A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab (STRIDE) Plus Gemcitabine and Cisplatin (GEMCIS) in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma (cHCC-CCA)

This is a single arm phase 2 study of Single Tremelimumab with Regular Interval Durvalumab (STRIDE) plus Gemcitabine and Cisplatin (GEMCIS) in locally advanced unresectable/metastatic combined hepatocellular-cholangiocarcinoma (cHCC-CCA). Cycles 1 through 8 will be in 3 week intervals and Cycles 9+ will be in 4 week intervals. Tremelimumab is administered at 300mg intravenously once at Cycle 1. Durvalumab is administered at 1500mg intravenously every 3 weeks for Cycles 1-8, then every 4 weeks for Cycles 9+. Gemcitabine is administered at 1000mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Cisplatin is administered at 25mg/m^2 intravenously on Day 1 and Day 8 of Cycles 1-8 only. Subjects will require a visit with appropriate laboratory work prior to the start of each cycle. Disease assessment will occur at screening and then every 9 weeks until the end of Cycle 9. Disease assessments will then occur every 8 weeks. Subjects will continue treatment until progression per RECIST 1.1, toxicity or subject/physician decision. A maximum of 24 months treatment from Cycle 1 Day 1 is allowed.

Start Date01 Jul 2026

Sponsor / Collaborator

Hoosier Cancer Research Network

[+2]

NCT06824363

/ RecruitingEarly Phase 1IIT

Proof of Principle Study Evaluating Single Dose Dual Immune Checkpoint Inhibitors to Increase Intra-tumoral T Cells in Esophageal, Gastroesophageal Junction, and Gastric Adenocarcinomas With ARID1A Mutations: ESR-22-22082

This is a proof of principle clinical trial determining efficacy of single dose dualimmune checkpoint inhibitors to increase intra-tumoral T cells in esophageal, gastroesophageal junction, and gastric adenocarcinomas. These are subjects who have not previously been treated for their disease, who are willing to undergo biopsy procedures, who's disease has not spread to other parts of the body, who's tumors have ARID1A mutations.

Start Date25 May 2026

Sponsor / Collaborator

University of California, Irvine

ChiCTR2600124441

/ RecruitingPhase 2

Efficacy analysis of hyperthermic intraperitoneal chemotherapy(HIPEC)combined with systemic conversion therapy and cytoreductive surgery (CRS) in colorectal cancer appendiceal cancer with peritoneal metastasis

Start Date13 May 2026

Sponsor / Collaborator

Nanjing General Hospital of Nanjing Military Command

100 Clinical Results associated with Tremelimumab

100 Translational Medicine associated with Tremelimumab

100 Patents (Medical) associated with Tremelimumab

721

Literatures (Medical) associated with Tremelimumab

01 Jul 2026·ANTICANCER RESEARCH

Pretreatment Tumor-infiltrating CD8 ⁺ T Cell Numbers Are Associated With the Response to Tremelimumab Plus Durvalumab in Hepatocellular Carcinoma

Article

Author: Suzuki, Hideo ; Kurosaka, Kazuki ; Hamamoto, Taikan ; Kuwano, Akifumi ; Motomura, Kenta ; Tanaka, Kosuke ; Yada, Masayoshi ; Ohishi, Yoshihiro

BACKGROUND/AIM:

Hepatocellular carcinoma (HCC) shows heterogeneous responses to treatment with immune checkpoint inhibitors, and predictive biomarkers for dual immune checkpoint blockade remain insufficiently defined. The STRIDE regimen, combining tremelimumab and durvalumab, improves the survival of patients with unresectable HCC, but a substantial proportion of patients experience early progression. We investigated whether pretreatment intratumoral CD8⁺ tumor-infiltrating lymphocyte (TIL) density was associated with treatment response and progression-free survival (PFS) in patients treated with STRIDE.

PATIENTS AND METHODS:

This retrospective, single-center study included 26 consecutive patients with unresectable HCC who received STRIDE and underwent pretreatment liver tumor biopsy. CD8⁺ TIL density was assessed using immunohistochemistry. Tumors were classified as CD8-high or CD8-low using a prespecified cutoff (15.9 cells/high-power field).

RESULTS:

Fifteen patients were classified as CD8-high and 11 as CD8-low. The objective response rate was significantly higher in the CD8-high group than in the CD8-low group (60.0% vs. 9.1%, p=0.005). The median PFS was significantly longer in the CD8-high group [8.8 months, 95% confidence interval (CI)=3.0-24.5] than in the CD8-low group (2.0 months, 95%CI=0.8-7.2; p=0.019). The frequency of grade ≥2 immune-related adverse events did not differ significantly between groups.

CONCLUSION:

Pretreatment intratumoral CD8⁺ TIL density was associated with an improved response and a longer PFS in STRIDE-treated HCC. Baseline tumor immune contexture may serve as a practical predictive biomarker for STRIDE. These findings are exploratory and hypothesis-generating, and require validation in larger prospective studies.

