Drugs / Savolitinib
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-small cell lung carcinoma 2 milestones | |||||
| Filed | US (FDA) | ORPATHYS | non-small cell lung carcinoma | 2026-09-29 | “AstraZeneca has submitted a New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) for ORPATHYS® (savolitinib) plus TAGRISSO®” hutch-med.com ↗ |
| Filed | China (NMPA) | — | non-small cell lung carcinoma | 2025-05-23 | “SACHI data supports the New Drug Application (NDA) for this oral-only treatment, which has been accepted and granted priority review in China.” hutch-med.com ↗ “Submitted a China NDA[6] for savolitinib as a treatment for patients with MET[7] Exon 14 skipping alteration NSCLC[8].” hutch-med.com ↗ “Savolitinib sNDA[19] accepted by NMPA[20] for first-line and second-line METex14 NSCLC in 2024” hutch-med.com ↗ |
| Filed SMARCA4-deficient sarcoma of thorax 1 milestone | |||||
| Filed | China (NMPA) | — | SMARCA4-deficient sarcoma of thorax | 2020-05-29 | “On May 29, 2020, a new drug application (“NDA”) for savolitinib in this setting was accepted for review by the China National Medical Products Administration.” hutch-med.com ↗ “NDA for savolitinib for the treatment of non-small cell lung cancer (“NSCLC”) with MET Exon 14 skipping mutations has been accepted for review” hutch-med.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | China (NMPA) | — | MET-amplified non-small cell lung cancer | 2025-01-02 | “Savolitinib NDA accepted by the NMPA with Priority Review status” hutch-med.com ↗ |
Trials 48
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 117 trials | ||||||
| Phase 1 | NCT06348355 | Apr → Jun 2024 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05888207 | Jun → Aug 2023 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT05768360 | Apr → Jun 2023 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04675021 | Nov 2020 → Jan 2021 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04187456 | Dec 2019 → Mar 2020 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04179071 | Dec 2019 → Mar 2020 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04121910 | Nov 2019 → Jan 2020 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT04118842 | Oct 2019 → Feb 2020 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT03598244 | Nov 2018 → Apr 2025 overdue | diffuse intrinsic pontine glioma, medulloblastoma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03258515 | Sep 2017 → Mar 2018 | cancer | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT02630420 | Jan 2017 → Jan 2018 | colorectal cancer | Yale University | Withdrawn | No outcome recorded Stop: Business |
| Phase 1 | NCT02374645 | Apr 2015 → Feb 2018 | non-small cell lung carcinoma | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT02252913 | Sep 2014 → Dec 2015 | gastric cancer | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT02143466 | Aug 2014 → Mar 2020 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02017236 | Nov 2013 → Mar 2014 | — | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT01985555 | May 2013 → Apr 2019 | neoplasm | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1 | NCT01773018 | Feb 2012 → Dec 2015 | neoplasm | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT07683403 | Jun 2026 → Jun 2028 expected | colorectal cancer | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT05777278 | Jul 2023 → Aug 2027 expected | non-small cell lung carcinoma | The First Affiliated Hospital of Guangzhou Medical University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT02447406 | Apr 2015 → Jun 2020 | gastric adenocarcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Phase 222 trials · 3 met primary · 2 missed | ||||||
| Phase 2 | NCT07322783 | Jan 2025 → Dec 2026 expected | non-small cell lung carcinoma | Qingdao Central Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06692491 | Jan 2025 → Dec 2027 expected | — | Peking University Shenzhen Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06563999 | Nov 2024 → Nov 2027 expected | lung carcinoma | Sun Yat-sen University | Recruiting | No outcome recorded |
| Phase 2 | NCT05620628 | Jan 2023 → Dec 2026 expected | gastric adenocarcinoma | Jeeyun Lee | Recruiting | No outcome recorded |
| Phase 2 | NCT05374603 | Nov 2022 → Jan 2027 expected | lung cancer | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05163249 | May 2022 → Apr 2024 overdue | non-small cell lung carcinoma | Guangdong Association of Clinical Trials | Active not recruiting | Met primary |
