Orpathys (savolitinib) / AstraZeneca, Hutchmed - LARVOL DELTA

Osimertinib (osi) + savolitinib (savo) vs platinum–pemetrexed (plat–pem) in EGFRm MET-overexpressed (OE) and/or -amplified (AMP) advanced NSCLC post-osi: SAFFRON Phase (Ph) 3 primary results (ESMO 2026) - No abstract available

Late-breaking abstract • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Savolitinib or Placebo Combined with Osimertinib in Treatment-Naïve Advanced NSCLC with EGFR Mutation and MET Overexpression: Results from the Phase 3 SANOVO Study (ESMO 2026) - No abstract available

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

Evaluating the Impact of CYP1A2 Inhibition on the Pharmacokinetics of Savolitinib: A Phase 1 Open-Label Study. (PubMed, Pharmacol Res Perspect) - "These data suggest a significant drug-drug interaction between savolitinib and the strong CYP1A2 inhibitor, fluvoxamine, and that CYP1A2 is involved in the formation of M2, but not M3. No new safety concerns were observed when savolitinib was administered alone or with twice-daily fluvoxamine."

Journal • P1 data • PK/PD data • CYP1A2

HUTCHMED (China) Limited…announces that new and updated data from several studies of compounds discovered by HUTCHMED will be presented at the European Society for Medical Oncology ('ESMO') Congress 2026 (GlobeNewswire) - "The SANOVO China Phase III Study has been selected for a Proffered Paper oral presentation. The study evaluated the combination in previously untreated patients with locally advanced or metastatic NSCLC harboring activating EGFR mutations and MET overexpression. The trial reported positive high-level results on August 31, 2026, demonstrating a statistically significant and clinically meaningful improvement in PFS and a clinically meaningful benefit in OS versus osimertinib monotherapy."

P3 data • Non Small Cell Lung Cancer

HUTCHMED Highlights Clinical Data to be Presented at the ESMO Congress 2026 (GlobeNewswire) - "The SAFFRON Global Phase III Study has been selected for a Presidential Symposium oral presentation. The study evaluated the combination in patients with epidermal growth factor receptor (EGFR)-mutated NSCLC with MET overexpression or amplification following disease progression on osimertinib. The trial reported positive high-level results on August 17, 2026, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival ('PFS') and overall survival ('OS') compared to doublet platinum-based chemotherapy."

P3 data • Non Small Cell Lung Cancer

Osimertinib With or Without Savolitinib as 1L in De Novo METaberrant, EGFRm Advanced NSCLC: An Updated Analysis From FLOWERS (IASLC-WCLC 2026) - P2 | "Besides, these findings suggest dual inhibition of osimertinib plus savolitinib is changing the biology of acquired resistance and demonstrate preliminary proof of mechanism with potent inhibition of resistance via the EGFR and MET pathways. These results support its potential as a 1L treatment option for these patients."

Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • MET

Savolitinib in MET-amplified gastric or gastroesophageal junction adenocarcinoma: a phase 2 trial. (PubMed, Nat Med) - P2 | "Savolitinib monotherapy showed encouraging antitumor activities and a tolerable safety profile in heavily treated, later-line METamp G/GEJ cancers, supporting further investigation in randomized controlled trials. ClinicalTrials.gov identifier: NCT04923932 ."

Journal • P2 data • Gastric Adenocarcinoma • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • MET

SAVANNAH: Savolitinib (savo) + osimertinib (osi) in patients (pts) with EGFRm advanced NSCLC and METoverexpression (OverExp) and/or amplification (Amp) following progressive disease (PD) on osi (ELCC 2025) - P2, P3 | "After PD on 1L osi, savo 300 mg BID + osi was well tolerated and demonstrated clinically meaningful and durable response in pts with EGFRm advanced NSCLC with MET IHC 3+/≥90% and/or FISH10+ status. This combination offers a potential treatment option in this setting and is under further investigation in the ongoing Ph 3 SAFFRON study (NCT05261399)."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

Efficacy of Savolitinib vs Sunitinib in Patients With MET-Driven Papillary Renal Cell Carcinoma: The SAVOIR Phase 3 Randomized Clinical Trial. (PubMed, JAMA Oncol) - P3 | "Further investigation of savolitinib as a treatment option for MET-driven PRCC is warranted. ClinicalTrials.gov Identifier: NCT03091192."

Clinical • Journal • P3 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Savolitinib plus osimertinib in epidermal growth factor receptor (EGFR)-mutated advanced non-small cell lung cancer with MET overexpression and/or amplification following disease progression on osimertinib: primary results from the phase II SAVANNAH study. (PubMed, Ann Oncol) - P2 | "Savolitinib 300 mg b.i.d. plus osimertinib demonstrated high, clinically meaningful and durable responses in patients with EGFR-mutated, advanced NSCLC with MET IHC3+/≥90% and/or FISH10+ status following progression on first-line osimertinib. The combination was well tolerated and may provide a new oral targeted treatment approach in this setting."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

A phase IIIb study of savolitinib in patients with locally advanced or metastatic NSCLC harboring MET exon 14 mutation (ELCC 2024) - P2, P3 | "The most common ones (≥5%) were hepatic function abnormal (16.9%), alanine aminotransferase increased (14.5%), aspartate aminotransferase increased (12.0%), gamma-glutamyltransferase increased (6.0%), and oedema peripheral (6.0%). Table: 1MO BIRC assessed Treatment-naïve n=87 Previously treated n=79 ORR, % (95% CI) 62.1 (51.0, 72.3) 39.2 (28.4, 50.9) DCR, % (95% CI) 92.0 (84.1, 96.7) 92.4 (84.2, 97.2) mDoR, mos (95% CI) 12.5 (8.3, 15.2) 11.1 (6.6, -) mTTR, mos (95% CI) 1.4 (1.4, 1.5) 1.6 (1.4, 2.7) mPFS, mos (95% CI) 13.7 (8.5, 16.6) 11.0 (8.3, 16.6) Conclusions The data showed an encouraging efficacy and a tolerable safety profile of savolitinib in treatment for METex14-mutated NSCLC, offering a new standard treatment option for naïve and treated pts for this population."

Clinical • Metastases • P3 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • MET

SAVANNAH: Biomarker Concordance and Acquired Resistance in Patients with EGFRm MET-OverExp and / or Amp NSCLC (IASLC-WCLC 2025) - P2 | "MET ctDNA NGS had high specificity but modest sensitivity for MET FISH10+ detection, with further reduced sensitivity when IHC90+ was also considered. Acquired resistance mutation profiles to savolitinib ± osimertinib included known on-target and suspected bypass signalling resistance mechanisms."

Biomarker • Clinical • Discordant • Preclinical • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • BRAF • EGFR • ERBB3 • MET

Osimertinib with or without savolitinib as first-line treatment for MET-aberrant, EGFR-mutant NSCLC: randomized phase 2 trial (FLOWERS). (PubMed, Nat Commun) - P2 | "Treatment-related adverse events of grade 3 or higher occurred in 2 patients (8.7%) in cohort 1 and 12 patients (57.1%) in cohort 2. Osimertinib plus savolitinib showed promising antitumor activity and manageable safety."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Osimertinib With or Without Savolitinib as 1L in De Novo MET Aberrant, EGFRm Advanced NSCLC (CTONG 2008): A Phase II Trial (IASLC-WCLC 2024) - "This is the first prospective, randomized study to explore the efficacy and safety of osimertinib with or without savolitinib in treatment naïve pts with EGFRm, MET-aberrant advanced NSCLC. Combination therapy with osimertinib and savolitinib showed clinically meaningful improvement in ORR with a manageable safety profile. It has potential to provide a novel first-line treatment option for these patients."

Metastases • P2 data • Dermatology • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pruritus • Solid Tumor • Thrombocytopenia

Phase II Study Investigating the Safety and Efficacy of Savolitinib and Durvalumab in Metastatic Papillary Renal Cancer (CALYPSO). (PubMed, J Clin Oncol) - P2 | "The combination of savolitinib and durvalumab was tolerable and associated with high cRRs in the exploratory MET-driven subset."

IO biomarker • Journal • Metastases • P2 data • CNS Disorders • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Evaluation of MET Detection Methods and Cutoffs in EGFR-Mutated Non-small Cell Lung Cancer Following Disease Progression on Osimertinib in the phase II SAVANNAH study. (PubMed, Clin Cancer Res) - P2 | "Purpose In the phase II SAVANNAH study (NCT03778229), savolitinib 300 mg BID plus osimertinib demonstrated a high objective response rate (ORR; 56%) in patients with EGFR-mutated advanced non-small cell lung cancer and high levels of MET overexpression and/or amplification following first-line osimertinib (primary efficacy population). These MET cutoffs will be used to determine eligibility in the ongoing phase III SAFFRON study. Our work highlights the importance of appropriate biomarker selection in EGFR-mutated, MET‑overexpressed and/or amplified, advanced NSCLC and supports MET biomarker cutoffs as a useful approach to identify patients most likely to respond to therapy."

Journal • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • MET

Efficacy of MET-TKI in ALK-rearranged,MET-aberrant Advanced NSCLC After Resistance to ALK-TKI (IASLC-WCLC 2026) - "Five patients received crizotinib or ensartinib, while 8 patients received alectinib/lorlatinib combined with savolitinib/vebreltinib/capmatinib. Lung cancer drug-sensitive organoids could offer personalized medication guidance. Further research is needed for further exploration in the future."

Clinical • Metastases • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • ALK • MET

CALYPSO: A three-arm randomized phase II study of durvalumab alone or with savolitinib or tremelimumab in previously treated advanced clear cell renal cancer. (ASCO 2022) - P2 | "This randomised phase II study did not demonstrate significant efficacy for S alone or in combination with D in RCC. The addition of T to D did not demonstrate clearly superior efficacy to D in this setting."

