In addition to all the efforts in the fight against the COVID-19 pandemic, Roche has continued to develop innovative medicines for other serious diseases.
By Andrew Humphreys • [email protected]
Telephone: +41 61 688 11 11
OUTCOMES CREATIVITY INDEX SCORE: 54
Manny Awards — 5
Cannes Lions — 15
Clio Health — 10
Creative Floor Awards — 24
MM+M Awards — N/A
One Show — N/A
(All sales are in millions of dollars, except EPS, and were translated using the Federal Reserve Board’s average rate of exchange in 2020: SFr 0.9389)
Net income $16,049
Diluted EPS $17.60
R&D expense $12,944
Net income $8,311
Diluted EPS $9.64
R&D expense $7,125
Best-Selling Rx Products
(All sales are in millions of dollars and were translated using the Federal Reserve Board’s average rate of exchange in 2020: SFr 0.9389)
Activase, TNKase $1,407
Activase, TNKase $637
Roche is a worldwide pioneer in pharmaceuticals and diagnostics concentrated on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics, as well as growing capabilities in the field of data-driven medical insights help the company deliver truly personalized healthcare.
Roche is the world’s largest biotechnology company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and CNS diseases. Roche is additionally the global leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. In recent years, the company has invested in genomic profiling and real-world data partnerships and has become an industry-leading partner for medical insights.
Roche is active in more than 100 countries. U.S.-based biotech leader Genentech is a wholly owned member of Roche, which is the majority shareholder in Chugai Pharmaceutical, one of Japan’s leading drug companies.
COVID-19 Therapeutics & Tests
“The COVID-19 pandemic outbreak has posed an unprecedented challenge for healthcare systems across the globe. The Roche Group has responded to this challenge with both its pharmaceuticals and diagnostics businesses,” according to the company’s management team. “In March 2020 the Diagnostics Division launched its cobas SARS-CoV-2 PCR test. This runs on the high-volume fully automated cobas 6800 and cobas 8800 Systems based on PCR technology, which are installed in major hospitals and laboratories around the world. Roche Diagnostics has also continued to complement its portfolio with point-of-care tests, such as the SARS-CoV-2 Rapid Antigen test. In the Pharmaceuticals Division, Actemra/RoActemra has been adopted by many countries in their treatment guidelines to treat patients with severe COVID-19 pneumonia, and in August 2020, the Roche Group announced that it is partnering with Regeneron to develop, manufacture and distribute its investigational neutralizing antibody combination.”
Roche received Emergency Use Authorization (EUA) from the FDA in June 2021 for intravenous Actemra/RoActemra (tocilizumab) for treating COVID-19 in hospitalized adults and pediatric patients (2 years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). The EUA is based on results from four randomized, controlled trials that assessed Actemra/RoActemra for the treatment of COVID-19 in more than 5,500 hospitalized patients. The results of these clinical trials suggest that Actemra/RoActemra may improve outcomes in patients receiving corticosteroids and requiring supplemental oxygen or breathing support.
Roche reported during March that the REMDACTA clinical study of Actemra/RoActemra plus Veklury did not meet the trial’s primary endpoint of improved time to hospital discharge for patients with severe COVID-19 pneumonia or key secondary endpoints compared to Veklury alone. The study was performed in collaboration with Gilead Sciences.
In other clinical trials of Actemra/RoActemra for COVID-19 pneumonia, EMPACTA met the study’s primary endpoint while COVACTA did not. The antiviral medication Veklury was invented and developed by Gilead and is approved or authorized for temporary use for treating COVID-19.
Japan during July 2021 became the first country to approve Ronapreve (casirivimab and imdevimab) for the treatment of mild-to-moderate COVID-19. The full approval is based on a worldwide Phase III study that found casirivimab and imdevimab reduced hospitalization or death by 70 percent in high-risk non-hospitalized patients.
“Ronapreve has been shown to improve survival in high-risk, non-hospitalized COVID-19 patients by reducing the risk of hospitalization and death. In addition, its ability to retain activity against emerging variants, including the Delta variant, has been demonstrated in preclinical studies,” stated Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development.
A Phase III prevention study demonstrated subcutaneous administration of Ronapreve reduced risk of symptomatic COVID-19 infections by 81 percent. Roche reported in April that among individuals who still experienced symptomatic infections, those who received casirivimab and imdevimab were able to clear the virus faster and had much shorter symptom duration. In a cohort of recently infected asymptomatic patients, the antibody cocktail reduced the overall risk of progressing to symptomatic COVID-19 by 31 percent.