| Phase 2 | NCT04923932 | Jul 2021 → Apr 2026 | gastric cancer, gastroesophageal junction adenocarcinoma | Hutchison Medipharma Limited | Completed | Met primary |
| Phase 2 | NCT04606771 | Sep 2020 → Dec 2022 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04322890 | Apr 2020 → Dec 2026 expected | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT04322578 | Mar 2020 → Mar 2025 | non-small cell lung carcinoma | Hunan Province Tumor Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT03833440 | Oct 2019 → Oct 2024 | non-small cell lung carcinoma | Assistance Publique Hopitaux De Marseille | Unknown | No outcome recorded |
| Phase 2 | NCT03592641 | Jul 2019 → Jul 2021 | colon adenocarcinoma, rectum adenocarcinoma | National Cancer Institute (NCI) | Terminated | Missed primary Stop: Enrollment |
| Phase 2 | NCT03944772 | Jun 2019 → May 2025 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03778229 | Jan 2019 → Aug 2024 overdue | carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03385655 | Aug 2018 → Oct 2024 overdue | prostate cancer | Canadian Cancer Trials Group | Active not recruiting | No outcome recorded |
| Phase 2 | NCT02447380 | Jul 2017 → Feb 2019 | gastric adenocarcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02897479 | Dec 2016 → Dec 2021 | lung sarcomatoid carcinoma | Hutchison Medipharma Limited | Unknown | No outcome recorded |
| Phase 2 | NCT02761057 | Jul 2016 → Oct 2023 | papillary renal cell carcinoma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 2 | NCT02819596 | May 2016 → Jul 2024 | clear cell renal carcinoma, papillary renal cell carcinoma | Queen Mary University of London | Completed | Missed primary |
| Phase 2 | NCT02449551 | Feb 2016 → Dec 2020 | gastric adenocarcinoma | Samsung Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT02127710 | Apr 2014 → Apr 2016 | papillary renal cell carcinoma | AstraZeneca | Completed | No outcome recorded |
| Phase 2 | NCT02117167 | Apr 2014 → Dec 2018 | non-small cell lung carcinoma | UNICANCER | Completed | No outcome recorded |
| Phase 36 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT05261399 | Aug 2022 → Jun 2026 overdue | non-small cell lung carcinoma | AstraZeneca | Active not recruiting | Met primary |
| Phase 3 | NCT05015608 | Nov 2021 → Aug 2025 | non-small cell lung carcinoma | Hutchison Medipharma Limited | Completed | Met primary |
| Phase 3 | NCT05043090 | Oct 2021 → Dec 2025 overdue | papillary renal cell carcinoma | AstraZeneca | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05009836 | Sep 2021 → May 2028 expected | non-small cell lung carcinoma | Hutchmed | Active not recruiting | Met primary |
| Phase 3 | NCT04923945 | Aug 2021 → Nov 2024 | non-small cell lung carcinoma | Hutchison Medipharma Limited | Completed | No outcome recorded |
| Phase 3 | NCT03091192 | Jul 2017 → Aug 2019 overdue | renal cell carcinoma | AstraZeneca | Active not recruiting | Missed primary |
News releases announcing trial results or a regulatory action · 42
| Date | Issuer | Release |
|---|---|---|
| 2026-09-29 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Submission of US NDA for ORPATHYS® plus TAGRISSO® in MET-Driven EGFR-Mutated Lung Cancer hutch-med.com ↗ |
| 2026-09-01 | Alexion Pharmaceuticals, Inc. | Results Tagrisso plus Orpathys demonstrated statistically significant and highly clinically meaningful improvement in progression-free survival in 1st-line MET-overexpressing EGFR-mutated lung cancer astrazeneca.com ↗
The PFS benefit was demonstrated in both the high MET (IHC 3+) and the intention-to-treat (ITT) trial populations (IHC 2+, IHC 3+). |
| 2026-08-31 | Hutchison Medipharma Limited | Results HUTCHMED Announces SANOVO Trial Demonstrated Significant Progression-Free Survival Benefit of ORPATHYS® Plus TAGRISSO® in Treatment-Naïve Patients with MET-Overexpressing EGFR-mutated Lung Cancer in China hutch-med.com ↗
ORPATHYS® (savolitinib) plus TAGRISSO® (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (“PFS”) versus TAGRISSO® alone in both the high MET and intention-to-treat (“ITT”) patient populations. |
| 2026-08-17 | Hutchison Medipharma Limited | Results HUTCHMED Announces ORPATHYS® Plus TAGRISSO® Demonstrated Statistically Significant and Clinically Meaningful Improvements in Progression-Free and Overall Survival in MET-Driven EGFR-Mutated Lung Cancer After Progression on TAGRISSO® hutch-med.com ↗ |
