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COMPANY:
Roche

i
Other names: Poseida | Vindico NanoBioTechnology, | Vindico NanoBioTechnology | AntlerA Therapeutics | Genentech, | Chugai | Tanox | Lexent Bio | Lexent Bio, | Hoffmann-La Roche | Carmot | Foundation Medicine, | Telavant | Good Therapeutics | TIB MOLBIOL | Spark Therapeutics, | Roche | Innovatis | Genentech | Marcadia Biotech | InterMune | Tensha Therapeutics | Adheron Therapeutics | Forsight Vision4 | Anadys Pharma | Santaris | Seragon | Piramed Limited | Trophos | Foundation Medicine | Ignyta | Flatiron Health | @Roche | Tusk Therapeutics | Borean Pharma | Arius Research | Promedior | Spark Therapeutics | Marcadia Biotech, | Adheron Therapeutics, | Promedior, | Ventana Medical Systems | Inflazome | GenMark Diagnostics, | GenMark Diagnostics
Related tests:
Evidence

News

29d
Updated Safety Run-In Results From LOTIS-5: A Phase 3, Randomized Trial of Loncastuximab Tesirine With Rituximab Versus Immunochemotherapy in Patients With R/R DLBCL/HGBL (DGHO 2025)
P3 | "Fixed duration Lonca-R showed no new safety signals and demonstrated encouraging antitumor activity, with signs of durable response in 4 patients who maintained CR for >28 months after EOT. Lonca-R resulted in lower median Cmax than monotherapy in C1. CD19 staining was not predictive of efficacy."
Clinical • P3 data
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CD19 (CD19 Molecule)
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Rituxan (rituximab) • Zynlonta (loncastuximab tesirine-lpyl)
29d
Initial Results From LOTIS-7: A Phase 1b Study of Loncastuximab Tesirine Plus Glofitamab in Patients With Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL) (DGHO 2025)
P1 | "Lonca-Glofit in R/R B-NHL showed a manageable/consistent safety profile and encouraging efficacy in heavily-pretreated aggressive lymphoma patients. Results suggest Lonca complements Glofit's mechanism and provides additive efficacy.Results previously presented: EHA 2025."
Clinical • P1 data
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CD20 (Membrane Spanning 4-Domains A1) • CD8 (cluster of differentiation 8) • IL6 (Interleukin 6) • CD4 (CD4 Molecule)
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Zynlonta (loncastuximab tesirine-lpyl) • Columvi (glofitamab-gxbm)
1m
Split dose R-CHOP mitigates toxicity while preserving dose intensity and response in frail elderly patients with diffuse large B cell lymphoma (DLBCL) - a Wisconsin oncology network (WON) study (ASH 2025)
"Many OA receive non-anthracycline based treatment(tx), or attenuated regimens (i.e. R-miniCHOP) to avoid toxicity. Despite significant comorbidity and ahigh prevalence of factors associated with STox, events were less common than expected in this group.De-escalation of therapy appears feasible for pts with interim uMRD/PET- response, limiting toxicitywithout impacting long-term outcomes. These findings suggest that SD R-CHOP warrants further study infrail OA with DLBCL at high risk for STox."
Clinical
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clonoSEQ
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Rituxan (rituximab) • vincristine
2ms
Roche presents major advances for its sequencing by expansion technology(1), including a new GUINNESS WORLD RECORD™, at the ASHG conference 2025 (Roche Press Release)
"Roche...presented major updates on its innovative sequencing by expansion (SBX) technology at the American Society of Human Genetics (ASHG) 2025 Annual Meeting in Boston, USA. Following its recent unveiling, SBX is already being recognized by early evaluators in the sequencing community for its combination of speed, flexibility, and longer reads, which significantly expands research possibilities."
Clinical data
5ms
Subgroup analysis of the efficacy and safety of cabozantinib ± atezolizumab in patients from CONTACT-03 who received first-line treatment with immuno-oncology–based combinations (KCRS 2025)
