Roche Holding AG

Roche Holding AG is a research healthcare company. It operates through the Roche Pharmaceuticals and Diagnostics segments. The Roche Pharmaceutical division comprises the business segments, such as Roche Pharmaceuticals and Chuga. The Diagnostic division consists of the following four business areas: centralized and point of care solutions, molecular diagnostics, tissue diagnostics and diabetes care. The company was founded by Fritz Hoffmann-La Roche on October 1, 1896 and is headquartered in Basel, Switzerland.

Roche (RHHBY) obtains EU approval for Lunsumio for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) and label expansion of Tecentriq.

Roche (RHHBY) Gets EU Nod for Lunsumio, Tecentriq Label Expansion

Basel, 9 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the United States Food and Drug Administration (U.S. FDA) has approved Foundation Medicine's FoundationOne®CDx as a companion diagnostic (CDx) for Roche's Rozlytrek® (entrectinib). FoundationOne CDx is a comprehensive genomic profiling (CGP) pan-tumour tissue biopsy test that assesses an individual's cancer to identify the unique molecular ‘fingerprint' of the tumour. It is the first and only U.S. FDA-approved CDx to identify patients with ROS1 fusion-positive non-small cell lung cancer (NSCLC), or patients with NTRK fusion-positive cancers, for whom treatment with Rozlytrek may be appropriate.

U.S. FDA approves Foundation Medicine's FoundationOne®CDx as a companion diagnostic for Roche's Rozlytrek® (entrectinib)

Basel, 09 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has approved Tecentriq® (atezolizumab) as an adjuvant treatment, following complete resection and platinum-based chemotherapy, for adults with non-small cell lung cancer (NSCLC) with a high risk of recurrence* whose tumours express PD-L1≥50% and who do not have EGFR mutant or ALK-positive NSCLC. “Today's approval represents an important advance, as Tecentriq becomes the first cancer immunotherapy approved in Europe for the treatment of certain types of early-stage NSCLC,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “Since approximately half of all people with early NSCLC develop recurrence after surgery, which in some cases is no longer curable, treating this cancer at an earlier stage offers the best chance to prevent recurrence.” This approval is based on results from an interim analysis of the Phase III IMpower010 study. The results showed treatment with Tecentriq, following complete resection and platinum-based chemotherapy, reduced the risk of disease recurrence or death (DFS) by 57% (hazard ratio [HR]=0.43, 95% CI: 0.26-0.71)** in people with resected Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥50%, who do not have EGFR mutant or ALK-positive NSCLC, compared with best supportive care (BSC).1 A DFS benefit was consistently seen across most subgroups including histology or stage of disease with adjuvant Tecentriq, compared with BSC. Overall survival (OS) data for patients with PD-L1 high resected Stage II-III NSCLC, and who do not have EGFR mutant or ALK-positive disease are immature and were not formally tested at the DFS interim analysis, however, a trend towards OS improvement with Tecentriq was seen, with a stratified HR of 0.39 (95% CI: 0.18-0.82).2 Follow-up will continue with planned analyses of more mature OS data later this year. Safety data for Tecentriq were consistent with its known safety profile and no new safety signals were identified.1 “Today's approval now offers patients in Europe, whose tumours express high levels of PD-L1, the opportunity to reduce their risk of disease recurrence following surgery and chemotherapy,” said Professor Enriqueta Felip, Head of the Thoracic Cancer Unit at Vall d'Hebron Institute of Oncology, Barcelona, Spain. “This milestone reinforces the need for biomarker testing at diagnosis for all people with NSCLC, irrespective of disease stage, to ensure they receive optimal treatment.” To date, Tecentriq has been approved in 19 countries, including the US and China, as adjuvant treatment, following complete resection and chemotherapy, for adults with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours express PD-L1≥1%. In three countries, including Canada and the UK, Tecentriq has been approved as adjuvant, treatment following complete resection and chemotherapy, for adult patients with Stage II-IIIA NSCLC (UICC/AJCC 7th edition) whose tumours have PD-L1 expression on ≥50% of tumour cells. Tecentriq has shown clinically meaningful benefit in various types of lung cancer, with six currently approved indications in countries around the world. It was the first approved cancer immunotherapy for the first-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with carboplatin and etoposide (chemotherapy). Tecentriq also has four approved indications in advanced or metastatic NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies. Tecentriq is available in three dosing options, providing the flexibility to choose administration every two, three or four weeks. Roche has an extensive development programme for Tecentriq including multiple ongoing and planned Phase III studies across lung, genitourinary, skin, breast, gastrointestinal, gynaecological, and head and neck cancers. This includes studies evaluating Tecentriq both alone and in combination with other medicines, as well as studies in metastatic, adjuvant and neoadjuvant settings across various tumour types. About the IMpower010 study IMpower010 is a Phase III, global, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq compared with BSC, in participants with Stage IB-IIIA NSCLC (UICC/AJCC 7th edition), following surgical resection and up to 4 cycles of adjuvant cisplatin-based chemotherapy. The study randomised 1,005 people with a ratio of 1:1 to receive either Tecentriq (up to 16 cycles) or BSC. The primary endpoint is investigator-determined DFS in the PD-L1-positive Stage II-IIIA, all randomised Stage II-IIIA and intention-to-treat (ITT) Stage IB-IIIA populations. Key secondary endpoints include overall survival in the overall study population, ITT Stage IB-IIIA NSCLC. About lung cancer Lung cancer is one of the leading causes of cancer death globally.3 Each year 1.8 million people die as a result of the disease; this translates into more than 4,900 deaths worldwide every day.3 Lung cancer can be broadly divided into two major types: NSCLC and SCLC. NSCLC is the most prevalent type, accounting for around 85% of all cases.4 Approximately 50% of patients with NSCLC are diagnosed with early-stage (Stages I and II) or locally advanced (Stage III) disease.4 Today, about half of all people with early lung cancer still experience a cancer recurrence following surgery.5 Treating lung cancer early, before it has spread, may help prevent the disease from returning and provide people with the best opportunity for a cure. About Tecentriq Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma. Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (PD-L1), which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as a subcutaneous injection to help address the growing burden of cancer treatment for patients and healthcare systems. About Roche in lung cancer Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have six approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease. About Roche in cancer immunotherapy Roche's rigorous pursuit of groundbreaking science has contributed to major therapeutic and diagnostic advances in oncology over the last 50 years, and today, realising the full potential of cancer immunotherapy is a major area of focus. With over 20 molecules in development, Roche is investigating the potential benefits of immunotherapy alone, and in combination with chemotherapy, targeted therapies or other immunotherapies with the goal of providing each person with a treatment tailored to harness their own unique immune system to attack their cancer. Our scientific expertise, coupled with an innovative pipeline and extensive partnerships, gives us the confidence to continue pursuing the vision of finding a cure for cancer by ensuring the right treatment for the right patient at the right time.

