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

NCT06563999

/ RecruitingPhase 2IIT

Neoadjuvant Umbrella Trial Directed by Next Generation Sequencing for Patients With Unresectable Stage III NSCLC Harboring Rare Mutations (Without EGFR Sensitizing Mutations)

This umbrella trial directed by next generation sequencing (NGS) includes patients with treatment-naive unresectable stage III non-small-cell lung cancer (NSCLC). The aim of the umbrella study is to evaluate the efficacy of induction NGS-directed targeted therapies followed by surgery for stage III NSCLC patients whose tumor harbors a rare mutation.

Start Date01 Nov 2024

Sponsor / Collaborator

Sun Yat-Sen University

NCT06348355

/ CompletedPhase 1

A Phase I, Open-label, Positron-Emission Tomography Study to Determine Brain Exposure of [11C]Savolitinib in Healthy Volunteers

The purpose of this study is to measure brain exposure of [11C]savolitinib in healthy volunteers.
This study will determine brain exposure of [11C]savolitinib in up to 8 healthy volunteers under physiological conditions, ie, when the BBB is intact. The study design allows up to 3 site visits. Two PET examinations will be performed for each healthy volunteer. The first PET examination will use IV administration of [11C]savolitinib. The second PET examination using [11C]savolitinib will occur after a single oral dose of 300 mg of savolitinib. PET image analysis will include kinetic compartment modelling using arterial input function, and will generate a set of brain exposure parameters (eg, maximum %ID, maximum [11C]savolitinib concentration in brain, partition coefficients between brain and plasma).

Start Date12 Apr 2024

Sponsor / Collaborator

AstraZeneca PLC

100 Clinical Results associated with Savolitinib

100 Translational Medicine associated with Savolitinib

100 Patents (Medical) associated with Savolitinib

213

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.

21 Apr 2026·CURRENT DRUG METABOLISM

Advancing MET-Aberrant NSCLC Therapy with Glumetinib: Pharmacokinetics, Efficacy, Safety, Drug Interactions, and Clinical Prospects.

Article

Author: Yin, Xiaoyu ; Zhang, Zhiqing ; Lu, Ming

Targeting Mesenchymal-Epithelial Transition Factor (MET) gene aberrations has emerged as a pivotal strategy in the precision treatment of Non-Small Cell Lung Cancer (NSCLC). Among these, MET exon 14 (METex14) skipping mutation represents a well-established and significant therapeutic target. Glumetinib, a highly selective oral MET inhibitor developed in China, has been approved by the National Medical Products Administration (NMPA) and the Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of advanced or relapsed NSCLC with METex 14 skipping mutation. Glumetinib has not yet received approval from the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA). However, a phase II clinical trial is ongoing in the United States, planning to enroll 78 patients with advanced c-MET-positive NSCLC, which may support future regulatory submissions. Preclinical investigations have shown that glumetinib effectively inhibits MET-driven tumors by specifically targeting c-Met kinase activity and its associated downstream signaling pathways. In the pivotal phase II GLORY trial, patients with METex14-positive NSCLC were administered glumetinib (300 mg/day) and demonstrated an Objective Response Rate (ORR) of 66% and a median Progression-Free Survival (PFS) of 8.5 months. Notably, patients with brain metastases exhibited an ORR of 85%. Treatment-Related Adverse Events (TRAEs) of grade≥3 severity were reported in 54% of patients, with only 8% discontinuing treatment due to TRAEs, suggesting a manageable safety profile. From the perspective of China's healthcare system, glumetinib is considered more cost-effective than savolitinib in treating NSCLC patients with METex14 skipping. The clinical applications of glumetinib are broadening to encompass strategies to overcome drug resistance and combination therapies. This manuscript seeks to provide a comprehensive overview of the essential characteristics, mechanism of action, pharmacokinetics, efficacy, safety, drug interactions, and cost-effectiveness of glumetinib while also exploring its future therapeutic potential.

20 Apr 2026·JOURNAL OF CLINICAL ONCOLOGY

CALYPSO: Final Results of Savolitinib and Durvalumab Combination in Metastatic Papillary Renal Cancer

Article

Author: Patel, Poulam ; Powles, Thomas ; Mendez-Vidal, Maria Jose ; Rodriguez-Vida, Alejo ; Ralph, Christy ; Thistlethwaite, Fiona C. ; Gascó, Amaya ; Srinivasan, Gopalakrishnan ; Szabados, Bernadett E. ; Hartmaier, Ryan ; Valderrama, Begoña P. ; Glen, Hilary ; Childress, Merrida ; Jackson-Spence, Francesca ; Markovets, Aleksandra ; Suárez, Cristina ; Larkin, James ; Jamal, Fahmida ; Ackerman, Charlotte ; Boyle, Patrick ; Priyadarshini, Garima ; Li, Wenshu

PURPOSE:

The CALYPSO study demonstrated activity of savolitinib and durvalumab in MET -driven papillary renal cancer (PRC). We report final efficacy outcomes and exploratory circulating tumor DNA (ctDNA) biomarker analysis.

METHODS:

This single-arm phase II study evaluated savolitinib and durvalumab in treatment-naïve or pretreated PRC. End points included overall response rate (ORR), progression-free survival (PFS), and overall survival (OS). FoundationOne CDx assessed DNA alterations and MET /PD-L1 or MET /tumor mutational burden (TMB) copositivity. ctDNA collected at baseline and on treatment was correlated with outcomes.

