COMPANY:

Roche

"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."

P3 | " Pts with ER+, HER2– eBC who had BC surgery and (neo)adjuvant chemotherapy (if indicated) were randomized 1:1 to once-daily 30 mg GIRE or SOC ET (anastrozole/letrozole/exemestane [aromatase inhibitors; AIs] or tamoxifen [TAM]) for 5 years (y) of treatment (tx). Adjuvant GIRE improved IDFS and DRFI vs SOC ET; benefit was consistent irrespective of menopausal status. PRE-M pts experienced a 42% reduction in the risk of developing metastatic disease and POST-M pts a 24% reduction. Safety was comparable between menopausal groups and there were few discontinuations, regardless of menopausal status, although PRE-M and POST-M pts receiving GIRE had fewer tx discontinuations than those receiving an AI or TAM in the PRE-M and POST-M settings."

"These infections can be difficult to detect due to nonspecific symptoms and have high morbidity and mortality.Case Report The patient is a 41-year-old male with a history of non-ischemic cardiomyopathy with LVAD placement (2015) complicated by chronic driveline infection status post 3 HTs: first in 2017 with antibody mediated rejection requiring ECMO/ATG/IVIG/PLEX/bortezomib; then in 2020 with early vasculopathy treated with multivessel PCI and tocilizumab; third HT in 6/2025. Findings were consistent with a ruptured mycotic aneurysm.Summary Antifungal prophylaxis in HT recipients is only administered in specific case scenarios and not universally. This case suggests that re-do HT recipients, given their cumulative immunosuppression exposure, may also benefit from fungal prophylaxis."

"She was listed for OHT following desensitization with IVIG, PLEX, and tocilizumab...The patient is over 1-year post OHT and doing well without any episodes of rejection.Summary Using PLEX to replace 1.5x plasma volumes with FFP is an effective method to rapidly replete F11 levels in a volume neutral manner allowing for OHT of our sensitized patient. This case serves as a model for rapid optimization of patients with HC for urgent surgery in a volume neutral manner."