Glofitamab

Lunsumio VELO reduces administration time from 2-4 hours to approximately one minuteAvailability of Lunsumio VELO allows treatment aligned to people’s clinical needs and personal preferences Approval supported by data demonstrating compelling complete response rate in third-line or later follicular lymphoma, which typically becomes harder to treat after each relapse1,2 Basel, 22 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved CD20xCD3 bispecific Lunsumio VELO™ (mosunetuzumab), as a subcutaneous (SC) formulation, for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy, based on results from the phase I/II GO29781 study.1 Based on the study results, Lunsumio VELO is approved under accelerated approval. Full approval for this regimen may be contingent on verification and confirmation of benefit in a confirmatory trial. “Since follicular lymphoma often requires lifelong management, reducing the burden of care for these individuals is of paramount importance,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “With this FDA approval, treatment can now be administered in just one minute, which significantly reduces the time patients spend in the clinic and helps to align care with their individual needs and preferences.” Lunsumio VELO reduces treatment administration time with an approximately one-minute injection, compared with a 2-4 hour intravenous (IV) infusion. Like Lunsumio administered intravenously, Lunsumio VELO can be administered outpatient and is a fixed-duration treatment given for a defined period, which could be as short as six months. By contrast, treat-to-progression treatment options are designed to be given to patients indefinitely until disease progression or until treatment can no longer be tolerated. “This approval is a significant step in broadening access to effective treatments for people living with follicular lymphoma,” said Dr Ian Flinn, MD, PhD, Tennessee Oncology and One Oncology. “With its manageable cytokine release syndrome profile and reduced administration time, Lunsumio VELO enables oncologists to deliver advanced care in community practice settings.” The FDA approval is supported by the primary analysis of the GO29781 study that evaluated Lunsumio VELO in patients with third-line or later (3L+) FL. Results showed the objective response rate and complete response rate in patients treated with Lunsumio VELO were 75% (95% confidence interval [CI]: 64–83%) and 59% (95% CI: 48–69%), respectively.1 The median duration of response was 22.4 months (95% CI: 16.8–22.8).1 The most common adverse reactions (≥20%) were injection site reactions, fatigue, rash, cytokine release syndrome (CRS), COVID-19 infection, musculoskeletal pain and diarrhoea.1 The CRS rate was 30% and events were mostly low grade (Grade 1–2, 28%; Grade 3, 2.1%), occurred during Cycle 1, and all resolved after a median duration of two days (range: 1–15).1 CRS can be severe and life-threatening. Lunsumio IV was the first bispecific antibody approved for 3L+ FL. Long-term data from the SC and IV arms of the GO29781 study were presented at the 67th American Society of Hematology Annual Meeting and Exposition. These data have been submitted to other healthcare authorities around the world. Recently, the European Commission granted conditional marketing authorisation of Lunsumio SC for the treatment of adult patients with R/R FL after two or more lines of systemic therapy. Roche continues to advance its bispecific antibody programme in lymphoma, with ongoing phase III studies evaluating Lunsumio and Lunsumio VELO in earlier lines of treatment. This includes the SUNMO study investigating Lunsumio VELO in combination with Polivy® (polatuzumab vedotin) in second-line or later large B-cell lymphoma, and the MorningLyte study investigating Lunsumio VELO in combination with lenalidomide in previously untreated FL. About the GO29781 study The GO29781 [NCT02500407] study is a phase I/II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of mosunetuzumab administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The efficacy of Lunsumio VELO™ (mosunetuzumab) was established on the basis of objective response rate and duration of response. About follicular lymphomaFollicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.3,4 It typically responds well to treatment but is often characterised by periods of remission and relapse.3,4 The disease typically becomes harder to treat each time a patient relapses and early progression can be associated with poor long-term prognosis.2 It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.4,5 About Lunsumio VELO™ (mosunetuzumab)Lunsumio VELO is a subcutaneous formulation of mosunetuzumab, a 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. Lunsumio VELO is being investigated as a monotherapy and in combination with other medicines, for the treatment of people with B cell non-Hodgkin lymphomas, including follicular lymphoma, large B-cell lymphoma, and other indications. About Roche in haematologyRoche 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 administered intravenously), Lunsumio SC/VELO™ (mosunetuzumab administered subcutaneously) 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. 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. 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. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References[1] Roche data on file. [2] Fowler NH, at al. Moving T-Cell Therapies into the Standard of Care for Patients with Relapsed or Refractory Follicular Lymphoma: A Review. Targ Oncol. 2024;19:495–510.[3] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited December 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.[4] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited December 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.