Polivy (polatuzumab vedotin-piiq) / Roche, Pfizer - LARVOL DELTA

POLATUZUMAB VEDOTIN, RITUXIMAB, GEMCITABINE AND OXALIPLATIN (POLA-R-GEMOX) FOR RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): RESULTS FROM THE RANDOMIZED PHASE III POLARGO TRIAL (EHA 2025) - P3 | "Background: Polatuzumab vedotin is approved in frontline and R/R DLBCL, with the latter involving a combination with bendamustine and rituximab (Tilly H, et al. This study met its primary and all key secondary endpoints. Pola-R-GemOx demonstrated a statistically significant and clinically meaningful benefit in OS and PFS, with a 40% reduction in risk of death relative to R-GemOx. Pola-R-GemOx was associated with known risks of individual components, including PN and infection, but neither significantly impacted study endpoints."

Clinical • P3 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain • Thrombocytopenia

Efficacy and Safety of Glofitamab Plus Polatuzumab Vedotin in Relapsed/Refractory Large B-Cell Lymphoma Including High-Grade B-Cell Lymphoma: Results From a Phase Ib/II Trial. (PubMed, J Clin Oncol) - P1/2 | "Glofit-Pola demonstrated high efficacy and durable responses, with manageable safety, in heavily pretreated patients with R/R LBCL, including patients with HGBCL and previous CAR T-cell therapy failure."

Journal • P1/2 data • B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Phase II frontline chemolight R-pola-glo trial induces high and durable response rates in elderly and medically unfit/frail patients with aggressive B-cell lymphoma (ASH 2025) - "For this reason, we developed R‑Pola‑Glo, comprising the CD20 antibodyrituximab (R), the antibody‑drug conjugate polatuzumab vedotin (anti‑CD79B; Pola), and the bispecificantibody glofitamab (CD20×CD3; Glo)...Cycle 1 included obinutuzumab, Pola, and step‑up Glo (2.5/10 mg); cycles 2‑6 combined R, Pola,and Glo at 30 mg; cycles 7‑12 consisted of Glo consolidation (30 mg)...Exploratory subgroup analysis suggested that R‑Pola‑Glo efficacy was consistent across allsGA risk groups and mitigated the adverse prognostic impact of classical IPI factors, including LDH.ConclusionsR-Pola-Glo achieved high and durable CMR rates with an expected and manageable safety profile,translating into favorable 1-year survival rates in elderly/frail and medically unfit patients with aggressiveB-cell lymphoma. Compared with other regimens for this population, R‑Pola‑Glo demonstrated higherresponse rates and improved survival outcomes at 1 year, strongly supporting its further..."

Clinical • P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Geriatric Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Respiratory Syncytial Virus Infections • CD79B

CONSOLIDATED FINANCIAL STATEMENTS (IFRS) (Non-Audited) (for the year ended December 31, 2025) (Chugai Press Release) - "Oncology products sales were ¥246.5 billion (a decrease of 0.5% year on year). Sales of the mainstay product Avastin...decreased due to the market penetration of generic drugs and the effects of the NHI drug price revisions. In addition, sales of Perjeta (an anti-HER2 humanized monoclonal antibody, anti-cancer agent) decreased significantly, mainly due to the ongoing replacement of Perjeta with the new product Phesgo...a subcutaneous combination drug containing Perjeta. Meanwhile, in addition to the significant increase in sales of Phesgo, the market penetration of Lunsumio (antineoplastic agent/anti-CD20/CD3 humanized bispecific monoclonal antibody), launched in March 2025, was also favorable, and the mainstay product Polivy (an antimicrotubule binding anti-CD79b monoclonal antibody, anti-cancer agent) performed strongly."

Commercial • Cervical Cancer • Colorectal Cancer • Diffuse Large B Cell Lymphoma • Fallopian Tube Cancer • Follicular Lymphoma • Glioblastoma • Hepatocellular Cancer • HER2 Positive Breast Cancer • Indolent Lymphoma • Lung Non-Squamous Non-Small Cell Cancer • Ovarian Cancer • Peritoneal Cancer • Renal Cell Carcinoma

Testing Drug Treatments After CAR T-cell Therapy in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - P2 | N=396 | Recruiting | Sponsor: SWOG Cancer Research Network | Trial completion date: Dec 2029 ➔ Jun 2030 | Trial primary completion date: Dec 2025 ➔ Jun 2030

Trial completion date • Trial primary completion date • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Secondary Central Nervous System Lymphoma

A REAL-WORLD ANALISYS OF AXICABTAGENE CILOLEUCEL AS SECOND LINE TREATMENT IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMAS: A REPORT FROM RETE EMATOLOGICA PUGLIESE (REP) (EBMT 2026) - "Bridging therapy was administered to 29/36 patients, most commonly polatuzumab-based regimens (52%), followed by platinum/ARA-C combinations (38%) and radiotherapy (10%). In this real-world cohort, second-line Axi-cel in R/R DLBCL demonstrated high early response rates, manageable toxicity, and survival outcomes comparable to pivotal trials. Our experience supports the effectiveness of Axi-cel in routine practice and highlights the importance of integrated post–CAR-T therapeutic strategies, including bispecific antibodies, in the modern management of refractory DLBCL."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Lymphoma • Non-Hodgkin’s Lymphoma • Septic Shock

SALVAGE STRATEGIES AND OUTCOMES AFTER EARLY-LINE CD19 CAR T-CELL THERAPY FAILURE IN LARGE B-CELL LYMPHOMA (EBMT 2026) - "Prior CAR-T exposure included axicabtagene ciloleucel (51%), isoantigenic maraleucel (24%), tisagenlecleucel (22%), and point-of-care products (4%); 70% had received CAR-T therapy in the third-line setting.The overall response rate (ORR) to first salvage therapy was 50%, including 34% complete and 16% partial responses...1B–C), most commonly including bispecific antibodies (n=54), involved-site radiotherapy (n=40), bendamustine-based therapy (n=24), and polatuzumab-containing therapy (n=24); treatment categories were not mutually exclusive... In this large multicenter cohort of LBCL patients relapsing after early-line CD19 CAR-T therapy, salvage treatment achieved clinically meaningful responses regardless of prior CAR-T treatment line. Early post–CAR-T relapse identified a high-risk subgroup with poor outcomes. Immunotherapy-based salvage strategies showed the most favorable activity, supporting their preferential consideration and underscoring the need for prospective..."

CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

Mosunetuzumab and polatuzumab combined with axicabtagene ciloleucel induce high complete response rates at day+90 in Relapsed/Refractory large B-cell lymphoma (ASH 2025) - P2 | "Futility (assessed dynamically) was rejected after 11 pts achieved a CR at Day +90.Treatment consisted of 3 phases: following leukapheresis on Day -36, pts received bridging therapy withstep-up dosing of mosun IV (1 mg on Day -35, 2 mg on Day -28 and 60 mg on Day -21) combined withpola IV (1.8 mg/kg on Day -21); pts then received standard lymphodepletion with fludarabine andcyclophosphamide from Day -5 to Day -3, followed by axi-cel infusion on Day 0. Mosun-pola in combination with axi-cel was effective, inducing high complete response rates at Day +90.No increase in acute CAR-T related toxicities were seen. Follow-up to assess durability of CR is ongoing."

Clinical • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Thrombocytopenia • CD79B

PICKING STRONG BRIDGING REGIMENS BEFORE CD19 CAR-T CELL THERAPY OF LARGE B CELL LYMPHOMA – HOW HISTOLOGY AND HIGH LDH IMPACT LONG-TERM OUTCOMES (EBMT 2026) - "Bridging choices were grouped as No-Bridging, radiotherapy, ancient (Pixantrone, CHOP-variants), intensive (e.g., R-DHAP, R-MATRIX), R-gemcitabine/oxaliplatin (R-GemOx), sequential, R-Polatuzumab (R-Pola), or R-Pola-Bendamustine (Pola-BR)... 508 patients (384 DLBCL-NOS, 124 trFL) treated with Axi-cel (65.2%), Tisa-cel (25.4%), or Liso-cel (9.4%) were included... Our dataset is limited by the retrospective nature including a possible bias that worse bridging outcome may prevent patients from CAR-T infusion. We found outcomes were distinct for trFL and DLBCL-NOS. In NOS, responses to bridging as well as any LDH-elevation strongly and independently influenced outcomes."