01 Jun 2026·EUROPEAN JOURNAL OF CANCER

Early and late survival dynamics of immunotherapy combinations in advanced HCC: Anchored indirect comparison of atezolizumab plus bevacizumab versus durvalumab + tremelimumab

Article

Author: Rossari, Federico ; Kumada, Takashi ; Kudo, Masatoshi ; Ferrara, Michele ; Finkelmeier, Fabian ; Rimassa, Lorenza ; Vitale, Alessandro ; Tada, Toshifumi ; Scartozzi, Mario ; Camera, Silvia ; Pia D'Agata, Alessandra ; Passeri, Laura ; Persano, Mara ; Yip, Terry Cheuk-Fung ; Rimini, Margherita ; Presa, José ; Masi, Gianluca ; Cheon, Jaekyung ; Tamburini, Emiliano ; Casadei-Gardini, Andrea ; Suda, Goki ; Shimose, Shigeo ; Lim, Ho Yeong ; Yoo, Changhoon ; Piscaglia, Fabio ; Lonardi, Sara ; Foschi, Francesco Giuseppe

BACKGROUND AND AIMS:

Atezolizumab plus bevacizumab (A+B) and STRIDE (tremelimumab plus durvalumab) represent two of the approved first-line immunotherapy strategies for unresectable hepatocellular carcinoma (HCC). As no head-to-head trial exists, we assessed temporal differences in survival benefit using complementary analytic frameworks.

METHODS:

Three independent analyses were conducted: (1) anchored indirect comparison using reconstructed survival from IMbrave150 and HIMALAYA; (2) a real-world A+B cohort (n = 883) weighted via MAIC to match STRIDE baseline characteristics; and (3) a propensity-matched population-level dataset from TriNetX (n = 309 per arm). Time-interval hazard ratios (HRs), RMST, and conditional landmark survival were calculated. Proportional hazards were assessed by Schoenfeld testing; pooled interval HRs were synthesized through meta-analysis.

RESULTS:

Across all models, A+B showed a consistent early advantage. In the first 6 months, the pooled HR favored A+B (0.75; 95% CI 0.64-0.88), with absolute survival differences of + 5-7%. From 6-12 months, HRs remained numerically favorable but non-significant. Between 12 and 24 months, pooled HRs approached neutrality (0.93-1.06), with confidence intervals crossing unity and no meaningful absolute survival differences. Beyond 24-36 months, the effect reversed in favor of STRIDE (anchored HR 1.41; RWD HR 2.52; TriNetX HR 1.47). Meta-analysis confirmed a progressive late benefit for STRIDE from 36 to 60 months (pooled HR 1.54-1.75). Schoenfeld tests indicated time-dependent effects in all frameworks (p < 0.05), and ΔRMST trajectories were highly concordant (Pearson r > 0.97).

CONCLUSIONS:

A+B is associated with stronger early tumor control, while STRIDE provides more durable long-term survival beyond 2-3 years. These findings support selecting therapy based on temporal treatment objectives and advocate for biomarkers predicting early versus sustained treatment benefit.

01 Jun 2026·Clinical Journal of Gastroenterology

Durvalumab and tremelimumab combination therapy achieved remarkable response in primary hepatic undifferentiated carcinoma with high PD-L1 expression

Article

Author: Kawahara, Michihiko ; Arihiro, Koji ; Nakagiri, Tetsuya ; Tsuge, Masataka ; Fujii, Yasutoshi ; Hayes, C Nelson ; Ono, Atsushi ; Oka, Shiro ; Fujino, Hatsue ; Kawaoka, Tomokazu

Primary hepatic undifferentiated carcinoma is an extremely rare and aggressive malignancy with no established systemic therapy, and the efficacy of immune checkpoint inhibitors (ICIs) remains unknown. We report a 67-year-old man with compensated hepatitis C-related cirrhosis who presented with a 27 mm segment 8 liver lesion and lymph node and bone metastases. Liver biopsy revealed undifferentiated carcinoma with high programmed death-ligand 1 (PD-L1) expression, and combination therapy with durvalumab and tremelimumab (Dur/Tre) was initiated. Shortly after treatment, the patient developed cranial nerve palsies (III, VII, VIII), suspected to represent either an immune-related adverse event or Ramsay Hunt syndrome; his symptoms improved with prednisolone and valaciclovir, allowing Dur/Tre to be resumed. After four courses, partial tumor shrinkage was achieved, and after 17 courses the primary tumor had decreased to 10 mm with complete resolution of nodal metastases, without further significant adverse events. To our knowledge, this is the first report of primary hepatic undifferentiated carcinoma with high PD-L1 expression demonstrating a sustained response to Dur/Tre. This case suggests that PD-L1 expression may serve as a potential biomarker for predicting ICI responsiveness in this rare and aggressive tumor.