[5] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco-iarc-who-int.libproxy1.nus.edu.sg/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf. Roche Global Media RelationsPhone: +41 61 688 8888 / e-mail: media.relations@roche.com Hans Trees, PhDPhone: +41 79 407 72 58Sileia UrechPhone: +41 79 935 81 48 Nathalie AltermattPhone: +41 79 771 05 25Lorena CorfasPhone: +41 79 568 24 95 Simon GoldsboroughPhone: +44 797 32 72 915Karsten KleinePhone: +41 79 461 86 83 Kirti PandeyPhone: +49 172 6367262Yvette PetillonPhone: +41 79 961 92 50 Dr Rebekka SchnellPhone: +41 79 205 27 03 Roche Investor Relations Dr Bruno EschliPhone: +41 61 68-75284e-mail: bruno.eschli@roche.comDr Sabine BorngräberPhone: +41 61 68-88027e-mail: sabine.borngraeber@roche.com Dr Birgit MasjostPhone: +41 61 68-84814e-mail: birgit.masjost@roche.com Investor Relations North America Loren KalmPhone: +1 650 225 3217e-mail: kalm.loren@gene.com Attachment Media Investor Release Lunsumio VELO FDA Approval English

Issued on behalf of GT Biopharma, Inc. VANCOUVER, BC, Dec. 19, 2025 /PRNewswire/ -- Equity Insider News Commentary – The oncology sector's pivot toward platform-based precision therapies has signaled smart money abandoning single-asset risk for companies engineering multiple drugs from validated mechanisms[1]. Antibody-drug conjugate pipelines expanding past 200 clinical candidates demonstrate how platform technologies enable rapid target-s while preserving core therapeutic advantages, creating sustainable competitive moats that command premium valuations[2]. This structural shift toward modularity positions companies with proprietary engines to capture multiple therapeutic opportunities simultaneously, benefiting GT Biopharma, Inc. (NASDAQ: GTBP), ADC Therapeutics SA (NYSE: ADCT), Sutro Biopharma, Inc. (NASDAQ: STRO), Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX), and TScan Therapeutics, Inc. (NADSAQ: TCRX). Platform technologies now account for 60% of total pharma pipeline value, with immunotherapies commanding over 45% of cancer drug revenues as investors reward modularity over one-shot bets[1]. Clinical-stage biotechs securing $120 million rounds for ADC linker platforms underscore how capital flows toward companies demonstrating platform versatility, where validated mechanisms can address multiple indications without rebuilding infrastructure, compressing development timelines while multiplying commercial opportunities[3]. GT Biopharma, Inc. (NASDAQ: GTBP), a clinical-stage immuno-oncology company, recently reported advancing its Phase 1 clinical trial of GTB-3650 to Cohort 4, where patients now receive 10μg/kg/day dosing. The company specializes in developing next-generation immunotherapy treatments targeting some of the world's most resistant cancer types through its proprietary natural killer cell engager TriKE platform. GT Biopharma's Phase 1 dose escalation trial evaluates GTB-3650 in patients facing relapsed or refractory blood cancers expressing CD33, particularly acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). These cancers represent exceptionally challenging cases where conventional treatments have either failed completely or provided only temporary benefit before disease returned. The therapy harnesses the patient's natural killer cells, an immune cell type that instinctively identifies and eliminates abnormal cells, directing them to attack cancer specifically. Treatment delivery follows a continuous infusion schedule structured as two-week treatment periods followed by two-week rest intervals, with cycles continuing up to four months depending on individual patient response. "We are highly encouraged by the continued progress of our Phase 1 clinical trial evaluating GTB-3650 in cancer patients, which has now advanced to Cohort 4 at a dose level of 10 µg/kg/day," said Michael Breen, Executive Chairman and CEO. "We look forward to assessing higher doses, as we are now approaching the efficacy range predicted by preclinical in vivo leukemia models, and we plan to share the next trial update in the first quarter of 2026." The six patients enrolled throughout Cohorts 1, 2, and 3 have completed GTB-3650 treatment successfully, establishing the therapy's safety profile across escalating dose concentrations. GT Biopharma indicates the current Cohort 4 dose of 10μg/kg/day represents a threshold where clinical efficacy becomes more likely, supported by encouraging immunological biomarker trends and zero dose-limiting toxicities across all completed cohorts. The first-in-human Phase 1 protocol plans for approximately 14 patients distributed across seven cohorts, with each cohort enrolling two patients at progressively increasing doses starting from 1.25μg/kg/day in Cohort 1 and potentially reaching 100μg/kg/day in Cohort 7 if warranted. Following Cohort 4, three additional escalation levels remain: Cohort 5 testing 25μg/kg/day, Cohort 6 evaluating 50μg/kg/day, and Cohort 7 examining the maximum protocol dose of 100μg/kg/day. The company anticipates providing its next comprehensive trial update during first quarter 2026. Beyond hematologic malignancies, GT Biopharma is advancing GTB-5550, targeting B7H3, a protein prevalent across multiple solid tumor categories including breast, lung, ovarian, pancreatic, bladder, and prostate cancers. Regulatory submission to initiate GTB-5550 human trials is expected in late December 2025 or January 2026. Designed as a subcutaneous injection, GTB-5550 offers the potential for eventual self-administration at home, significantly reducing patient burden. Both therapeutic candidates leverage GT Biopharma's proprietary TriKE platform utilizing specialized antibody fragments initially discovered in camels and llamas. These molecules provide distinct advantages compared to traditional antibodies through their compact size and enhanced stability. GT Biopharma maintains