Imfinzi (durvalumab) / AstraZeneca - LARVOL DELTA

Seminal Abstract: ULTRASENSITIVE DETECTION AND TRACKING OF CIRCULATING TUMOR DNA (CTDNA) AND ASSOCIATION WITH RELAPSE AND SURVIVAL IN LOCALLY ADVANCED CERVICAL CANCER (LACC): PHASE 3 CALLA TRIAL ANALYSES (IGCS 2025) - P3 | "The global randomized CALLA trial (NCT03830866) of durvalumab (D) in combination with CRT followed by D (D+CRT arm) vs CRT (CRT arm) did not significantly improve progression-free survival (PFS) in a biomarker unselected intent-to-treat (ITT) population...Reused with permission. This abstract was accepted and previously presented at the 2025 ASCO Annual Meeting."

Circulating tumor DNA • IO biomarker • Metastases • P3 data • Cervical Cancer • Oncology • Solid Tumor • PD-L1

Final Results from a First-in-Human Phase 1 Study of the Dual Isocitrate Dehydrogenase (IDH) 1/2 Inhibitor, LY3410738, in Advanced Solid Tumors Harboring IDH1 or IDH2 Mutations. (PubMed, Clin Cancer Res) - P1 | "LY3410738 demonstrated largely cytostatic antitumor activity in IDH1- or IDH2-mutated cholangiocarcinoma and IDH1-mutated gliomas. LY3410738 plus cisplatin-gemcitabine exhibited favorable antitumor activity in patients with treatment-naïve IDH-mutated cholangiocarcinoma, warranting further exploration as a treatment strategy."

First-in-human • Journal • P1 data • Biliary Cancer • Brain Cancer • Cholangiocarcinoma • Glioma • Oncology • Solid Tumor • IDH1 • IDH2

Urinary tumor DNA (utDNA) and circulating tumor DNA (ctDNA) in patients (pts) with muscle-invasive bladder cancer (MIBC) who received perioperative durvalumab (D) in NIAGARA. (ASCO-GU 2026) - P3 | " Cisplatin-eligible pts with MIBC (cT2-T4aN0/1M0) were randomized 1:1 to receive perioperative D plus NAC (cisplatin + gemcitabine) and RC (D arm) or NAC and RC alone (comparator [C] arm). This analysis suggests that lower BL levels and pre-RC clearance of utDNA are associated with better EFS and shows the addition of D to NAC increased utDNA clearance. utDNA status at pre-RC was more closely associated with pCR vs prior findings for ctDNA status. Combined pre-RC ctDNA and utDNA analysis was associated with EFS and may provide complementary insights into disease stage at RC."

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

Intratumoral bacteria are immunosuppressive and promote immunotherapy resistance in head and neck squamous cell carcinoma. (PubMed, Nat Cancer) - P1 | "To address this, here we analyzed oropharyngeal HNSCCs treated with neoadjuvant durvalumab (anti-PDL1) alone or in combination with tremelimumab (anti-CTLA4) from the CIAO clinical trial ( NCT03144778 ). Increasing intratumoral bacteria abundance was sufficient to induce resistance to anti-PDL1 ICB, irrespective of bacterial species tested. Together, these findings demonstrate that high intratumoral bacteria abundance is a key suppressor of antitumor immunity and promotes immunotherapy resistance."

Journal • Head and Neck Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck

Concurrent thoracic radiotherapy (TRT), platinum/etoposide chemotherapy, and durvalumab immunotherapy in extensive-stage (ES) small cell lung cancer (SCLC): A phase III trial. (ASCO 2026) - P3 | "Patients received 4 courses of carboplatin (AUC 5), etoposide (100 mg/m2 iv day 1-3 or 100 mg/m2 iv day 1 plus 200 mg/m2 po days 2-4) and durvalumab 1500 mg q3w, followed by durvalumab 1500 mg q4w until progression, unacceptable toxicity or patients wished to discontinue. The addition of TRT after the first cycle of chemo-ICI did not improve treatment outcomes in ES SCLC."

Late-breaking abstract • P3 data • Gastrointestinal Disorder • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

ctDNA based MRD detection in stage III NSCLC treated with chemoradiotherapy and durvalumab. (PubMed, J Thorac Oncol) - "Detectable ctDNA during and after durvalumab was associated with markedly shorter PFS in unresectable stage III NSCLC. Serial ctDNA-based MRD assessment may help identify patients at high risk of relapse who could benefit from alternative or intensified treatment strategies, ideally within prospective clinical trials."

Circulating tumor DNA • Clinical • Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Neoadjuvant Durvalumab + Chemotherapy for Resectable/Borderline Resectable Stage IIB-IIIB NSCLC: MDT-BRIDGE Primary Analysis (IASLC-WCLC 2026) - P2, P3 | "Close MDT follow-up allowed most patients to receive curative-intent treatment (92.3% had surgery/CRT) and post-definitive therapy (82.4% had adjuvant/consolidation durvalumab). Finally, preliminary efficacy outcomes were encouraging, and the adjuvant and consolidation safety profiles were consistent with prior studies."

Clinical • Late-breaking abstract • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Perioperative durvalumab plus fluorouracil, leucovorin, oxaliplatin, and docetaxel for resectable gastric and gastro-oesophageal junction adenocarcinoma (MATTERHORN): final results of overall survival and event-free survival by pathological response in a global, randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. (PubMed, Lancet) - P3 | "Perioperative durvalumab plus FLOT improved overall survival versus placebo plus FLOT and is a new standard treatment option for patients with resectable gastric or gastro-oesophageal junction adenocarcinoma."

IO biomarker • Journal • P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • PD-L1

ATHENEA, a Phase II Study of Atezolizumab as Neoadjuvant, Adjuvant and Maintenance Treatment for Stage IIIA-IIIB NSCLC Patients (IASLC-WCLC 2026) - "The standard treatment for unresectable stage III patients is concurrent chemoradiotherapy (cCRT) followed by durvalumab for 1 year (PACIFIC regimen)...Methods : ATHENEA is an ongoing multicenter, open-label, phase II clinical trial (EUCT Number: 2024-515984-68-00) that evaluates the efficacy of 3 cycles of neoadjuvant treatment with atezolizumab 1200 mg plus carboplatin AUC6 and paclitaxel 200mg/m 2 in stage IIIA and IIIB NSCLC patients...Patients will undergo tumor assessments by body CT scan at baseline, at post neoadjuvant treatment prior to surgery or cCRT, after surgery (for resectable patients), after cCRT treatment (for non-resectable patients), during treatment with atezolizumab in adjuvant/post cCRT phase every 12 weeks and thereafter, every 3 months for the first 2 years and every 6 months until the 5-year follow-up period is completed. Currently 47 patients have been included in the study."

Clinical • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • EGFR • ROS1 • STK11

Durvalumab plus definitive chemoradiotherapy versus definitive chemoradiotherapy in patients with locally advanced esophagus carcinoma : ARION PRODIGE 67 randomized phase 2 trial (ESMO 2026) - No abstract available

Clinical • Metastases • P2 data • Esophageal Cancer • Oncology

Liver function trajectory and post-progression outcomes in the Phase 3 EMERALD-3 study of tremelimumab (T) + durvalumab (D) ± lenvatinib (L) + transarterial chemoembolisation (TACE) in participants (pts) with embolisation-eligible hepatocellular carcinoma (eeHCC) (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Ivonescimab plus chemotherapy versus durvalumab plus chemotheray as first-line treatment for advanced biliary tract cancer: a randomized, controlled, double- blinded, phase 3 trial (HARMONi-GI1) (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P3 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Perioperative durvalumab with or without tremelimumab plus neoadjuvant enfortumab vedotin in muscle-invasive bladder cancer: results from the Phase 3 VOLGA trial (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Tarlatamab plus durvalumab (durva) vs durva as 1L maintenance (1LM) therapy following durva, platinum, and etoposide (1L durva + EP) in extensive-stage small cell lung cancer (ES-SCLC): Primary analysis of the phase 3 DeLLphi-305 trial (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • P3 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

OPTIMUM: A randomized phase 2 study of maintenance olaparib (Ola) with or without durvalumab (Durva) in DDR gene-mutated advanced biliary tract cancer (aBTC) (ESMO 2026) - No abstract available

Clinical • Late-breaking abstract • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

AstraZeneca’s supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab) in combination with enfortumab vedotin (EV) has been accepted and granted Priority Review in the US for the treatment of patients with muscle-invasive bladder cancer (MIBC) who are ineligible for or have declined cisplatin-based chemotherapy. (AstraZeneca Press Release) - "The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for its regulatory decision, is anticipated during the fourth quarter of 2026...The sBLA is based on results from the VOLGA Phase III trial, which will be presented at a forthcoming medical meeting. In a planned interim analysis, perioperative treatment with Imfinzi in combination with neoadjuvant EV demonstrated statistically significant and clinically meaningful improvements in event-free survival (EFS) and overall survival (OS) versus radical cystectomy (surgery to remove the bladder) with or without approved adjuvant treatment."

FDA approval • FDA filing • Priority review • Bladder Cancer

Final overall survival (OS) and the association of pathological outcomes with event-free survival (EFS) in MATTERHORN: A randomised, phase III study of durvalumab (D) plus 5-fluorouracil, leucovorin, oxaliplatin and docetaxel (FLOT) in resectable gastric / gastroesophageal junction (G / GEJ) adenocarcinoma (ESMO 2025) - P3 | "Conclusions A statistically significant and clinically meaningful improvement in OS was seen with D + FLOT vs P + FLOT, and OS also improved irrespective of PD-L1 status. EFS was improved with D + FLOT vs P + FLOT in pts with any degree of pR and regardless of ypN status."

Clinical • Late-breaking abstract • P3 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Oncology • PD-L1

Long-term survival and cure fraction in patients with advanced hepatocellular carcinoma under immunotherapy in randomized controlled trials and real-world data. (PubMed, Clin Cancer Res) - "Across trials and real-world data, ICIs combinations achieve long-term survival in 10-15% of advanced HCC patients, with cure fractions of 7-9%."

Journal • Real-world evidence • Hepatitis C • Hepatocellular Cancer • Infectious Disease • Oncology • Solid Tumor

Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin Malignancy (clinicaltrials.gov) - P1 | N=10 | Active, not recruiting | Sponsor: University of Southern California | Trial completion date: Aug 2027 ➔ Mar 2028 | Trial primary completion date: Aug 2026 ➔ Mar 2027

Checkpoint inhibition • Trial completion date • Trial primary completion date • Oncology • Skin Cancer • Solid Tumor • LAG3

Predictive Model for First-Line Chemo-Immunotherapy in Driver-Negative Lung Adenocarcinoma With Brain Metastases (IASLC-WCLC 2026) - "Immune checkpoint inhibitors (ICIs) included tislelizumab (n=20), pembrolizumab (n=18), camrelizumab (n=17), sintilimab (n=15), toripalimab (n=5), and durvalumab (n=1), all administered in combination with chemotherapy. Conclusions : A prediction model incorporating Ki-67, PD-L1, NLR, and neurologic symptoms demonstrated strong discriminative ability for estimating systemic response to first-line chemo-immunotherapy in LUAD-BM. DoR was associated with PFS, whereas TTR was not, indicating that the maintenance of tumor response rather than early response onset may be more relevant to long-term outcomes."

Clinical • Predictive model • Brain Cancer • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • PD-L1

A Prospective, Multicenter, Exploratory Clinical Study of Tislelizumab Combined With Nintedanib for Consolidation Treatment of LS-SCLC (IASLC-WCLC 2026) - "In the ADRIATIC study, durvalumab was associated with any-grade pneumonia in 38.2% of patients (3.1% grade 3-4). Secondary endpoints include1-y PFS rate, incidence of radiation pneumonitis, overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Exploratory endpointsare potential prognostic and predictive biomarkers."

Clinical • IO biomarker • Idiopathic Pulmonary Fibrosis • Immunology • Infectious Disease • Lung Cancer • Pneumonia • Pulmonary Disease • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor

Association of Early Versus Late Time of Day Immune Checkpoint Inhibitors Administration With Survival Outcomes in Gastric and Esophageal Cancers: A Meta-Analytical Evaluation (ACG 2026) - "Eligible studies included patients with advanced gastric or esophageal cancer treated with ICIs, including nivolumab, pembrolizumab, sintilimab, camrelizumab, tislelizumab, toripalimab, and durvalumab, administered either as monotherapy or in combination with chemotherapy. A total of 702 patients were included, comprising 520 patients with gastric cancer and 182 patients with esophageal cancer. In gastric cancer, early ICI administration was associated with significantly improved OS (pooled HR, 0.61; 95% CI, 0.49â0.77) and PFS (pooled HR, 0.62; 95% CI, 0.43â0.89). In esophageal cancer, early administration was associated with improved PFS (pooled HR, 0.40; 95% CI, 0.22â0.72)."

Checkpoint inhibition • Esophageal Cancer • Gastric Cancer • Oncology • Solid Tumor

Survival in unresectable hepatocellular carcinoma: Comparison of four treatments based on patients reconstructed from Kaplan-Meier curves of randomized trials. (PubMed, World J Gastrointest Pharmacol Ther) - "Our study compared the efficacy of the main first-line treatments recommended for unresectable HCC. While we were able to rank the magnitude of efficacy across these treatments, the intrinsic limitations of our methods (primarily the reconstruction of IPD and the indirect nature of the treatment comparisons) should be borne in mind."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor

Immune checkpoint inhibitors plus chemotherapy for early-stage or locally -advanced triple-negative breast cancer: a systematic review and Bayesian network meta-analysis of randomized trials. (PubMed, Front Oncol) - "In sensitivity analyses, durvalumab (neoadjuvant) + CT and pembrolizumab (perioperative) + CT yielded identical HRs (0.24 and 0.63, respectively). Safety profiles varied: camrelizumab (perioperative) + CT (OR 0.60, 95% CrI 0.34-1.04) and pembrolizumab (neoadjuvant) + CT (OR 0.53, 95% CrI 0.28-1.01) suggested reduced risks of AEs ≥3, but these findings did not achieve statistical significance and were supported by low-to-very-low certainty evidence...Future head-to-head RCTs are warranted to confirm these observations and to better define long-term safety profiles. https://www.crd.york.ac.uk/prospero/, identifier CRD420261385223."

Checkpoint inhibition • Journal • Retrospective data • Review • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A Phase II Trial of Induction Camrelizumab Plus Chemotherapy Followed by Chemoradiotherapy and Consolidation in Limited-Stage SCLC (IASLC-WCLC 2025) - P2 | "Although durvalumab consolidation has enhanced outcomes compared to traditional concurrent chemoradiotherapy (CRT), disease progression remains a formidable challenge...Patients were randomly assigned (1:1) to either an experimental regimen of induction immunotherapy and chemotherapy (two cycles of camrelizumab plus etoposide-platinum [EP] or etoposide-carboplatin [EC]) followed by CRT, prophylactic cranial irradiation (PCI), and up to 12 months of camrelizumab consolidation (camrelizumab group), or a control regimen of induction chemotherapy (EP or EC) followed by CRT and PCI (cCRT group)...Conclusions : These findings suggest that induction camrelizumab plus chemotherapy followed by CRT and camrelizumab consolidation may improve both PFS and OS in LS-SCLC without exacerbating toxicity. Further research to refine treatment sequencing could provide vital improvements in managing this challenging disease."

P2 data • Lung Cancer • Non Small Cell Lung Cancer • Pneumonia • Small Cell Lung Cancer • Solid Tumor