334

News (Medical) associated with Tremelimumab

27 Jul 2026

·www.businesswire.com

Sonesitatug vedotin demonstrated a statistically significant and highly clinically meaningful improvement in overall survival in 2nd and later-line CLDN18.2-positive advanced gastric/GEJ cancers

WILMINGTON, Del.--(BUSINESS WIRE)--Positive high-level results from the CLARITY-Gastric01 global Phase III trial showed that sonesitatug vedotin (Sone-Ve) demonstrated a statistically significant and highly clinically meaningful improvement in overall survival (OS) in 2nd and later-line Claudin 18.2-positive advanced gastric cancers versus investigator’s choice of therapy. The trial included patients with locally advanced or metastatic gastric cancer, gastroesophageal junction (GEJ) cancer, or esophageal adenocarcinoma (EAC) with Claudin 18.2 (CLDN18.2) expression on at least 25% of tumor cells at any staining intensity. The trial had dual primary endpoints of OS in 3rd and later-line treatment and progression-free survival (PFS) in the overall trial population. The trial met the dual primary endpoint of OS in 3rd and later-line treatment, and a key secondary endpoint of OS in the overall trial population of patients treated in the 2nd and later-line setting, demonstrating a statistically significant and highly clinically meaningful improvement. For the other dual primary endpoint of PFS as assessed by blinded independent central review (BICR), results showed a trend toward improved PFS in patients treated in the 2nd and later-line setting but did not reach statistical significance. The majority of patients with gastric/GEJ cancers are diagnosed at an advanced or metastatic stage, where the prognosis is especially poor and treatment options are limited, with less than 20% surviving more than one year.1,2 CLDN18.2 has emerged as an important therapeutic target for these patients, with an estimated 60% of gastric/GEJ cancers expressing CLDN18.2 in 25% or more of tumor cells.3 Each year, there are roughly 183,500 patients in the US, EU, China and Japan treated in the 2nd and later-line setting for advanced or metastatic CLDN18.2-positive, non-HER2-positive gastric/GEJ cancers.4 Rui-Hua Xu, M.D., Ph.D., Professor in the Department of Medical Oncology, Sun Yat-Sen University Cancer Center, Guangzhou, China, and principal investigator of the trial said: “Metastatic gastric cancer is an aggressive disease with very limited options once patients progress after first-line treatment. Sone-Ve is the first CLDN18.2-targeted antibody drug conjugate to demonstrate an overall survival benefit in this setting and has the potential to establish a new precision treatment for a broader population of patients with CLDN18.2 expression.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, said: “Sone-Ve has the potential to reshape the treatment of gastric cancer by replacing classic chemotherapy with this novel targeted antibody drug conjugate to improve outcomes for patients. These transformative results from the first Phase III readout for Sone-Ve, together with our broad development program, highlight the potential for Sone-Ve to become an important new medicine in CLDN18.2-positive cancers.” Sone-Ve was well tolerated, and its profile was consistent with the known safety profile of Sone-Ve with no new safety signals identified. Sone-Ve is a potential global first-in-class CLDN18.2-targeting antibody drug conjugate (ADC) with a monomethyl auristatin E (MMAE) payload. These data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Sone-Ve has received Orphan Drug Designation from the US Food and Drug Administration and the European Commission for the treatment of gastric and GEJ cancers. It has also received Breakthrough Designation in China for the 2nd-line treatment of gastric cancer. Notes Gastric and GEJ cancers Gastric (stomach) cancer is the fifth most common cancer worldwide and the fifth-leading cause of cancer-related death.5 Nearly one million new patients were diagnosed with gastric cancer in 2024, with approximately 650,000 deaths reported globally. In many regions, its incidence has been increasing in patients younger than 50 years old, along with other gastrointestinal (GI) malignancies.5 GEJ cancer is a type of gastric cancer that arises from and spans the area where the esophagus connects to the stomach.6 Most advanced gastric cancer patients will eventually experience disease progression after standard 1st-line therapies, and subsequent lines yield poor outcomes, with median survival of 5-9 months for patients receiving 2nd and later-line systemic treatments.7-9 CLARITY-Gastric01 CLARITY-Gastric01 is a randomized, open-label, sponsor-blinded, multicenter, global Phase III trial evaluating Sone-Ve as a 2nd and later-line therapy for patients with advanced or metastatic gastric cancer, GEJ cancer, or EAC with CLDN18.2 expression in 25% or more of tumor cells, with IHC+ of any intensity. In the trial, patients were randomized 1:1:1 in Stage 1 (dose selection) to Sone-Ve monotherapy 2.2 mg/kg or 1.8 mg/kg every three weeks, or investigator’s choice of therapy, the comparator arm. In Stage 2, the trial continued with Sone-Ve 2.2 mg/kg as the recommended Phase III dose. The efficacy analyses from this study will also provide the basis to evaluate the clinical performance of the Ventana SP455 assay for the identification of patients with advanced or metastatic gastric, GEJ or EAC cancers expressing CLDN18.2 who may benefit from Sone-Ve. The trial is being conducted in 175 centers across 19 countries, including in North America, Europe, South America and Asia. Its dual primary endpoints are PFS as assessed by BICR in the 2nd and later-line setting and OS in the 3rd and later-line setting. A key secondary endpoint is OS in the 2nd and later-line setting. Sonesitatug Vedotin (Sone-Ve) Sone-Ve is a novel ADC targeting CLDN18.2, a protein