University Hospital Heidelberg

The GMMG-HD7 trial evaluated isatuximab (Isa) combined with lenalidomide, bortezomib, and dexamethasone (RVd) in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation (ASCT). Results showed significantly higher minimal residual disease negativity (MRDneg) rates with Isa-RVd (66%) compared to RVd alone (48%) after induction therapy, and higher continued MRDneg rates during maintenance therapy. The addition of Isa enhanced MRDneg rates and improved progression-free survival (PFS) outcomes, with MRDneg status being a significant prognostic factor for PFS. The trial demonstrated that Isa-RVd improves MRDneg rates and provides long-term benefits, particularly for patients maintaining MRDneg status throughout treatment.

Biannual lenacapavir vaccinations offer 96% reduced HIV infection risk compared to Truvada, with better convenience and lower stigma. Gilead plans global approval, prioritizing low-income regions, despite $42,000/year cost in the US. Concerns exist over potential drug resistance.

Real-world data from University Hospital Heidelberg show beti-cel's efficacy in eliminating transfusion dependence in transfusion-dependent β-thalassemia patients, with all 8 patients achieving transfusion independence. Safety concerns include pituitary-gonadal endocrine dysfunction and other adverse events, similar to clinical trial findings. The study highlights the need for less toxic conditioning regimens.

HDP-101, an anti-BCMA ADC, showed promising efficacy and manageable toxicity in relapsed/refractory multiple myeloma patients, with 50% response rate in a 100 μg/kg cohort. A phase 1 trial will continue with modified dose-escalation cohorts, aiming for a dose-expansion phase in 2025. HDP-101's synthetic design may overcome drug resistance and target cells with ultra-low antigen expression.

Heidelberg Pharma to present new HDP-101 clinical data at the 21st International Myeloma Society Annual Meeting in Rio De Janeiro, showing initial promising results in relapsed multiple myeloma.

IDMC recommended continuation of IO Biotech's Phase 3 trial of IO102-IO103 without modifications after a safety and efficacy interim analysis. No new safety signals were observed, and the primary endpoint of progression-free survival is projected to be reached in the first half of 2025.