| 2026-08-17 | Alexion Pharmaceuticals, Inc. | Results Tagrisso plus Orpathys demonstrated statistically significant and clinically meaningful improvements in progression-free and overall survival in MET-driven EGFR-mutated lung cancer after progression on Tagrisso astrazeneca.com ↗ |
| 2026-07-02 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NMPA Approval for ORPATHYS® for the treatment of Gastric Cancer Patients with MET Amplification hutch-med.com ↗ |
| 2026-05-22 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Clinical Data to be Presented at the 2026 ASCO Annual Meeting hutch-med.com ↗
The study met its primary endpoint of objective response rate (“ORR”) per RECIST 1.1, as assessed by the Independent Review Committee (“IRC”). |
| 2026-01-14 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Publication of Phase III SACHI Results in The Lancet hutch-med.com ↗
The SACHI trial, now published in The Lancet, provides compelling evidence that savolitinib combined with osimertinib can transform outcomes for patients with EGFR-mutated NSCLC with MET amplification. |
| 2025-12-30 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NDA Acceptance in China with Priority Review Status for Savolitinib for the treatment of Gastric Cancer Patients with MET Amplification hutch-med.com ↗ |
| 2025-12-08 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Expanded Coverage on National Reimbursement Drug List and Inclusion in the First Commercial Insurance Drug List in China hutch-med.com ↗
ORPATHYS® (savolitinib) is included for treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with MET exon 14 skipping alteration. |
| 2025-06-30 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces China Approval for ORPATHYS® in Combination with TAGRISSO® for the Treatment of Lung Cancer Patients with MET Amplification After Progression on First-Line EGFR Inhibitor Therapy hutch-med.com ↗
This new approval by the NMPA was based on data from the SACHI Phase III trial of the ORPATHYS® and TAGRISSO® combination (NCT05015608), having met the pre-defined primary endpoint of progression-free survival (“PFS”) in a pre-planned interim analysis. |
| 2025-06-02 | Hutchison Medipharma Limited | Results HUTCHMED Highlights SACHI Phase III Study Data Presented at the 2025 ASCO Annual Meeting hutch-med.com ↗
The all-oral chemotherapy-free combination of savolitinib plus osimertinib demonstrated significant PFS benefit with a favorable safety profile in the SACHI Phase III China study |
| 2025-05-23 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Clinical Data to be Presented at the 2025 ASCO Annual Meeting hutch-med.com ↗
SACHI had met the pre-defined primary endpoint of progression-free survival (PFS) in a planned interim analysis. |
| 2025-03-25 | AstraZeneca | Results New study results reinforce Tagrisso as the backbone therapy for EGFR-mutated lung cancer across stages and settings astrazeneca.com ↗
SAVANNAH and ORCHARD Phase II trials show the addition of Orpathys or Datroway to Tagrisso upon disease progression demonstrates strong clinical activity |
| 2025-03-20 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Savolitinib SAVANNAH Phase II and Other Data at European Lung Cancer Congress 2025 hutch-med.com ↗
SAVANNAH Phase II trial demonstrated high and durable response rates with savolitinib plus TAGRISSO® in MET-high lung cancer, representing a promising chemo-free oral treatment strategy to address mechanisms of resistance in the advanced setting |
| 2025-01-14 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NMPA Full Approval for ORPATHYS® (savolitinib) in China for Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC hutch-med.com ↗
The NMPA has also converted the prior conditional approval of ORPATHYS® in the previously treated patient population to full approval. |
| 2025-01-02 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces NDA Acceptance in China with Priority Review Status for ORPATHYS® and TAGRISSO® Combination in Lung Cancer Patients with MET amplification After Progression on First-Line EGFR Inhibitor Therapy hutch-med.com ↗
has been accepted and granted priority review by the China National Medical Products Administration (“NMPA”). |
| 2024-12-12 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Breakthrough Therapy Designation in China for ORPATHYS® and TAGRISSO® Combination in Certain Lung Cancer Patients After Disease Progression on EGFR Inhibitor Therapy hutch-med.com ↗ |