The REGN-COV 2069 study evaluated the ability of the casirivimab and imdevimab combo to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The study, which was jointly performed with the National Institute of Allergy and Infectious Diseases (NIAID) – part of the National Institutes of Health (NIH) – met the primary and key secondary endpoints. Additionally, individuals treated with casirivimab and imdevimab who still experienced a symptomatic infection resolved their symptoms on average within one week, versus three weeks with placebo.
Roche confirmed during January that the U.S. Department of Health and Human Services (HHS) and the Department of Defense (DOD) would purchase additional supply of the casirivimab and imdevimab antibody cocktail for use in non-hospitalized COVID-19 patients as part of Operation Warp Speed. The U.S. government would provide these additional doses at no cost to patients.
The new agreement covered 1.25 million additional doses of the antibody cocktail, bringing the total potential U.S. supply to more than 1.5 million doses. Regeneron is distributing the antibody cocktail in the United States and Roche is responsible for non-U.S. distribution.
Roche is also assessing AT-527 for the treatment and prevention of COVID-19 in partnership with Atea Pharmaceuticals. Interim results presented in June from a Phase II study indicated rapid and sustained antiviral activity against SARS-CoV-2 in hospitalized COVID-19 patients. The companies are jointly developing the oral direct-acting antiviral (DAA) agent, which is derived from Atea’s purine nucleotide prodrug platform.
As of July, Roche was ramping up the company’s production capacity for AT-527 – which requires a complex manufacturing process – as much as possible.
Reinforcing the company’s position as a world-leading supplier of COVID-19 diagnostics, the cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System was granted an FDA EUA in June for PCR testing of symptomatic and asymptomatic individuals at the point of care (with results within 20 minutes).
Roche received CE Mark during June for the company’s SARS-CoV-2 Antigen Self Test Nasal for at-home testing. The test was made available in countries accepting the CE Mark through pharmacies and other locations, in packs of five tests. An early version of the test was made available as a home-test in various European markets under local special approval pathways beginning in February 2021.
According to Roche, the SARS-CoV-2 Antigen Self Test Nasal allows individuals to quickly and conveniently test themselves for COVID-19 at home using a simple nasal swab. The test works seamlessly with NAVIFY Pass, Roche’s digital solution that enables individuals and healthcare providers to immediately store, display and share their COVID-19 test results and vaccine status via a unique QR code.
Roche introduced the cobas SARS-CoV-2 Variant Set 1 Test in March 2021 to help monitor emerging coronavirus mutations that originated in the U.K. (B.1.1.7), South Africa (B.1.351) and Brazil (P.1). The test is designed to detect key spike mutations in virus variants associated with increased human-to-human transmission. Roche says accurate detection and differentiation of SARS-CoV-2 mutations can help assess the spread of circulating variants and monitor their potential impact on therapeutics, vaccines and public health interventions..The test runs on widely used high-throughput systems and is intended only for research purposes.
The Roche SARS-CoV-2 Rapid Antigen Test received special approval in February 2021 for at-home patient self-testing using nasal swabs in Germany.
Roche obtained the CE Mark for the SARS-CoV-2 Rapid Antigen Test Nasal, as announced Feb. 1. In comparison to the Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects samples from the front nose area instead of the nasopharynx, resulting in a simplified and faster testing procedure.
Financial & Product Performance
Management says the Roche Group’s business has so far proved to be largely resilient in the difficult pandemic environment. For 2020, the Roche Group generated sales growth of 1 percent at constant exchange rates (CER) and core operating profit growth of 4 percent. IFRS net income rose 17 percent due to the prior period including significant goodwill write-offs, and Core EPS increased 4 percent. According to Roche, the appreciation of the Swiss franc against almost all currencies had an adverse impact on the results expressed in Swiss francs versus constant exchange rates of 6 percentage points on sales, 8 percentage points on core operating profit and 9 percentage points on Core EPS.
Sales in the Pharmaceuticals Division during 2020 declined 2 percent due to biosimilar erosion, which Roche says was especially pronounced in the United States, and COVID-19 effects. The uptake of new medicines globally continued to be strong and partly compensated for these effects, according to Roche. Diagnostics Division sales of COVID-19-related tests during 2020 amounted to CHF 2.6 billion ($2.77 billion) and drove the 14 percent growth in divisional sales, which more than offset a decrease in routine testing across the portfolio.