CAR T-Cell Therapy • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

IMPACT OF PRIOR B-CELL-DIRECTED IMMUNOTHERAPY ON THE OUTCOME OF CD19 CAR T-CELL THERAPY IN AGGRESSIVE B-CELL LYMPHOMA (EBMT 2026) - "Background: B-cell-directed immunotherapies (BCDI), such as CD19 chimeric antigen receptor T-cell therapy (CAR-T), antibody-drug conjugates including polatuzumab vedotin (pola), and bispecific antibodies (BSA) have revolutionized the treatment of large B-cell lymphoma (LBCL)...BCDI exposure (excluding rituximab) prior to CAR-T, including bridging therapy, was categorized as BSA, pola-based regimens, and other BCDI, including obinutuzumab, brentuximab vedotin, and loncastixumab tesirine...BCDI-exposed patients more often had ≥3 prior treatment lines (54.8% vs. 43.0%, p<0.001), more frequent axicabtagene ciloleucel usage (63.8% vs. 56.0%, p=0.012), and higher complete/partial remission (CR/PR) rates at lymphodepletion (40.2% vs. 29.1%, p<0.001).Three-year overall survival (OS) was numerically inferior with prior BCDI (41.3% vs. 49.7%, p=0.07), without differences in progression-free survival (PFS) (35.0% vs. 37.2%), relapse incidence (52.0% vs. 51.5%), or NRM (13.0%..."

CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION AFTER FAILING CAR-T THERAPY FOR PATIENTS WITH RELAPSED/REFRACTORY LARGE B CELL LYMPHOMA: SPANISH MULTICENTER GETH-TC/GELTAMO STUDY (EBMT 2026) - "75% of the patients received axi-cel; 19/44 (44%) had achieved CR after CAR-T as best response. Our data confirmed that allo-HSCT is a feasible and a potentially curative option for eligible patients with R/R LBCL failing after CAR-T therapy, with a high PFS and low NRM. Most of the patients received targeted therapies as a bridging to allo-HSCT such as bispecific antibodies, polatuzumab and anti-PD1/PDL1 based regimens. Further prospective studies are needed to confirm these results."

Clinical • Acute Graft versus Host Disease • B Cell Lymphoma • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Transplantation

A MULTICENTER PHASE II STUDY OF GLOFITAMAB PLUS POLATUZUMAB-R-CHP FOR PATIENTS WITH HIGH-RISK DIFFUSE LARGE B-CELL LYMPHOMA (ICML 2025) - P2 | "Research funding declaration: Genentech/Roche Background: While polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (pola-R-CHP) resulted in improved outcomes for patients (pts) with newly diagnosed DLBCL as compared to R-CHOP (Tilly et al. Glofit-pola-R-CHP resulted in a high CR rate meeting the prespecified primary endpoint in pts with newly diagnosed DLBCL, and without new safety signals. When glofit was added after C2 of chemoimmunotherapy, CRS was uncommon and low grade. Further evaluation of this regimen is warranted."

Clinical • P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

2026 Update on the Management of Diffuse Large B-Cell Lymphoma. (PubMed, Am J Hematol) - "R-CHP remains the backbone of therapy, and frontline therapeutic options in fit patients are pola-R-CHP and R-CHOP, whereas elderly or frail/unfit patients may be treated with R-mini-CHOP or palliation...In the relapsed/refractory setting, there has been a rapid growth in the therapeutic armamentarium, including bispecific antibody combinations with chemotherapy, bispecific antibodies with antibody-drug conjugates, and brentuximab vedotin + lenalidomide + rituximab. Multiple novel trials are further advancing the field away from chemotherapy including targeted therapy-antibody combinations, new bispecific antibodies and bispecific antibody combinations, immunomodulatory agents, and cellular therapy. In this review, we summarize recent data and discuss ongoing efforts to improve the management of DLBCL."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Geriatric Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

