Atezolizumab

Lunsumio provides high rates of deep and long-lasting responses in third-line and later follicular lymphoma, a disease that typically becomes harder to treat each time a patient relapses1,2 Lunsumio subcutaneous offers a new treatment option that can significantly reduce administration time to approximately one minute Availability of Lunsumio SC allows patients to receive treatment aligned to clinical requirements and lifestyle preferences 19 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional marketing authorisation of Lunsumio® (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. Approval is based on results from the phase I/II GO29781 study, which showed that Lunsumio SC had pharmacokinetic non-inferiority compared with intravenous (IV) administration, with no unexpected safety signals.3 “Building on the benefits of its fixed-duration dosing schedule, Lunsumio can now be administered with a one-minute subcutaneous injection, providing people with relapsed or refractory follicular lymphoma an additional treatment option to help meet their individual clinical requirements and lifestyle preferences,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Developing new formulations of our medicines is part of our commitment to offering greater flexibility and a better treatment experience for patients.” Lunsumio SC is a fixed-duration treatment that can be initiated in the outpatient setting and has the potential to substantially reduce treatment administration time with an approximately one-minute injection, compared with a 2-4 hour IV infusion. Lunsumio has shown a favourable benefit-risk profile and high rates of deep and durable remissions with both IV and SC administration routes in third-line or later (3L+) FL.1,4 Lunsumio IV was the first bispecific antibody approved for 3L+ FL and has shown sustained responses, with 57% of patients who achieved a CR still in remission at five years.1 Long-term data from the SC and IV arms of the GO29781 study will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition. These data have been submitted to other healthcare authorities around the world, including the US Food and Drug Administration. Phase III studies involving Lunsumio SC are ongoing, including the MorningLyte trial investigating Lunsumio SC in combination with lenalidomide in previously untreated FL. Lunsumio, along with Columvi® (glofitamab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio. Continuing to explore new formulations and combinations of these medicines across different disease areas and lines of treatment is part of Roche’s commitment to improve the patient experience and provide more choice to suit diverse patient and healthcare system needs. The GO29781 study is a phase II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab), administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The primary objective for the SC cohort was to show pharmacokinetic (PK) non-inferiority of the SC formulation of Lunsumio compared with the IV formulation, based on the study’s co-primary endpoints. Key secondary endpoints include complete response (CR) rate, objective response rate (ORR), duration of response, progression-free survival, safety and tolerability. This approval is based on a primary analysis that explored Lunsumio administered subcutaneously in patients with 3L+ follicular lymphoma. Results from the primary analysis showed PK non-inferiority compared with IV administration, and the ORR and CR rates in patients treated with the fixed-duration, subcutaneous formulation of Lunsumio were 74.5% (95% confidence interval [CI]: 64.4-82.9%) and 58.5% (95% CI: 46.9-68.6%), respectively, as evaluated by the independent review faculty. The median duration of CR was 20.8 months (95% CI: 18.8-not evaluable [NE]) for patients receiving Lunsumio SC. The most common all-grade adverse events were injection-site reactions (60.6%; all Grade 1-2), fatigue (35.1%), and cytokine release syndrome (CRS; 29.8%). Overall, the rate and severity of CRS were low; events were low grade (Grade 1-2, 27.7%; Grade 3, 2.1%), occurred during cycle 1 and all fully resolved in a median of two days (range 1-15 days).3 Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.2,5 It typically responds well to treatment but is often characterised by periods of remission and relapse.2 The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis.5 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.5,6 Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. 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 Lunsumio 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 follicular lymphoma and diffuse large B-cell lymphoma, other blood cancers and autoimmune disorders. 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), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). 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 clinical practice. For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045. 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] Budde E, et al. Fixed treatment duration mosunetuzumab continues to demonstrate clinically meaningful outcomes in patients with relapsed/refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies: 5-year follow-up of a pivotal Phase II study. Presented at: ASH Annual Meeting and Exposition; 2025 Dec 6-9; San Diego, CA, USA. Abstract #5352. [2] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited November 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc. [3] Roche data on file. [4] Assouline S, et al. Fixed-duration subcutaneous mosunetuzumab continues to demonstrate high rates of durable responses in patients with relapsed/refractory follicular lymphoma after ≥2 prior therapies: 3-year follow-up from a pivotal Phase II study. Presented at: ASH Annual Meeting and Exposition; 2025 Dec 6-9; San Diego, CA, USA. Abstract #5353. [5] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited November 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes. [6] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited November2025]. 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.