Coming off the 2020 financial year in which Roche Group sales declined by CHF 3.14 billion ($3.35 billion) versus the 2019 period, first-half 2021 sales rose 8 percent at constant exchange rates to CHF 30.71 billion ($32.71 billion). Core operating profit for the 2021 first-half period grew 4 percent. IFRS net income improved 2 percent while Core EPS went up 6 percent compared to first-half 2020. According to Roche, the appreciation of the Swiss franc against most currencies had an adverse net impact on the results expressed in Swiss francs compared to constant exchange rates of 3 percentage points on sales and 5 percentage points on core operating profit, IFRS net income and Core EPS.
The 8 percent sales growth in CER was fueled by the Diagnostics Division, where there was continued growth in the sales of COVID-19-related products along with a rebound in routine testing across all regions as pandemic measures eased. Sales for the division totaled CHF 9.04 billion ($9.63 billion) during the January-June 2021 period.
Sales in the Pharmaceuticals Division during first-half 2021 were lower due to biosimilar competition, notably in the United States, although the continuing uptake of new medicines helped to compensate for this. Core operating profit growth of 4 percent reflects the sales growth, combined with increased cost of sales, due to the increasing proportion of diagnostics sales in the overall sales mix as well as an increase of 19 percent in R&D costs in the Pharmaceuticals Division.
During the first six months of 2021, the COVID-19 pandemic continued to affect sales across the entirety of Roche’s business. Sales in the Pharmaceuticals Division were reported at CHF 21.67 billion ($23.08 billion. The 3 percent decrease at CER was driven by biosimilar competition, particularly in the United States. Despite this, there was increasing demand for new medicines, including Ronapreve, Ocrevus, Hemlibra, Tecentriq, Evrysdi and Kadcyla. These medicines contributed a combined CHF 2.3 billion ($2.45 billion) at CER in new sales. Overall, the COVID-19 pandemic continued to have a negative impact on the division’s sales because of reduced hospitalizations and outpatient visits remaining lower than they would otherwise have been.
The Diagnostics Division produced sales of CHF 9.04 billion ($9.63 billion), growing 51 percent at CER during first-half 2021. According to Roche, the growth is mainly due to sales of COVID-19-related products, notably the cobas SARS-CoV-2 PCR test and the SARS-CoV-2 Rapid Antigen test. Total sales of all COVID-19-related tests at CER were CHF 2.5 billion ($2.66 billion). Roche says routine testing, which was greatly affected by the pandemic during 2020, rebounded across all regions during the first six months of 2021. As a direct result, sales increased in all regions, notably in the Europe, Middle East and Africa region, which generated sales growth of 70 percent, and in the Asia-Pacific region, where the growth came in at 44 percent.
Roche Group’s Core EPS grew 6 percent in CER (1 percent increase in Swiss franc terms), supported by the results from treasury operations. IFRS net income during the 2021 first half rose 2 percent (3 percent decrease in Swiss franc terms) due to an increase in spending on restructurings and the base effect of income from the release of litigation provisions in the first six months of 2020. Operating free cash flow totaled CHF 8.1 billion ($8.63 billion), an increase of 71 percent, due to the base effect of the significant increases in net working capital and spending on in-licensing and alliance arrangements during first-half 2020. The free cash flow amounted to CHF 6.0 billion ($6.39 billion), a 99 percent increase, due to growth in operating free cash flow. The GenMark Diagnostics acquisition was completed for CHF 1.7 billion ($1.8 billion).
According to Roche, despite the continued strong impact of biosimilars, full-year 2021 sales are expected to grow in the low- to mid-single digit range, at constant exchange rates. “Core earnings per share are targeted to grow broadly in line with sales, at constant exchange rates. Roche expects to increase its dividend in Swiss francs further,” management says.
Acquisitions, Deals & Partnerships
Roche agreed on a definitive merger deal in March 2021 with GenMark Diagnostics to access novel technology to test for broad range of pathogens with one patient sample. Roche agreed to acquire GenMark Diagnostics for $24.05 per share for a total transaction value of $1.8 billion on a fully diluted basis. The transaction was completed in April.