found in the stomach lining and a validated therapeutic target in oncology, particularly for GI cancers. Sone-Ve consists of an anti-CLDN18.2 monoclonal antibody, a protease-degradable linker and a cytotoxic small molecule MMAE payload. AstraZeneca entered into a global exclusive license agreement with KYM Biosciences to develop and commercialize Sone-Ve in March 2023. In addition to CLARITY-Gastric01, Sone-Ve is being evaluated in the CLARITY-Gastric02 Phase III trial in combination with capecitabine, with or without rilvegostomig, as a 1st-line treatment for advanced or metastatic gastric cancer, GEJ cancer and EAC. In Phase II development, Sone-Ve is being evaluated in patients with advanced solid tumors in multiple combinations across settings, including in CLDN18.2-positive pancreatic and biliary tract cancers (BTC). AstraZeneca in GI cancers AstraZeneca has a broad development program for the treatment of GI cancers across several medicines and a variety of tumor types and stages of disease. In 2024, GI cancers collectively represented approximately 5 million new cancer cases leading to approximately 3.3 million deaths.10 Within this program, the Company is committed to improving outcomes in gastric, liver, biliary tract, esophageal, pancreatic and colorectal cancers. Durvalumab, an anti-PDL1 antibody, is approved in the US, China, EU, Japan and other countries in combination with chemotherapy in locally advanced or metastatic BTC, in combination with tremelimumab-actl in unresectable hepatocellular carcinoma (HCC) and in combination with FLOT chemotherapy (fluorouracil, leucovorin, oxaliplatin, and docetaxel) in early-stage and locally advanced gastric and GEJ cancers. Durvalumab is also approved as a monotherapy in unresectable HCC in Japan, China and the EU. Fam-trastuzumab deruxtecan-nxki, a HER2-directed ADC is approved in the US, China, EU, Japan and several other countries for HER2-positive advanced gastric cancer. Fam-trastuzumab deruxtecan-nxki is jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. Olaparib, a first-in-class PARP inhibitor, is approved in the US and several other countries for the treatment of BRCA-mutated metastatic pancreatic cancer. Olaparib is developed and commercialized in collaboration with Merck & Co., Inc., known as MSD outside the US and Canada. Savolitinib, an oral, potent, and highly selective MET tyrosine kinase inhibitor (TKI), has received conditional approval in China for the treatment of patients with locally advanced or metastatic gastric cancer or GEJ adenocarcinoma harboring MET amplification who have progressed on at least two prior lines of systemic therapy. Savolitinib is being jointly developed and commercialized by AstraZeneca and HUTCHMED. The Company is also assessing rilvegostomig, a PD-1/TIGIT bispecific antibody, in combination with chemotherapy as an adjuvant therapy in BTC, and in combination with fam-trastuzumab deruxtecan-nxki in previously untreated, HER2-expressing, locally advanced or metastatic BTC. Rilvegostomig is also being evaluated in combination with bevacizumab with or without tremelimumab-actl as a 1st-line treatment in patients with advanced HCC, and as a 1st-line combination treatment in patients with HER2-positive, or CLDN18.2-positive and HER2-negative, locally advanced unresectable or metastatic gastric and GEJ cancers. In addition to Sone-Ve, AstraZeneca is also advancing AZD5863, a novel CLDN18.2/CD3 T-cell engager bispecific antibody licensed from Harbour Biomed in Phase I development. In early development, AstraZeneca is developing AZD7003, a Glypican 3 armored CAR T, in HCC. The Company is also advancing a pan-KRAS inhibitor program licensed from Jacobio Pharma, which is being evaluated in Phase I trials in advanced solid tumors with KRAS alterations, including in pancreatic ductal adenocarcinoma. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyze changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialization of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca-us.com and follow the Company on social media @AstraZeneca. References Davis JA, et al. Treatment heterogeneity and overall survival in patients with advanced/metastatic gastric or gastroesophageal junction adenocarcinoma in the United States. J Gastrointest Oncol . 2022 Jun;13(3):949-957. Cancer Research UK. Survival for stomach cancer. https://www.cancerresearchuk.org/about-cancer/stomach-cancer/survival . Accessed July 2026. Poniewierska-Baran A, et al. Claudin18.2 as a Promising Therapeutic Target in Gastric Cancer. Cells. 2025;14(16):1285. AstraZeneca PLC. Investor Relations Epidemiology Spreadsheet. Top 8 Countries. Available at: https://www.astrazeneca.com/investor-relations.html . Accessed July 2026. World Health Organization. International Agency for Research on Cancer. Stomach Fact Sheet. Available at: https://gco.iarc.who.int/today/en/fact-sheets-cancers/7/stomach . Accessed July 2026. National Cancer Institute. Gastroesophageal junction. Available at: https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gastroesophageal-junction . Accessed July 2026. Abderhalden LA, et al. Clinical Outcomes for Previously Treated Patients with Advanced Gastric or Gastroesophageal Junction Cancer: A Systematic Literature Review and Meta-Analysis. J Gastrointest Cancer. 2023;54(4):1031-1045. Ford HE, et al. Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. ⁠ The Lancet Oncology , 2014;15(1), 78-86. Wilke H, et al. Ramucirumab plus paclitaxel versus placebo plus paclitaxel in patients with previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (RAINBOW): a randomised, multicentre, double-blind, phase 3 trial. ⁠ The Lancet Oncology , 2014;15(11), 1224-1235. World Health Organization. World Cancer Fact Sheet. Available at https://gco.iarc.who.int/today/en/fact-sheets-populations/900/world . Accessed July 2026. US- 114581 Last Updated 7/26