RESULTS:

At 41-months median follow-up, ORR was 34% (95% CI, 20.0 to 51.0) in the intention-to-treat (ITT) population (N = 41) and 53% (95% CI, 28.0 to 77.0) in MET -driven patients (n = 17). Median PFS was 6.5 (95% CI, 2.7 to 12.0) versus 13.9 months (95% CI, 2.9 to 23.8), and OS was 18.3 (95% CI, 7.3 to 30.7) versus 27.4 months (95% CI, 9.3 to 37.4), in the ITT population and the MET -driven population, respectively. PD-L1 (66% positive) and TMB (median 2.5 mut/Mb) status did not correlate with response. Baseline ctDNA positivity (10/21) correlated with shorter OS (median 7.3 v 33.3 months), while ctDNA clearance and mean variant allele frequency reduction correlated with improved OS (median 31.3 v 7.2 and 31.3 v 15.5 months, respectively).

CONCLUSION:

Savolitinib plus durvalumab shows OS in MET -driven PRC, supporting the ongoing SAMETA RIII trial (ClinicalTrials.gov identifier: NCT05043090 ). ctDNA may be a useful predictive biomarker.

132

News (Medical) associated with Savolitinib

22 May 2026

·www.biospace.com

AstraZeneca to showcase Phase III data in liver, breast and bladder cancers and potential first-in-class rare disease therapy at ASCO 2026

EMERALD-3 late-breaking presentation will showcase benefit of IMFINZI ® (durvalumab) and IMJUDO ® (tremelimumab-actl) in early liver cancer Phase III data from SERENA-6, DESTINY-Breast09 and TROPION-Breast02 span all three major subtypes of metastatic breast cancer CARES Phase III results will demonstrate highly clinically meaningful benefit of anti-fibril therapy, anselamimab, for kappa light chain amyloidosis WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca advances its ambition to eliminate cancer as a cause of death and transform outcomes for people living with rare diseases with new data across its diverse, industry-leading portfolio and pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting, May 29 to June 2, 2026. More than 85 abstracts will feature 10 approved and 13 potential new medicines from the Company, including 25 oral presentations. Highlights include: EMERALD-3: Phase III trial of IMFINZI ® (durvalumab) in combination with IMJUDO ® (tremelimumab-actl), with or without lenvatinib, and transarterial chemoembolization (TACE) in patients with unresectable hepatocellular carcinoma (HCC) eligible for embolization (Oral Abstract #LBA4000). CARES: Phase III clinical program of anselamimab, a potential first-in-class anti-fibril therapy from Alexion, AstraZeneca Rare Disease, in newly diagnosed patients with light chain (AL) amyloidosis receiving standard of care for underlying plasma cell dyscrasia, including results from a prespecified subgroup analysis based on involved kappa (κ) or lambda (λ) free light chain (Oral Abstract #7501). SERENA-6: Final progression-free survival 2 (PFS2) results and circulating tumor DNA (ctDNA) clearance data linked to longer-term efficacy outcomes from the SERENA-6 Phase III trial of camizestrant in combination with widely approved cyclin-dependent kinase (CDK) 4/6 inhibitors in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumors have an emergent ESR1 mutation (Oral Abstract #LBA1007). BLUESTAR: Updated safety and efficacy results from the BLUESTAR Ph I/IIa trial of the B7-H4-directed ADC puxitatug samrotecan (Puxi-Sam) in patients with relapsed/metastatic B7-H4-positive endometrial and ovarian cancer who progressed on prior standard-of-care therapy (Rapid Oral Abstract #5515). Puxi-Sam was recently granted Breakthrough Therapy Designation by the US Food and Drug Administration (FDA) in this setting. PRIMAVERA: Safety and preliminary efficacy from the first-in-human Phase I PRIMAVERA trial of the protein arginine methyltransferase 5 (PRMT5) inhibitor AZD3470 as monotherapy in relapsed/refractory classic Hodgkin lymphoma (Oral Abstract #7003). Phase I initial results for NT-175 T-cell receptor therapy in TP53 R175H-mutated unresectable, advanced and/or metastatic solid tumors including pancreatic adenocarcinoma (Oral Abstract #2506). TROPION-Breast02: Additional efficacy endpoints from the TROPION-Breast02 Phase III trial of DATROWAY ® (datopotamab deruxtecan-dlnk) as 1st-line treatment for patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) who are not candidates for PD-1/PD-L1 inhibitors (Oral Abstract #1002). DESTINY-Breast09: Exploratory analysis of treatment duration and clinical outcomes by complete response, partial response or stable/progressive disease in the DESTINY-Breast09 Phase III trial of ENHERTU ® (fam-trastuzumab deruxtecan-nxki) in combination with pertuzumab for the 1st-line treatment of patients with HER2-positive metastatic breast cancer (Rapid Oral Abstract #1021). POTOMAC: Five-year overall survival and patient-reported outcomes from the Phase III POTOMAC trial of IMFINZI plus Bacillus Calmette-Guérin (BCG) induction and maintenance therapy in patients with high-risk non-muscle-invasive bladder cancer (Rapid Oral Abstract #4624). Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “The data at ASCO for our innovative medicines and next-wave assets further our strategy to redefine patient outcomes by taking novel combinations into earlier stages of disease and advancing new modalities. New data for ENHERTU, DATROWAY and camizestrant reinforce their transformational potential in breast cancer. We’re also excited to share first clinical data for our T-cell receptor therapy, NT-175, and our PRMT5 inhibitor, AZD3470, as well as updated data for our most advanced in-house antibody drug conjugate, Puxi-Sam, which was recently granted Breakthrough Therapy Designation by the FDA. Collectively, these datasets underscore the strength and depth of our oncology pipeline.” Dave Fredrickson, Executive Vice President, Oncology Haematology Business Unit, AstraZeneca, said: “The EMERALD-3 data for IMFINZI and IMJUDO in early liver cancer exemplify our successful strategy to move immunotherapy regimens into earlier stages of cancer where we can further improve outcomes for patients. With more than a dozen different indications approved across five cancer medicines in the last six months alone, we are reaching more patients with our growing portfolio, underscoring both the quality of our innovation and the strength of our business.” Gianluca Pirozzi, Head of Development, Regulatory and Safety, Alexion, said: "Results from the CARES Phase III clinical program highlight the pioneering potential of anselamimab as a first-in-class, anti-fibril therapy for patients with kappa light chain amyloidosis. Its novel mechanism of action is designed to target and deplete amyloid deposits in affected organs, with potential to extend survival and reduce cardiovascular hospitalizations." AstraZeneca is collaborating with Daiichi Sankyo to develop and commercialize ENHERTU and DATROWAY. Key AstraZeneca presentations during ASCO 2026 1 Lead Author Abstract Title Presentation details (CDT) Antibody drug conjugates Loi, S Trastuzumab deruxtecan (T-DXd) + durvalumab (D) in patients (pts) with previously untreated HER2+ unresectable/metastatic breast cancer (mBC): Final analysis from DESTINY-Breast07. Abstract #1012 Clinical Science Symposium May 31, 2026 9:18am Cescon, DW First-line datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (TNBC) for whom immunotherapy was not an option: Additional efficacy endpoints from the TROPION-Breast02 study. Abstract #1002 Oral Abstract Session June 2, 2026 10:09am Mileshkin, LR Updated safety and efficacy of puxitatug samrotecan (Puxi-Sam, AZD8205) in patients (pts) with endometrial cancer (EC) or ovarian cancer (OC): Phase 1/2a BLUESTAR study. Abstract #5515 Rapid Oral Abstract Session May 30, 2026 9:00am Park, YH A DESTINY-Breast09 analysis of treatment duration and clinical outcomes by best response to trastuzumab deruxtecan (T-DXd) + pertuzumab (P). Abstract #1021 Rapid Oral Abstract Session May 31, 2026 12:42pm Untch, M Secondary safety analysis of trastuzumab deruxtecan (T-DXd) vs trastuzumab emtansine (T-DM1) in DESTINY-Breast05: Clinical and demographic risk factors of interstitial lung disease (ILD) and radiation pneumonitis (RP). Abstract #516 Rapid Oral Abstract Session June 1, 2026 10:57am Shitara, K Sonesitatug vedotin (Sone-Ve) monotherapy in patients (pts) with claudin 18.2–positive (CLDN18.2+) advanced or metastatic gastric or gastroesophageal junction (GEJ) cancers: Data from CLARITY-PanTumor01. Abstract #4023 Poster Session May 30, 2026 9:00am Janjigian, Y First-line (1L) trastuzumab deruxtecan (T-DXd)–based regimens in advanced HER2-expressing gastric cancer (GC), gastroesophageal junction adenocarcinoma (GEJA), or esophageal adenocarcinoma (EA): Safety results from DESTINY-Gastric03 (DG-03) Part 2 arms D and F, and Part 4. Abstract #4022 Poster Session May 30, 2026 9:00am Zhang, Y Trastuzumab deruxtecan (T-DXd) for pretreated patients in China with HER2 IHC 3+ solid tumors: DESTINY-PanTumor03 Part 1 primary analysis. Abstract #3026 Poster Session May 30, 2026 1:30pm Immuno-oncology Abou-Alfa, GK Efficacy and safety results from EMERALD-3: A phase 3, randomized study of tremelimumab plus durvalumab with or without lenvatinib combined with transarterial chemoembolization (TACE) in participants (pts) with unresectable embolization-eligible hepatocellular carcinoma (eeHCC). Abstract #LBA4000 Oral Abstract Session June 1, 2026 9:45am Skoulidis, F Tremelimumab (T) + durvalumab (D) + chemotherapy (CT) vs pembrolizumab (P) + CT in 1L non-squamous (NSQ) metastatic NSCLC (mNSCLC) with STK11 , KEAP1 , and/or KRAS mutations (mut): Interim analysis (IA) of the phase 2b TRITON study. Abstract #8515 Rapid Oral Abstract Session May 30, 2026 1:45pm Heymach, JV Impact of neoadjuvant durvalumab (D) on tumor microenvironment (TME) features and their association with event-free survival (EFS) in patients with resectable NSCLC (R-NSCLC) from the phase 3 AEGEAN trial. Abstract #8015 Rapid Oral Abstract Session May 31, 2026 5:30pm De Santis, M Durvalumab (D) in combination with BCG induction and maintenance (I + M) therapy for BCG-naive, high-risk non–muscle-invasive bladder cancer (NMIBC): 5-year overall survival (OS) analysis and patient-reported outcomes (PROs) from POTOMAC. Abstract #4624 Rapid Oral Abstract Session June 1, 2026 8:12am IO Bispecifics O’Sullivan, CC Neoadjuvant rilvegostomig (R) + trastuzumab deruxtecan (T-DXd) in high-risk HER2-negative breast cancer: Results from the I-SPY 2.2 trial. Abstract #LBA514 Rapid Oral Abstract Session June 1, 2026 10:45am Zhou, J First-line rilvegostomig (R) + chemotherapy (CTx) in advanced biliary tract cancer (BTC): Updated analysis of GEMINI-Hepatobiliary substudy 2 cohort A. Abstract #88 Poster Session May 30, 2026 9:00am Guo, Y Volrustomig monotherapy for recurrent/metastatic HNSCC: Substudy 2 of the eVOLVE-02 phase 2 study. Abstract #482 Poster Session May 30, 2026 1:30pm Tumor drivers and resistance Wang, Z Osimertinib with/without chemotherapy in patients with persistent ctDNA EGFR mutant (EGFRm) NSCLC at 3 weeks after 1L osimertinib: A randomized phase II study (FLAME study). Abstract #LBA101 Clinical Science Symposium May 30, 2026 8:40am Bidard, FC First-line (1L) camizestrant (CAMI) for emergent ESR1 mutations ( ESR1 m) in advanced breast cancer (ABC): Final progression-free survival 2 (PFS2) from the phase III SERENA-6 trial. Abstract #LBA1007 Oral Abstract Session June 2, 2026 11:57am Peng, Z A phase 2 pivotal study of savolitinib in patients with MET -amplified gastric cancer or gastroesophageal junction adenocarcinomas. Abstract #4011 Rapid Oral Abstract Session June 1, 2026 1:27pm Cell Therapy Surana, R Initial phase 1 study results of NT-175 engineered T-cell therapy in TP53 R175H–mutated unresectable advanced solid tumors. Abstract #2506 Oral Abstract Session May 31, 2026 10:00am Epigenetics Derenzini, E A phase 1 study of the PRMT5 inhibitor AZD3470 in patients with relapsed/refractory classic Hodgkin lymphoma (PRIMAVERA). Abstract #7003 Oral Abstract Session May 30, 2026 4:00pm Rare Disease Wechalekar, AD Phase 3 randomized trial to evaluate the impact of anselamimab on all-cause mortality in κ light chain amyloidosis. Abstract #7501 Oral Abstract Session May 29, 2026 2:57pm Chen, AP Final analysis of KOMET (NCT04924608), a phase 3 study of selumetinib in adults with NF1-PN. Abstract #3110 Poster Session May 30, 2026 1:30pm 1 More than 85 abstracts at ASCO 2026 will feature AstraZeneca medicines and pipeline molecules IMPORTANT SAFETY INFORMATION FOR IMFINZI ® (durvalumab) There are no contraindications for IMFINZI ® (durvalumab) or IMJUDO ® (tremelimumab-actl). Severe and Fatal Immune-Mediated Adverse Reactions Important immune-mediated adverse reactions listed under Warnings and Precautions may not include all possible severe and fatal immune-mediated reactions. Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue. Immune-mediated adverse reactions can occur at any time after starting treatment or after discontinuation. Monitor patients closely for symptoms and signs that may be clinical manifestations of underlying immune-mediated adverse reactions. Evaluate clinical chemistries including liver enzymes, creatinine, adrenocorticotropic hormone (ACTH) level, and thyroid function at baseline and before each dose. In cases of suspected immune-mediated adverse reactions, initiate appropriate workup to exclude alternative etiologies, including infection. Institute medical management promptly, including specialty consultation as appropriate. Withhold or permanently discontinue IMFINZI and IMJUDO depending on severity. See USPI Dosing and Administration for specific details. In general, if IMFINZI and IMJUDO requires interruption or discontinuation, administer systemic corticosteroid therapy (1 mg to 2 mg/kg/day prednisone or equivalent) until improvement to Grade 1 or less. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Consider administration of other systemic immunosuppressants in patients whose immune-mediated adverse reactions are not controlled with corticosteroid therapy. Immune-Mediated Pneumonitis IMFINZI and IMJUDO can cause immune-mediated pneumonitis, which may be fatal. The incidence of pneumonitis is higher in patients who have received prior thoracic radiation. IMFINZI as a Single Agent In patients who did not receive recent prior radiation, the incidence of immune-mediated pneumonitis was 2.4% (34/1414), including fatal (<0.1%), and Grade 3-4 (0.4%) adverse reactions. In patients who received recent prior radiation, the incidence of pneumonitis (including radiation pneumonitis) in patients with unresectable Stage III NSCLC following definitive chemoradiation within 42 days prior to initiation of IMFINZI in PACIFIC was 18.3% (87/475) in patients receiving IMFINZI and 12.8% (30/234) in patients receiving placebo. Of the patients who received IMFINZI (475), 1.1% were fatal and 2.7% were Grade 3 adverse reactions. The incidence of pneumonitis (including radiation pneumonitis) in patients with LS-SCLC following chemoradiation within 42 days prior to initiation of IMFINZI in ADRIATIC was 14% (37/262) in patients receiving IMFINZI and 6% (16/265) in patients receiving placebo. Of the patients who received IMFINZI (262), 0.4% had a fatal adverse reaction and 2.7% had Grade 3 adverse reactions. The frequency and severity of immune-mediated pneumonitis in patients who did not receive definitive chemoradiation prior to IMFINZI were similar in patients who received IMFINZI as a single agent or with ES-SCLC or BTC when given in combination with chemotherapy. IMFINZI with IMJUDO Immune‑mediated pneumonitis occurred in 1.3% (5/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.3%) and Grade 3 (0.2%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated pneumonitis occurred in 3.5% (21/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.5%), and Grade 3 (1%) adverse reactions. Immune-Mediated Colitis IMFINZI with IMJUDO and platinum-based chemotherapy can cause immune-mediated colitis, which may be fatal. IMFINZI and IMJUDO can cause immune-mediated colitis that is frequently associated with diarrhea. Cytomegalovirus (CMV) infection/reactivation has been reported in patients with corticosteroid-refractory immune-mediated colitis. In cases of corticosteroid-refractory colitis, consider repeating infectious workup to exclude alternative etiologies. IMFINZI as a Single Agent Immune-mediated colitis occurred in 2% (37/1889) of patients receiving IMFINZI, including Grade 4 (<0.1%) and Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune‑mediated colitis or diarrhea occurred in 6% (23/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (3.6%) adverse reactions. Intestinal perforation has been observed in other studies of IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated colitis occurred in 6.5% (39/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including fatal (0.2%) and Grade 3 (2.5%) adverse reactions. Intestinal perforation and large intestine perforation were reported in 0.1% of patients. Immune-Mediated Hepatitis IMFINZI and IMJUDO can cause immune-mediated hepatitis, which may be fatal. IMFINZI as a Single Agent Immune-mediated hepatitis occurred in 2.8% (52/1889) of patients receiving IMFINZI, including fatal (0.2%), Grade 4 (0.3%) and Grade 3 (1.4%) adverse reactions. IMFINZI with IMJUDO Immune‑mediated hepatitis occurred in 7.5% (29/388) of patients receiving IMFINZI and IMJUDO, including fatal (0.8%), Grade 4 (0.3%) and Grade 3 (4.1%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hepatitis occurred in 3.9% (23/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including fatal (0.3%), Grade 4 (0.5%), and Grade 3 (2%) adverse reactions. Immune-Mediated Endocrinopathies Adrenal Insufficiency : IMFINZI and IMJUDO can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. IMFINZI as a Single Agent Immune-mediated adrenal insufficiency occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated adrenal insufficiency occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated adrenal insufficiency occurred in 2.2% (13/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.8%) adverse reactions. Hypophysitis : IMFINZI and IMJUDO can cause immune-mediated hypophysitis. Hypophysitis can present with acute symptoms associated with mass effect such as headache, photophobia, or visual field cuts. Hypophysitis can cause hypopituitarism. Initiate symptomatic treatment including hormone replacement as clinically indicated. IMFINZI as a Single Agent Grade 3 hypophysitis/hypopituitarism occurred in <0.1% (1/1889) of patients who received IMFINZI. IMFINZI with IMJUDO Immune-mediated hypophysitis/hypopituitarism occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated hypophysitis occurred in 1.3% (8/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. Thyroid Disorders (Thyroiditis, Hyperthyroidism, and Hypothyroidism) : IMFINZI and IMJUDO can cause immune-mediated thyroid disorders. Thyroiditis can present with or without endocrinopathy. Hypothyroidism can follow hyperthyroidism. Initiate hormone replacement therapy for hypothyroidism or institute medical management of hyperthyroidism as clinically indicated. IMFINZI as a Single Agent Immune-mediated thyroiditis occurred in 0.5% (9/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. Immune-mediated hyperthyroidism occurred in 2.1% (39/1889) of patients receiving IMFINZI. Immune-mediated hypothyroidism occurred in 8.3% (156/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated thyroiditis occurred in 1.5% (6/388) of patients receiving IMFINZI and IMJUDO. Immune-mediated hyperthyroidism occurred in 4.6% (18/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.3%) adverse reactions. Immune-mediated hypothyroidism occurred in 11% (42/388) of patients receiving IMFINZI and IMJUDO. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated thyroiditis occurred in 1.2% (7/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy. Immune-mediated hyperthyroidism occurred in 5% (30/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-mediated hypothyroidism occurred in 8.6% (51/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.5%) adverse reactions. IMFINZI with Carboplatin and Paclitaxel Immune-mediated hypothyroidism occurred in 14% (34/235) of patients receiving IMFINZI in combination with carboplatin and paclitaxel. Type 1 Diabetes Mellitus, which can present with diabetic ketoacidosis : Monitor patients for hyperglycemia or other signs and symptoms of diabetes. Initiate treatment with insulin as clinically indicated. IMFINZI as a Single Agent Grade 3 immune-mediated Type 1 diabetes mellitus occurred in <0.1% (1/1889) of patients receiving IMFINZI. IMFINZI with IMJUDO Two patients (0.5%, 2/388) had events of hyperglycemia requiring insulin therapy that had not resolved at last follow-up. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated Type 1 diabetes mellitus occurred in 0.5% (3/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy including Grade 3 (0.3%) adverse reactions. Immune-Mediated Nephritis with Renal Dysfunction IMFINZI and IMJUDO can cause immune-mediated nephritis. IMFINZI as a Single Agent Immune-mediated nephritis occurred in 0.5% (10/1889) of patients receiving IMFINZI, including Grade 3 (<0.1%) adverse reactions. IMFINZI with IMJUDO Immune-mediated nephritis occurred in 1% (4/388) of patients receiving IMFINZI and IMJUDO, including Grade 3 (0.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated nephritis occurred in 0.7% (4/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0.2%) adverse reactions. Immune-Mediated Dermatology Reactions IMFINZI and IMJUDO can cause immune-mediated rash or dermatitis. Exfoliative dermatitis, including Stevens-Johnson Syndrome (SJS), drug rash with eosinophilia and systemic symptoms (DRESS), and toxic epidermal necrolysis (TEN), has occurred with PD-1/L-1 and CTLA-4 blocking antibodies. Topical emollients and/or topical corticosteroids may be adequate to treat mild to moderate non-exfoliative rashes. IMFINZI as a Single Agent Immune-mediated rash or dermatitis occurred in 1.8% (34/1889) of patients receiving IMFINZI, including Grade 3 (0.4%) adverse reactions. IMFINZI with IMJUDO Immune-mediated rash or dermatitis occurred in 4.9% (19/388) of patients receiving IMFINZI and IMJUDO, including Grade 4 (0.3%) and Grade 3 (1.5%) adverse reactions. IMFINZI with IMJUDO and Platinum-Based Chemotherapy Immune-mediated rash or dermatitis occurred in 7.2% (43/596) of patients receiving IMFINZI in combination with IMJUDO and platinum-based chemotherapy, including Grade 3 (0. Contacts Media Inquiries Fiona Cookson +1 212 814 3923 Lauren-Jei McCarthy +1 347 918 7001 US Media Mailbox: usmediateam@astrazeneca.com Read full story here

Phase 3Clinical ResultPhase 2ASCOPhase 1

22 May 2026

·www.biospace.com

HUTCHMED Highlights Clinical Data to be Presented at the 2026 ASCO Annual Meeting

HONG KONG and FLORHAM PARK, N.J., May 22, 2026 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) today announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the American Society of Clinical Oncology (“ASCO”) Annual Meeting taking place from May 29 to June 2, 2026 in Chicago, USA. Results from the pivotal Phase II registration study of savolitinib in gastric cancer or gastroesophageal junction adenocarcinoma patients with MET amplification in China will be presented during a rapid oral session. The study met its primary endpoint of objective response rate (“ORR”) per RECIST 1.1, as assessed by the Independent Review Committee (“IRC”). As of the data cut-off of October 8, 2025, the IRC-assessed ORR was 32.3% (95%CI: 21.2%, 45.1%), exceeding the pre-specified efficacy threshold. Secondary endpoints included the IRC-assessed disease control rate (DCR) of 63.1%, median time to response (TTR) of 1.4 months, median duration of response (DoR) of 9.7 (95%CI: 3.7, 18.5) months, and median progression-free survival (PFS) of 4.0 (95%CI: 2.6, 5.0) months, respectively. The data supported the New Drug Application (NDA) submission to the China National Medical Products Administration (NMPA), which was accepted and granted priority review in December 2025. Additionally, further analyses of the fruquintinib’s FRESCO, FRESCO-2, FRUSICA-1 and FRUSICA-2 studies, as well as investigator-initiated studies of fruquintinib and surufatinib spanning across a diverse range of potential tumor indications will be presented. Details of the presentations, including links to available abstracts, are as follows: Abstract title Presenter / Lead Author Presentation details SPONSORED STUDIES A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas Zhi Peng, Beijing, China 4011 Rapid Oral Abstract Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Monday, June 1, 2026 1:15 PM CDT Tumor shrinkage and depth of response with fruquintinib in patients with metastatic colorectal cancer: Results from FRESCO and FRESCO-2 Elena Elez, Barcelona, Spain 3555 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Efficacy of fruquintinib plus sintilimab versus axitinib or everolimus by scores of IMDC risk factors and PD-L1 expression at baseline in previously treated advanced renal cell carcinoma: A subgroup analysis of FRUSICA-2 study Kaiwei Yang, Beijing, China 4531 Poster Session: Genitourinary Cancer – Kidney and Bladder Efficacy with fruquintinib plus sintilimab versus axitinib or everolimus in advanced renal cell carcinoma: A post-hoc analysis from FRUSICA-2 trial by baseline tumor burden Yuanyuan Qu, Shanghai, China 4533 Poster Session: Genitourinary Cancer – Kidney and Bladder Association of Palmar-plantar erythrodysesthesia syndrome (PPES), hypothyroidism and clinical outcome in previously treated endometrial cancer (EMC) with pMMR status: A subgroup analysis of FRUSICA-1 Xiaotian Han, Shanghai, China e17612 Publication Only: Gynecologic Cancer INVESTIGATOR-INITIATED STUDIES Efficacy and safety of fruquintinib combined with chemotherapy versus bevacizumab combined with chemotherapy as second-line treatment for metastatic colorectal cancer: A prospective, multicenter, randomized controlled trial Jianmin Xu, Shanghai, China LBA3563 Poster Session: Gastrointestinal Cancer – Colorectal and Anal CONCEPT (combination of cetuximab plus fruquintinib treatment ± immunotherapy): A multicenter, randomized, open-label phase II trial in first-line pMMR RAS/BRAF wild-type unresectable metastatic colorectal cancer Yue Liu, Hangzhou, China TPS3680 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with tislelizumab vs trifluridine/tipiracil and bevacizumab in MSS mCRC without active liver metastases: The IKF-080/QUINTIS trial Joseph Tintelnot, Hamburg, Germany TPS3684 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase 2 study of fruquintinib combined with sintilimab and chidamide in refractory MSS metastatic colorectal cancer: Preliminary efficacy and safety Chang Wang, Changchun, China 2631 Poster Session: Developmental Therapeutics – Immunotherapy Fruquintinib plus FOLFIRI or mFOLFOX6 as second-line therapy for patients with RAS-mutant metastatic colorectal cancer (mCRC): A phase II, multicenter, open-label study Yun Xu, Shanghai, China 3528 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A randomized phase II trial of fruquintinib plus capecitabine versus capecitabine alone as maintenance therapy following first-line chemotherapy in metastatic colorectal cancer (mCRC) Wenhua Li, Shanghai, China 3534 Poster Session: Gastrointestinal Cancer – Colorectal and Anal A phase II trial of fruquintinib combined with cadonilimab in refractory MSS/pMMR colorectal cancer with pulmonary metastases Mengzhou Guo, Shanghai, China 3552 Poster Session: Gastrointestinal Cancer – Colorectal and Anal Biomarker-driven assessment of immunochemotherapy with or without fruquintinib as first-line treatment for advanced gastric/GEJ adenocarcinoma: Initial clinical results and subgroup analysis from the MGC-FLORA study Xiaodong Zhu, Shanghai, China 4063 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Phase II study of utidelone plus fruquintinib for the treatment of platinum-resistant recurrent ovarian cancer (FRUTD trial) Hao Wen, Shanghai, China 5579 Poster Session: Gynecologic Cancer Fruquintinib alternating with bevacizumab plus capecitabine as maintenance therapy after first-line treatment in metastatic colorectal cancer (mCRC): A multicenter, open-label, phase II study Wangjun Liao, Guangzhou, China e15539 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Intermittent fruquintinib plus trifluridine/tipiracil in refractory metastatic colorectal cancer (mCRC): A single-center, single-arm phase II study Yifu He/Jiayu Niu, Hefei, China e15560 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Phase I study of liposomal irinotecan plus fruquintinib as third- or later-line therapy for metastatic colorectal cancer Qian Li, Nanning, China e15571 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Chidamide combined with serplulimab and regorafenib or fruquintinib as third-line therapy for advanced colorectal cancer (C-ooperate/SCOG-C001): A single-arm, exploratory, multicenter, phase 2 trial Wei Li, Suzhou, China e15583 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Real-world use of fruquintinib in refractory metastatic colorectal cancer in the United States Vasu Bansal, Kansas City, US e15713 Publication Only: Gastrointestinal Cancer – Colorectal and Anal Fruquintinib in combination with sintilimab and CAPEOX as first-line treatment for advanced gastric/gastroesophageal junction adenocarcinoma: A single-arm, open-label, multicenter phase Ib/II study (FUNCTION) Beibei Chen, Zhengzhou, China e16033 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Fruquintinib in combination with camrelizumab, paclitaxel liposome, and nedaplatin as first-line treatment for advanced esophageal squamous cell carcinoma (ESCC): Updated results from a single-arm, phase II study Yanhong Gu, Nanjing, China e16070 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Updated results of surufatinib combined with gemcitabine and cisplatin and immune checkpoint inhibitor (ICI) for unresectable locally advanced or metastatic intrahepatic cholangiocarcinoma Xuetao Shi/Jingtao Zhong, Jinan, China 4136 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib plus KN046 and chemotherapy as first-line treatment for advanced pancreatic ductal adenocarcinoma: Updated results and biomarker analysis from a phase 1b/2 trial Wenquan Wang, Shanghai, China 4198 Poster Session: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Surufatinib combined with toripalimab for the treatment of recurrent ovarian clear cell carcinoma: Update of a prospective single center, single-arm phase II clinical trial Huijuan Yang, Shanghai, China 5586 Poster Session: Gynecologic Cancer Surufatinib for advanced or metastatic chemotherapy-refractory thymic epithelial tumor: A single-arm, single-center, phase II study Bei Xu, Shanghai, China 8119 Poster Session: Lung Cancer – Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Surufatinib combined with anti-PD-1/PD-L1 antibody in the second line or monotherapy in third line treatment of advanced hepatocellular carcinoma: A single-arm, open-label, multi-center phase II study Fuxiang Zhou, Wuhan, China e16172 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Efficacy and safety of surufatinib combined with immune checkpoint inhibitors plus chemotherapy in patients with biliary tract cancers: A real-world study Shasha Fan, Changsha, China e16222 Publication Only: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and Hepatobiliary Osimertinib plus savolitinib in osimertinib-resistant non-small-cell lung cancer with low level gene copy number MET: A multi-center, open-label, and phase 2 study Xiang Han, Qingdao, China e20079 Publication Only: Lung Cancer – Non-Small Cell Local-Regional/ Small Cell/Other Thoracic Cancers About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. Since inception it has focused on bringing drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved around the world including in the US, Europe and Japan. For more information, please visit: or follow us on LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to its expectations regarding the therapeutic potential of fruquintinib, savolitinib and surufatinib, the further clinical development for fruquintinib, savolitinib and surufatinib, its expectations as to whether any studies on fruquintinib, savolitinib and surufatinib would meet their primary or secondary endpoints, and its expectations as to the timing of the completion and the release of results from such studies. Such risks and uncertainties include, among other things, assumptions regarding enrollment rates and the timing and availability of subjects meeting a study’s inclusion and exclusion criteria; changes to clinical protocols or regulatory requirements; unexpected adverse events or safety issues; the ability of fruquintinib, savolitinib and surufatinib, including as combination therapies, to meet the primary or secondary endpoint of a study, to obtain regulatory approval in different jurisdictions and to gain commercial acceptance after obtaining regulatory approval; the potential markets of fruquintinib, savolitinib and surufatinib for a targeted indication, and the sufficiency of funding. In addition, as certain studies rely on the use of other drug products as combination therapeutics, such risks and uncertainties include assumptions regarding their safety, efficacy, supply and continued regulatory approval. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries +852 2121 8200 / ir@hutch-med.com Media Enquiries FTI Consulting – +44 20 3727 1030 / HUTCHMED@fticonsulting.com Ben Atwell / Tim Stamper +44 7771 913 902 (Mobile) / +44 7779 436 698 (Mobile) Brunswick – Zhou Yi +852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Panmure Liberum Nominated Advisor and Joint Broker Atholl Tweedie / Emma Earl / Rupert Dearden +44 20 7886 2500 Cavendish Joint Broker Geoff Nash / Nigel Birks +44 20 7220 0500 Deutsche Numis Joint Broker Duncan Monteith / Ramin Naji +44 20 7545 8000

Clinical ResultPhase 2ASCOPhase 1Immunotherapy

29 Apr 2026

·endpoints.news

AstraZeneca cuts a couple of late-stage life-cycle trials after disappointing efficacy

AstraZeneca said it had stopped several mid- and late-stage trials of some of its pipeline programs in the past few months, potentially limiting some of the life-cycle extensions it was hoping for. Its first-quarter presentation shows it has canned a Phase 3 trial called ARTEMIS, assessing the complement inhibitor Ultomiris in acute kidney injury associated with cardiac surgery. The company said the trial showed no evidence of efficacy at an interim analysis. There were no new safety concerns, and AstraZeneca will continue to assess Ultomiris in other uses. AstraZeneca also shut down a late-stage renal cell carcinoma (RCC) trial of Imfinzi plus the MET inhibitor Orpathys, which it licensed from China’s Hutchmed. The trial missed its primary endpoint of progression-free survival versus Pfizer’s Sutent, which has been on sale for RCC for 20 years. A Phase 3 trial of Breztri in the lung disease COPD met its primary endpoint by showing improved inhaling capacity during exercise versus placebo. But AstraZeneca disclosed that the trial missed statistical significance on its second primary objective, which assessed the drug versus dual therapy with an inhaled steroid and a long-acting beta-2 agonist on measures of hyperinflation. Also, the company abandoned development of the growth hormone receptor antagonist ALXN2420, which was in a Phase 2 study for acromegaly, for strategic reasons. ALXN2420 was originally developed by the Japanese company PeptiDream and licensed to Amolyt Pharma before Amolyt’s acquisition by AstraZeneca. AstraZeneca also ended development of atuliflapon, a FLAP inhibitor, for efficacy reasons. It was in a mid-stage trial in asthma. Several other key readouts were delayed. Data from two trials of AstraZeneca’s TROP2-directed ADC Datroway in non-small cell lung cancer will now come next year, Jefferies analysts wrote in a same-day note. They added that the trial was tweaked to include biomarker measurements, and this contributed to the delayed results. Phase 3 data on the transthyretin depleter cliramitug in transthyretin amyloid cardiomyopathy are also now expected in 2027 at the earliest. AstraZeneca licensed the drug from Neurimmune in 2022. Overall, however, AstraZeneca had a good quarter. Its revenue and core operating profit increased to $15.3 billion and $5.4 billion, respectively, as sales of its kidney and heart drug Farxiga and other products including Ultomiris came in higher than Wall Street had expected.

Phase 3Phase 2AcquisitionDrug ApprovalClinical Trial Termination

100 Deals associated with Savolitinib

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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
Carcinoma	Phase 3	United States	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Japan	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Austria	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Belgium	AstraZeneca PLC	03 Aug 2022
Carcinoma	Phase 3	Bulgaria	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


NCT03598244 (CTgov)	Phase 1	Refractory Central Nervous System Lymphoma \| Recurrent Medulloblastoma \| Refractory Medulloblastoma ... View more	41	X-Ray Imaging+Savolitinib	oakyulqiir = afnvgjdoiy hhvxeeyajo (tylstjjejk, vodtifzyno - hfbradkrzp) 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)	cdtabydtys(comcbholne) = smsnhtdbof pbpnnvsisq (zpjnptvefv, 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)	cdtabydtys(comcbholne) = xxwwrdopwf pbpnnvsisq (zpjnptvefv, 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	iokjtfklko(icydlmcnwj) = lahfczzpke hgkjhagwan (zbowfwotmd, 7.3 - 30.7) View more	Positive	20 Apr 2026
				Savolitinib and Durvalumab (MET-driven patients)	iokjtfklko(icydlmcnwj) = tatwegmvek hgkjhagwan (zbowfwotmd, 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)	dxkpgqkyie(vobiysilhu) = ulmkhulxkw nmiwookvhk (oswtjjcdfz, 31 - 53) View more	Positive	01 Apr 2026
				Savolitinib (Non-small cell lung cancer with MET exon 14 mutation + Previously treated)	dxkpgqkyie(vobiysilhu) = ouucpjstom nmiwookvhk (oswtjjcdfz, 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	edwqjqhxls(bipxgitznk) = srrcpsskja fesfkgqijx (ujgjteruri, 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	olqncghapb(pxosmjgkjk) = dlvclpbfjm zwcnmgvjiy (omhlmtobtw, 38.5 - 80.3) View more	Positive	13 Jan 2026
				Osimertinib 80 mg + Savolitinib 300 mg	olqncghapb(pxosmjgkjk) = zwkrittbbs zwcnmgvjiy (omhlmtobtw, 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)	udpyzsehjd(lyjxuesdxk) = hvnsrattbo asidcosxzb (rrwbdjhbkk ) Met View more	Positive	01 Jan 2026
				Chemotherapy (pemetrexed + cisplatin or carboplatin) (ITT population)	udpyzsehjd(lyjxuesdxk) = rednkmqaif asidcosxzb (rrwbdjhbkk ) 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	ephdylgzju(dpysonjrdc) = eidbmmdbkp eylysmlgyf (xwskkpzfuy, 29 - 82) View more	Positive	01 Jan 2026
				Savolitinib + Placebo	ephdylgzju(dpysonjrdc) = lergexmfzc eylysmlgyf (xwskkpzfuy, 2 - 38) View more
NCT05015608 (SACHI, ESMO_ASIA2025)	Phase 3	Non-Small Cell Lung Cancer MET amplification	431	Savolitinib + Osimertinib	liujjrktjo(xlvwwrfcwc) = uigrofsnrz yvrhpxikpb (svoyjfbcwb ) View more	Positive	05 Dec 2025
				Chemotherapy	liujjrktjo(xlvwwrfcwc) = fgshdthhqv yvrhpxikpb (svoyjfbcwb ) View more
NCT05015608 (SACHI, ESMO_ASIA2025)	Phase 3	Second line EGFR-mutant \| MET-amplified	256	Savo+Osi/Crossover	afrulzyrby(tpdcztskeg) = upeblarhmy ozdknwslsj (edirtuvvdh ) View more	Positive	05 Dec 2025
				Pemetrexed+Platinum	afrulzyrby(tpdcztskeg) = naccbtjrym ozdknwslsj (edirtuvvdh ) View more

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