GenMark provides molecular diagnostic tests designed to detect multiple pathogens from a single patient sample. The company’s ePlex platform delivers rapid and actionable results so clinicians can determine the cause of infection and the most effective treatment, potentially saving lives and alleviating the healthcare burden. The addition of GenMark’s proprietary multiplex technology complements Roche’s diagnostic offering, addressing a wide array of infectious disease testing needs, including respiratory and bloodstream infections.
Roche inked a definitive share purchase deal with long-term partner TIB Molbiol Group to expand the PCR-test portfolio in the fight against new infectious diseases. The acquisition of TIB Molbiol is expected to close during fourth-quarter 2021. Management says TIB Molbiol excels in ultra-rapid assay development for emerging infectious disease, strongly demonstrated during the COVID-19 pandemic. The acquisition allows Roche to further expand the portfolio of more than 45 CE-IVD assays and 100-plus research use assays on Roche`s LightCycler PCR instruments.
Roche renewed a partnership with Sysmex in January 2021 to deliver hematology testing solutions. Roche says this successful long-running partnership continues to evolve and bring hematology testing innovations to laboratories around the world. The updated deal aims to use IT systems to lead to improved clinical decision making and customer experience.
Pharma Product Approvals & Pipeline Updates
Actemra/RoActemra in March became the first biologic therapy approved by the FDA for slowing the rate of decline in pulmonary function in adults with systemic sclerosis-associated interstitial lung disease. In a worldwide study, Actemra/RoActemra reduced the rate of progressive loss of lung function in people with SSc-ILD versus placebo. The FDA had previously granted Priority Review designation to Actemra/RoActemra for treating SSc-IL, a progressive disease that can significantly impact lung function and can be life-threatening.
Roche’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection was approved during April by the FDA across all approved U.S. indications. Xolair represents the only U.S.-approved biologic designed to target and block immunoglobulin E (IgE) for treating moderate-to-severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps.
The U.S. Food and Drug Administration during July 2021 accepted Roche’s Biologics License Application (BLA), under Priority Review, for faricimab as a treatment for neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME). The U.S. regulatory agency additionally accepted the company’s submission for diabetic retinopathy. The European Medicines Agency has additionally validated the faricimab Marketing Authorization Application filing in nAMD and DME.
Roche says across four Phase III studies, half of patients receiving faricimab could extend treatment time to every four months – the first time this level of durability has been achieved in Phase III nAMD and DME trials. If cleared for marketing, faricimab would represent the first medicine designed to target two distinct pathways that drive retinal diseases that can cause vision loss.
Tecentriq (atezolizumab) was given the green light by European Commission in May 2021 as a first-line monotherapy treatment for people with a type of metastatic non-small cell lung cancer. In a Phase III trial, Tecentriq significantly improved overall survival in people with high PD-L1 expression compared with chemotherapy. The approval represents Tecentriq’s fourth indication in metastatic non-small cell lung cancer and fifth indication in lung cancer overall in the European Union.
Data from the Phase III IMpower010 study reported in September 2021 reinforce the significant disease-free survival benefit offered by Tecentriq for people with Stage II-IIIA non-small cell lung cancer (NSCLC) whose tumors express PD-L1≥1%. Published in The Lancet, Tecentriq is the first cancer immunotherapy to demonstrate positive Phase III results in the adjuvant lung cancer setting.
The FDA granted Priority Review to Tecentriq as adjuvant treatment for certain people with early non-small cell lung cancer based on results of the IMpower010 trial. The marketing application is being reviewed under the FDA’s Real-Time Oncology Review pilot program.
Pivotal Phase III data presented at the American Society of Clinical Oncology (ASCO) congress in June 2021 showed Tecentriq helps certain people with early lung cancer live significantly longer without their disease returning. The product improved disease-free survival by more than one-third in people with PD-L1-positive resectable early-stage lung cancer, versus best supportive care. Tecentriq is the first cancer immunotherapy to demonstrate positive Phase III results in the adjuvant lung cancer setting.
The U.S. regulatory agency’s Oncologic Drugs Advisory Committee (ODAC) voted 10 to 1 in favor of maintaining accelerated approval of Tecentriq for treating adults with locally advanced or metastatic urothelial carcinoma (mUC, bladder cancer) who are not eligible for cisplatin-containing chemotherapy and whose tumors express high levels of PD-L1 (PD-L1–stained tumor-infiltrating immune cells covering ≥5 percent of the tumor area) as determined by an FDA-approved test or are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. The ODAC meeting in late April 2021 was part of an industry-wide review of accelerated approvals with confirmatory studies that have not met their primary endpoint(s) and have yet to gain regular approvals.