Phase 3Clinical ResultPhase 1License out/inDrug Approval

22 Jul 2026

·www.biospace.com

Wainua flop narrows AstraZeneca’s path to $80B goal ahead of high-risk readouts

iStock, Korakrich Suntornnites With a Phase 3 failure denting the rare disease drug’s prospects, AstraZeneca has little room for error as it plots a path toward its ambitious 2030 sales target. As AstraZeneca exited the first quarter, initially skeptical analysts were coming around to the potential for the drugmaker to hit its goal of growing sales to $80 billion by 2030. But less than three months later, the shocking Phase 3 failure of rare disease drug Wainua has left the company needing wins in two high-risk readouts to maintain its trajectory toward the towering target. The FDA approved Wainua, an antisense oligonucleotide inhibitor, in December 2023 for the treatment of transthyretin amyloidosis (ATTR) with polyneuropathy. Months later, AstraZeneca named Wainua as one of the drugs underpinning its belief that it could grow sales to $80 billion by 2030. At the time, the consensus estimate of analysts put AstraZeneca’s 2030 sales at $66.8 billion. Wainua has yet to contribute significantly to AstraZeneca’s path to $80 billion, with sales totaling just $212 million last year. But the drugmaker was predicting peak revenues in excess of $5 billion until the Phase 3 flop derailed plans to expand Wainua’s label to cover ATTR cardiomyopathy (ATTR-CM). ezstandalone.cmd.push(function () { ezstandalone.showAds(129); }); AstraZeneca still thinks it can hit $80 billion, though. Before that disappointing readout, the company-sponsored consensus projected 2030 sales of $82.7 billion, Leerink Partners analysts said in a July 9 note to investors. Removing ATTR-CM reduced that forecast to $80.8 billion, reflecting about $1.9 billion in Wainua sales in 2030. AstraZeneca’s management acknowledged that the setback “decreases headroom” but is still confident the company can achieve the 2030 goal, the analysts said. Cardiovascular disease AstraZeneca, Ionis’ Wainua woes send waves across ATTR-CM space The failure of AstraZeneca and Ionis’ Wainua in a late-stage study of ATTR-CM casts doubt on Alnylam’s next-generation candidate but is good news for others in the space, including BridgeBio and Intellia Therapeutics. July 10, 2026 · 3 min read · Tristan Manalac Read more Plotting a path to $80B The coming months will feature readouts that could intensify questions about whether AstraZeneca can hit its target. This year, the company is scheduled to report data from SERENA-4 and AVANZAR, late-phase clinical trials that Leerink analysts called binary events subject to “prior investor uncertainty.” SERENA-4 is testing the investigational oral SERD camizestrant in first-line, HR-positive breast cancer. AVANZAR is assessing the antibody-drug conjugate Datroway, already marketed for second-line non-small cell lung cancer (NSCLC) and forms of breast cancer, in first-line NSCLC. Leerink analysts predicted that SERENA-4 could add non–risk adjusted peak sales of $2.8 billion for camizestrant and that AVANZAR could boost Datroway sales by $2.2 billion. AstraZeneca, which won its first FDA approval for Datroway in January 2025, reported sales of ¥47.6 billion (~$293 million) and $43 million in the first quarter of 2026. The analysts see the trials as risky, putting the probability of success at 20% for SERENA-4 and at 50% for AVANZAR. Skepticism about the chances of the studies succeeding extends beyond Leerink, with analysts at Guggenheim