exclusive worldwide licensing rights from the University of Minnesota for this technology. CONTINUED… Read this and more news for GT Biopharma, Inc. at: ADC Therapeutics SA (NYSE: ADCT) presented updated data from its LOTIS-7 Phase 1b trial showing ZYNLONTA in combination with glofitamab achieved an 89.8% overall response rate and 77.6% complete response rate across 49 efficacy-evaluable patients with relapsed/refractory diffuse large B-cell lymphoma. The combination demonstrated strong efficacy in both relapsed (100% ORR, 91.7% CR) and primary refractory populations (80% ORR, 64% CR) while maintaining a manageable safety profile with cytokine release syndrome occurring in 36.7% of patients across dose levels. "We're excited that these data continue to demonstrate a manageable safety profile and strong efficacy including deep and durable responses in 2L+ r/r DLBCL patients treated with ZYNLONTA plus glofitamab," said Mohamed Zaki, MD, PhD, CMO of ADC Therapeutics. "We are well on the way to completing enrollment of approximately 100 patients at the selected dose and plan to share full results at a medical congress and through a publication by the end of next year." ADC Therapeutics expects to complete enrollment of approximately 100 patients at the selected 150 µg/kg dose during the first half of 2026. The company plans to share full data at a medical meeting and submit for publication by the end of 2026 while assessing regulatory and compendia strategies for this potential best-in-class bispecific antibody-based combination. Sutro Biopharma, Inc. (NASDAQ: STRO) has dosed the first cohort of patients in its Phase 1 trial evaluating STRO-004, a next-generation Tissue Factor-targeting exatecan antibody-drug conjugate designed for enhanced stability, potency, and tumor selectivity. The multicenter trial is assessing safety, pharmacokinetics, and preliminary anti-tumor activity in patients with TF-expressing solid tumors including non-small cell lung cancer, head and neck squamous cell carcinoma, cervical cancer, colorectal cancer, pancreatic ductal adenocarcinoma, and bladder cancer. "Dosing the initial patients in this trial marks an important milestone in bringing forward new treatment options for patients with TF–expressing cancers—many of whom face limited therapy options and difficult prognoses," said Jane Chung, CEO of Sutro Biopharma. "STRO-004 is engineered to deliver potent, sustained anti-tumor activity and higher exposure compared to approved therapies, with the goal of reaching tumors that are resistant to standard approaches." The dose-escalation phase features high entry doses supported by strong tolerability in non-human primates at up to 50 mg/kg, with initial clinical data expected in mid-2026. Sutro's proprietary cell-free platform produces STRO-004 with site-specific β-glucuronidase cleavable linker and exatecan payload at a drug-to-antibody ratio of 8, designed to enhance stability and maximize efficacy. Crinetics Pharmaceuticals, Inc. (NASDAQ: CRNX) dosed the first patient in its Phase 1/2 BRAVESST trial evaluating CRN09682 for neuroendocrine tumors and other somatostatin receptor 2-expressing solid tumors. The investigational nonpeptide drug conjugate represents the lead candidate from Crinetics' proprietary NDC platform, designed to bind selectively to SST2-expressing tumor cells while promoting rapid receptor internalization to release a cytotoxic payload directly within tumors. "We developed CRN09682 to address the need for a more efficacious, safer, and convenient targeted therapy for patients with SST2-expressing tumors," said Stephen Betz, Ph.D., Chief Scientific Officer and Co-Founder of Crinetics. "Dosing the first patient in the Phase 1/2 study marks a major milestone for CRN09682 and our NDC platform as a whole. CRN09682 is the first clinical exploration of this new modality, which we believe has the potential to unlock a new generation of receptor-targeted therapies to treat tumors with precision." The first-in-human, open-label trial will enroll up to 150 participants with dose escalation followed by expansion phases evaluating safety, tolerability, pharmacokinetics and preliminary anti-tumor activity. CRN09682 utilizes traditional chemical synthesis methods, eliminating manufacturing constraints required by most antibody drug conjugates and radiopharmaceuticals. TScan Therapeutics, Inc. (NASDAQ: TCRX) announced positive updated data from its ALLOHA Phase 1 trial showing TSC-101 continued to demonstrate favorable relapse-free survival (HR=0.50) and overall survival (HR=0.61) in patients with hematologic malignancies undergoing allogeneic hematopoietic cell transplantation. All three TSC-101-treated patients who reached two-year follow-up remained relapse-free compared to only one of four patients (25%) in the control arm, with no dose-limiting toxicities observed across all dose levels. "These updated data from our Phase 1 study continue to highlight a positive safety and efficacy profile of TSC-101 in patients with heme malignancies undergoing allogeneic HCT," said Chrystal U. Louis, MD, CMO of TScan Therapeutics. "All three patients who reached two years of follow-up have no detectable disease as they have remained relapse-free and in complete donor chimerism. Additionally, there have been no dose-limiting toxicities and patients who received TSC-101 continue to show improved relapse-free and overall survival compared to control-arm patients." TScan is focused on enrolling the remaining patients necessary to support its fixed-dosing regimen and expects to initiate a pivotal study in the second quarter of 2026. The company plans to expand its heme program in 2026 with product candidates designed to double the addressable patient population for post-transplant maintenance therapy. 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