| 2024-11-28 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Continued Inclusion of ORPATHYS® (savolitinib) in the National Reimbursement Drug List in China at Current Terms hutch-med.com ↗
the updated National Reimbursement Drug List (“NRDL”) effective on January 1, 2025 will continue to include ORPATHYS® (savolitinib) at the same terms as the current two-year agreement. |
| 2024-10-16 | Hutchison Medipharma Limited | Results HUTCHMED Announces that TAGRISSO® plus ORPATHYS® demonstrated high, clinically meaningful response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial hutch-med.com ↗ |
| 2024-09-10 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Clinical Data to be Presented at ESMO Congress 2024 and the 2024 World Conference of Lung Cancer hutch-med.com ↗
Patients treated with osimertinib plus savolitinib (Cohort 2, N=21) showed deeper and more durable response over osimertinib monotherapy (Cohort 1, N=23) along the study follow-up. |
| 2024-03-28 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Savolitinib sNDA Accepted in China for Treatment-Naïve or Previously Treated Patients with Locally Advanced or Metastatic MET Exon 14 NSCLC hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the supplemental New Drug Application (“sNDA”) for savolitinib, in adult patients with locally advanced or metastatic non-small cell lung cancer (“NSCLC”) with mesenchymal epithelial transition factor (“MET”) exon 14 skipping alteration, has been accepted for review by the China National Medical Products Administration (NMPA). |
| 2023-09-12 | Hutchison Medipharma Limited | Results HUTCHMED Highlights Presentation of Results from the Phase IIIb Trial of Savolitinib at the 2023 World Conference of Lung Cancer hutch-med.com ↗
At median follow-up of 11.1 months, median progression free survival (mPFS) was 13.8 months (95% CI: 9.7 months to not reached). |
| 2023-08-29 | Hutchison Medipharma Limited | Regulatory HUTCHMED Receives Breakthrough Therapy Designation in China for Savolitinib for Gastric Cancer hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that the Center for Drug Evaluation of China’s National Medical Products Administration (“NMPA”) has granted Breakthrough Therapy Designation (“BTD”) to savolitinib for the treatment of locally advanced or metastatic gastric cancer or gastroesophageal junction (“GEJ”) adenocarcinoma patients with mesenchymal epithelial transition factor (“MET”) amplification who have failed at least two lines of standard therapies. |
| 2023-01-18 | Hutchison Medipharma Limited | Regulatory HUTCHMED Announces Agreement with NHSA for Inclusion of ORPATHYS® in the National Reimbursement Drug List in China hutch-med.com ↗
ORPATHYS® (savolitinib) has been included in the updated National Reimbursement Drug List (“NRDL”) |
| 2022-08-08 | Hutchison Medipharma Limited | Results HUTCHMED and AstraZeneca Announce that TAGRISSO® Plus Savolitinib Demonstrated 49% Objective Response Rate in Lung Cancer Patients with High Levels of MET Overexpression and/or Amplification in SAVANNAH Phase II Trial hutch-med.com ↗ |
| 2022-08-08 | AstraZeneca | Results Tagrisso plus savolitinib demonstrated 49% objective response rate in lung cancer patients with high levels of MET overexpression and/or amplification in SAVANNAH Phase II trial astrazeneca.com ↗
Preliminary results from the SAVANNAH Phase II trial showed that Tagrisso (osimertinib) plus savolitinib demonstrated an objective response rate (ORR) of 49% (95% confidence interval [CI], 39-59%) in patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) with high levels of MET overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with Tagrisso. |
| 2022-08-01 | Hutchison Medipharma Limited | Results HUTCHMED Reports 2022 Interim Results and Provides Business Updates hutch-med.com ↗
First presentation of SAVANNAH data showing 52% response rate and 9.6 month duration of response in 2L+ post-TAGRISSO® NSCLC1 patients with high MET2 levels and no prior chemotherapy |
| 2022-07-13 | Hutchison Medipharma Limited | Results HUTCHMED Highlights First Presentation of Results of the SAVANNAH Global Phase II Trial of Savolitinib plus TAGRISSO® at the 2022 WCLC Annual Meeting hutch-med.com ↗
HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces the first presentation of results from the ongoing SAVANNAH global Phase II trial at the upcoming International Association for the Study of Lung Cancer (IASLC) 2022 World Conference on Lung Cancer (“WCLC”), taking place August 6-9 in Vienna, Austria. |