Securities characterizing investor expectations as “very low.” The failure of the trials would remove rungs from the ladder that AstraZeneca climbs toward its $80 billion target. AstraZeneca has tipped each drug to generate peak sales of $5 billion or more. SERENA-4 and AVANZAR are central to the blockbuster forecasts. Camizestrant is awaiting approval in another indication, but in a May 8 note to investors Guggenheim analysts called that commercial opportunity “limited.” Analysts have generally been less confident in the 2030 aim than AstraZeneca itself seems to be. Although the Guggenheim team said the consensus of its peers did reach $80 billion in December, the firm’s own estimate was lower, at $76.4 billion. It raised that number to $79.6 billion in April, based on developments including Phase 3 data on the chronic obstructive pulmonary disease prospect tozorakimab, but following the Wainua setback, Guggenheim’s 2030 forecast for the company fell back down to $78 billion. The analysts now foresee Wainua sales of $500 million, down from $2 billion before the Phase 3 flop. Removing the ATTR-CM opportunity from the Leerink model similarly resulted in a drop in risk-adjusted 2030 total revenues, from $79.5 billion to $78.6 billion. Earnings AstraZeneca bullish on $80B sales goal after beating expectations, Phase 3 data wins After a quarter in which sales topped $15 billion and key readouts went AstraZeneca’s way, the company is increasingly confident that its 2030 revenue target is in reach. April 29, 2026 · 2 min read · Nick Paul Taylor Read more Fallback options AstraZeneca has options if setbacks to SERENA-4 and AVANZAR impede its pursuit of the 2030 sales goal. The $80 billion objective “was on an organic basis, and that does not assume any M&A of any size and scale,” AstraZeneca CFO Aradhana Sarin said on the company’s earnings call in February. While AstraZeneca is aiming to hit its 2030 target without M&A, Sarin said the company has “substantial firepower” for deals. AstraZeneca will “remain very disciplined in terms of what type of assets we bring in,” partly because it requires “substantial investments in R&D” to create shareholder value after buying a drug candidate, Sarin said. Organically, AstraZeneca could smooth its path to $80 billion by beating sales expectations for its existing growth drivers and planned launches or by lessening the impact of loss of exclusivity on drugs such as Lynparza and Farxiga. Guggenheim analysts said elecoglipron, an oral GLP-1 asset, is “underappreciated,” but with the small molecule entering Phase 3 this year, it is not on AstraZeneca’s roadmap to $80 billion. The roadmap features assets including the cancer medicines Imfinzi and Imjudo, blood pressure drug Baxfendy and rare disease candidate efzimfotase alfa. Guggenheim analysts foresee a “standard, slow [cardiovascular disease] ramp” for Baxfendy, with Medicare Part D reimbursement negotiations expected in 2027 or 2028. If the pipeline stutters, AstraZeneca’s ability to squeeze more sales from existing assets could be key to hitting its 2030 target. The company’s commercial teams have impressed recently, helping to power sales past analyst expectations in the third and fourth quarters of 2025 and the first quarter of 2026. AstraZeneca plans to release its second-quarter earnings results on July 27.

Phase 3Drug Approval

14 Jul 2026

·www.astrazeneca.com

AstraZeneca enters exclusive global license agreement for novel oral EGFR inhibitor Zegfrovy for lung cancer with Dizal Pharmaceutical

