Polatuzumab Vedotin-Piiq

Pictured: Roche's building in Shanghai, China/iStock, Robert Way Roche released its first-quarter 2024 earnings results on Wednesday posting a 6% decline in sales compared to the same prior year period, as the company continued to be weighed down by weak demand for COVID-19 products and currency headwinds while narrowly beating analysts’ expectations. In the first quarter of 2024, the pharma group’s sales brought in around $15.79 billion, down from its Q1 2023 earnings of approximately $16.78 billion. The performance of Roche’s pharmaceuticals division likewise slowed by 6% in the quarter, with its sales falling to $11.96 billion from $12.71 billion in the same period last year. CEO Thomas Schinecker in a statement attributed the decline to the ongoing contraction of the COVID-19 market and to the “appreciation of the Swiss franc versus most currencies,” which in turn had a significant adverse impact on the group’s sales reported in Swiss francs. At constant exchange rates, Roche’s earnings grew by 2%. Excluding pandemic-related products, sales increased by 7%. “After this quarter, the COVID-19-related impact on sales is largely behind us,” Schinecker added. The eye treatment Vabysmo (faricimab-svoa) emerged as Roche’s strongest growth driver, bringing in $927.4 million in Q1, a 108% increase compared with the same period in 2023 while beating the analyst consensus. Vabysmo was first approved in February 2022 for wet age-related macular degeneration and diabetic macular edema. The drug picked up another approval in October 2023 for retinal vein occlusion. The blood cancer therapy Polivy (polatuzumab vedotin-piiq) and breast cancer medicine Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzfx) were also strong growth contributors in Q1. These assets brought in $424 million and $273 million, respectively, representing sales increases of 70% and 81%. Roche’s top-performing asset was Ocrevus which secured $1.82 billion in Q1, representing 8% growth from the same time period in 2023. As for its pipeline, the pharma group disclosed in Wednesday’s earnings presentation that it had discontinued the development of four early-stage assets including camonsertinib—which was being trialed in solid tumors—and belvarafenib, which was likewise being assessed for solid tumors in combination with Genentech’s Cotellic (cobimetinib). Roche also terminated two new molecular candidates—one for colorectal cancer and one for psychiatric disorders. Looking forward to the rest of the year, Roche reaffirmed its 2024 outlook and noted in its statement that the company expects a sales increase in the mid-single digit range at constant exchange rates. To meet its forecast, Roche has several milestones lined up including a potential U.S. and European Union approval for crovalimab in paroxysmal nocturnal hemoglobinuria and for subcutaneous Ocrevus in relapsing or primary progressive multiple sclerosis. The pharma group is also preparing for key readouts for the Phase III VERONA study of Venclexta plus azacitidine in first-line myelodysplastic syndrome, as well as the Phase IIb PADOVA trial of prasinezumab in Parkinson’s disease. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Columvi, in combination with chemotherapy, demonstrated a statistically significant improvement in overall survival for people with relapsed or refractory diffuse large B-cell lymphoma Data from the STARGLO study will be submitted to health authorities and presented at an upcoming medical meeting 15 April 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the Phase III STARGLO study met its primary endpoint of overall survival. The study demonstrated that people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant, lived longer when treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx. Safety of the combination appeared consistent with the known safety profiles of the individual medicines. The data will be submitted to health authorities and shared at an upcoming medical meeting. “People with this aggressive lymphoma facing relapse or progression after initial treatment have limited options – particularly those who are ineligible for stem cell transplant,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Building on Columvi’s established benefits, these data demonstrate the potential of this combination regimen to improve survival outcomes in earlier lines of treatment.” Columvi was the first fixed-duration bispecific antibody to receive accelerated approval by the U.S. Food and Drug Administration and conditional marketing authorisation from the European Commission to treat people with R/R DLBCL after two or more lines of systemic therapy. These approvals were based on positive results of Columvi as a monotherapy from the pivotal Phase I/II NP30179 study in patients with R/R DLBCL who had previously received two or more prior treatments. Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to be off-the-shelf and ready for infusion, so patients can start treatment soon after diagnosis. This is particularly important for patients with highly aggressive disease who are at risk of rapid disease progression. Columvi is given as a fixed-duration treatment, offering people with R/R DLBCL who have failed two or more lines of therapy a treatment end date and the possibility of a treatment-free period, unlike continuous treatments. The STARGLO study [GO41944; NCT04408638] is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant.1 Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.1 Columvi is a CD20xCD3 T-cell engaging bispecific antibody designed to target CD3 on the surface of T-cells and CD20 on the surface of B-cells. Columvi was designed with a novel 2:1 structural format. This T-cell engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T-cells, a type of immune cell, and two regions that bind to CD20, a protein on B-cells, which can be healthy or malignant. This dual-targeting brings the T-cell in close proximity to the B-cell, activating the release of cancer cell-killing proteins from the T-cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines, including Polivy® (polatuzumab vedotin), in earlier lines of treatment for people with B-cell non-Hodgkin lymphomas, including diffuse large B-cell lymphoma and other blood cancers. DLBCL is the most common form of non-Hodgkin lymphoma (NHL), accounting for about one in three cases of NHL.2 DLBCL is an aggressive (fast-growing) type of NHL.2 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.3 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes. Approximately 160,000 people worldwide are diagnosed with DLBCL each year.2, 4 Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 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, Hemlibra® (emicizumab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, Tecentriq® (atezolizumab), 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. 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 recognising our endeavour 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 fifteenth 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. References [1] ClinicalTrials.gov. A Phase III Study Evaluating Glofitamab in Combination With Gemcitabine + Oxaliplatin vs Rituximab in Combination With Gemcitabine + Oxaliplatin in Participants With Relapsed/Refractory Diffuse Large B-Cell Lymphoma: NCT04408638 [Internet; cited April 2024]. Available from: https://classic.clinicaltrials.gov/ct2/show/NCT04408638. [2] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited April 2024]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics. [3] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858. [4] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited April 2024]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf. The content above comes from the network. if any infringement, please contact us to modify.