SAN DIEGO--(BUSINESS WIRE)--Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced alignment with the U.S. Food and Drug Administration (“FDA”) regarding the design of its pivotal study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC). The Company and the FDA completed a recent Type C meeting and have agreed on the key elements of the Phase 3 trial, which will evaluate pelareorep in combination with chemotherapy with or without a checkpoint inhibitor (“CPI”) compared to chemotherapy alone. As a result, Oncolytics now has a clear path to launch what it believes will be the only such pivotal study of an immunotherapy in mPDAC, an indication for which immunotherapies have provided very little benefit. “We now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape,” said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. “The data speaks for itself, but we want to sincerely thank the FDA for its great work in helping us clear this initial regulatory hurdle. Although we still have work to do, we are laser-focused on bringing potential treatments to pancreatic cancer patients who desperately need more options.” The pivotal trial design includes a control arm of gemcitabine plus nab-paclitaxel (GnP), an experimental arm evaluating GnP plus pelareorep and an additional optional experimental arm evaluating GnP plus pelareorep plus a CPI. The primary endpoint of the study is overall survival. Progression-free survival and objective response rate are secondary endpoints. The trial will be statistically powered to demonstrate a clinically meaningful survival benefit and will potentially incorporate an interim analysis to support the option for an accelerated registration timeline. Either experimental arm or potentially both could meet the required success criteria. The study protocol also permits flexibility in CPI selection for the triple-combination arm. Pelareorep has been combined successfully with multiple checkpoint inhibitors—including atezolizumab, pembrolizumab, nivolumab, and retifanlimab—in gastrointestinal and other tumor types. The final CPI choice will reflect ongoing discussions internally and with potential partners. Dr. Thomas Heineman, Chief Medical Officer of Oncolytics, stated, “The FDA’s feedback confirms that our design is appropriate to support registration if successful. We are now completing the administrative activities necessary to initiate the study, including finalizing the protocol, generation of supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete.” The Company is engaged in study start-up activities, including protocol review and site selection, and will provide periodic updates on the trial initiation process. About Oncolytics Biotech Inc. Oncolytics is a clinical-stage biotechnology company developing pelareorep, an investigational intravenously delivered double-stranded RNA immunotherapeutic agent. Pelareorep has demonstrated encouraging results in multiple first-line pancreatic cancer studies, two randomized Phase 2 studies in metastatic breast cancer, and early-phase studies in anal and colorectal cancer. It is designed to induce anti-cancer immune responses by converting immunologically “cold” tumors “hot” through the activation of innate and adaptive immune responses. The Company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in metastatic pancreatic and breast cancers, of which both development programs have received Fast Track designation from the FDA, and other gastrointestinal tumors. Oncolytics is actively pursuing strategic partnerships to accelerate development and maximize commercial impact. For more about Oncolytics, please visit: www.oncolyticsbiotech.com or follow the Company on social media on LinkedIn and on X @oncolytics. Forward-looking statements This press release contains forward-looking statements, within the meaning of Section 21E of the U.S. Securities Exchange Act of 1934, as amended, and forward-looking information under applicable Canadian securities laws (such forward-looking statements and forward-looking information are collectively referred to herein as “forward-looking statements”). Forward-looking statements contained in this press release include statements regarding beliefs as to the potential, registration, mechanism of action and benefits of pelareorep as a cancer therapeutic; expectations regarding the initiation, design, protocol, lead principal investigator, and outcomes of a planned study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma; expectations relating to outcomes of ongoing and future studies; Oncolytics’ plan to continue actively pursuing strategic partnerships; its goals, strategies and objectives; and its belief in the clinical promise of pelareorep in metastatic pancreatic and other gastrointestinal cancers. In any forward-looking statement in which Oncolytics expresses an expectation or belief as to future results, such expectations or beliefs are expressed in good faith and are believed to have a reasonable basis, but there can be no assurance that the statement or expectation or belief will be achieved. These statements involve known and unknown risks and uncertainties that may cause actual results to differ materially from those anticipated. These risks include, but are not limited to, regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Please refer to Oncolytics’ public filings with securities regulators in the United States and Canada for more information. The Company assumes no obligation to update forward-looking statements, except as required by law.