AstraZeneca has entered into an exclusive license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), a novel oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. AstraZeneca will acquire worldwide rights to develop and commercialise Zegfrovy. Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. Approximately 80-85% of lung cancer patients globally have NSCLC. About 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia, have EGFR-mutated (EGFRm) NSCLC. Roughly one in four patients with EGFRm NSCLC has a tumour with an exon 20 insertion mutation or other atypical mutation for which targeted treatment options are limited. Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations. With this agreement, we will bring a differentiated, oral targeted treatment to these patients with limited options across the globe.” Dr. Xiaolin Zhang, Chief Executive Officer of Dizal said: “As a leading global company with a strong lung cancer franchise, AstraZeneca will help ensure patients around the world can benefit from this innovation discovered by Dizal scientists in China. Zegfrovy is the only oral targeted therapy for EGFR exon 20 insertion non-small cell lung cancer approved in the US and China for patients following prior systemic therapy.” Dizal recently announced positive results from the global WU-KONG28 Phase III trial of Zegfrovy in 1st-line NSCLC with exon 20 insertion EGFR mutations. These data were presented as a Late-Breaking Abstract Oral Presentation at the 2026 American Society of Clinical Oncology Annual Meeting and simultaneously published in The New England Journal of Medicine. Supported by these results, a Supplemental New Drug Application for approval in the 1st-line setting has been submitted to the US Food and Drug Administration (FDA) and China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE have also both granted Breakthrough Therapy Designation to Zegfrovy in this setting. Sunvozertinib (Zegfrovy) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC as a Category 2A recommended subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines® for detailed recommendations.1 Financial considerations AstraZeneca will make an upfront payment to Dizal of $600m and additional payments of up to $900m upon achievement of specific development, regulatory and sales-related milestones. Additionally, Dizal will receive tiered royalties on the global sales of Zegfrovy. The transaction is expected to close in the second half of 2026, subject to customary closing conditions and regulatory clearances. The transaction does not impact AstraZeneca’s financial guidance for 2026. Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.2 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.2-3 Approximately 75% of people are diagnosed with advanced NSCLC.4 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.5-7 Zegfrovy Zegfrovy is an irreversible EGFR inhibitor targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. Zegfrovy is approved in the US and China for the treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. In addition, Zegfrovy also demonstrated encouraging anti-tumour activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon 20 insertions. Zegfrovy showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related treatment-emergent adverse events were Grade 1/2 in nature and clinically manageable. AstraZeneca in lung cancer AstraZeneca is working to bring patients with lung cancer closer to cure through the detection and treatment of early-stage disease, while also pushing the boundaries of science to improve outcomes in the resistant and advanced settings. By defining new therapeutic targets and investigating in innovative approaches, the Company aims to match medicines to the patients who can benefit most. The Company’s comprehensive portfolio includes leading lung cancer medicines and the next wave of innovations, including Tagrisso and Iressa (gefitinib); Imfinzi (durvalumab) and Imjudo (tremelimumab); Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan) in collaboration with Daiichi Sankyo; Orpathys (savolitinib) in collaboration with HUTCHMED; as well as a pipeline of potential new medicines and combinations across diverse mechanisms of action. AstraZeneca is a founding member of the Lung Ambition Alliance, a global coalition working to accelerate innovation and deliver meaningful improvements for people with lung cancer, including and beyond treatment. AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/NYSE: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Disease, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on Social Media @AstraZeneca. Contacts For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here. References 1. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026). https://www.nccn.org/login?ReturnURL=https://www.nccn.org/professionals/physician_gls/pdf/nscl.pdf. Accessed July 2026. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed August 2025. 3. American Cancer Society. What Is Lung Cancer?. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2025. 4. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. 5. Keedy VL, et al. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal Growth Factor Receptor (EGFR) Mutation Testing for Patients with Advanced Non-Small-Cell Lung Cancer Considering First-Line EGFR Tyrosine Kinase Inhibitor Therapy. J Clin Oncol. 2011:29;2121-27. 6. Szumera-Ciećkiewicz A, et al. EGFR Mutation Testing on Cytological and Histological Samples in Non-Small Cell Lung Cancer: a Polish, Single Institution Study and Systematic Review of European Incidence. Int J Clin Exp Pathol. 2013;6:2800-2812. 7. Ellison G, et al. EGFR Mutation Testing in Lung Cancer: a Review of Available Methods and Their Use for Analysis of Tumour Tissue and Cytology Samples. J Clin Pathol. 2013;66:79-89. Matthew Bowden Company Secretary AstraZeneca PLC Oncology Corporate and financial

Phase 3Drug ApprovalLicense out/inASCOBreakthrough Therapy

100 Deals associated with Tremelimumab

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KEGG	Wiki	ATC	Drug Bank
D06657	Tremelimumab	-	DB11771

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hepatocellular Carcinoma	Canada	AstraZeneca Canada, Inc.	31 Aug 2023
Advanced Hepatocellular Carcinoma	European Union	AstraZeneca AB	20 Feb 2023
Advanced Hepatocellular Carcinoma	Iceland	AstraZeneca AB	20 Feb 2023
Advanced Hepatocellular Carcinoma	Liechtenstein	AstraZeneca AB	20 Feb 2023
Advanced Hepatocellular Carcinoma	Norway	AstraZeneca AB	20 Feb 2023
metastatic non-small cell lung cancer	European Union	AstraZeneca AB	20 Feb 2023
metastatic non-small cell lung cancer	Iceland	AstraZeneca AB	20 Feb 2023
metastatic non-small cell lung cancer	Liechtenstein	AstraZeneca AB	20 Feb 2023
metastatic non-small cell lung cancer	Norway	AstraZeneca AB	20 Feb 2023
Advanced Lung Non-Small Cell Carcinoma	Japan	AstraZeneca KK	23 Dec 2022
Non-Small Cell Lung Cancer	United States	AstraZeneca AB	10 Nov 2022
Unresectable Hepatocellular Carcinoma	United States	AstraZeneca AB	21 Oct 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Non-Muscle Invasive Bladder Neoplasms	Phase 3	United States	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Japan	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Argentina	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Austria	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Brazil	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Canada	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Chile	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	France	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Germany	AstraZeneca PLC	05 Aug 2021
Non-Muscle Invasive Bladder Neoplasms	Phase 3	Greece	AstraZeneca PLC	05 Aug 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06904170 (Prodige 89 UCGI 44 ALICE, ESMO_GI2026 \| ESMO_GCC2026)	Phase 2/3	Hepatocellular Carcinoma	196	-	zqcxvdpfux(schvsyofep) = wkaluwlrdg unowgostpo (edkdyssgjl )	Positive	02 Jul 2026
				TremelimumabDurvalumab + TremelimumabDurvalumabab	zqcxvdpfux(schvsyofep) = sxiwjsyjfb unowgostpo (edkdyssgjl )
NCT05883644 (SIERRA, ESMO_GI2026 \| ESMO_GCC2026)	Phase 3	Unresectable Hepatocellular Carcinoma First line	111	Tremelimumab + Durvalumab	neoybyyhfq(rvowopmezn) = mnlttqnpru cbfxmdbbet (kyikdtyazi, 8.5 - 22.4) View more	Positive	02 Jul 2026
				Tremelimumab + Durvalumab (Child-Pugh B7/B8 with ECOG 0-1)	neoybyyhfq(rvowopmezn) = qwolyhpquq cbfxmdbbet (kyikdtyazi, 1.4 - 18.7) View more
ESMO_GI2026 \| ESMO_GCC2026	Not Applicable	Hepatocellular Carcinoma	71	Atezolizumab plus Bevacizumab	bnmgrfmmtc(qyxeoilzaq) = mzktcvoeea lfmmzbhbkx (jqhmspxldj ) View more	Positive	02 Jul 2026
				Durvalumab plus Tremelimumab	zagzlsgjzi(xttuvxymgn) = dlqedslbkz omhpeifpiv (oltcovastk )
NCT04605731 (ESMO_GI2026 \| ESMO_GCC2026)	Phase 1	Locally Advanced Hepatocellular Carcinoma	25	Y90 + durvalumab + tremelimumab	lykkxkjlfo(gorwkffhap) = bdgmzbnvmk wycssfqjbg (egrhwuyqvp ) View more	Positive	02 Jul 2026
NCT04159974 (RICE, ASCO2026)	Phase 2	Adenocarcinoma of Esophagus Adjuvant \| Neoadjuvant	56	Neoadjuvant durvalumab + chemoradiotherapy (CROSS)	ukuppvrjgx(hkgghwtexp) = krvjgocikh iioyyuluoo (koigbrlykk ) View more	Positive	29 May 2026
				Neoadjuvant durvalumab + chemoradiotherapy (CROSS)	mtbttjtodw(bscbefxnau) = eeyhuwlvhm njwxiwvooq (zcsxfhlvha ) View more
NCT06680739 (SERPENTINE, ASCO2026)	Phase 2	pMMR/MSS/MSI-L Colon Cancer	24	durvalumab+tremelimumab (without liver metastases)	sapvptbtif(pdmfggpkwt) = nssfikbtas acmlicwdoi (mlkvdmcjsk ) View more	Positive	29 May 2026
NCT05301842 (EMERALD-3, ASCO2026)	Phase 3	Unresectable Hepatocellular Carcinoma	668	Tremelimumab + Durvalumab + Lenvatinib + TACE	yrlsvdmxmy(yzedrbyokl) = lykwxnnxhk wyytqwppfc (dnhthkjppb )	Positive	29 May 2026
ASCO2026	Not Applicable	Hepatocellular Carcinoma First line	506	Atezolizumab/Bevacizumab	ysblhuback(gftwtyzyps) = ibqkteiqsx bhnuztvbvw (raubcswlgw )	Positive	29 May 2026
				Durvalumab/Tremelimumab	ysblhuback(gftwtyzyps) = sefxqlsmvi bhnuztvbvw (raubcswlgw )
ASCO2026	Not Applicable	metastatic non-small cell lung cancer PD-L1	2,726	Durvalumab	ujkcrrwuza(addtgqzbtn): HR = 0.97 (95.0% CI, 0.74 - 1.27) View more	Negative	29 May 2026
				Durvalumab + Tremelimumab
NCT06008093 (TRITON, ASCO2026)	Phase 2	STK11 Mutation Non-Small Cell Lung Cancer First line STK11 \| KEAP1 \| KRAS	84	Tremelimumab (T) + durvalumab (D) + chemotherapy (CT)	covlcqrslw(ndhpxasgng) = ttavvnnlmq sitguddsnz (anydrgegcq, 33.5 - 64.1) View more	Positive	29 May 2026
				pembrolizumab (P) + CT	covlcqrslw(ndhpxasgng) = zijxqxybsz sitguddsnz (anydrgegcq, 27.1 - 56.6) View more

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