On August 27, Roche announced the decision to voluntarily withdraw the U.S. accelerated approval for Tecentriq in combination with chemotherapy (Abraxane, albumin-bound paclitaxel; nab-paclitaxel) for treating adults with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1, as determined by an FDA-approved test. Roche made this decision following consultation with the FDA, based on the regulatory agency’s evaluation of the mTNBC treatment landscape and in accordance with the requirements of the accelerated approval program. Roche management said the decision only impacts the mTNBC indication in the United States.
Roche announced during March the voluntary withdrawal of the U.S. indication for Tecentriq in prior-platinum treated metastatic urothelial carcinoma.
Roche unveiled updated data in January 2021 confirming Tecentriq in combination with Avastin substantially improves overall survival in people with the most common form of liver cancer. According to the company, Tecentriq in combination with Avastin provides the longest overall survival seen in a front-line Phase III trial in unresectable hepatocellular carcinoma (HCC).
The novel anti-TIGIT tiragolumab was granted FDA Breakthrough Therapy Designation during February in combination with Tecentriq for PD-L1-high non-small cell lung cancer. The BTD is based on the randomized Phase II CITYSCAPE trial demonstrating encouraging efficacy and safety with tiragolumab plus Tecentriq in people with PD-L1-positive metastatic non-small cell lung cancer.
Evrysdi (risdiplam) was approved by the European Commission during March 2021 as the first at-home treatment for spinal muscular atrophy (SMA). The EC cleared Evrysdi for the treatment of 5q SMA in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies. SMA is a leading genetic cause of death in infants and 5q SMA represents the most common form of the disease.
Roche presented new data at World Muscle Society (WMS) 2021 demonstrating pre-symptomatic babies with SMA treated with Evrysdi maintained the ability to swallow. Roche says Evrysdi has shown consistent clinically meaningful efficacy in adults, children, and babies 2 months and older and has been approved in 58 countries.
“These new data for Evrysdi may help extend the potential benefits of this medicine to the youngest SMA patients. Also, the data from SRP-9001 have helped to optimize the design of the upcoming Phase III trial for DMD,” stated Levi Garraway, M.D., Ph.D, Chief Medical Officer and Head of Global Product Development at Roche.
Data for Evrysdi published in the New England Journal of Medicine demonstrates significant improvement in survival and motor milestones in babies with Type 1 SMA. The FIREFISH Part 2 trial of the Phase II/III global study demonstrated treatment with Evrysdi helped babies stay free of permanent ventilation, sit without support and improve across a range of motor milestones.
Clinical data reported during June 2021 from JEWELFISH, the first study in a diverse population aged 1 to 60 years with SMA who received prior treatment, demonstrated a consistent safety profile and >2-fold increase in SMN protein levels. In preliminary data for the RAINBOWFISH study, pre-symptomatic babies with SMA treated with Evrysdi for at least one year were able to sit, stand and walk.
Two-year data reported in March demonstrated Evrysdi continues to show improvement or maintenance of motor function in people aged 2-25 years with Type 2 or Type 3 SMA.
Roche’s Xofluza was approved by the European Commission for treating influenza during January 2021. Xofluza represents the first new influenza antiviral for patients in almost 20 years. The EC approved single-dose, oral Xofluza for treating uncomplicated influenza in patients aged 12 years and older and for post-exposure prophylaxis of influenza in individuals aged 12 years and above.
Enspryng was the recipient of European Commission approval in June 2021 as the first at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD).Enspryng is the only treatment approved for both adults and adolescents in the European Union with AQP4-IgG seropositive NMOSD. In Phase III trials, the new product significantly reduced the amount and severity of relapses in people with AQP4-IgG seropositive NMOSD.
Enspryng is the first NMOSD treatment that is administered subcutaneously every four weeks, enabling home dosing after appropriate training. The medicine can be used as a monotherapy or in combination with immunosuppressive therapy to reduce relapses and prevent permanent disability.
In another European Commission approval, Venclyxto-based combinations were cleared for marketing in May for adults with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy. The EC approved Venclyxto (venetoclax) in combination with the hypomethylating agents azacitidine and decitabine for the treatment of adults with newly diagnosed AML who are ineligible for intensive chemotherapy. Approval is based on the results of two key trials, Phase III VIALE-A and Phase I/II M14-358, of Venclyxto combined with hypomethylating agents in adults with newly diagnosed AML, who are ineligible for intensive chemotherapy.
The FDA granted Breakthrough Therapy Designation for Venclexta in combination with azacitidine for treating patients with myelodysplastic syndromes (MDS). The designation is based on interim results from the Phase Ib M15-531 trial evaluating Venclexta/Venclyxto plus azacitidine in people with previously untreated higher-risk MDS. This Breakthrough Therapy Designation awarded in July marked the 11th for Roche’s hematology medicines and the sixth for Venclexta for the drug’s potential across multiple blood cancers.
Roche announced data at EHA 2021 reinforcing efficacy of Venclexta/Venclyxto combinations in chronic lymphocytic leukemia (CLL) and acute myeloid leukemia (AML). Four-year follow-up analysis from the Phase III CLL14 trial demonstrated progression-free survival rate of 74 percent in previously untreated patients with CLL three years after completion of a one-year fixed-duration treatment with Venclexta/Venclyxto combined with Gazyva/Gazyvaro. New Phase III MURANO trial data suggested certain genetic risk factors may help tailor treatments for patients with previously treated CLL. A post-hoc analysis from the Phase III VIALE-A trial in newly diagnosed AML indicated increased duration of response, event-free survival and overall survival in patients who achieved undetectable minimal residual disease.
Roche in September received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for Gavreto (pralsetinib) for the treatment of adults with rearranged during transfection (RET) fusion-positive advanced NSCLC. The medicine demonstrated robust and durable clinical responses in people with NSCLC with RET fusions. If cleared for this indication, Gavreto would represent the first targeted treatment approved by the EMA that includes first-line treatment of individuals with RET fusion-positive advanced NSCLC.
The FDA accepted Roche’s Biologics License Application (BLA), under Priority Review, for Port Delivery System (PDS) with ranibizumab for treating neovascular or “wet” age-related macular degeneration (nAMD). Neovascular AMD is a leading cause of blindness for people aged 60 and older and impacts 20 million people around the globe.
If granted approval, PDS would be a first-of-its-kind therapeutic approach, offering people living with nAMD an alternative to frequent eye injections of anti-vascular endothelial growth factor (VEGF), the standard of care. An FDA approval decision is anticipated by Oct. 23, 2021. The European Medicines Agency has validated the PDS Marketing Authorization Application in nAMD.
Roche says the latest advances with immunotherapies in non-Hodgkin lymphoma presented at ASCO 2021 were encouraging. Data from the emerging T-cell engaging bispecific antibodies, mosunetuzumab and glofitamab, and the antibody-drug conjugate Polivy, demonstrate the potential of these novel immunotherapeutic approaches for people with various types of blood cancer.
Phase III POLARIX data unveiled in August demonstrated Polivy (polatuzumab vedotin) in combination with Rituxan/MabThera (rituximab) plus cyclophosphamide, doxorubicin and prednisone (R-CHP) is the first regimen in 20 years to significantly improve outcomes in a previously untreated aggressive form of lymphoma compared to standard of care. That drug combination met the clinical trial’s primary endpoint by showing significantly improved and clinically meaningful progression-free survival in people with previously untreated diffuse large B-cell lymphoma (DLBCL) compared to Rituxan/MabThera plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP).
According to Roche, prolonging survival without disease advancement could be transformative for newly diagnosed DLBCL patients as 40 percent of patients relapse after disease progression.
Final analysis reported in July from the Phase IIIb STASEY trial – including data from 193 people with hemophilia A – further support the benefit/risk profile of Hemlibra (emicizumab), with no new safety signals identified. STASEY is one of the largest open-label trials primarily investigating safety and tolerability of a medicine for people with hemophilia A with factor VIII inhibitors. Hemlibra additionally continued to show effective bleed control with a high proportion of participants (82.6 percent) achieving zero treated bleeds.
New data released during April for Ocrevus (ocrelizumab) reinforce significant benefit on slowing disease progression in relapsing and primary progressive multiple sclerosis (RRMS). Roche said 85 percent of treatment-naïve, early-stage RRMS patients achieved no evidence of disease activity (NEDA) in the open-label Phase IIIb ENSEMBLE trial.
Additionally, the medicine significantly slowed loss of brain tissue within T2 MRI lesions in primary progressive multiple sclerosis (PPMS) in a post-hoc analysis of the Phase III ORATORIO trial. OCREVUS-treated patients demonstrate the highest adherence and persistence rates versus other disease-modifying therapies (DMTs) in two-year U.S. claims analysis.
