Tecentriq (atezolizumab) / Roche - LARVOL DELTA

Hematologic adverse events associated with immune checkpoint inhibitors: A real-world pharmacovigilance analysis using the faers database (ASH 2025) - "We employed 8 ICIs (including the brand and generic names)—atezolizumab, avelumab, cemiplimab, durvalumab, ipilimumab, nivolumab, pembrolizumab, and tremelimumab in the analysis. This large, real-world pharmacovigilance study provides comprehensive insight into hematologic adverse events associated with ICIs. Immune thrombocytopenia was the most prominent signal across agents, with additional drug-specific patterns observed. These findings underscore the need for focused monitoring strategies and may inform clinical decision-making and future prospective safety evaluations."

Adverse events • Checkpoint inhibition • Clinical • Real-world • Real-world evidence • Acute Myelogenous Leukemia • Aplastic Anemia • Autoimmune Hemolytic Anemia • Febrile Neutropenia • Hematological Malignancies • Immune Thrombocytopenic Purpura • Immunology • Leukemia • Lymphoma • Myelodysplastic Syndrome • Neutropenia • Oncology • Thrombocytopenia • Thrombocytopenic Purpura • ROR1

Early versus late onset hematologic immune‐related adverse events following immune checkpoint inhibition: Temporal patterns, clinical profiles, and risk stratification in faers reports (2014–2025) (ASH 2025) - "Agent-level analysis showed significantly reduced fatality odds with pembrolizumab (OR 0.44; 95% CI 0.42–0.46), atezolizumab (OR 0.54; 95% CI 0.52–0.56), avelumab (OR 0.54; 95% CI 0.49–0.59), durvalumab (OR 0.53; 95% CI 0.46–0.60), and ipilimumab (OR 0.84; 95% CI 0.79–0.88) versus nivolumab. Early and late hem-irAEs represent distinct clinical entities. Early events, driven by cytopenias, may reflect acute immune activation, while late events involve marrow failure with greater morbidity. Despite marginally lower fatality, late hem-irAEs were more often serious."

Adverse events • Checkpoint inhibition • Clinical • IO biomarker • Aplastic Anemia • Hematological Disorders • Hemophagocytic lymphohistiocytosis • Immunology • Neutropenia • Oncology • Rare Diseases • Thrombocytopenia

The efficacy of immunotherapy in alveolar soft part sarcoma (ASPS): A case report (ASH 2025) - "Informed by prior pediatric ASPS studies, his initial treatment regimen consisted of axitinib and pembrolizumab, a TKI and ICI respectively...In the setting of worsening disease/evolving mixed response, the patient was transitioned to a similar regimen of atezolizumab and cabozantinib...By analyzing this patient's unique ASPS tumor characteristics, it became possible to develop a targeted and effective treatment approach. Overall, this case supports the synergistic effect of TKIs and ICIs on ASPS while highlighting their limited side effect profile, suggesting an opportunity for future studies on combinations of immunotherapies."

Case report • Clinical • IO biomarker • Alveolar Soft Tissue Sarcoma • Cough • Respiratory Diseases • Sarcoma • Solid Tumor • ASPSCR1 • PD-L1 • TFE3

Efficacy of novel agents in the treatment of acute myeloid leukemia and myelodysplastic syndrome: A systematic review and meta-analysis (ASH 2025) - "Newer agents included for AML were Guadectiabine, Magrolimab, Alvocidib, Enasidenib, Flotetuzumab, Vadastuximab, Mitoxantrone, Pevonedistat, Entospletinib, Eprenetapopt, Belinostat, Onvansertib, Panobinostat, Cediranib Maleate, Nilotinib, Emavusertib, and anti-CD45 antibody (DOTA-BC8). The newer agents investigated for MDS included Rigosertib, Imetelstat, Pembrolizumab, Enasidenib, Sabatolimab, Ivosidenib, Elitercept, Pevonedistat, Emavusertib, Atezolizumab, and Olutasidenib...All patients were treated concomitantly with either azacitidine (77%) or decitabine (23%)... This meta-analysis and systematic review demonstrate promising efficacy for novel agents in AML and MDS patients. There is a need for prospective trials with larger patient populations to investigate these agents further."

Retrospective data • Review • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Neutropenia • TP53

Spatial communication modules identify prognostic cell-cell signaling hubs in chronic graft-versus-host disease (ASH 2025) - "In multivariate analysis, MCIMs-0 and -6 were independently associated withincreased mortality (HR=2.08 and 2.83), while MCIM-3 showed a protective trend (HR=0.51).SpatialDrug2Cell, applied to MCIM-localized cell populations and spatially restricted therapeutic targets,highlighting candidate agents such as rituximab, atezolizumab, and plerixafor. Our analysis establishes spatially resolved MCIMs as prognostic biomarkers in chronicGVHD. Our analysis establishes spatially resolved MCIMs as prognostic biomarkers in chronicGVHD. The emergence of high-risk communication modules in MSGs, particularly in patients with fataloutcomes, reveals tissue-localized immune architectures associated with disease progression. Byintegrating STARComm with adapted drug inference tools like SpatialDrug2Cell, we identify clinicallyrelevant, spatially anchored therapeutic targets in routinely sampled tissues."

Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology • CXCL12 • CXCR4 • SDC4

Immune checkpoint inhibitor–associated cytopenias: A decade of real-world signal detection from faers (2014–2025) (ASH 2025) - "Nivolumab, pembrolizumab,and atezolizumab accounted for over 85% of these cases...Other notable signalsincluded durvalumab with pancytopenia (ROR 1.67), ipilimumab with thrombocytopenia (ROR 1.43), andpembrolizumab with AIHA (ROR 1.74)...In this decade-long pharmacovigilance analysis, hematologic irAEs, particularly AIHA and ITP, weredisproportionately associated with ICIs, most notably anti–PD-L1 agents. Most occurred with combinationregimens, but monotherapy regimenss were not exempt. Our findings emphasize the importance ofearly recognition, diagnostic evaluation, and multidisciplinary management of new-onset cytopeniasduring immunotherapy."

Checkpoint inhibition • Clinical • Real-world • Real-world evidence • Agranulocytosis • Anemia • Aplastic Anemia • Autoimmune Hemolytic Anemia • Granulocytopenia • Immune Thrombocytopenic Purpura • Immunology • Neutropenia • Oncology • Thrombocytopenia • Thrombocytopenic Purpura • ROR1

Incidence and clinical outcomes of hematologic immune-related toxicities in patients with solid malignancies treated with immune checkpoint inhibitors (ASH 2025) - "Specific ICI agents included nivolumab (60.7%), atezolizumab (19.3%), and durvalumab(18.4%); and 21.4% of patients received more than one...Preceding ICI therapyincluded pembrolizumab (n=2), nivolumab (n=1) and combination nivolumab/ipilimumab (n=1).Mean time to development of irAE was 75.8 days (ranging from 29 days to 144 days)...Although no irAE ITP or TTP cases were identified, alterations in hematologicparameters are common in malignancy, including from chemotherapy or the cancer itself, sosome may have gone unrecognized. HIT was diagnosed in two cases shortly after ICI initiation.These data highlight the need for multicenter databases employing a systematic approach tocapture and characterize hematologic irAEs across diverse patient populations."

Checkpoint inhibition • Clinical • Clinical data • Autoimmune Hemolytic Anemia • Biliary Cancer • Immune Thrombocytopenic Purpura • Immunology • Infectious Disease • Lung Cancer • Melanoma • Oncology • Pneumonia • Respiratory Diseases • Septic Shock • Solid Tumor • Thrombocytopenia • Thrombocytopenic Purpura

Excellent outcomes with anti-PD1 therapy in relapsed/refractory primary mediastinal large B-cell lymphoma: Real-world data from the lysa group (ASH 2025) - "In 2L, 84% received platinum-based chemotherapy; prior autologous SCTand CAR-T were given in 3 and 7 patients, respectively.CPIs included pembrolizumab (n=66), nivolumab (n=33), and atezolizumab (n=1), administered asmonotherapy (n=39), in combination with brentuximab vedotin (Bv; n=52), or with other agents (n=9). This large real-world cohort confirms the high efficacy and sustained responses of CPIs in R/RPMBL. These results support broader and earlier integration of CPIs in the treatment strategy for thishigh-risk population."

Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Primary Mediastinal Large B-Cell Lymphoma

Real-world burden and risk analysis of hematologic iraes in patients treated with immune checkpoint inhibitors: 5-year cohort study (ASH 2025) - "Hence, we evaluated the frequency, spectrum, and risk factors of hematologicirAEs in patients with melanoma, renal cell carcinoma, or urothelial carcinoma treated with ICIs at atertiary cancer center.Methods We conducted a single-center, retrospective cohort study at the American University of Beirut MedicalCenter (AUBMC), including adult patients (N = 116) who received at least one dose of ipilimumab,nivolumab, pembrolizumab, atezolizumab, or durvalumab between January 1, 2019, and January 31,2024. Although usually rare in literature, we found hematologic irAEs to be common but mild and manageablewith ICIs. No significant predictors were identified. Early monitoring and supportive care are key."

Checkpoint inhibition • Clinical • Real-world • Real-world evidence • Autoimmune Hemolytic Anemia • Genito-urinary Cancer • Hematological Malignancies • Immunology • Melanoma • Myelodysplastic Syndrome • Neutropenia • Oncology • Renal Cell Carcinoma • Solid Tumor • Thrombocytopenia • Urothelial Cancer

Bleed-versus-clot paradox under immune-checkpoint inhibition: A decade-long US faers analysis reveals divergent class-specific hemostatic phenotypes (ASH 2025) - "Atezolizumab had the strongest thrombotic signal (ROR 1.60, 95 % CI 1.44–1.78), whiletoripalimab and atezolizumab had the highest bleeding signals (2.08, 1.32–3.27; and 2.60, 2.31–2.93,respectively). FAERS data reveal divergent hemostatic profiles under ICI therapy: PD-L1 blockade favors thrombosis,while toripalimab, a novel PD-1 antibody, drives immune-mediated bleeding. These class-specifictoxicities appear mechanistically distinct and temporally early, often manifesting within the first 60 daysof treatment. This suggests that current approaches treating all ICIs as a uniform risk group may obscurecritical safety signals."

Checkpoint inhibition • Oncology • Thrombosis • CTLA4 • ROR1

Pirtobrutinib, venetoclax, and obinutuzumab for patients with richter transformation: A phase 2 trial (ASH 2025) - P2 | "Threepts had no response (1 pt with previously untreated RT who received venetoclax +obinutuzumab for CLL; 1 pt with prior BR and Ibrutinib + obinutuzumab for CLL, and prior atezolizumab + venetoclax +obinutuzumab, and R-CHOP + venetoclax for RT; 1 pt with no prior CLL therapy and R-EPOCH forRT).Two of the responding pts underwent consolidative allo-SCT. We report results of combined pirtobrutinib, venetoclax, and obinutuzumab in ptswith untreated or R/R RT. We observed an ORR rate of 67% and a 12-month EFS and OS rates of73% and 82%, respectively."

Clinical • IO biomarker • P2 data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Richter's Syndrome • TP53

Extended Follow-Up Analysis of First-Line Atezolizumab in Extensive-Stage Small Cell Lung Cancer: A Real-World Multicenter Prospective Cohort Study. (PubMed, Thorac Cancer) - "This study outlined the real-world effectiveness and safety of first-line atezolizumab immunochemotherapy for ES-SCLC patients over an extended follow-up, noting that local treatment and post-progression therapy were associated with improved survival."

Journal • Observational data • Real-world evidence • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

BI12 Systematic review of checkpoint inhibitor-induced epidermal necrolysis: a clinical entity distinct from 'classic' Stevens-Johnson syndrome/toxic epidermal necrolysis. (PubMed, Br J Dermatol) - "We identified 39 patients who developed ICI-induced SJS/TEN following treatment with either pembrolizumab, nivolumab, atezolizumab or nivolumab-ipilimumab combination. This review of recently published cases reinforces the concept that ICI-EN, although resembling SJS/TEN, possesses unique and idiosyncratic features. There is a need for a greater understanding of the clinical and immunological phenotype of ICI-EN, particularly the prebullous phase, to aid with prophylaxis and management."

Checkpoint inhibition • Journal • Review • Atopic Dermatitis • Dermatology • Immunology • Mucositis • Oncology • Steven-Johnson Syndrome • Stomatitis • Urticaria

Evaluating Length of Treatment With PD-1/PD-L1 Inhibitor in Advanced Solid Tumors (clinicaltrials.gov) - P3 | N=161 | Completed | Sponsor: Dan Zandberg | Recruiting ➔ Completed | N=578 ➔ 161 | Trial completion date: Nov 2031 ➔ Nov 2025 | Trial primary completion date: Nov 2030 ➔ Oct 2025

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Anal Carcinoma • Biliary Cancer • Bladder Cancer • Breast Cancer • Cervical Cancer • Cholangiocarcinoma • Colorectal Cancer • Esophageal Cancer • Gastric Cancer • Genito-urinary Cancer • Head and Neck Cancer • Hepatocellular Cancer • Kidney Cancer • Lung Cancer • Melanoma • Merkel Cell Carcinoma • Non Small Cell Lung Cancer • Oncology • Ovarian Cancer • Renal Cell Carcinoma • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck • Triple Negative Breast Cancer

Invited Discussant – Asian perspectives on: 1- Perioperative (periop) enfortumab vedotin (EV) plus pembrolizumab (pembro) in participants (pts) with muscle-invasive bladder cancer (MIBC) who are cisplatin-ineligible: The phase III KEYNOTE-905 study & 2 - IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (ESMO Asia 2025) - No abstract available

Circulating tumor DNA • Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

IMvigor011: A phase III trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (ESMO Asia 2025) - No abstract available

Circulating tumor DNA • Clinical • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Matching adjusted indirect comparison of safety between atezolizumab and serplulimab for patients with ES-SCLC (ESMO Asia 2025) - "We conducted an indirect comparison to evaluate the safety of atezo and serplu in patients with ES-SCLC. Patients who received atezo or serplu combined with carboplatin and etoposide as first-line treatment for ES-SCLC in phase 3 trials were included in this analysis. In this MAIC analysis of ES-SCLC, compared with atezo, serplu shows a higher incidence of fatal and grade ≥3 TEAEs, and a broader spectrum of common TEAEs. Given the nature of indirect comparison, further studies are warranted to verify the findings."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Survival outcomes of immune checkpoint inhibitor use in advanced non-small cell lung cancer patients with coexisting idiopathic pulmonary fibrosis (ESMO Asia 2025) - "pembrolizumab, nivolumab, or atezolizumab). Although statistical significance was not reached, ICI therapy demonstrated a clinically meaningful extension of survival in advanced NSCLC patients with coexisting IPF. The lack of significance may be attributed to the small sample size, potentially underpowering the analysis. Additionally, the severity of IPF was not accounted for, which may have influenced outcomes."

Checkpoint inhibition • Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

RYZ101 (225Ac-DOTATATE) + carboplatin + etoposide + atezolizumab in treatment-naïve patients with somatostatin receptor-expressing (SSTR2+) extensive-stage small-cell lung cancer (ES-SCLC) (ESMO Asia 2025) - P1 | "The preliminary safety profile of RYZ101 + SoC for first-line treatment of patients with ES-SCLC was favorable, with no treatment discontinuations due to AEs and no DLTs. The RP2D was 10.2 MBq. Dose expansion has begun."

Clinical • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • SSTR • SSTR2

Clinical outcomes and safety of continuous immunotherapy and anti-angiogenic combination therapy beyond progression in patients with extensive-stage small cell lung cancer: A retrospective real-world study (ESMO Asia 2025) - "This multi-center retrospective study aimed to investigate the efficacy of continuous immunotherapy (I) and addition of anti-angiogenic agent (A) in relapsed ES-SCLC. We retrospectively reviewed the medical records of ES-SCLC patients treated with first-line I+C therapy in three medical centers in Shandong Province. From Jan 2020 to Dec 2024, 354 patients were enrolled and 241 (68.1%) received PD-L1 antibody including atezolizumab, durvalumab, adebrelimab, while 113 (31.9%) received PD-1 antibody such as serplulimab. Continuous immunotherapy beyond progression in ES-SCLC demonstrates a trend toward prolonged second-line PFS, but does not improve the overall survival. In the second-line treatment, chemotherapy remains an indispensable cornerstone."

Clinical data • Combination therapy • Real-world • Real-world evidence • Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Phase II study of atezolizumab plus chemotherapy in patients with advanced nonsquamous non-small-cell lung cancer and poor performance status (ESMO Asia 2025) - "Pts received atezolizumab (1200 mg/body, day 1), carboplatin (AUC 5, day 1), and nab-paclitaxel (75 mg/m2, days 1 and 8) every three weeks for up to four cycles, followed by maintenance atezolizumab (1200 mg/body, day 1) every three weeks until disease progression or unacceptable toxicity. Atezolizumab plus chemotherapy is a promising treatment option for pts with advanced nonsquamous NSCLC and an ECOG PS of 2."

Clinical • Metastases • P2 data • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Immunotherapy in neuroendocrine prostate carcinoma: Can we mirror the small cell lung cancer approach? Real-world outcomes with immune checkpoint inhibitors (ESMO Asia 2025) - "Atezolizumab was combined with carboplatin plus etoposide in 6 patients and with docetaxel plus carboplatin in 5 patients. While ICIs have transformed the management of extensive-stage SCLC by extending survival beyond chemotherapy alone, their application in NEPC has yielded encouraging outcomes. Some patients derive meaningful clinical benefit, though confirmation in larger studies is warranted."

Checkpoint inhibition • Clinical • IO biomarker • Real-world • Real-world evidence • Genito-urinary Cancer • Lung Cancer • Neuroendocrine Carcinoma • Neuroendocrine Tumor • Oncology • Prostate Cancer • Small Cell Lung Cancer • Solid Tumor • BRCA2 • EGFR • FGFR • KMT2D • MLH1 • MYC • NF1 • PDGFRB • PIK3CA • PTEN • RB1 • SYP • TP53

ARTEMIDE-HCC01: A phase III, randomised, open-label, sponsor-blinded, multicentre, global study of rilvegostomig in combination with bevacizumab with or without tremelimumab as first-line (1L) treatment for unresectable hepatocellular carcinoma (uHCC) (ESMO Asia 2025) - P3 | "In the randomisation period, ∼1200 patients will be randomised 1:1:1 to receive tremelimumab, rilvegostomig and bevacizumab (arm A), rilvegostomig and bevacizumab (arm B) or atezolizumab and bevacizumab (arm C) until progression/unacceptable toxicity. Other endpoints include OS (arm B vs arm C), ORR, duration of response, progression-free survival, safety and quality of life. Enrolment began May 2025 and is ongoing."

Clinical • Combination therapy • IO biomarker • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor • AFP • CTLA4 • PD-L1 • TIGIT

Real-world outcomes of patients with advanced hepatocellular carcinoma: A retrospective cohort study (ESMO Asia 2025) - "Background: Atezolizumab plus bevacizumab (A + B) is standart first-line treatment for advanced HCC (aHCC)...A+B was administered in 17 (10.7%) pts, lenvatinib was administered in 67 (42.1%) pts, and sorafenib was administered in 70 (44%) pts...Lenvatinib and nivolumab were the most commonly administered 2nd regimens (24.1% and 25.9%, respectively)... Only one-third of pts received 2nd-line therapy for aHCC. TKI-based therapy post-lenvatinib exposure results in longer OS than switching to ICIs. Preserved liver function (ALBI G1) and good PS (ECOG PS 0-1) were associated with improved OS."

Metastases • Real-world • Real-world evidence • Retrospective data • Hepatocellular Cancer • Oncology • Solid Tumor

Comparative pathologic complete response of neoadjuvant chemotherapy with PD-1/PD-L1 inhibitors in locally advanced gastric or gastroesophageal junction adenocarcinoma: A systematic review and Bayesian network meta-analysis (ESMO Asia 2025) - "Moderate effects were seen with Camrelizumab + NCT (OR 4.65, CrI: 1.72–13.2; SUCRA 56.94) and Durvalumab + NCT (OR 3.09, CrI: 0.688–13.9; SUCRA 40.12). Atezolizumab + NCT (OR 2.20, CrI: 0.739–8.27; SUCRA 28.04) and Toripalimab + NCT (OR 3.23, CrI: 0.563–20.3; SUCRA 43.21) showed lower efficacy. The addition of PD-1/PD-L1 inhibitors to NCT may enhance pCR in locally advanced gastric or GEJ cancer. The addition of PD-1/PD-L1 inhibitors to NCT may enhance pCR in locally advanced gastric or GEJ cancer. Tislelizumab, Pembrolizumab, and Sintilimab demonstrated the most promising results, although wide credible intervals reflect substantial uncertainty for several regimens. Further comparative trials and long-term outcome data are needed to optimize NICT strategies."

Metastases • Retrospective data • Review • Esophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor