Savolitinib Plus Cetuximab and FOLFOX Chemotherapy Versus Cetuximab and FOLFOX Chemotherapy as First-line Treatment for RAS/BRAF Wild-type Metastatic Colorectal Cancer: a Prospective, Randomized, Controlled, Multicenter, Open-label Study

The goal of this clinical trial is to learn if adding savolitinib to cetuximab plus FOLFOX chemotherapy works as a first-line treatment for patients with RAS/BRAF wild-type metastatic colorectal cancer, and to evaluate its safety. The main questions it aims to answer are:
Does the addition of savolitinib improve the objective response rate (ORR) compared to cetuximab plus FOLFOX alone?
What medical problems (adverse events) do participants experience when taking savolitinib in combination with cetuximab and FOLFOX?
Researchers will compare savolitinib plus cetuximab and FOLFOX (experimental group) versus cetuximab and FOLFOX alone (control group) to see if the triplet regimen provides better tumor response and survival outcomes.
Participants will:
Take oral savolitinib once daily in repeated 14-day cycles (or receive control treatment), combined with weekly cetuximab and bi-weekly FOLFOX chemotherapy
Visit the clinic every 2 weeks or 4 weeks for treatment administration, safety monitoring, and laboratory tests
Undergo tumor imaging assessments every 8 weeks (4 cycles) to evaluate treatment response and disease progression
Have regular follow-up visits for 30 days after the last dose, and then every 3 months for survival follow-up

Start Date30 Jun 2026

Sponsor / Collaborator

Fudan University

CTR20261803

/ RecruitingPhase 3

评价赛沃替尼对比紫杉醇治疗伴MET基因扩增的局部晚期或转移性胃癌和胃食道连接部腺癌患者疗效和安全性的随机、对照、开放标签、多中心III期临床研究

[Translation] A randomized, controlled, open-label, multicenter phase III clinical trial evaluating the efficacy and safety of cerovatinib versus paclitaxel in patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma with MET gene amplification.

1. 评价赛沃替尼对比紫杉醇治疗MET基因扩增的局部晚期或转移性胃癌及胃食道连接部腺癌患者的临床疗效；2 评价赛沃替尼对比紫杉醇治疗MET基因扩增的局部晚期或转移性胃癌及胃食道连接部腺癌患者的其他临床疗效；3评价赛沃替尼对比紫杉醇治疗MET基因扩增的局部晚期或转移性胃癌及胃食道连接部腺癌患者的安全性和耐受性； 4 评价赛沃替尼对比紫杉醇对患者生活质量评分的影响。

[Translation]

1. To evaluate the clinical efficacy of cefertinib versus paclitaxel in treating patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma with MET gene amplification; 2. To evaluate other clinical efficacy of cefertinib versus paclitaxel in treating patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma with MET gene amplification; 3. To evaluate the safety and tolerability of cefertinib versus paclitaxel in treating patients with locally advanced or metastatic gastric cancer and gastroesophageal junction adenocarcinoma with MET gene amplification; 4. To evaluate the impact of cefertinib versus paclitaxel on patients' quality of life scores.

Start Date15 Jun 2026

Sponsor / Collaborator

Hutchison MediPharma Ltd.

NCT06692491

/ Not yet recruitingPhase 2IIT

A Phase II Clinical Study on Precision Treatment of Rare Tumours in China Guided by Patient-Derived Tumor Organoids (PDO) and Next-Generation Sequencing (NGS)

The objective of this Phase II, open-label, multicenter, non-randomised controlled clinical trial is to guide precision treatment for patients with rare tumours based on Patient-Derived Organoids/Next-Generation Sequencing drug screening.

Start Date01 Jan 2025

Sponsor / Collaborator

Peking University Shenzhen Hospital

100 Clinical Results associated with Savolitinib

100 Translational Medicine associated with Savolitinib

100 Patents (Medical) associated with Savolitinib

221

Literatures (Medical) associated with Savolitinib

31 Dec 2026·RENAL FAILURE

A tri-scale in silico framework integrating pharmacovigilance and mechanistic modeling suggests tepotinib-associated acute kidney injury risk

Article

Author: Bai, Zhixun ; Wang, Qin ; Zheng, Rubin ; Han, Jinfen ; Lyu, Jiayi ; Lu, Jing ; Deng, Miao ; Chen, Jiaxi

Proactive safety evaluation of molecularly targeted therapies requires generalizable frameworks that integrate real-world evidence with mechanistic insights. As a case in point, tepotinib, a mesenchymal-epithelial transition (MET) inhibitor for non-small cell lung cancer, has a known pulmonary toxicity profile, but its link to acute kidney injury (AKI) and underlying mechanism remain unclear. We devised a tri-scale in silico strategy encompassing population-scale pharmacovigilance signal extraction from the FDA Adverse Event Reporting System (FAERS) (2020-2025) via disproportionality analysis (Reporting Odds Ratio, ROR, and Proportional Reporting Ratio, PRR), network toxicology-based multi-target exploration for shared target and hub gene identification, and mechanistic docking-based molecular plausibility assessment using the Cavity-detection guided Blind Docking (CB-Dock2) platform. Pharmacovigilance analysis identified a significant renal impairment signal (ROR = 20.60). Network toxicology suggested potential nephrotoxicity and revealed 173 shared targets and prioritizing six hub genes (HSP90AA1, AKT1, EGFR, CASP3, TNF, SRC). These genes were shown to be critically involved in PI3K-Akt and MAPK pathways. Molecular docking revealed high-affinity binding between tepotiniband all six hub targets (Vina scores: -8.0 to -10.6 kcal/mol), providing a structural basis for the postulated mechanistic link to AKI. These findings not only highlight the necessity for enhanced renal monitoring in tepotinib-treated patients but, more broadly, establish the FAERS-NetDock Pipeline as a reusable, generalizable and hypothesis-generating framework for evaluating tyrosine kinase inhibitors (TKIs)-induced nephrotoxicity; this framework is immediately applicable to profiling the safety of other TKIs (e.g. crizotinib, capmatinib, savolitinib, afatinib and osimertinib) and is readily adaptable for de-risking a wider spectrum of targeted therapies.

01 Aug 2026·EUROPEAN UROLOGY

KIM-1 in Advanced Papillary and Clear Cell Renal Cell Carcinoma

Article

Author: Xu, Wenxin ; Powles, Thomas ; Coca Membribes, Sara ; Mein, Charles ; Suárez, Cristina ; Larkin, James ; Valderrama, Begoña P ; Patel, Poulam M ; Ackerman, Charlotte

Kidney injury molecule 1 (KIM-1) is a promising biomarker in adjuvant clear cell renal cell carcinoma (ccRCC), but its relevance in advanced ccRCC or papillary RCC (pRCC) remains unclear. CALYPSO (NCT02819596) was a prospective, multi-arm trial that evaluated durvalumab alone or in combination with tremelimumab or savolitinib in metastatic ccRCC and pRCC. Circulating KIM-1 levels were measured at baseline and on-treatment. The primary endpoint was to explore if KIM-1 levels were raised in pRCC. Analyses were exploratory and p values were nominal. KIM-1 was measured in 123 patients with ccRCC and 31 patients with pRCC. Higher median concentrations occurred in pRCC compared to ccRCC (7835 vs 5470 pg/ml, p = 0.05). Reductions in KIM-1 levels occurred with systemic therapy in both ccRCC and pRCC (-59.2% and -32% respectively). In pRCC, radiological responders had significantly lower baseline KIM-1 levels (p = 0.025). In ccRCC, high baseline KIM-1 levels were associated with significantly shorter overall survival (OS) (hazard ratio [HR] 1.77; 95% CI, 1.15-2.72; p = 0.01). Also, an increase in KIM-1 during therapy was linked to worse progression-free survival (HR 1.7; 95% CI, 1.13-2.58; p = 0.01) and OS (HR 1.95; 95% CI, 1.23-3.08; p = 0.004) in ccRCC. This exploratory analysis supports the utility of KIM-1 in advanced ccRCC and pRCC.

01 Jul 2026·Thoracic Cancer

Sequential EGFR T790M , MET c. 3010C >G‐Associated Exon 14 Alteration, and RET ‐ CCDC6 Fusion in EGFR ‐Mutant NSCLC : A Case Report

Article

Author: Wang, Dan‐He ; Zhu, Yan ; Wang, Chan ; Hu, Nan‐Lin ; Wu, Shi‐Kai

ABSTRACT:

Acquired resistance to epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) in EGFR‐mutant non–small‐cell lung cancer (NSCLC) is heterogeneous, and serial re‐biopsy may uncover actionable mechanisms. We report a 55‐year‐old man with stage IVB lung adenocarcinoma harboring EGFR L858R and TP53 R282W. First‐line icotinib produced a partial response (PR) with progression‐free survival (PFS) of 7 months. Rebiopsy at progression identified acquired EGFR T790M together with a MET c.3010C>G exon 14‐related alteration. Almonertinib induced a second PR lasting 7 months. After renewed progression, almonertinib plus savolitinib achieved another PR for 8 months, supporting MET‐dependent bypass resistance. Biopsy of a newly progressive iliac metastasis then showed emergence of RET‐CCDC6 fusion, whereas T790M and the MET alteration were no longer detected. Because selective RET inhibition was initially unaffordable, the patient received pemetrexed‐carboplatin plus continued almonertinib, followed by selpercatinib plus almonertinib. Local radiotherapy to oligoprogressive bone and lung lesions prolonged benefit from systemic therapy. At the latest follow‐up in January 2026, the patient remained alive nearly 50 months after diagnosis. This case illustrates clonal evolution under treatment pressure and highlights three practical lessons: repeat molecular testing at each clinically meaningful progression, matched combination targeted therapy for actionable bypass alterations, and local ablative radiotherapy for oligoprogression.

148

News (Medical) associated with Savolitinib

01 Sep 2026

·firstwordpharma.com

Tagrisso combo succeeds in first-line MET-overexpressing lung cancer study

AstraZeneca and HUTCHMED's combination of Tagrisso (osimertinib) plus Orpathys (savolitinib) has posted a third Phase III win – and its first in the first-line setting – with a significant progression-free survival (PFS) benefit in MET-overexpressing EGFR-mutated non-small-cell lung cancer (NSCLC)."Co-occurring MET overexpression in treatment-naïve EGFR-mutated [NSCLC] often compromises the long-term durability of EGFR-TKI (tyrosine kinase inhibitor) monotherapy," said Yi-Long Wu, leading principal investigator of the SANOVO study, in a release Tuesday. "Addressing both pathways upfront with an all-oral, biomarker-directed regimen offers a powerful new approach for these patients…[and] could reshape primary treatment strategy for this distinct patient population."The Chinese study included 326 previously untreated patients with locally advanced or metastatic NSCLC who had activating EGFR mutations and MET overexpression. Participants were randomised to Tagrisso once daily plus either placebo or selective MET-TKI therapy with Orpathys.The PFS benefit was statistically significant and described by the companies as "highly clinically meaningful" in both the high-MET population (IHC 3+) and the broader intention-to-treat population, which included patients with IHC 2+ or 3+ MET expression. Overall survival (OS), a key secondary endpoint, also showed a "very encouraging clinical benefit," the companies said, though follow-up is continuing and mature results haven't yet been disclosed."These positive data…build on the growing body of evidence demonstrating the benefit of adding Orpathys to backbone Tagrisso to intercept MET-driven resistance, delay progression and improve outcomes," said Leora Horn, SVP for Late Development, Oncology R&D at AstraZeneca.SANOVO follows the Phase III SACHI trial, which led to the combo's approval in China last year for EGFR-mutated NSCLC with MET amplification following progression on an EGFR-TKI. That study showed a 66% reduction progression or death compared to platinum-based chemotherapy.More recently, the global Phase III SAFFRON trial showed that Tagrisso plus Orpathys significantly improved both PFS and OS in EGFR-mutated NSCLC with MET overexpression or amplification after progression on Tagrisso (see – Spotlight On: AstraZeneca eyes further enhancement of Tagrisso's cornerstone role in EGFRm lung cancer and Spotlight On: Investors shrug off mixed pipeline updates from AstraZeneca).Meanwhile, the safety profile of Tagrisso plus Orpathys in SANOVO was consistent with the known profiles of the individual medicines, with no new safety findings reported. The data will be presented at a future medical meeting and shared with regulatory authorities, with HUTCHMED CEO Weiguo Su indicating the results could support regulatory submissions for first-line use in China.

Phase 3Clinical Result

01 Sep 2026

·www.biospace.com

AstraZeneca completes global license agreement for oral EGFR inhibitor ZEGFROVY® (sunvozertinib) for lung cancer

WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced the successful completion of the previously announced exclusive license agreement with Dizal Pharmaceutical Co., Ltd for ZEGFROVY ® (sunvozertinib), an oral irreversible epidermal growth factor receptor ( EGFR ) inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialize ZEGFROVY. ZEGFROVY is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8% underscoring the unmet need for new treatment options. 1 ZEGFROVY is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication. Sunvozertinib (ZEGFROVY ) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines ® ) for NSCLC. It is recommended as a subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines ® for detailed recommendations. 2 A supplemental New Drug Application for approval of ZEGFROVY in the 1st-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global WU-KONG28 Phase III trial of ZEGFROVY in 1st-line NSCLC with EGFR exon 20 insertion 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 . ZEGFROVY has also been submitted for approval in the 1st-line setting to China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to ZEGFROVY in this setting. Financial considerations AstraZeneca will make an upfront payment of $600m to Dizal together with 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. This transaction does not impact AstraZeneca’s financial guidance for 2026. IMPORTANT SAFETY INFORMATION Interstitial Lung Disease/Pneumonitis ZEGFROVY can cause severe and life-threatening interstitial lung disease (ILD)/pneumonitis. In the safety population of 121 patients, ILD/pneumonitis occurred in 1.7% of patients. ZEGFROVY was discontinued due to ILD/pneumonitis in 0.8% of patients. Monitor patients for new or worsening pulmonary symptoms indicative of ILD/pneumonitis (eg, dyspnea, cough, and fever). Immediately withhold ZEGFROVY in patients with suspected ILD/pneumonitis and permanently discontinue ZEGFROVY if ILD/pneumonitis is confirmed. Gastrointestinal Adverse Reactions ZEGFROVY can cause severe gastrointestinal adverse reactions including diarrhea, nausea, and vomiting. In the safety population of 121 patients, serious gastrointestinal adverse reactions occurred in 1.7% of patients, including 0.8% Grade 3 nausea. Diarrhea occurred in 73% of patients who received ZEGFROVY, including 2.5% Grade 3. Diarrhea leading to dosage interruption or dose reduction occurred in 5% of patients and required permanent discontinuation of ZEGFROVY in 0.8% of patients. Nausea and vomiting occurred in 43% of patients, including 3.3% Grade 3 events. Nausea and vomiting leading to dosage interruption or dose reduction occurred in 7% of patients and permanent discontinuation of ZEGFROVY in 0.8% of patients. Administer ZEGFROVY with food to reduce gastrointestinal adverse reactions. Monitor patients for gastrointestinal toxicity, and provide supportive care, including anti-diarrheals, anti-emetics, or fluid replacement, as indicated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Dermatologic Adverse Reactions ZEGFROVY can cause severe rash including acneiform dermatitis and pruritus. Based on the safety population of 121 patients, dermatologic adverse reactions occurred in 68% of patients including 9% acneiform dermatitis. Grade 3 dermatologic adverse reactions were 7% rash, 0.8% acneiform dermatitis, and 0.8% pruritus. Instruct patients to use alcohol-free (eg, isopropanol-free, ethanol-free) emollient cream during treatment with ZEGFROVY and to avoid the use of irritating skin products (eg, products containing retinol or retinoic acid, benzoyl peroxides). Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Ocular Toxicity ZEGFROVY can cause ocular toxicity including keratitis, dry eye symptoms, blurred vision, and visual impairment. Based on the safety population of 121 patients, ocular toxicity occurred in 13% of patients who received ZEGFROVY, including keratitis in 0.8% of patients. Promptly refer patients with new or worsening eye symptoms to an ophthalmologist. Advise discontinuation of contact lenses until ocular symptoms are evaluated. Withhold, reduce the dose, or permanently discontinue ZEGFROVY based on severity. Embryo-Fetal Toxicity ZEGFROVY can cause fetal harm when administered to a pregnant woman. In animal reproduction studies, oral administration of sunvozertinib to pregnant animals during the period of organogenesis resulted in structural abnormalities at concentrations below the human exposure at the recommended dose based on area under the curve (AUC). Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose, since ZEGFROVY can render some hormonal contraceptives ineffective. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Adverse Reactions The most common (≥20%) adverse reactions were: diarrhea, rash, decreased appetite, stomatitis, fatigue, nausea, paronychia, vomiting, constipation, musculoskeletal pain, pruritus, dry skin, urinary tract infection, abdominal pain and decreased weight. The most common (≥2%) Grade 3 or 4 laboratory abnormalities were: decreased lymphocytes, increased lipase, decreased hemoglobin, increased amylase, increased creatine kinase, decreased neutrophils, decreased potassium, increased aspartate aminotransferase, increased alanine aminotransferase, decreased sodium, increased magnesium, and increased alkaline phosphatase. Drug Interactions Strong CYP3A Inhibitors : Avoid concomitant use. If concomitant use cannot be avoided, reduce ZEGFROVY dose and monitor for increased ZEGFROVY adverse reactions. Strong and Moderate CYP3A Inducers : Avoid concomitant use. If concomitant use cannot be avoided, increase ZEGFROVY dose. Hormonal Contraceptives : Avoid concomitant use. Advise females of reproductive potential to use effective non-hormonal contraception during treatment with ZEGFROVY and for 2 weeks after the last dose. Concomitant use of ZEGFROVY with CYP3A substrates decreased their plasma concentrations where minimal concentration changes may lead to therapeutic failure of hormonal contraceptives. Use in Special Populations Lactation : Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with ZEGFROVY and for 2 weeks after the last dose. Infertility : ZEGFROVY may impair fertility in females and males. The reversibility of the effects on females was not assessed. The effects on male fertility were reversible. INDICATION ZEGFROVY is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Please see complete Prescribing Information , including Patient Information for ZEGFROVY. Notes NSCLC Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths. 3 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases. 3-4 Approximately 75% of people are diagnosed with advanced NSCLC. 5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFR m NSCLC. 6-8 ZEGFROVY ® (sunvozertinib) ZEGFROVY ® (sunvozertinib) 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. Supplemental New Drug Applications for approval of ZEGFROVY in the 1st-line setting have also 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 both granted Breakthrough Therapy Designation to ZEGFROVY in this setting. 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 osimertinib and gefitinib; durvalumab and tremelimumab-actl; sunvozertinib; fam-trastuzumab deruxtecan-nxki and datopotamab deruxtecan-dlnk in collaboration with Daiichi Sankyo; 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 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 Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Lung Cancer, 2021; 162, 154-161. National Comprehensive Cancer Network. Non-Small Cell Lung Cancer. (Version 6.2026). . 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. World Health Organization. International Agency for Research on Cancer. Lung Cancer Fact Sheet. Available at: . Accessed August 2025. American Cancer Society. What Is Lung Cancer?. Available at: . Accessed August 2025. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. 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. 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. 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. US-115844 Last Updated 9/26 Contacts Media Inquiries Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com

Drug ApprovalPhase 3License out/inBreakthrough TherapyASCO

01 Sep 2026

·www.astrazeneca.com

AstraZeneca completes global license agreement for oral EGFR inhibitor Zegfrovy for lung cancer

AstraZeneca today announced the successful completion of the previously announced exclusive license agreement with Dizal Pharmaceutical Co., Ltd for Zegfrovy (sunvozertinib), an oral irreversible epidermal growth factor receptor (EGFR) inhibitor for patients with lung cancer. Through this agreement, AstraZeneca has acquired worldwide rights to develop and commercialise Zegfrovy. Zegfrovy is approved in the US and China for the 2nd-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. Patients with NSCLC with EGFR exon 20 insertion mutations experience a real-world five-year overall survival rate as low as 8%underscoring the unmet need for new treatment options.1 Zegfrovy is already available to patients in China in the 2nd-line setting and AstraZeneca will launch in the US during the fourth quarter of 2026 for this indication. Sunvozertinib (Zegfrovy) is included in the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for NSCLC. It is recommended as a subsequent therapy option for patients with EGFR exon 20 insertion mutation-positive advanced or metastatic NSCLC. See NCCN Guidelines® for detailed recommendations.2 A supplemental New Drug Application for approval of Zegfrovy in the 1st-line setting has been accepted by the US Food and Drug Administration (FDA), supported by positive results from the global WU-KONG28 Phase III trial of Zegfrovy in 1st-line NSCLC with EGFR exon 20 insertion 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. Zegfrovy has also been submitted for approval in the 1st-line setting to China’s Center for Drug Evaluation (CDE). The US FDA and China’s CDE both granted Breakthrough Therapy Designation to Zegfrovy in this setting. Financial considerations AstraZeneca will make an upfront payment of $600m to Dizal together with 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. This 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.3 Lung cancer is broadly split into small cell lung cancer or NSCLC, the latter accounting for 80-85% of cases.3-4 Approximately 75% of people are diagnosed with advanced NSCLC.5 Additionally, about 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.6-8 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. Supplemental New Drug Applications for approval of Zegfrovy in the 1st-line setting have also 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 both granted Breakthrough Therapy Designation to Zegfrovy in this setting. 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); Zegfrovy (sunvozertinib); 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. Bazhenova L, et al. Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations. Lung Cancer, 2021; 162, 154-161. 2. 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. 3. 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. 4. American Cancer Society. What Is Lung Cancer?. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed August 2025. 5. Chen HJ, et al. Long-term survival of advanced lung adenocarcinoma by maintenance chemotherapy followed by EGFR-TKI. Medicine. 2021;100(6):e24688. 6. 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. 7. 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. 8. 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

Drug ApprovalPhase 3License out/inASCOBreakthrough Therapy

100 Deals associated with Savolitinib

External Link

KEGG	Wiki	ATC	Drug Bank
D11139	Savolitinib	L01XE	DB12048

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Gastroesophageal junction adenocarcinoma	China	Hutchison MediPharma Ltd.	30 Jun 2026
Stomach Cancer	China	Hutchison MediPharma Ltd.	30 Jun 2026
EGFR mutation MET positive Non-small Cell Lung Cancer	China	Hutchison MediPharma Ltd.	24 Jun 2025
MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer	China	Hutchison MediPharma Ltd.	22 Jun 2021

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
MET gene amplification Non-small Cell Lung Cancer	NDA/BLA	China	Hutchison MediPharma Ltd.	31 Dec 2024
Papillary Renal Cell Carcinoma	NDA/BLA	-	HUTCHMED (China) Ltd.	06 Jun 2022
c-Met positive Stomach Cancer	Phase 3	China	Hutchison MediPharma Ltd.	15 Jun 2026
HER2 positive Gastroesophageal Junction Adenocarcinoma	Phase 3	China	Hutchison MediPharma Ltd.	15 Jun 2026
Carcinoma	Phase 3	United States	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Japan	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Belgium	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Greece	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Malaysia	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Philippines	AstraZeneca PLC	03 Aug 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


WCLC2026	Not Applicable	MET gene amplification Non-small Cell Lung Cancer First line MET Amplification \| PD-L1 Expression	4	savolitinib	rktsqstswo(asvfhcwtwl) = zfeperleol vvmdrpwllo (aiqpfjkqce )	Positive	12 Sep 2026
				carboplatinnab-paclitaxel + carboplatinnab-paclitaxel + carboplatinnab-paclitaxel	rktsqstswo(asvfhcwtwl) = ccoxjesvoz vvmdrpwllo (aiqpfjkqce )
NCT05163249 (FLOWERS, WCLC2026)	Phase 2	Non-Small Cell Lung Cancer First line EGFR m \| MET amplification and/or overexpression	44	Osimertinib	krevpazetp(uojhmfkdsk) = mpcsatlrxs hjfjlvrmqc (xqvvtsseub, 8.3 - NE) View more	Positive	12 Sep 2026
				Osimertinib + Savolitinib	krevpazetp(uojhmfkdsk) = eiobeiwsku hjfjlvrmqc (xqvvtsseub, 14.1 - NE) View more
NCT03598244 (CTgov)	Phase 1	Refractory Central Nervous System Lymphoma \| Recurrent Medulloblastoma \| Refractory Medulloblastoma ... View more	41	X-Ray Imaging+Savolitinib	gvnlpjlbiv = avpvynwort aiwsjwbmnw (yaevhrzwxm, ysqdowgahl - gzpmtyszee) View more	-	23 Jun 2026
NCT04923932 (ASCO2026)	Phase 2	c-Met positive Stomach Cancer \| Gastroesophageal junction adenocarcinoma MET-amplified	65	Savolitinib 200 mg (BW < 50 kg) or 300 mg (BW ≥50 kg) BID (MET-amplified gastric cancer or gastroesophageal junction adenocarcinoma)	lbzkeoqssb(suwltbydkr) = rilmwvbspe aalfgbbosp (vvlcacdrbd, 21.2 - 45.1) View more	Positive	29 May 2026
				Savolitinib 200 mg (BW < 50 kg) or 300 mg (BW ≥50 kg) BID (baseline ctDNA MET-positive)	lbzkeoqssb(suwltbydkr) = lukgouuygo aalfgbbosp (vvlcacdrbd, 29.8 - 61.3) View more
NCT05043090 \| NCT02819596 (CALYPSO, Pubmed \| J Clin Oncol)	Phase 2	Neoplasm Metastasis MET \| PD-L1 \| tumor mutational burden (TMB)	41	Savolitinib and Durvalumab	txdjsphdvl(owomzjupdo) = lyqdzjbisa lzavbkcdto (utyhshwtio, 7.3 - 30.7) View more	Positive	20 Apr 2026
				Savolitinib and Durvalumab (MET-driven patients)	txdjsphdvl(owomzjupdo) = ebrbilefib lzavbkcdto (utyhshwtio, 9.3 - 37.4) View more
NCT04923945 (Pubmed \| Lancet Reg Health West Pac)	Phase 3	MET Exon 14 Skipping Mutation Non-small Cell Lung Cancer MET exon 14-mutated	166	Savolitinib (Non-small cell lung cancer with MET exon 14 mutation + Treatment-naïve)	onzvmndotd(ndomxcdeuk) = mkxkuesifv qlodcltgpo (aisgzkvyhk, 31 - 53) View more	Positive	01 Apr 2026
				Savolitinib (Non-small cell lung cancer with MET exon 14 mutation + Previously treated)	onzvmndotd(ndomxcdeuk) = rgovhtibwg qlodcltgpo (aisgzkvyhk, 51 - 72)
NCT03944772 (ORCHARD, Pubmed \| J Thorac Oncol)	Phase 2	EGFR mutation MET positive Non-small Cell Lung Cancer Second line EGFR-Mutated \| MET Alterations	32	Osimertinib plus Savolitinib	kekwdshkse(ptktztimta) = nwfyketiem lqgynrxroq (tcqzgdubpg, 34 - 60) View more	Positive	01 Feb 2026
NCT05163249 (FLOWERS, Pubmed \| Nat Commun)	Phase 2	EGFR mutation MET positive Non-small Cell Lung Cancer First line EGFR mutations \| MET amplification or overexpression	44	Osimertinib 80 mg	ljvfwixvsy(cjahjvfuaf) = nofwaiirdf xblwmpwgxz (jtlcgdfatt, 38.5 - 80.3) View more	Positive	13 Jan 2026
				Osimertinib 80 mg + Savolitinib 300 mg	ljvfwixvsy(cjahjvfuaf) = hknfcpmptu xblwmpwgxz (jtlcgdfatt, 69.6 - 98.8) View more
NCT05015608 (SACHI, Pubmed \| Lancet \| Biospace) Manual	Phase 3	EGFR mutation MET positive Non-small Cell Lung Cancer MET Amplification \| EGFR Mutation	211	Savolitinib+osimertinib (ITT population)	cwnknyyqyr(hwygceeqrs) = devslhgopt tuniewypgb (zlgivseewu ) Met View more	Positive	01 Jan 2026
				Chemotherapy (pemetrexed + cisplatin or carboplatin) (ITT population)	cwnknyyqyr(hwygceeqrs) = nqoxdsccgg tuniewypgb (zlgivseewu ) Met View more
NCT03778229 (SAVANNAH, Pubmed \| Clin Lung Cancer)	Phase 2	MET gene amplification Non-small Cell Lung Cancer MET Amplified \| EGFR Mutated	30	Savolitinib 300 mg QD + Osimertinib 80 mg QD	mjdzfxhkjc(cdedropdwa) = xjuwoxmtlz lrmpdrnnjc (jrnueewrsm, 29 - 82) View more	Positive	01 Jan 2026
				Savolitinib + Placebo	mjdzfxhkjc(cdedropdwa) = nqoefpcjkp lrmpdrnnjc (jrnueewrsm, 2 - 38) View more

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