Beyond R-CHOP: The rise of antibody-drug conjugates in DLBCL. (PubMed, Blood Rev) - "Recently, ADCs have expanded the DLBCL therapeutic landscape, with the approvals of CD79b-targeted polatuzumab vedotin and CD19-directed loncastuximab tesirine for R/R and even frontline disease. However, the clinical application of ADCs is accompanied by challenges, including the management of characteristic toxicities, understanding and overcoming mechanisms of resistance. This review systematically synthesizes the mechanisms of action, updated clinical evidence, toxicity profiles, and resistance mechanisms of ADCs in DLBCL, while also discusses management strategies and provides perspectives on future directions."

Journal • Review • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD22 • CD79B • TNFRSF8

PROs vs clinician-reported adverse events in a large clinical trial: findings from the phase 3 POLARIX study. (PubMed, Blood) - P3 | "The phase 3 POLARIX study (NCT03274492) demonstrated superior progression-free survival (PFS) and a similar safety profile with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin and prednisone (Pola-R-CHP) vs rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) in patients with previously untreated DLBCL. GI symptoms (diarrhea, constipation, nausea, and vomiting) were generally similar between treatment arms and returned to baseline levels after treatment completion. These HRQoL data underscore the complementarity of PROs, as an adjunct to clinician-reported AEs, in evaluating the efficacy and tolerability of new treatments, including Pola-R-CHP, which may represent a new benchmark for patient-reported HRQoL in previously untreated DLBCL."

Adverse events • Journal • P3 data • B Cell Lymphoma • Constipation • Diffuse Large B Cell Lymphoma • Fatigue • Gastroenterology • Gastrointestinal Disorder • Hematological Disorders • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Real-world outcome and dose intensity of Pola-R-CHP versus R-CHOP/R-THP-COP in newly diagnosed diffuse large B-cell lymphoma: a single-center, retrospective cohort study. (PubMed, BMC Cancer) - No abstract available

Journal • Real-world evidence • Retrospective data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pain

RE-MIND2: comparative effectiveness of tafasitamab plus lenalidomide versus polatuzumab vedotin/bendamustine/rituximab (pola-BR), CAR-T therapies, and lenalidomide/rituximab (R2) based on real-world data in patients with relapsed/refractory diffuse large B-cell lymphoma. (PubMed, Ann Hematol) - P=N/A, P2 | "Although based on limited patient numbers, these data may help to contextualize emerging therapies for R/R DLBCL. CLINICAL TRIAL REGISTRATION: NCT04697160 (January 6, 2021)."

HEOR • Journal • Real-world • Real-world evidence • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation • CD19

Frontmind: A Phase III, Multicenter, Randomized, Double-Blind Study of Tafasitamab + Lenalidomide + R-CHOP Versus R-CHOP Alone for Newly Diagnosed High-Intermediate and High-Risk Diffuse Large B-Cell Lymphoma (ASH 2022) - P1, P3 | "Background R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) is the standard of care for newly diagnosed and untreated diffuse large B-cell lymphoma (DLBCL); however, approximately 30–40% of patients relapse or become refractory...POLARIX (NCT03274492) evaluated a modified regimen substituting polatuzumab vedotin for vincristine (pola-R-CHP), showing a modest improvement in PFS without OS benefit between treatment arms, indicating an unmet clinical need remains...The sensitivity and specificity of minimal residual disease (MRD) for early detection of disease progression is an exploratory endpoint; further MRD parameters may also be investigated. The study is funded by MorphoSys AG and conducted with the scientific support of members of the Fondazione Italiana Linfomi and the German Lymphoma Alliance."

