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

MOSUNETUZUMAB PLUS POLATUZUMAB VEDOTIN IS SUPERIOR TO R-GemOx IN TRANSPLANT-INELIGIBLE PATIENTS WITH R/R LBCL: PRIMARY RESULTS OF THE PHASE III SUNMO TRIAL (ICML 2025) - P3 | "The primary analysis of the Phase III SUNMO study demonstrated that M-Pola, a novel bispecific-ADC combination therapy, met its primary endpoints with a statistically significant and clinically meaningful improvement in PFS and ORR compared with R-GemOx. Mosunetuzumab plus polatuzumab vedotin as a fixed-duration, outpatient, off-the shelf regimen with a differentiated safety profile is an effective and valuable option for pts with transplant-ineligible R/R LBCL."

Clinical • Late-breaking abstract • P3 data • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD79B

THE BENEFIT OF POLA-R-CHP IN DLBclass-DEFINED MOLECULAR SUBSETS OF NEWLY DIAGNOSED DLBCL IN THE POLARIX TRIAL (ICML 2025) - P3 | "The POLARIX clinical trial (NCT03274492) was a randomized, double-blind, placebo-controlled, international Phase 3 study that compared the efficacy of pola-R-CHP (polatuzumab [anti-CD79B] vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone) versus R-CHOP (R-CHP and vincristine) in newly diagnosed patients with intermediate- to high-risk (IPI 2–5) DLBCL. These data indicate that newly diagnosed patients with the genetically defined C5 subset of DLBCLs derive the greatest benefit from Pola-R-CHP therapy. More broadly, the study supports the use of DLBclass to design molecularly-driven clinical trials and inform practice."

Late-breaking abstract • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Oncology • CD79B

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

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

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

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

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

Improvements in health-related quality of life (HRQoL) in the SUNMO study: Subcutaneous (SC) mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) vs rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after at least one prior therapy (ASH 2025) - P3 | "In SUNMO, Mosun-Pola provided benefits across multiple aspects of HRQoL compared withR-GemOx, particularly in maintaining/improving physical functioning, fatigue, lymphoma symptoms, andPN. Pts treated with Mosun-Pola achieved clinically meaningful improvements in PROs, with scoresexceeding the MCID in several domains and exhibiting a delay in deterioration of >1 year for physicalfunctioning, and >2 months for PN and lymphoma symptoms. Improved PROs with Mosun-Pola vs R-GemOx suggest benefits in HRQoL with chemotherapy-free bispecific antibody combinations."

Clinical • HEOR • B Cell Lymphoma • Gastroenterology • Gastrointestinal Disorder • Gynecologic Cancers • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Peripheral Neuropathic Pain

Transcriptional profiling refines DLBCL classification and identifies subtypes with distinct therapeutic vulnerabilities (ASH 2025) - P3 | "Although no conventional LG subset previously showed asignificant PFS benefit with pola-R-CHP over R-CHOP, MCDsig DLBCLs had significantly improved PFS with pola-R-CHP(HR 0.41, 95% CI: 0.26-0.66), even after adjusting for IPI, age, and cell-of-origin (HR 0.36, 95% CI: 0.22-0.59). LymphGen-sig is a novel gene expression-based platform that complements conventional geneticclassification by 1) expanding subtype assignment to include previously unclassified cases, 2) reassigning A53 DLBCLsinto potentially more biologically relevant subtypes, and 3) uncovering a subset of LymphGen-unclassified DLBCLs thatderive benefit from pola-R-CHP treatment."

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

Polatuzumab Vedotin Combined With R-ICE (PolaR-ICE) as Second-Line Therapy in Diffuse Large B-Cell Lymphoma. (PubMed, Am J Hematol) - P2 | "Our findings demonstrate that Pola-RICE is a safe and effective salvage regimen for r/r DLBCL, which can be considered for patients with late relapse or in areas where CAR T access may be limited. Trial Registration: ClinicalTrials.gov identifier: NCT04665765."

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

Knee-Deep in Bias: When the Low-Probability Diagnosis of Double-Expressor Lymphoma Wins. (PubMed, Cureus) - "Over months, her condition progressed to include lytic bone lesions, soft tissue masses, and ultimately, widespread systemic involvement requiring definitive management at a higher-level facility. The case underscores how resource disparities in remote settings can obscure rare diagnoses, emphasizing the need for heightened clinical suspicion, innovative diagnostic strategies, streamlined referral processes, and/or expansion of virtual healthcare to improve outcomes in such vulnerable populations."

Journal • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Gout • Hematological Malignancies • Inflammatory Arthritis • Lymphoma • Musculoskeletal Pain • Non-Hodgkin’s Lymphoma • Oncology • Pain • Rheumatology

Current evidence and strategies for bridging therapy in CD19-directed chimeric antigen receptor T-cell therapy for relapsed/refractory large B-cell lymphomas. (PubMed, Ann Hematol) - "Unresolved questions remain, including the optimal implementation of bispecific antibodies as BT regimens, the timing and duration of Bruton’s tyrosine kinase inhibitors administration, the safety and efficacy of reusing polatuzumab vedotin in previously exposed patients, and the standardization of radiotherapy protocols. In conclusion, the rational selection and application of BT strategies hold promise for improving the clinical outcomes of R/R LBCL patients undergoing CAR T-cell therapy."