Roche continues to advance science in multiple sclerosis and is exploring the investigational medicine fenebrutinib. Data reported in April from the highly selective, non-covalent, reversible oral BTKi support the new drug candidate’s safety profile in several autoimmune diseases and high potency, which Roche says is encouraging for the ongoing Phase III trials in RMS and PPMS. Fenebrutinib is a dual inhibitor of B-cell and myeloid lineage-cell activation, which may offer a novel approach to slowing disease progression by targeting acute and chronic inflammatory aspects of MS.
Diagnostic Approvals, Launches & Updates
Roche received FDA marketing approval in August 2021 for the first companion diagnostic to identify deficient Mismatch Repair (dMMR) solid tumor patients eligible for anti-PD-1 immunotherapy. The VENTANA MMR RxDx Panel aids in identifying patients whose solid tumors are deficient in DNA mismatch repair who may be eligible for Jemperli (dostarlimab-gxly) monotherapy, an anti-PD-1 immunotherapy from GlaxoSmithKline. The test assesses a panel of MMR proteins in tumors to provide significant treatment information to clinicians. According to Roche, the GSK collaboration represents an important step towards a personalized healthcare strategy for certain solid tumor patients.
FDA marketing approval was granted in April for the VENTANA MMR RxDx Panel for advanced or recurrent endometrial cancer patients. This approval marks the first companion diagnostic to identify endometrial cancer patients eligible for immunotherapy. According to Roche, MMR is a molecular mechanism that functions to correct certain errors that can spontaneously occur during DNA replication. Testing can identify patients eligible for treatment with GSK’s Jemperli monotherapy, which was approved by U.S. regulators on April 22, 2021.
Roche launched during April new ways (claim extensions) to use the company’s cardiovascular tests, empowering clinicians to improve screening, diagnosis and treatment of millions of people. The company says these gold standard biomarkers have proven to be successful in supporting cardiovascular disease management and can help clinicians diagnose heart attacks (Troponin T) and manage heart failure more effectively (NT-proBNP).
Roche launched the Elecsys Anti-p53 immunoassay during April in all markets accepting the CE Mark to aid diagnosis of various cancer types. Anti-p53 antibodies mistakenly target a patient’s own tissues, resulting in growth of solid tumors. Anti-p53 screening helps to diagnose throat, bowel and breast cancers earlier, thereby elevating the chances that a patient responds to a treatment.
The company launched the Elecsys Epstein-Barr Virus (EBV) immunoassay panel during March in countries accepting the CE Mark to improve EBV infection staging. The panel accurately identifies the EBV infection stage from a single blood sample, which means less confirmatory testing and, potentially, faster patient diagnosis. According to Roche, clear and quick diagnosis of acute infection enables physicians to decide faster on treatment for transplant patients. The EBV panel can be used to rule out other acute infections, including missed HIV infections.
In September 2021, the company launched three respiratory test panels on the cobas 6800/8800 Systems in CE markets to help identify multiple pathogens with overlapping symptoms in patients. The three molecular PCR diagnostic test panels simultaneously detect and differentiate common respiratory pathogens: influenza A, influenza B and respiratory syncytial virus (RSV); adenovirus (ADV), human metapneumovirus (hMPV) and enterovirus/rhinovirus (EV/RV); and parainfluenza 1, 2, 3, and 4.
Roche’s cobas MTB and cobas MTB-RIF/INH tests for use on the cobas 6800/8800 Systems were included during July as part of the updated World Health Organization policy guidelines on nucleic acid amplification tests to detect tuberculosis and drug-resistant TB.
Eight new configurations for cobas pro integrated solutions were introduced by Roche during March in countries accepting the CE Mark. This analyzer can deliver up to 4,400 tests per hour, doubling previous testing capacity.
In another March launch in countries accepting the CE Mark, Roche introduced the cobas pure integrated solutions analyzer to help simplify operations in small to medium sized labs.
The FDA granted Breakthrough Device Designation in February for Roche’s Elecsys Growth Differentiation Factor-15 (GDF-15) assay to help identify patients suitable for innovative treatment addressing unintentional weight loss in cancer patients.
During January, the company announced the CE-IVD launch of Roche’s automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath HER2 Dual ISH image analysis for breast cancer to help determine the best treatment strategy for each patient.