Ellen Sigal, Roy Herbst: Friends and FDA to focus on real-world evidence, AI, and streamlined trials in 2024

Investigational Orca-T treatment for hematologic malignancies meets primary endpoint in phase III trial

Orca Bio, a late-stage biotechnology company, on March 17 announced results from the pivotal phase III Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia, acute lymphoblastic leukemia, high-risk myelodysplastic syndrome and mixed-phenotype acute leukemia. Orca-T is manufactured using highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors.

March 28, 2025

Vol.51 No.12

Guest Editorial

Health innovation and health equity: Ensuring technologies advance resilience, justice, and compassionate care

Technological innovations are often hailed as transformative tools capable of revolutionizing healthcare. From gene editing for conditions like sickle cell disease to AI predicting hospital readmissions, to telemedicine expanding healthcare access, these advancements have the potential to change the way we treat diseases.

By Jamillah Hoy-Rosas

AI tool helps predict who will benefit from focal therapy for prostate cancer, study shows

A study led by UCLA investigators shows that AI could play a key role in improving treatment outcomes for patients with prostate cancer by helping physicians determine who is most likely to benefit from partial gland cryoablation, a minimally invasive procedure that treats localized prostate tumors.

Elahere shows survival benefit in long-term analysis for ovarian cancer patients in phase III study

AbbVie announced the final analysis of the confirmatory phase III MIRASOL trial evaluating the efficacy and safety of Elahere in women with folate receptor alpha-positive platinum-resistant ovarian cancer compared to chemotherapy.

Genmab’s Rina-S shows promise in treating advanced ovarian cancer

Genmab A/S announced on March 17 updated data from cohort B1 of the phase I/II RAINFOL-01 study of rinatabart sesutecan, an investigational folate receptor-alpha-targeted, TOPO1 antibody-drug conjugate that showed Rina-S 120 mg/m2 every three weeks resulted in a confirmed objective response rate of 55.6% (95% CI: 30.8-78.5) in heavily pre-treated ovarian cancer patients regardless of FRα expression levels.