European Commission approves Roche's Tecentriq as adjuvant treatment for a subset of people with early-stage non-small cell lung cancer

Dell Technologies

Alliant Energy

With U.S. stocks showing signs of recovery, activity has picked up in recent weeks as traders seek to capitalize on a potential market bottom. Volume has been unusually high in the following three names.

Heavy Buying Points to Upside for These 3 Stocks

Basel, 8 June 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission has granted conditional marketing authorisation for the CD20xCD3 T-cell engaging bispecific antibody Lunsumio® (mosunetuzumab), for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) who have received at least two prior systemic therapies. Lunsumio is an off-the-shelf therapy that is readily available, so people do not have to wait to start treatment.

European Commission approves Roche's first-in-class bispecific antibody Lunsumio for people with relapsed or refractory follicular lymphoma

Repare Therapeutics

Shares of Repare Therapeutics Inc. RPTX, -4.68% jumped 24.5% in premarket trading on Thursday, the day after the company said it signed a worldwide licensing and collaboration agreement with Roche Holding AG ROG, +0.74% to develop and commercialize Repare's experimental tumor treatment. The drug, camonsertib, is being tested as a way to treat tumors with specific synthetic-lethal genomic alterations.

Roche, Repare's licensing deal includes milestone payments worth up to $1.2 billion

Shares of Repare Therapeutics Inc. were trading higher in Wednesday's after-hours session, following news the company entered a worldwide license and collaboration agreement with Roche ROG, -1.13% to develop and commercialize camonsertib.

Repare Therapeutics shares rise 18% after news of Roche deal

The FDA approves a label expansion of Roche's (RHHBY) SMA drug Evrysdi to include less than two-month old babies with SMA.