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

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

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

Real-world use of polatuzumab vedotin combined with bendamustine and rituximab for patients with relapsed or refractory large B-cell lymphoma. (PubMed, Korean J Intern Med) - "Pola-BR provided meaningful disease control in patients with R/R DLBCL. Its use as a bridging therapy before CAR T-cell infusion was associated with high response rates, favorable safety, and a successful transition to cellular therapy, underscoring its value as a practical option in this setting."

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

POLATUZUMAB VEDOTIN, RITUXIMAB, GEMCITABINE AND OXALIPLATIN (POLA-R-GEMOX) FOR RELAPSED/REFRACTORY (R/R) DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL): PHASE III POLARGO TRIAL (ICML 2025) - P3 | "Introduction: Polatuzumab vedotin is approved in frontline and R/R DLBCL; the latter involving combination with bendamustine and rituximab (Tilly et al. 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 is an alternative treatment option for pts with transplant-ineligible R/R DLBCL not previously exposed to polatuzumab vedotin, which avoids the risk of T-cell depleting regimens and their potential deleterious effects on subsequent therapies."

P3 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Indolent Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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

A bridge, not a destination: clarifying the role of polatuzumab vedotin plus bendamustine and rituximab in relapsed/refractory diffuse large B-cell lymphoma. (PubMed, Korean J Intern Med) - No abstract available

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

Chugai Pharmaceutical Co., Ltd…announced today that it obtained regulatory approval from the Ministry of Health, Labour and Welfare (MHLW) for the additional indication of the combination therapy of anti-cancer agent / anti-CD20/CD3 humanized bispecific monoclonal antibody Lunsumio subcutaneous injection 5mg and 45mg [generic name: mosunetuzumab (genetical recombination)] (hereafter, Lunsumio) (Chugai Press Release) - "...and anti-cancer agent/antimicrotubule-binding anti-CD79b monoclonal antibody Polivy intravenous infusion 30 mg and 140 mg [generic name: polatuzumab vedotin (genetical recombination)] (hereafter, Polivy) for the treatment of relapsed or refractory large B-cell lymphoma...This approval is based on the results of the global, multi-center, randomized Phase III SUNMO study..."

Japan approval • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • High-grade B-cell lymphoma • Large B Cell Lymphoma

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

THE TOTAL COST OF CARE AND BUDGET IMPACT OF INTRODUCING MOSUNETUZUMAB PLUS POLATUZUMAB VEDOTIN FOR SECOND-LINE OR LATER (2L+) TREATMENT OF RELAPSED/REFRACTORY LARGE B-CELL LYMPHOMA (LBCL) TO A UNITED STATES (US) HEALTH PLAN (ISPOR 2026) - P3 | "Comparators included rituximab plus gemcitabine and oxaliplatin (R-GemOx) per the Phase 3 SUNMO trial (NCT05171647) and FDA-approved treatments, including axicabtagene ciloleucel (Axi-cel), lisocabtagene maraleucel (Liso-cel), tisagenlecleucel (Tisa-cel), tafasitamab plus lenalidomide (Tafa+len), glofitamab, epcoritamab, loncastuximab tesirine (Lonca), and polatuzumab plus bendamustine and rituximab (Pola-BR). Adding Mosun-Pola to a US payer formulary resulted in a small budget impact that remained robust in OWSA. TCC for Mosun-Pola was lower versus treat-to-progression epcoritamab, Tafa+len and CAR-T regimens. Given the small budget impact and improved clinical outcomes versus R-GemOx demonstrated in the Phase 3 SUNMO trial, Mosun-Pola is a meaningful option for 2L+ relapsed/refractory LBCL."

Clinical • Cost of care • HEOR • B Cell Lymphoma • Hematological Malignancies • Inflammation • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

SKYGLO: An Open-Label Study Comparing Glofitamab and Polatuzumab Vedotin + Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone Versus Pola-R-CHP in Previously Untreated Patients With Large B-Cell Lymphoma (clinicaltrials.gov) - P3 | N=1130 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Trial primary completion date: Dec 2027 ➔ Oct 2027

Trial primary completion date • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD20

DURABLE EFFICACY WITH FIXED-DURATION EPCORITAMAB + POLATUZUMAB, VEDOTIN, RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE (POLA-R-CHP) FOR 1L DLBCL (EPCORE NHL-5) (ICML 2025) - P1/2 | "Introduction: First-line (1L) standard of care for diffuse large B-cell lymphoma (DLBCL) is R plus C, H, vincristine, and P (R-CHOP), and it continues to evolve with pola-R-CHP showing higher complete response rates (CRR) of 78% and longer progression-free survival than R-CHOP (Tilly 2022), However, additional therapies are needed to further improve cure rates for 1L patients (pts). Fixed-duration epcor + pola-R-CHP with follow-up of 16.1 mos in pts with newly diagnosed DLBCL continues to show high ORR and CRR across all subgroups with no new safety signals. Data continue to support that adding epcor to 1L SOC drives deep and durable responses. CRS was low-grade with predictable timing of onset."

Clinical • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • High-grade B-cell lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

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

PRAC confirmed that the benefit–risk balance of Polivy (polatuzumab vedotin) remains unchanged. However, the SmPC and Package Leaflet will be updated to add infusion site extravasation injury as a warning and “uncommon” undesirable effect, and to reclassify transaminases increased under the SOC Hepatobiliary disorders. The marketing authorisation will be varied accordingly. (European Medicines Agency) - Pharmacovigilance Risk Assessment Committee (PRAC) Minutes of meeting on 12 – 15 Jan 2026: [AI generated summary]

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