Clinical • Late-breaking abstract • P2 data • Immune Modulation • Inflammation • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

First-Line Treatment of De Novo MET Amplification With High PD-L1 Expression in NSCLC: A Case Series (IASLC-WCLC 2026) - "The KUNGPENG study established the efficacy of vebreltinib in this setting—leading to its NMPA approval in China, the optimal first-line strategy for patients with concurrent MET amplification and high PD-L1 expression remains unclear...NGS revealed MET copy number gain (CN 6.17), and FISH confirmed clustered amplification.The first-line savolitinib started in July 12, 2024...The first-line chemo-immunotherapy with sintilizumab, nab-paclitaxel, and carboplatin, achieving a PR with a PFS of 8 months...best response is PR with PFS 6m.He received pemetrexed, carboplatin, and pembrolizumab for second-line therapy, achieving a durable PR till now more than 2 years .Case 4: 65-year-old male, heavy smoker...Biomarkers showed high PD-L1 (95%) and MET IHC (95%, 3+), with NGS revealing MET CN 3.8 and MET cluster amplification by FISH.He received first-line pemetrexed, carboplatin, and sintilimab for six cycles and then maintenance with pemetrexed+sintilimab achieving a PR with a..."

Clinical • IO biomarker • Cough • Interstitial Lung Disease • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Pulmonary Disease • Respiratory Diseases • Solid Tumor • MET • PD-L1

Final Overall Survival Analysis of S1500: A Randomized, Phase II Study Comparing Sunitinib With Cabozantinib, Crizotinib, and Savolitinib in Advanced Papillary Renal Cell Carcinoma. (PubMed, J Clin Oncol) - P2 | "In conclusion, we observed no significant difference in OS across treatment arms. Although cabozantinib represents a well-supported option for advanced PRCC, the lack of survival benefit underscores the need to develop novel therapies for this disease."

Journal • Metastases • P2 data • Genito-urinary Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

KIM-1 levels in papillary renal cell carcinoma from the CALYPSO trial. (ASCO-GU 2026) - P2 | " Serum KIM-1 concentrations were analyzed in patients with papillary RCC (n=32) and clear cell RCC (n=123) enrolled in a prospective randomized phase II trial evaluating durvalumab plus savolitinib (D+S) for papillary RCC. KIM-1 levels are raised in papillary RCC. They correlated with tumor biology, MET status and response to treatment. Baseline serum KIM-1 levels according to clinical characteristics in papillary and clear cell RCC."

IO biomarker • Tumor mutational burden • Clear Cell Renal Cell Carcinoma • Genito-urinary Cancer • Oncology • Papillary Renal Cell Carcinoma • Renal Cell Carcinoma • Solid Tumor • KIM1 • PD-L1

A phase 2 pivotal study of savolitinib in patients with MET-amplified gastric cancer or gastroesophageal junction adenocarcinomas. (ASCO 2026) - P2 | "Savolitinib showed clinical efficacy and a tolerable safety profile in pts with MET-amplified GC/GEJa who had received ≥2 lines of prior therapy, supporting it to be a future treatment option for this genetically defined population."

Clinical • P2 data • Gastric Cancer • Gastroesophageal Junction Adenocarcinoma • Oncology • Solid Tumor • BRAF • EGFR • FGFR2 • KRAS • MET • PIK3CA

Pathologic concordance rate and outcomes by histologic subtype in advanced papillary renal cell (pRCC) carcinoma: An analysis from the SWOG S1500 (PAPMET) trial. (ASCO 2023) - P2 | " Patients with advanced pRCC who had received up to 1 line of therapy were randomized to receive either sunitinib, or cabozantinib, crizotinib or savolitinib stratified by pRCC subtype (type 1, type 2 or not otherwise specified [NOS])... Designation of pRCC subtype by central review did not identify a subset of patients with greater clinical benefit from cabozantinib. Further, classification of subtype was challenged by discordance in both local and central review. Supporting the removal of type 1 and 2 designations from the 2022 WHO guidelines, these findings highlight the limited clinical value and significant challenges associated with subtyping of pRCC."

Discordant • Metastases • Oncology • MET

Osimertinib+Savolitinib to Overcome Acquired MET-Mediated Resistance in Epidermal Growth Factor Receptor Mutated MET-Amplified Non-Small Cell Lung Cancer: TATTON. (PubMed, Cancer Discov) - P1 | "Increased antitumor activity may occur with MET copy-number ≥10. EGFRm circulating tumor DNA clearance on treatment predicted longer PFS in patients with detectable baseline ctDNA, while acquired resistance mechanisms to osimertinib+savolitinib were mediated by MET, EGFR, or KRAS alterations."

Journal • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • KRAS • MET

Real-world safety assessment of MET-targeted therapies: a pharmacovigilance analysis using the FAERS database. (PubMed, Drugs Context) - "In cluster analysis, key adverse drug reactions (e.g. infusion-related reactions for amivantamab, hepatotoxicity for savolitinib, peripheral swelling for capmatinib and peripheral oedema for tepotinib) primarily occur as isolated events with limited co-occurrence of multiple toxicities. These findings support individualized monitoring and evidence-based treatment selection for older patients, those with comorbidities or patients at high risk with MET-altered NSCLC."

Adverse events • Journal • Real-world evidence • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Pulmonary Disease • Solid Tumor • HGF