Imfinzi (durvalumab) / AstraZeneca - 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

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

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

PACIFIC-5: a phase III clinical trial of consolidation durvalumab in patients with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy. (PubMed, J Hematol Oncol) - P3 | "PACIFIC-5 met its primary endpoint of improved PFS after either cCRT or sCRT. Follow-up for overall survival is ongoing."

IO biomarker • Journal • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR

COLUMBIA 1: COLUMBIA-1: Novel Oncology Therapies in Combination With Chemotherapy and Bevacizumab as First- Line Therapy in MSS-CRC (clinicaltrials.gov) - P1/2 | N=61 | Active, not recruiting | Sponsor: MedImmune LLC | Trial completion date: Nov 2025 ➔ Nov 2026

Trial completion date • Colorectal Cancer • Oncology • Solid Tumor

TOURMALINE study of durvalumab (D) in combination with gemcitabine (G)-based chemotherapy in advanced biliary tract cancer (aBTC): early safety and efficacy results in participants (pts) from Asia (ESMO Asia 2025) - P3 | "We report early safety and efficacy data within a subgroup of pts from Asia. Pts receive D 1500 mg (first infusion: 60 min; subsequent infusions: 30 min) with an investigator-selected G-based chemotherapy (D + G alone or in combination with oxaliplatin [O], carboplatin [C], cisplatin [cis], tegafur-gimeracil-oteracil [S-1], cis + S-1, or cis + nab-paclitaxel [P]). In pts from Asia, the safety profiles of all study tx were manageable. Safety results for pts from Asia were comparable to the global TOURMALINE population and TOPAZ-1 study. Interim ORR is promising."

Clinical • Combination therapy • Metastases • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Efficacy and safety of perioperative durvalumab plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric/gastroesophageal junction (G/GEJ) adenocarcinoma in Asia: A subgroup analysis of the MATTERHORN trial (ESMO Asia 2025) - P3 | "Consistent with global MATTERHORN results, D + FLOT improved efficacy vs P + FLOT with a manageable safety profile in Asian pts with resectable G/GEJ adenocarcinoma."

Clinical • Gastroesophageal Junction Adenocarcinoma • Oncology

Immune checkpoint inhibitor–related meningitis: two cases with contrasting clinical course and outcome (ESMO Asia 2025) - "Case 1: A 69-year-old man with stage T4N3M1 small-cell lung cancer achieved a near-complete response after EP + Durvalumab ×4, followed by 7 cycles of maintenance...Case 2: A 41-year-old woman with stage cT4bN2M0 triple-negative breast cancer received neoadjuvant Paclitaxel/Carboplatin + Pembrolizumab ×4, then AC + Pembrolizumab ×4, followed by mastectomy...These cases underscore the wide spectrum of ICI-related meningitis—from atypical autoimmune antibody–positive presentation with full recovery to fulminant leptomeningeal involvement and rapid fatality. Early recognition, exclusion of infection, and tailored immunosuppression are crucial for prognosis."

Checkpoint inhibition • Clinical • Breast Cancer • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor • Triple Negative Breast Cancer

Triple-negative breast cancer with somatic BRCA1 mutation and metaplastic progression in a young woman: A case report (ESMO Asia 2025) - "She underwent modified radical mastectomy with sentinel lymph node biopsy, followed by adjuvant doxorubicin–cyclophosphamide (AC) for 4 cycles, which was complicated by pneumonitis and heart failure. Weekly paclitaxel for 11 cycles was discontinued due to fatigue and elevated troponin, despite a normal ECG...She received gemcitabine–cisplatin for 2 cycles with stable disease, followed by cytoreductive palliative surgery with reconstruction, and then 2 additional cycles of gemcitabine–cisplatin...She was treated with docetaxel–capecitabine for 1 cycle with poor response, followed by sacituzumab govitecan for 3 cycles, which resulted in disease progression. Currently, the patient is on eribulin plus durvalumab, having completed 1 cycle...This case illustrates an unusual histological evolution from medullary carcinoma to metaplastic carcinoma, and subsequently to mucoepidermoid carcinoma. It raises important questions about the optimal timing of genomic testing and the..."