P3 | "The current analysis evaluated progression-free survival (PFS) by blinded independent central review (BICR), overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety in the subgroup of patients who received first-line standard-of-care IO–IO (ipilimumab–nivolumab) or IO–TKI (avelumab–axitinib, pembrolizumab–axitinib, or pembrolizumab–lenvatinib) combinations prior to enrolling in CONTACT-03...The data suggest that second-line cabozantinib is effective in patients with advanced RCC previously treated with contemporary first-line IO–IO or IO–TKI regimens. Safety outcomes were consistent with the overall study population."
Clinical
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Keytruda (pembrolizumab) • Opdivo (nivolumab) • Tecentriq (atezolizumab) • Yervoy (ipilimumab) • Lenvima (lenvatinib) • Bavencio (avelumab) • Cabometyx (cabozantinib tablet) • Inlyta (axitinib)
7ms
Roche announces new collaboration with Broad Clinical Labs to accelerate adoption of cutting-edge SBX sequencing technology (Roche Press Release)
"Roche...announced today a strategic collaboration with Broad Clinical Labs to develop and pilot groundbreaking applications using Roche’s recently unveiled next-generation sequencing (NGS) Sequencing By Expansion (SBX) technology. This collaboration will focus on harnessing the power of the SBX technology to transform clinical genomics and biomedical discovery."
Licensing / partnership
7ms
CHMP recommends EU approval of Roche’s Itovebi for PIK3CA-mutated, ER-positive, HER2-negative, advanced breast cancer (Roche Press Release)
"Roche...adopted a positive opinion for Itovebi™ (inavolisib), in combination with palbociclib (Ibrance®) and fulvestrant, for the treatment of adult patients with PIK3CA-mutated, oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, locally advanced or metastatic breast cancer, following recurrence on or within 12 months of completing adjuvant endocrine treatment."
EMA approval
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
7ms
MORPHEUS-Liver: A phase Ib/II, randomised study evaluating tiragolumab (tira) in combination with atezolizumab (atezo) and bevacizumab (bev) in patients (pts) with unresectable, locally advanced or metastatic hepatocellular carcinoma (uHCC) (ESMO-GI 2025)
P1/2 | "Background: IMbrave150 demonstrated statistically significant and clinically meaningful superior overall survival (OS) and progression-free survival (PFS) vs sorafenib, leading to atezo + bev becoming a first-line (1L) standard-of-care treatment for uHCC (Finn et al NEJM 2020). Longer term data continues to show that tira + atezo + bev is potentially more active than atezo + bev in pts with uHCC. Tira + atezo + bev also remains well tolerated. Tira + atezo + bev may be a promising novel 1L treatment option for pts with uHCC, and further study of this combination is ongoing in the phase 3 IMbrave152 clinical trial."
Clinical • P1/2 data • Combination therapy
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PD-L1 (Programmed death ligand 1) • TIGIT (T Cell Immunoreceptor With Ig And ITIM Domains 2)
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Avastin (bevacizumab) • Tecentriq (atezolizumab) • sorafenib • tiragolumab (RG6058)
7ms
Roche granted FDA Breakthrough Device Designation for first AI-driven companion diagnostic for non-small cell lung cancer (Roche Press Release)
"The VENTANA TROP2 (EPR20043) RxDx Device is an immunohistochemistry (IHC) assay combined with a digital pathology algorithm to determine patient treatment; The device uses artificial intelligence-based image analysis with a level of diagnostic precision not possible with traditional manual scoring methods; This Breakthrough Device Designation (BDD) demonstrates Roche’s continued innovation in companion diagnostics and digital pathology to enable more precise diagnosis in oncology."
FDA event
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VENTANA® TROP2 (EPR20043) RxDx Assay
8ms
Roche to invest USD 50 billion in pharmaceuticals and diagnostics in the United States over the next five years (GlobeNewswire)
"Roche...announced today that it will invest USD 50 billion into the United States of America in the next five years. These investments further strengthen Roche’s already significant US footprint with 13 manufacturing and 15 R&D sites across the Pharmaceutical and Diagnostics Divisions, and are expected to create more than 12,000 new jobs, including nearly 6,500 construction jobs, as well as 1,000 jobs at new and expanded facilities."
Licensing / partnership • Commercial