Oncology news archive

Investigational TAR-210 first-in-human results highlight the potential for local sustained release of erdafitinib with a novel intravesical delivery system Phase 1 results show a manageable safety profile with limited systemic toxicity, and early complete responses in patients with high-risk and intermediate-risk NMIBC

Niraparib and abiraterone acetate plus prednisone combination therapy also showed clinically relevant improvement versus standard of care in time to symptomatic progression and time to cytotoxic chemotherapy

Data show the potential impact of RYBREVANT® and chemotherapy combination as first-line treatment for patients with advanced non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations Late-breaking data presented in a Presidential Symposium at 2023 ESMO Congress and simultaneously published in The New England Journal of Medicine

Data from Cohort 1 of the Phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical standard-of-care chemotherapy

Three Phase 3 RYBREVANT® (amivantamab-vmjw) studies (MARIPOSA, MARIPOSA-2 and PAPILLON) in EGFR-mutated lung cancer achieved statistically significant and clinically meaningful progression-free survival endpoints and will be presented in Presidential Symposium sessions New results for investigational TAR-200 and TAR-210 novel intravesical delivery system highlight potential for transformational outcomes in the treatment of bladder cancer

Planned interim overall survival analysis showed a trend favoring the combination of RYBREVANT® and lazertinib compared to osimertinib* First pivotal study to show a clinically meaningful benefit in a chemotherapy-free regimen versus osimertinib

Presentations to highlight latest data across biologic, bispecific and CAR-T therapies with added insights from Global Multiple Myeloma Call-to-Action

Data presented at WCLC showed combining RYBREVANT ®, lazertinib and chemotherapy may address the diverse resistance that emerges after disease progression on osimertinib

MARIPOSA-2 is the first Phase 3 study to show statistically significant and clinically meaningful improvement in progression-free survival (PFS) in the post-osimertinib setting MARIPOSA-2 is the second RYBREVANT® Phase 3 study to show the potential to improve outcomes in patients with EGFR-mutated non-small cell lung cancer (NSCLC)

Submission Based on Confirmatory Data from Cohort 1 of the Phase 3 THOR Study, Which Showed a 36 Percent Reduction in the Risk of Death in Patients Treated with BALVERSA® Versus Chemotherapy

Application is supported by data from PAPILLON, the first randomized Phase 3 study to show clinically meaningful results in patients with NSCLC with EGFR exon 20 insertion mutations

Teclistamab, the first BCMA-targeting bispecific antibody to receive approval in Europe, maintained deep and durable responses, with reduced onset of Grade 3 or higher infections, in eligible patients with relapsed and refractory multiple myeloma (RRMM) switching from weekly to reduced, biweekly dosing schedule.1,2

Approval is based on the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study including the largest population of BRCA-positive patients in combination trials to date with metastatic castration-resistant prostate cancer (mCRPC) AKEEGA™ plus prednisone significantly improved radiographic progression-free survival compared to abiraterone acetate plus prednisone (AAP) in patients with BRCA-positive mCRPC

Bispecific antibody targeting GPRC5D receptor showed an overall response rate of more than 70 percent with durable responses, including in patients previously treated with a bispecific antibody or CAR-T cell therapy

First Phase 3 study to demonstrate clinically meaningful results versus standard of care in a newly diagnosed exon 20 population, a patient population with high unmet medical need

Application is supported by data from the Phase 3 CARTITUDE-4 study, which showed significant improvement in primary endpoint of progression-free survival (PFS) CARTITUDE-4 is the first randomized Phase 3 study investigating the efficacy of a cell therapy as early as after first relapse in multiple myeloma

More than 60 percent of patients achieved an overall response and 45.5 percent of patients achieved a complete response or better by nearly five months Additional data highlights strong efficacy with biweekly TECVAYLI® dosing and show strategies for improving cytokine release syndrome with prophylactic tocilizumab

Study results of novel drug-eluting technology highlight potential durability of TAR-200 in patient population with high unmet need