Clinical • P3 data • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Immune Modulation • Indolent Lymphoma • Inflammation • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

primary analysis of the smart stop trial: Lenalidomide, tafasitamab, rituximab, and acalabrutinib alone and with combination chemotherapy in newly diagnosed diffuse large B-cell lymphoma (ASH 2025) - P2 | "Background : First-line therapy for newly diagnosed large B-cell lymphoma (LBCL) has remainedchemotherapy-based for nearly five decades, with only incremental advances such as the addition ofrituximab and polatuzumab vedotin. The Smart Stop trial establishes that reducing or removing chemotherapy is feasible inpatients with newly diagnosed LBCL who achieve a complete response after targeted therapy, withoutcompromising curative potential. The combination of lenalidomide, tafasitamab, rituximab, andacalabrutinib is highly effective as an initial chemotherapy-free combination in patients with newlydiagnosed LBCL. Time to event data and ctDNA analysis will be updated for presentation at the meeting.Further trials are warranted to explore the Smart Stop approach in multicenter randomized trials, andadditional combinations are planned."

B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

Mosunetuzumab plus Pola-CHP compared with Pola-R-CHP in previously untreated DLBCL: final results from a Phase II study. (PubMed, Blood Adv) - P1/2 | "This Phase II study evaluated mosunetuzumab plus cyclophosphamide, doxorubicin, prednisone, and polatuzumab vedotin (Pola-M-CHP) versus Pola-rituximab (R)-CHP for first-line treatment of diffuse large B-cell lymphoma (DLBCL). Pola-M-CHP, although an active combination, did not demonstrate a clinical benefit over Pola-R-CHP in this small study. This trial was registered at www.clinicaltrials.gov as #NCT03677141."

Journal • P2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology

Mosunetuzumab plus polatuzumab vedotin in transplant-ineligible refractory/relapsed large B-cell lymphoma: primary results of the phase 3 SUNMO trial. (PubMed, J Clin Oncol) - P3 | "Mosun-Pola demonstrated superior efficacy verus R-GemOx, with significant improvements in both overall response rate and progression-free survival, and infrequent cytokine release syndrome events with a manageable safety profile.(Funded by F. Hoffmann-La Roche Ltd; ClinicalTrials.gov, NCT05171647)."

Journal • P3 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Transplantation

FIXED-DURATION OUTPATIENT SUBCUTANEOUS MOSUNETUZUMAB + POLATUZUMAB VEDOTIN SHOWS ROBUST EFFICACY IN A PHASE II STUDY OF RELAPSED/REFRACTORY POST-BTKi MANTLE CELL LYMPHOMA (ICML 2025) - P1/2 | "Fixed-duration, outpatient M-Pola demonstrates robust efficacy and manageable safety in R/R MCL, including in high-risk subgroups and the post-CAR T-cell setting. M-Pola appears to be a suitable regimen for pts with R/R MCL in need of rapid disease control."

Clinical • P2 data • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Oncology • TP53

Polivy + Lunsumio: Regulatory submission in US for 2L+ DLBCL in 2026 (Roche) - FY 2025 Results

FDA filing • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Oncology

Estimating the Survival Impact of Not Receiving CAR T-cell (CAR T) Therapy When Eligible in Patients with Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) in the United States (US) (TCT-ASTCT-CIBMTR 2026) - "BsAbs are recommended as monotherapy in third-line and later settings, and in combination with gemcitabine/oxaliplatin in second line CAR-T/ASCT ineligible patients. Recently, a phase III trial with mosunetuzumab plus polatuzumab vedotin in this same indication showed strong progression-free and overall survival, and response rates (Westin et al... Findings suggest that patients with R/R DLBCL experience improved survival outcomes when treated with CAR-T therapy, supporting its NCCN recommendation. While adherence is associated with better outcomes, clinical or logistical factors may limit guideline adherence. Nonetheless, the analysis highlights the impact of NCCN guideline deviations for CAR-T eligible patients, underscoring the importance of efforts to minimize misallocation and expand access to optimal therapies."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma

Polatuzumab Vedotin in Previously Untreated Diffuse Large B-Cell Lymphoma. (PubMed, N Engl J Med) - P3 | "Among patients with previously untreated intermediate-risk or high-risk DLBCL, the risk of disease progression, relapse, or death was lower among those who received pola-R-CHP than among those who received R-CHOP. (Funded by F. Hoffmann-La Roche/Genentech; POLARIX ClinicalTrials.gov number, NCT03274492.)."

Journal • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD79B