Roche's (RHHBY) Evrysdi Gets FDA Nod for Label Extension

AstraZeneca

Gilead Sciences

Daiichi Sankyo Co Ltd

Investors will want to keep an eye on developments at this week's meeting of the American Society of Clinical Oncology in Chicago, where four members of big pharma will share study results of their most promising cancer drugs. The news has the potential to move the shares of the presenters-- Daiichi Sankyo Co. Ltd.

ASCO Presentations Could Move Shares of Daiichi, AstraZeneca, Gilead and Roche

Basel, 31 May 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key milestones such as sitting and standing with half walking after 12 months of treatment. Evrysdi is now approved in the US to treat SMA in children and adults of all ages. Of the babies with 2 or 3 copies of the SMN2 gene (n=6), 100% were able to sit after one year of treatment with Evrysdi, 67% could stand and 50% of infants could walk independently. All infants were alive at 12 months without permanent ventilation. “The approval of Evrysdi for pre-symptomatic babies is particularly important, as early treatment of SMA, before symptoms start to arise, can help babies to achieve motor milestones,” said Richard Finkel, M.D., RAINBOWFISH Principal Investigator and Director of the Experimental Neuroscience Program at St. Jude Children's Research Hospital. “With the inclusion of SMA in newborn screening programmes, this approval provides the opportunity to start treating at home with Evrysdi soon after the diagnosis is confirmed.” As part of the label extension, the Evrysdi prescribing information has also been updated to include recent two-year pooled data from Parts 1 and 2 of the FIREFISH study, which demonstrate long-term efficacy and safety in symptomatic infants with Type 1 SMA. The study enrolled babies aged 1-7 months and after two years of treatment with Evrysdi at the recommended dose (n=58), 60% of infants were able to sit without support* for five seconds, 40% for 30 seconds and 28% of infants were able to stand.** Without treatment, infants do not achieve these milestones in the natural history of the disease. There were no treatment-related adverse events leading to withdrawal. The most common adverse reactions were upper respiratory tract infection (including nasopharyngitis, rhinitis), lower respiratory tract infection (including pneumonia, bronchitis), constipation, vomiting, and cough. “The priority review and subsequent approval of Evrysdi for babies under two months of age speaks to the urgent ongoing need for additional treatment options for babies with SMA,” said Levi Garraway, M.D., Ph. D., Roche's Chief Medical Officer and Head of Global Product Development. “Because of its efficacy in multiple settings, Evrysdi is now available for people with SMA from pre-symptomatic newborns to older adults. We are proud of this achievement, which has the potential to make a real difference to those living with SMA and their caregivers.” Evrysdi is approved in 81 countries and the dossier is under review in a further 27 countries. More than 5,000 patients have now been treated worldwide with Evrysdi in clinical trials, compassionate use or real-world settings. Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics. About Evrysdi ® ( risdiplam ) Evrysdi is a survival motor neuron 2 (SMN2) splicing modifier designed to treat SMA caused by mutations in chromosome 5q that lead to SMN protein deficiency. Evrysdi is administered daily at home in liquid form by mouth or by feeding tube. Evrysdi is designed to treat SMA by increasing and sustaining the production of the survival motor neuron (SMN) protein in the central nervous system (CNS) and peripheral tissues. SMN protein is found throughout the body and is critical for maintaining healthy motor neurons and movement. Evrysdi was granted PRIME designation by the European Medicines Agency (EMA) in 2018 and Orphan Drug Designation by the U.S Food and Drug Administration in 2017. In 2021, Evrysdi was awarded Drug Discovery of the Year by the British Pharmacological Society as well as the Society for Medicines Research award for Drug Discovery. Evrysdi is currently approved in 81 countries and the dossier is under review in a further 27 countries.

FDA approves Roche's Evrysdi for use in babies under two months with spinal muscular atrophy (SMA)

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved a label extension for Evrysdi® (risdiplam) to include babies under two months old with spinal muscular atrophy (SMA). The approval is based on interim efficacy and safety data from the RAINBOWFISH study in newborns, which showed that the majority of pre-symptomatic babies treated with Evrysdi achieved key

FDA Approves Genentech's Evrysdi (risdiplam) for Use in Babies Under Two Months With Spinal Muscular Atrophy (SMA)

Basel, 27 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from 3-7 June and the European Hematology Association (EHA) 2022 Congress from 9-12 June. Data from the phase II NP30179 expansion study demonstrated that, after a median follow-up of more than 12 months, fixed-duration glofitamab (given for a fixed amount of time, and not taken until disease progression) induces durable complete responses (CRs) in patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who had received a median of three prior therapies.1 “These data bring us one step closer towards our goal of finding solutions for people with heavily pre-treated diffuse large B-cell lymphoma, which often relapses and becomes more aggressive each time it returns,” said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. “The potential of glofitamab as a new fixed-duration, readily available treatment could be instrumental to improving outcomes for people with this difficult-to-treat cancer who otherwise have limited options.” The pivotal phase II NP30179 expansion study included patients with heavily pre-treated and highly refractory DLBCL, with 58.3% of patients refractory to their initial therapy and about one-third (33.1%) having received prior CAR T-cell therapy.1 After a median follow-up of 12.6 months, 39.4% of patients (n=61/155) achieved a CR (primary efficacy endpoint) and half of them (51.6%; n=80/155) achieved an overall response (the percentage of patients with a partial or complete response; secondary efficacy endpoint), as assessed by an independent review committee. The majority (77.6%) of complete responses were durable and ongoing at 12 months and the median duration of complete response had not yet been reached (not evaluable [16.8 months, not evaluable]). Cytokine release syndrome (CRS) was the most common adverse event occurring in 63.0% of patients. CRS events were predictable, generally low grade (mainly Grade 1 [47.4%] or 2 [11.7%]), occurred at initial doses, and only one patient discontinued glofitamab due to CRS. Incidence of Grade 3+ CRS was low (3.9%), with no Grade 5 events.1 “I'm encouraged by these data as they signify new hope for these patients who otherwise have limited effective treatment options and have faced disappointment from not responding to multiple rounds of treatments,” said Associate Professor Michael Dickinson, Haematologist and Lead of the Aggressive Lymphoma Disease Group within Clinical Haematology at Peter MacCallum Cancer Centre and Royal Melbourne Hospital, Australia. “These glofitamab data suggest that patients may be able to achieve durable responses with a set course of treatment that they don't have to take continuously until disease progression.” Data from the NP30179 study have been submitted for approval to the European Medicines Agency (EMA), and submissions to additional health authorities worldwide, including to the U.S. Food and Drug Administration (FDA), are planned this year. Glofitamab is being investigated in several clinical trials and explored in earlier lines of lymphoma treatment. Roche is committed to improving standards of care to enhance the treatment experience and outcomes for people with blood cancers and the scientific data we are sharing at ASCO and EHA from our portfolio propels us further towards this goal. Roche is investigating its CD20xCD3 T-cell engaging bispecific antibodies glofitamab and mosunetuzumab further as subcutaneous formulations and in additional phase III studies that will expand the understanding of their impact in earlier lines of treatment, with the aim of providing people with different types of lymphomas with robust and durable treatment outcomes. Additionally, the European Commission (EC) recently granted approval of Polivy® (polatuzumab vedotin) in combination with MabThera® (rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL), and the EMA's Committee for Medicinal Products for Human Use recommended mosunetuzumab for approval for patients with R/R follicular lymphoma, who have received at least two prior systemic therapies. Follow Roche on Twitter via @Roche and keep up to date with ASCO 2022 news and updates by using the hashtag #ASCO22. For exclusive materials sharing insights into Roche's vision and strategy, and providing context behind the data being presented, visit Roche's Oncology Newsroom here. About glofitamab Glofitamab is an investigational CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B-cells and CD3 on the surface of T-cells. Glofitamab is based on a novel structural format called ‘2:1'. It is engineered to have two ‘Fab' regions which bind to CD20, and one ‘Fab' region which binds to CD3. This dual targeting activates and redirects a patient's existing T-cells to engage and eliminate target B-cells by releasing cytotoxic proteins into the B-cells. A robust clinical development programme for glofitamab is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and mantle cell lymphoma, and other blood cancers. About the NP30179 study The NP30179 study [NCT03075696] is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of glofitamab in people with relapsed or refractory diffuse large B-cell lymphoma. Outcome measures include complete response rate by independent review committee (primary endpoint), overall response rate, duration of response, progression-free survival, safety and tolerability (secondary endpoints). About Roche in haematology Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 20 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, and Hemlibra® (emicizumab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibodies, glofitamab and mosunetuzumab, targeting both CD20 and CD3, and cevostamab, targeting both FcRH5 and CD3; Tecentriq® (atezolizumab), a monoclonal antibody designed to bind with PD-L1 and crovalimab, an anti-C5 antibody engineered to optimise complement inhibition. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further. About Roche Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world's largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice. In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

New pivotal data demonstrate clinical benefit of Roche's glofitamab, a potential first-in-class bispecific antibody for people with aggressive lymphoma

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new pivotal data on its investigational CD20xCD3 T-cell engaging bispecific antibody, glofitamab, will be presented for the first time at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 and the European Hematology Association (EHA) 2022 Congress from June 9-12. Data from the Phase II NP30179 expansion study demonstrated that,

New Pivotal Data Demonstrate Clinical Benefit of Genentech's Glofitamab, a Potential First-in-Class Bispecific Antibody for People With Aggressive Lymphoma

Roche's (RHHBY) Polivy combination receives the European Commission's approval for patients with previously untreated diffuse large B-cell lymphoma.

Roche (RHHBY) Gets EC Approval for Polivy Combination in DLBCL

Basel, 25 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the European Commission (EC) has granted approval of Polivy® (polatuzumab vedotin) in combination with MabThera®(rituximab) plus cyclophosphamide, doxorubicin, and prednisone (R-CHP) for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL). DLB CL is an aggressive blood cancer and the most common form of non-Hodgkin lymphoma.2 Each year in Europe, it is estimated that 40,000 people are diagnosed with DLBCL.3 While many patients are responsive to initial treatment, four out of ten are not cured with the current standard of care, and the majority of people who require subsequent lines of therapy have poor outcomes.4,5 Most DLBCL relapses occur within 24 months of starting treatment and patients who remain progression-free 24 months following initiation of first-line therapy have favourable survival outcomes.4 “After more than 20 years with very limited treatment advances, the approval of Polivy plus R-CHP marks a new era for people battling this aggressive disease,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We are delighted that the European Commission has approved this Polivy regimen and believe it has the potential to make a significant impact on the lives of people with DLBCL.” “The approval of Polivy plus R-CHP in the first-line setting is great news for people in the EU diagnosed with this aggressive lymphoma, giving them a greater opportunity for positive outcomes,” said Professor Hervé Tilly, POLARIX Principal Investigator and Professor of Haematology at the University of Rouen. “Treatment with this regimen has been shown to reduce the chance of relapse and therefore need for subsequent treatments, limiting the burden of DLBCL.” Today's EC approval was based on results from the phase III POLARIX study (GO39942), the first trial to show a clinically meaningful improvement in progression free survival (PFS), compared to standard of care rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP), in people with previously untreated DLBCL. All patients were followed for at least 24 months and at a median follow-up of 28.2 months, results of the study showed a 27% reduction in the risk of disease worsening or death with Polivy plus R-CHP compared to R-CHOP in first-line DLBCL (hazard ratio [HR] 0.73; 95% confidence interval [CI]: 0.57–0.95; P

Roche's Polivy combination approved by European Commission for people with previously untreated diffuse large B-cell lymphoma

Basel, 25 May 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) and its subsidiary TIB Molbiol have developed three unique LightMix® Modular Virus kits in response to recent monkeypox virus concerns. Multiple clusters of the monkeypox virus have been reported within the past two weeks in several European countries and North America, which are regions where the virus is not normally found.

Roche develops unique PCR tests to detect the monkeypox virus

Declining demand for COVID-19 screening tests calls for a new focus.