Case report • Clinical • IO biomarker • Tumor mutational burden • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Negative Breast Cancer • Oncology • Salivary Gland Cancer • Solid Tumor • Squamous Cell Carcinoma • Triple Negative Breast Cancer • BRCA • BRCA1 • HER-2 • PD-L1 • PGR • PTEN • RB1 • SF3B1 • STK11 • TMB • TP53

Consolidation thoracic radiotherapy with chemo-immunotherapy in patients with extensive-stage small cell lung cancer (ES-SCLC):CHEST-RT (TROG 20.01) trial (ESMO Asia 2025) - P2 | "Only 1/32 pt (3.1%) terminated durvalumab treatment due to TRT toxicity while 20(62.5%) ceased due to disease progression. This study finds that combining TRT with chemo-immunotherapy is safe and feasible in pts with ES-SCLC. A larger study will be required to confirm these findings."

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

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

Efficacy of immune checkpoint inhibitor combination chemotherapy in patients with recurrent non-small cell lung cancer after durvalumab consolidation following chemoradiotherapy: A multicenter retrospective study (NEJ066) (ESMO Asia 2025) - "ICIs demonstrated efficacy in patients with prior durvalumab consolidation who completed or discontinued it without PD, suggesting preserved sensitivity and continued clinical benefit."

Checkpoint inhibition • IO biomarker • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

Real-world outcomes in limited-stage SCLC: A 10-year retrospective analysis (ESMO Asia 2025) - "We conducted a retrospective study to compare our patient outcomes with the ADRIATIC control arm, providing a benchmark to assess future immunotherapy benefit. We reviewed records of 36 adults with LS-SCLC treated with platinum–etoposide chemotherapy and concurrent radiotherapy at a tertiary hospital in Melbourne, Australia (2015–2024). In this 10-year LS-SCLC cohort, best initial radiological response, BMI, smoking history and NLR were significantly associated with survival. As durvalumab becomes adopted into standard practice, our study provides a reference point for assessing its benefit and for validating prognostic biomarkers in a real-world cohort."

IO biomarker • Real-world • Real-world evidence • Retrospective data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Efficacy of durvalumab following concurrent chemoradiotherapy in unresectable EGFR-mutant NSCLC (ESMO Asia 2025) - "Background: Osimertinib is the current standard maintenance therapy following concurrent chemoradiotherapy (CCRT) for unresectable, locally advanced non-small cell lung cancer (NSCLC) harboring EGFR mutations (EGFR-MT). Durvalumab maintenance therapy following CCRT was associated with shorter PFS in EGFR-MT compared to non-EGFR. However, EGFR-MT with high PD-L1 expression may still benefit from durvalumab treatment."

Clinical • IO biomarker • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • EGFR • KRAS • PD-L1

Targeted therapy after durvalumab in non-small cell lung cancer with EGFR mutation: A retrospective real-world multicenter study (HOT2101) (ESMO Asia 2025) - "Durvalumab consolidation demonstrated sustained efficacy in unresectable stage III NSCLC with EGFRm, comparable to EGFR-negative patients. Although targeted therapy after durvalumab showed clinical activity, efficacy was inferior to osimertinib in maintenance after CRT (LAURA), adjuvant (ADAURA), and first-line (FLAURA) settings. This treatment sequence may be reasonable for some patients, though careful monitoring for pneumonitis is essential."

Real-world • Real-world evidence • Retrospective data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

TREMENDOUS-2: An open-label, multi-center phase II study of durvalumab and tremelimumab with lenvatinib as first-line treatment in patients with unresectable hepatocellular carcinoma (ESMO Asia 2025) - P2, P3 | "Background: In the global phase III HIMALAYA study (NCT03298451), a single, high priming dose of tremelimumab (anti-CTLA4) plus durvalumab (anti-PD-L1) termed STRIDE demonstrated statistically significant and clinically meaningful improvement in OS vs. sorafenib for the 1L treatment of pts with unresectable hepatocellular carcinoma (uHCC) (median OS of 16.4 vs. 13.8 months, HR=0.78), with a manageable safety profile. The key secondary endpoint is Grade ≥3 treatment-related adverse events within 6 months after treatment initiation. Other secondary endpoints include OS, ORR, DOR, DCR per RECIST 1.1 and PFS per mRECIST and safety."

Clinical • P2 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

Risk factors for immune-related adverse events associated with PD-1/PD-L1 inhibitors in hepatobiliary cancers (ESMO Asia 2025) - "ICIs administered included atezolizumab (n=86, 62.3%), durvalumab (n=50, 36.2%), and pembrolizumab (n=2, 1.4%). The incidence of irAEs may increase with prolonged use of ICIs in hepatobiliary cancers. Male sex and combination therapy with CTLA-4 inhibitors may be potential risk factors for irAEs."

Adverse events • Clinical • Biliary Cancer • Biliary Tract Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Looking beyond drug costs in immune-oncology treatments for unresectable hepatocellular carcinoma: A Singapore healthcare perspective analysis (ESMO Asia 2025) - "Background: Tremelimumab + durvalumab (STRIDE) and atezolizumab + bevacizumab (A+B) are recommended first-line (1L) treatment options for unresectable hepatocellular carcinoma (uHCC). This study suggests that STRIDE offers cost savings over A+B related to resource use and TEAE management in the treatment of Singaporean patients with uHCC."

Drug cost • HEOR • Hepatocellular Cancer • Oncology • Solid Tumor

Clinical outcome of first-line systemic treatment in patients with hepatocellular carcinoma with portal vein thrombosis (ESMO Asia 2025) - "There were 49%, 27%, 20%, 4% of patients were treated with sorafenib (SOR), Lenvatinib (LEN), atezolizumab/bevacizumab (Atezo/Bev), and durvalumab/tremelimumab (Durva/Treme), respectively. In this real-world data, HCC with PVT had a significantly poorer prognosis compared to those without. Although, combination immune check point inhibitors had higher ORR, there was no difference in term of PFS and OS when compared with LEN or SOR."

Clinical • Clinical data • Hepatocellular Cancer • Oncology • Solid Tumor

Neoadjuvant FLOT with or without durvalumab followed by S-1–based adjuvant therapy for gastric cancer: Real-world evidence from Asia (ESMO Asia 2025) - "Background: Perioperative FLOT (fluorouracil, leucovorin, oxaliplatin, docetaxel) is a Western standard for locally advanced gastric cancer but postoperative tolerability remains suboptimal in Asian patients... Neoadjuvant FLOT with or without durvalumab, followed by S-1–based adjuvant therapy, is feasible and effective in Asian patients with locally advanced or initially unresectable gastric cancer. Durvalumab addition improved R0 resection, ypCR, and conversion surgery rates, supporting a regionally optimized perioperative strategy. These real-world findings warrant validation in prospective, biomarker-driven trials."

Clinical • HEOR • IO biomarker • Real-world • Real-world evidence • Esophageal Cancer • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor

Spatial transcriptomics of extrahepatic cholangiocarcinoma unravels immunosuppressive features of cancer-associated fibroblasts (ESMO Asia 2025) - "A compressive characterization of CAF in eCCA is needed for the identification of therapeutic approaches able to improve CIT efficacy, that, so far, remains limited in these patients. We performed spatial transcriptomics on tumor specimens from 6 patients with advanced perihilar (p) or distal (d) CCA treated with durvalumab + cisplatin/gemcitabine. Our findings suggest that CAF with an anti-inflammatory and pro-tumorigenic phenotype might hamper the intratumoral recruitment of immune cells, and therefore limit CIT efficacy, in eCCA. A deeper characterization of CAF features and CAF-tumor interactions is ongoing to help the identification of strategies to improve CIT efficacy in eCCA."

IO biomarker • Biliary Cancer • Cholangiocarcinoma • Oncology • Solid Tumor • ACTA2 • PTPRC

Real-world outcomes of gemcitabine, cisplatin, and TS-1 (GCS) with or without immunotherapy in advanced biliary tract cancer (ESMO Asia 2025) - "Recent pivotal trials have established triplet regimens of gemcitabine and cisplatin (GC) with immunotherapy, durvalumab in TOPAZ-1 and pembrolizumab in KEYNOTE-966...Patients were categorized into two treatment groups: those receiving GCS alone and those receiving GCS in combination with immunotherapy (durvalumab or nivolumab)... This multicenter real-world study shows that GCS, with or without immunotherapy, is a feasible and effective option for advanced BTC, achieving survival outcomes comparable to or exceeding those in pivotal trials. These findings support GCS as a viable real-world strategy and highlight the need for prospective studies to define its optimal integration with immunotherapy."

Clinical • Metastases • Real-world • Real-world evidence • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor