Imjudo (tremelimumab-actl) / AstraZeneca, Pfizer - LARVOL DELTA

Five-year overall survival update from the HIMALAYA study of tremelimumab plus durvalumab in unresectable HCC. (PubMed, J Hepatol) - P3 | "At 5 years, STRIDE sustained an OS benefit versus sorafenib and maintained a manageable safety profile. OS benefit with STRIDE was improved in participants with disease control. Data suggest that any degree of tumour shrinkage with STRIDE can be associated with improved OS, indicating that conventional response measures may not fully capture STRIDE benefits. Nevertheless, participants experiencing deep responses appear to have the greatest benefit. STRIDE continues to set new benchmarks in uHCC with 1 in 5 patients alive at 5 years."

Journal • Hepatocellular Cancer • Oncology

Combined treatment of durvalumab, bevacizumab and tremelimumab in subjects with hepatocellular carcinoma (HCC) or biliary tract carcinoma (BTC). (ASCO 2025) - P2 | "The combination of durvalumab, bevacizumab and tremelimumab did not meet its primary endpoint but demonstrated a clinically meaningful overall survival benefit. No new safety signals were seen."

Clinical • Anemia • Biliary Cancer • Biliary Tract Cancer • Gastroenterology • Gastrointestinal Disorder • Hepatocellular Cancer • Immunology • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase II trial of zanzalintinib (XL-092) in combination with durvalumab and tremelimumab in unresectable hepatocellular carcinoma (ZENOBIA). (ASCO 2025) - P2 | "A Phase II study (CHECKMATE 040) reported an impressive objective response rate (ORR) of 29% with the combination of ipilimumab/nivolumab and Cabo but noted high toxicity rates...Comprehensive translational analyses include bulk RNA sequencing, spatial transcriptomics of baseline tumor biopsies, & serial ctDNA monitoring. Trial enrollment commenced in December 2024."

Combination therapy • P2 data • Gastroenterology • Gastrointestinal Disorder • Hepatocellular Cancer • Immunology • Oncology • Solid Tumor • AXL

Final efficacy data and biomarker analysis from the clear cell cohort of CALYPSO (ESMO 2025) - P2 | "Background CALYPSO is a phase II trial evaluating durvalumab (D), savolitinib (S) and tremelimumab (T) in previously treated advanced renal cell carcinoma (RCC). While response rates for DT were higher than D alone, the predefined requirements were not met. Other endpoints such as OS were not discriminatory compared to D monotherapy."

Biomarker • Clinical • IO biomarker • Tumor mutational burden • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • KIM1 • PD-L1 • TMB

First results from RAMPART: An international phase III randomised-controlled trial of adjuvant durvalumab monotherapy or combined with tremelimumab for resected primary renal cell carcinoma (RCC) led by MRC CTU at UCL (ESMO 2025) - P3 | "Results of Arms B vs A are expected in next 12 months. Table: LBA93 Risk at baseline A C Total N=340 N=225 N=565 Leibovich Intermediate Risk 151 (44%) 103 (46%) 254 (45%) Leibovich High Risk 172 (51%) 111 (49%) 283 (50%) M1NED 17 (5%) 11 (5%) 28 (5%) Conclusions Adjuvant therapy with durvalumab and tremelimumab after resection of RCC improved DFS, particularly among those at highest risk of relapse."

Clinical • Late-breaking abstract • Monotherapy • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma

Patient-reported outcomes in resected renal cell carcinoma: Active monitoring vs. durvalumab and tremelimumab in the RAMPART trial. (ASCO-GU 2026) - P3 | "Clinical Trial Registry Number: NCT03288532. The full, final text of this abstract will be available on Feb 23 at 05:00 PM EST."

Clinical • Patient reported outcomes • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Patient-Reported Outcomes with Consolidation Durvalumab Versus Placebo Following Concurrent Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer: Results from the Phase 3 ADRIATIC Trial. (PubMed, J Thorac Oncol) - "Consolidation durvalumab following cCRT did not compromise patients' GHS/QoL, functioning, or symptoms versus placebo, further supporting this treatment regimen as the new standard of care for LS-SCLC."

Journal • P3 data • Lung Cancer • Musculoskeletal Pain • Oncology • Pain • Small Cell Lung Cancer • Solid Tumor

Durvalumab after Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer. (PubMed, N Engl J Med) - P3 | "Adjuvant therapy with durvalumab led to significantly longer overall survival and progression-free survival than placebo among patients with limited-stage small-cell lung cancer. (Funded by AstraZeneca; ADRIATIC ClinicalTrials.gov number, NCT03703297.)."

Journal • Lung Cancer • Oncology • Pneumonia • Small Cell Lung Cancer • Solid Tumor

Durvalumab with or without tremelimumab in combination with chemotherapy in first-line metastatic non-small-cell lung cancer: outcomes by tumor mutational burden in POSEIDON. (PubMed, ESMO Open) - "First-line treatment with T (limited course) plus D (until progression) and four cycles of CT consistently improved clinical outcomes versus CT alone in both bTMB-high and -low subgroups, and also in both high and low tTMB subgroups, in patients with mNSCLC. Benefit appeared greater in the TMB-high versus TMB-low subgroups; the addition of anti-cytotoxic T lymphocyte-associated antigen-4 to anti-PD-L1 and CT seemed to increase the magnitude of this difference."

IO biomarker • Journal • Tumor mutational burden • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ALK • CTLA4 • EGFR • TMB

RMT in Non Small Cell Lung Cancer (IASLC-WCLC 2025) - "We report the preliminary safety and efficacy of restorative microbiota therapy (RMT) from the open-label safety-run-in portion of the randomized double-blind phase II Trial of RMT or placebo in combination with durvalumab and tremelimumab with chemotherapy in advanced Non-Small Cell Lung Cancer (NSCLC). Preliminary efficacy is promising, and the randomized double-blind placebo-controlled study is ongoing. Early data suggest that Collinsella in the stool is associated with treatment response."

Anorexia • Constipation • Gastroenterology • Gastrointestinal Disorder • Lung Cancer • Melanoma • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Safety results in Asian participants (pts) from the phase IIIb SIERRA study of durvalumab (D) and tremelimumab (T) as first-line (1L) treatment (tx) for pts with unresectable hepatocellular carcinoma (uHCC) and a poor prognosis (ESMO Asia 2025) - P3 | "The safety profile of STRIDE in Asian pts was manageable, despite enrolling pts with worse hepatic function, poorer ECOG PS or more advanced vascular invasion than those who are typically included in clinical trials for uHCC, and comparable to the global population of SIERRA."

Clinical • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

Pooled efficacy and safety with tremelimumab plus durvalumab in participants (pts) with unresectable hepatocellular carcinoma (uHCC) from the mainland China extension cohort, and Hong Kong (HK) and Taiwan (TW) subgroups from the global cohort in the phase III HIMALAYA study (ESMO Asia 2025) - P3 | "Background: STRIDE (Single Tremelimumab Regular Interval Durvalumab) significantly improved overall survival (OS) vs sorafenib (S; hazard ratio [HR], 0.78) in pts with uHCC in the Phase 3 HIMALAYA study (NCT03298451). In this pooled analysis of the mainland China extension cohort and HK and TW subgroups, OS improved with STRIDE and D vs S, with manageable safety through 3 yrs of follow-up. STRIDE and D continued to show long-term survival benefit vs S in pts from HK and TW through 5-yr of follow-up. These results demonstrate a favourable risk-benefit profile for STRIDE and D in pts with uHCC in these populations."

Clinical • P3 data • Hepatocellular Cancer • Oncology • Solid Tumor

A single-arm, single-center clinical study of toripalimab as adjuvant therapy for high-risk clear cell renal cell carcinoma after radical nephrectomy (ChiCTR) - P=N/A | N=100 | Not yet recruiting | Sponsor: The First Affiliated Hospital of Xi'an Jiaotong University; The First Affiliated Hospital of Xi'an Jiaotong University

New trial • Clear Cell Carcinoma • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Long-term survival and cure fraction in advanced hepatocellular carcinoma under immunotherapy in randomized controlled trials and real-world data (LCS 2026) - "Method We selected positive phase 3 randomized controlled trials of ICI regimens in first-line advanced HCC with mature follow-up (≥30 months) and analyzed a cohort of patients with HCC treated with atezolizumab– bevacizumab...Results HIMALAYA trial reported median follow-up of 60 months and MCMs estimate long-term survival of 12.8% (95%CI:8.5-18.6%) in durvalumab-tremelimumab versus 5.2% in sorafenib (95%CI:2.6-10.2%); cure fraction was not assessable.In CheckMate9DW (median follow-up: 35.2 month), MCMs estimated a long- term survival of 8.7% (95%CI:0.2–81.3%) versus 4.1% (95%CI:0.1-66.1%) and a cure fraction of 17.8% (95%CI:12.0–25.8%) versus 3.5% (95%CI:0.7–16.7%) for nivolumab-ipilimumab and sorafenib/lenvatinib respectively...MCM estimated 12.3% (95%CI:9.3-16.1%) of long-term survivors and 7.9% (95%CI:6.3-9.8%) of cure.Radiological response was associated with higher fraction of long-term survival and cure.In 1187 patients meeting the IMbrave150 criteria, MCM..."

Clinical • Metastases • Real-world • Real-world evidence • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

A Case of Simultaneous Resection of Single Lung and Liver Metastases with Combined Immunotherapy after Radical Surgery for Hepatocellular Carcinoma (PubMed, Gan To Kagaku Ryoho) - "Early postoperatively, he developed a single S3 metastasis in the left lung and started combination therapy with atezolizumab plus bevacizumab...He was treated with lenvatinib for a short period of time postoperatively, but recurred multiple metastases in both lungs on CT scan 3 months later. He has been treated with a combination of durvalumab plus tremelimumab while submitting to cancer genome testing, which revealed TMB-high and MSI-high. Tissue sampling is essential for the diagnosis of inter-hepatic metastasis or multicentric occurrence, and in the case of ipsilateral hepatopulmonary metastasis, trans-diaphragmatic approach surgery is effective for less incision surgery. Combined immunoadjuvant therapy for resected HCC has shown efficacy in short-term results."

Journal • Hepatocellular Cancer • Oncology • Solid Tumor • TMB

Durvalumab (D) plus tremelimumab (T) in advanced biliary tract carcinoma (BTC) patients (Pts) after failure of platinum-based chemotherapy (CTx): Final results of the IMMUNOBIL GERCOR D18-1 PRODIGE-57 phase II trial (ESMO 2025) - P2 | "A subset of Pts appeared to benefit from immunotherapy, not fully explained by PDL1. Results from additional tumor and blood ancillary program are pending."

Clinical • Metastases • P2 data • Biliary Cancer • Biliary Tract Cancer • Cholangiocarcinoma • Gallbladder 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

Sequential transarterial chemoembolization and stereotactic body radiotherapy followed by immunotherapy using single tremelimumab regular interval durvalumab in locally advanced, unresectable HCC (START-FIT using STRIDE): A single-arm, phase II, multi-centre study. (ASCO-GI 2026) - P2 | "START-FIT using STRIDE is safe and effective in locally advanced unresectable HCC resulted in 42% CR rate with an additional of 21% patients converted to curative surgery. Patient and tumor characteristics."

Clinical • Metastases • P2 data • Gastrointestinal Cancer • Hepatocellular Cancer

Multicentre phase II trial of cabozantinib in patients with hepatocellular carcinoma after immune checkpoint inhibitor treatment. (PubMed, J Hepatol) - P2 | "Cabozantinib demonstrates efficacy in patients with prior ICI. The survival data of second-line cabozantinib following the first-line ICI regimen provide reference for clinical trial testing post-ICI therapy. The number of prior line of treatment may be considered a stratification factor in randomized study."

Checkpoint inhibition • Journal • P2 data • Gastrointestinal Cancer • Hematological Disorders • Hepatocellular Cancer • Liver Cancer • Oncology • Solid Tumor • Thrombocytopenia

CAMILLA: Cabozantinib Plus Durvalumab With or Without Tremelimumab in Patients With Gastroesophageal Cancer and Other Gastrointestinal Malignancies (clinicaltrials.gov) - P1/2 | N=117 | Recruiting | Sponsor: Anwaar Saeed | Trial completion date: Jan 2028 ➔ Jun 2029 | Trial primary completion date: Jan 2027 ➔ Jun 2028

Trial completion date • Trial primary completion date • Colorectal Cancer • Esophageal Adenocarcinoma • Esophageal Cancer • Gastric Cancer • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Gastrointestinal Cancer • Hepatocellular Cancer • Oncology • Solid Tumor • MSI

Patterns of disease progression with durvalumab (D) after concurrent chemoradiotherapy (cCRT) in limited-stage small-cell lung cancer (LS-SCLC): Results from ADRIATIC (ELCC 2025) - P3 | " Pts with stage I–III LS-SCLC (stage I/II inoperable) and no progression after cCRT were randomised to D, D + tremelimumab (arm still blinded), or P, stratified by disease stage and prophylactic cranial irradiation (PCI) use. Findings suggest D consolidation reduced the rate of ET metastases and prolonged time to progression or death for IT and ET metastases, including brain/CNS metastases. D reduced brain/CNS metastases regardless of PCI use."

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

ALICE: Durvalumab and Tremelimumab With or Without Hepatic Arterial Infusion of Chemotherapy in Hepatocellular Carcinoma (clinicaltrials.gov) - P2/3 | N=196 | Recruiting | Sponsor: UNICANCER | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Gastric Cancer • Hepatocellular Cancer • Oncology • Solid Tumor

Cardiac Adverse Events Associated with Dual Immune Checkpoint Inhibitors: A Pharmacovigilance Analysis from the FDA Adverse Event Reporting System. (PubMed, Eur Heart J Cardiovasc Pharmacother) - "This study identified distinct associations between different dual ICIs treatment strategies and various cardiac adverse events. We further identified potential risk factors and co-reported symptoms of cardiotoxicity, which may aid in the early diagnosis and monitoring of ICI-associated cardiac adverse events."

Adverse events • Checkpoint inhibition • Journal • Cardiovascular • CNS Disorders • Genito-urinary Cancer • Immunology • Kidney Cancer • Myasthenia Gravis • Myositis • Oncology • Renal Cell Carcinoma • Solid Tumor

ADRIATIC: Durvalumab (D) as consolidation treatment (tx) for patients (pts) with limited-stage small-cell lung cancer (LS-SCLC). (ASCO 2024) - P3 | "ADRIATIC (NCT03703297), a phase 3, randomized, double-blind, placebo (PBO)-controlled, multicenter, global study, assessed D ± tremelimumab (T) as consolidation tx for pts with LS-SCLC who had not progressed after cCRT. D as consolidation tx after cCRT demonstrated a statistically significant and clinically meaningful improvement in OS and PFS compared with PBO in pts with LS-SCLC. D was well tolerated and AEs were consistent with the known safety profile, with no new signals observed. These data support consolidation D as a new SoC for pts with LS-SCLC who have not progressed after cCRT."

Clinical • Late-breaking abstract • Inflammation • Lung Cancer • Oncology • Pneumonia • Small Cell Lung Cancer • Solid Tumor

Primary efficacy results of tremelimumab and durvalumab in combination with trastuzumab in trastuzumab resistant advanced HER2-positive breast cancer: BCT1703 DIAmOND (ESMO-BC 2025) - P2 | "Median prior lines of therapy was 3 (IQR 2-5); 5.9% patients received prior T-Dxd. Dual CTLA-4 and PD-L1 inhibition is active in this T resistant setting. Promising signals were seen in ER-positive and PD-L1 positive patients. Further investigation of dual checkpoint blockade plus HER2-targeted therapies is warranted."

Clinical • Combination therapy • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • ER • HER-2