of subcutaneous amivantamab and lazertinib selected to showcase cutting-edge approaches in lung cancer during prestigious “Best of ASCO” program New data showcase first- and -best-in-class, complementary multiple myeloma therapies, including DARZALEX® (daratumumab), CARVYKTI® (ciltacabtagene autoleucel; cilta-cel), TECVAYLI® (teclistamab-cqyv) and TALVEY® (talquetamab-tgvs)

Updated results reinforce the potential of TAR-210 to transform treatment of non–muscle-invasive bladder cancer with fibroblast growth factor receptor (FGFR) alterations

Study highlights opportunity for treatment intensification in this population since approximately 50% of patients with high-risk localized prostate cancer (HRLPC) experience disease recurrence within two years of surgery

New data from Phase 2b SunRISe-1 study show rapid achievement of complete response (CR) with 98% achieving a CR within 12 weeks TAR-200 provides durable CRs in patients with Bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC) with carcinoma in situ – a disease area with limited treatment options for patients

This positive CHMP opinion establishes amivantamab as a new option, and the first fully-human EGFR-MET bispecific antibody, in the first-line treatment of EGFR exon 20 insertion-mutated NSCLC The recommendation is supported by data from the Phase 3 PAPILLON study, which showed amivantamab plus chemotherapy significantly improved progression-free survival in adult patients, versus chemotherapy alone1

Expanded indication for this one-time infusion may provide patients with a potential period away from their multiple myeloma treatment as early as first relapse1 Approval is based on results from the PHASE 3 CARTITUDE-4 study, in which treatment with cilta-cel in 1-3 prior lines of therapy reduced the risk of disease progression or death by 74 percent compared to standard therapies1

Expanded indication for this one-time infusion will provide more patients with a potential period away from their multiple myeloma treatment as early as first relapse Approval is based on results from the Phase 3 CARTITUDE-4 study, in which treatment with CARVYKTI® in 1-3 prior lines of therapy reduced the risk of disease progression or death by 59 percent compared to standard therapies

Featured data include new results from the Phase 3 MARIPOSA study, which has received U.S. FDA Priority Review, and the Phase 1b PALOMA study of subcutaneous amivantamab

FDA ODAC unanimously votes 11 to 0 supporting favorable risk-benefit assessment of CARVYKTI® based on results from the Phase 3 CARTITUDE-4 study

Acquisition strengthens Johnson & Johnson’s commitment to innovation in prostate cancer and deepens pipeline of next-generation antibody drug conjugates and targeted oncologic therapeutics

Submission supported by data from Phase 3 PERSEUS study, which showed the daratumumab subcutaneous formulation-based regimen significantly reduced the risk of progression or death, compared to standard of care regimen.1

Approval is based on results from the Phase 3 PAPILLON study, which demonstrated RYBREVANT® plus chemotherapy reduced the risk of disease progression or death by 61 percent versus chemotherapy alone in patients with previously untreated NSCLC with EGFR exon 20 insertion mutations National Comprehensive Cancer Network ® (NCCN ®) updated its NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ®) to recommend amivantamab-vmjw (RYBREVANT®) plus chemotherapy as a preferred first-line regimen for patients with NSCLC with EGFR exon 20 insertion mutations