Johnson & Johnson submits application to the European Medicines Agency for daratumumab SC-based quadruplet regimen for newly diagnosed multiple myeloma patients
- Johnson & Johnson has submitted a Type II variation application to the EMA for an indication extension of daratumumab SC in combination with bortezomib, lenalidomide, and dexamethasone (D-VRd) for newly diagnosed multiple myeloma patients.
- The submission is supported by data from the Phase 3 CEPHEUS study, which showed a 60.9% MRD-negativity rate and a 43% reduction in the risk of progression or death with D-VRd compared to VRd.
- The CEPHEUS study involved 395 patients who were either ineligible for stem cell transplantation or for whom transplantation was not planned, with a primary endpoint of MRD-negativity rate.
- Next steps include awaiting EMA's decision on the application, which could potentially transform frontline treatment for multiple myeloma patients.
Read more
Immatics updates phase 1b data on IMA203 in melanoma and plans phase 3 trial
- Immatics shared updated phase 1b data for IMA203 targeting PRAME in 28 metastatic melanoma patients, showing a 54% objective response rate and a median progression-free survival (PFS) of 6 months.
- The phase 3 trial, SUPRAME, will enroll 360 patients with unresectable or metastatic melanoma, comparing IMA203 to investigator's choice, with median PFS as the primary endpoint.
- The trial is set to start in December 2024, with completion of enrollment expected by 2026 and a pre-specified interim analysis in early 2026.
- Regulatory discussions with the FDA and the Paul Ehrlich Institute have confirmed the trial design, aiming for a Biologics License Application submission in early 2027.
Read more
Oncoinvent doses first patient in phase 2 trial of Radspherin for ovarian cancer
- Oncoinvent has initiated a Phase 2 trial of Radspherin in ovarian cancer patients with peritoneal carcinomatosis.
- The trial is a randomized controlled study focusing on progression-free survival post-surgery and chemotherapy.
- Radspherin is an alpha-radiation therapy designed for targeted treatment of cancers in body cavities.
- The study is being conducted across six centers in the US, UK, Norway, Spain, and Belgium.
Read more
Harbour BioMed publishes phase I study results for porustobart and toripalimab in advanced melanoma
- Harbour BioMed announced phase I trial results for porustobart combined with toripalimab in advanced solid tumors, focusing on melanoma.
- The trial showed a manageable safety profile with no new safety signals and promising antitumor activity, especially in PD-1 treatment-naïve mucosal melanoma.
- The study involved 40 patients, with 25% experiencing grade ≥3 treatment-related adverse events, and an objective response rate of 33.3% in the anti-PD-1/PD-L1 treatment-naïve subgroup.
- Further studies are planned to confirm these findings, particularly in mucosal melanoma patients.
Read more
