COMPANY:

Roche

"Treatment consisted of IVIG [38 (73.1%)], high-dose corticosteroids [30 (57.7%)], ATG [12 (23.1%)], rituximab [14 (26.9%)], and/or plasmapheresis [12 (23.1)].* In our cohort of HTx pts, pAMR2 mostly occurred early after HTx (≤1year) and was not associated with excess risk of advanced CAV, death or re-do HTx at 5-year follow-up. In our cohort of HTx pts, pAMR2 mostly occurred early after HTx (≤1year) and was not associated with excess risk of advanced CAV, death or re-do HTx at 5-year follow-up. However, repeat rejection was observed in pAMR2 group. Multi-center studies with larger sample size are needed to delineate prognosis of AMR as stratified by timing of occurrence, response to therapies, and concomitant elevation in other biomarkers."

"The VENTANA PTEN (SP218) RxDx Assay is a qualitative immunohistochemical assay intended to be used in the assessment of PTEN protein in prostate adenocarcinoma."

"FoundationOne CDx as a companion diagnostic for this therapy marks the company’s first approval leveraging its real-world data-powered CDx offering, a service that supports drug and diagnostic label expansion by supplementing clinical trials with expertly curated real-world evidence and integrated regulatory support."

"Intensive chemotherapy (IC) was given in 42%, lower intensity regimens (LIR; hypomethylating agent +/-venetoclax) in 47%, and 146 (29%) received hematopoietic stem cell transplantation (HSCT)... Unsupervised clustering identified six clinically distinct AML subgroups with OS differences independent of ELN 2022 risk classification. Cluster assignment was driven not only by dominant mutations but also by VAF and coM patterns, highlighting molecular heterogeneity beyond single-gene models."

"Rituximab (7.7%) and hydroxychloroquine (4.8%) were the most common prior immunotherapies.Baseline disease characteristics at NGS were comparable across exposure groups. Prior immune and/or chemo-radiotherapy exposures in ZRSR2-mutated myeloid neoplasms are associated with altered clinical phenotypes characterized by lower blast burden and distinct diagnostic classification without major molecular differences. Despite this less proliferative phenotype, exposed patients demonstrated numerically worse survival, with significant heterogeneity by prior neoplasm subtype, suggesting that exposure history may modify disease biology beyond baseline disease burden."

"Roche...announced today that it has entered into a definitive merger agreement to acquire PathAI, a US-based company in digital pathology and AI-powered technology for pathology laboratories and the biopharma industry. This acquisition builds on the successful partnership between Roche and PathAI, established in 2021 and scaled up in 2024 to include the development of AI-enabled companion diagnostic algorithms. Subject to the closing of the transaction, which is expected in the second half of the year, the acquired entity will become part of the Diagnostics division."

P3 | "Giredestrant(Gired), a next-generation oral SERD, was shown to be more potent than other SERDs and demonstrated superior antiproliferative activity vs anastrozole in the neoadj coopERA BC trial... Pts with Stage I-III ER+ HER2- eBC were randomized 1:1 to Gired 30 mg oral daily (with an LHRH agonist in pre- and peri-menopausal) or SoC ET (tamoxifen or AI) for 5 yrs... LidERA is the first Ph III trial to demonstrate benefit with an oral SERD in eBC. Gired resulted in a statistically significant and clinically meaningful IDFS improvement vs SoC ET in ER+, HER2- eBC. OS trended in favor of the gired arm, and DRFI was improved vs SoC ET."

"Emerging data show that trastuzumab deruxtecan (T-DXd) is redefining (neo-)adjuvant strategies according to DESTINY-Breast (DB)-05 and -11 trials...Prior pertuzumab or anthracyclines-based NAT were used in 32% and in 82% of pts, respectively... Post-neoadjuvant T-DM1 shows an excellent real-world effectiveness profile, with a low incidence of invasive disease recurrences. Notably, a large fraction of pts treated in routine practice would not have met DB-05/-11 trial eligibilities, and none with an iDFS event belonged to the "DB-11 only" population. These data highlight the value of real-world benchmarking to contextualize trial evidence and guide integration of antibody–drug conjugates in the curative scenario."

P1/2 | "The final analysis of ARROW confirms that pralsetinib yields clinically meaningful and durable responses in patients with RET-altered TC and MTC with a manageable safety profile consistent with prior reports. Efficacy summary. NE, not evaluable; NR, not reached."