Why Roche Needs to Invest in At-Home Diagnostics

Basel, 24 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held 3-7 June, 2022. Roche and its partners will present clinical studies across medicines, comprehensive genomic tests, and real-world data at this year's meeting. “At ASCO this year, progress from our portfolio, partnerships and collaborations showcase our commitment to advance innovation in cancer care,” said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. “We're especially pleased to present data from our broad haematology portfolio, including pivotal data for glofitamab, a potential first-in-class bispecific antibody that may improve the lives of people with heavily pre-treated aggressive lymphoma.” Focusing on improving outcomes in non-Hodgkin lymphoma New and updated data in non-Hodgkin lymphoma will be presented at ASCO. This includes pivotal data from the phase II NP30179 study evaluating glofitamab, an investigational CD20xCD3 T-cell engaging bispecific antibody, in heavily pre-treated patients with diffuse large B-cell lymphoma (DLBCL). DLBCL is an aggressive form of lymphoma, where as many as 40% of patients will relapse, at which point treatment options are limited and survival is shortened.1,2 Glofitamab is part of Roche's broad bispecific antibody development programme, which may offer a new immunotherapy-based approach to tackle a range of blood cancers. It is being investigated in several clinical trials including the STARGLO phase III study, evaluating glofitamab in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in autologous stem-cell transplant ineligible relapsed or refractory DLBCL. In addition, key findings from an analysis of the Asia subpopulation from the pivotal phase III POLARIX study investigating Polivy® (polatuzumab vedotin) in combination with MabThera/Rituxan plus cyclophosphamide, doxorubicin and prednisone (R-CHP) in people with newly diagnosed DLBCL will be featured. Polivy plus R-CHP is the first treatment regimen to significantly improve outcomes in previously untreated DLBCL in more than 20 years, potentially transforming treatment for people with this disease. Driving innovat ion in personalised cancer care More than 20 new pieces of research from partnerships with Foundation Medicine will be presented, which continue to support innovation as well as progress in personalised cancer care. This includes new data from the phase II Profiler02 study,* which investigates the use of a comprehensive genomic profiling testing panel from Foundation Medicine, with the aim of informing possible treatment decisions for patients based on their tumour's unique genomic information. Data from the imCORE network Additionally, three abstracts from the Immunotherapy Centers Of Research Excellence (imCORE) Network will be presented at ASCO: a phase I study investigating autogene cevumeran (an mRNA-based individualised neoantigen-specific immunotherapy [iNeST]***) in the adjuvant setting of pancreatic ductal adenocarcinoma;** a data mining study evaluating intermediate endpoints for survival in metastatic breast cancer in the real-world setting;** and a study identifying mechanisms of acquired resistance to immune checkpoint blockade.**

Data at the 2022 ASCO Annual Meeting highlight Roche's continued commitment to innovation in oncology and personalised healthcare

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from clinical trials of 18 approved and investigational medicines across more than 20 cancer types will be presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held June 3-7, 2022. Genentech and its partners will present clinical studies across medicines, comprehensive genomic tests, and real-world data at th

Data at the 2022 ASCO Annual Meeting Highlight Genentech's Continued Commitment to Innovation in Oncology and Personalized Healthcare

CAMBRIDGE, Mass.--(BUSINESS WIRE)--METiS announces that it is officially joining the Roche Accelerator

METiS Joins the Roche Accelerator

Roche (RHHBY) stock declines as the late-stage study evaluating tiragolumab plus Tecentriq fails to meet its co-primary endpoint of progression-free survival.

Roche (RHHBY) Phase III NSCLC Study Disappoints, Stock Down

Roche administrative-board Chairman Christoph Franz said on Thursday a wide product development pipeline at the Swiss pharma and diagnostics company would offset the loss in growth prospects from a failure in immuno-oncology development this week.

Roche chairman: broad pipeline can cushion blow from cancer setback

Basel, 12 May 2022 - Roche (SIX: RO, ROG; OTCQX: RHHBY), through its Global Access Program, and The Global Fund to Fight AIDS, Tuberculosis and Malaria are joining forces to build and strengthen diagnostic capacity and pandemic preparedness in low-and middle-income countries fighting against HIV and tuberculosis (TB).

Roche enters partnership with the Global Fund to support low- and middle-income countries in strengthening critical diagnostics infrastructure

FRANKFURT (Reuters) -Development of a new cancer treatment pioneered by Roche was thrown into doubt on Wednesday when the immunotherapy drug failed to slow progression of lung cancer in a second trial, hitting the Swiss pharmaceutical maker's shares.

Blow to Roche's cancer immunotherapy prospects as 2nd trial fails

Roche Holding AG ROG, -6.27% said Wednesday that an experimental immunotherapy tested in combination with the cancer treatment Tecentriq failed to meet the primary co-endpoint of progression-free survival in a Phase 3 clinical trial. The study was evaluating the combination therapy as a treatment for non-small cell lung cancer.

News for Roche Holding AG Stock (RHHBY)