| 2021-06-23 | AstraZeneca | Regulatory Orpathys approved in China for patients with lung cancer and MET gene alterations astrazeneca.com ↗
AstraZeneca and HUTCHMED’s Orpathys (savolitinib) has been granted conditional approval in China to treat patients with non-small cell lung cancer (NSCLC) with MET exon 14 skipping alterations who have progressed following prior systemic therapy or are unable to receive chemotherapy. |
| 2021-06-22 | Hutchison Medipharma Limited | Regulatory HUTCHMED announces savolitinib approved in China for patients with lung cancer with MET exon 14 skipping alterations hutch-med.com ↗
savolitinib has been granted conditional approval in China for the treatment of patients with non-small cell lung cancer (“NSCLC”) with MET exon 14 skipping alterations |
| 2021-02-13 | Exelixis | Results Exelixis Highlights Positive Results for CABOMETYX® (cabozantinib) in Patients with Metastatic Papillary Renal Cell Carcinoma in SWOG S1500/PAPMET Study at ASCO GU exelixis.com ↗
Enrollment into additional arms of the study examining the use of crizotinib or savolitinib was halted early based on predefined interim futility analyses comparing these agents with the sunitinib arm. |
| 2021-01-29 | AstraZeneca | Results Tagrisso extended disease-free survival regardless of prior adjuvant chemotherapy in early-stage EGFR-mutated lung cancer astrazeneca.com ↗
The safety profile of Tagrisso plus savolitinib was consistent with previous reports. |
| 2020-07-28 | Hutchison Medipharma Limited | Regulatory Chi-Med’s NDA for Savolitinib in Non-Small Cell Lung Cancer Granted Priority Review in China hutch-med.com ↗ |
| 2020-05-29 | Hutchison Medipharma Limited | Regulatory Chi-Med Announces NDA Acceptance in China for Savolitinib in the Treatment of Non-Small Cell Lung Cancer with MET Exon 14 Skipping Mutations hutch-med.com ↗ |
| 2020-05-29 | Hutchison Medipharma Limited | Results Chi-Med to Discuss Select Global Clinical Trial Data Presented at ASCO20 hutch-med.com ↗
Savolitinib in MET exon 14 skipping NSCLC efficacy evaluable patients demonstrated 49.2% ORR, 93.4% DCR and 9.6 months DoR, including 36% patients with more aggressive disease subtype |
| 2019-10-17 | Hutchison Medipharma Limited | Results Chi-Med highlights publication of Phase II data showing promising efficacy for Savolitinib in MET-amplified gastric cancers hutch-med.com ↗
Of the 10 associated clinical trials under the VIKTORY umbrella, the highest objective response rate (“ORR”) was observed in the MET amplification savolitinib monotherapy trial, which reported an ORR of 50% (10/20, 95% CI: 28.0 – 71.9). |
| 2019-02-12 | Hutchison Medipharma Limited | Results Chi-Med Highlights Preliminary Phase II Savolitinib / Imfinzi® Combination Data in Advanced Papillary Renal Cell Carcinoma at 2019 ASCO Genitourinary Cancers Symposium hutch-med.com ↗ |
| 2017-10-17 | Hutchison Medipharma Limited | Results Chi-Med and AstraZeneca’s Savolitinib Shows Encouraging Clinical Activity in Second-Line EGFR Mutation-Positive Lung Cancer with MET-Amplification hutch-med.com ↗
In both trials, the addition of savolitinib (600mg, once daily), an investigational selective inhibitor of mesenchymal epithelial transition factor (“c-MET”) receptor tyrosine kinase, to Tagrisso® (80mg, once daily) or Iressa® (250mg, once daily) demonstrated preliminary anti-tumor activity. |
| 2017-05-18 | Hutchison Medipharma Limited | Results Chi-Med Presents Clinical Data at ASCO 2017 Annual Meeting hutch-med.com ↗
3 patients received combination Tagrisso®/savolitinib therapy; all 3 had partial response (“PR”) under RECIST (Response Evaluation Criteria in Solid Tumors) guidelines. |
| 2017-04-07 | Hutchison Medipharma Limited | Results Chi-Med Presented Pre-clinical Data for Fruquintinib and Sulfatinib at the American Association for Cancer Research Annual Meeting 2017 hutch-med.com ↗
In multiple xenograft models derived from lung cancer or renal cell cancer with c-MET activation (amplification or over-expression), addition of fruquintinib to a c-MET inhibitor savolitinib (AZD6094, HMPL-504) also improved the tumor growth inhibition substantially. |
| 2017-02-14 | Hutchison Medipharma Limited | Results Chi-Med and AstraZeneca Present Savolitinib Papillary Renal Cell Carcinoma Phase II Results at 2017 Genitourinary Cancers Symposium hutch-med.com ↗
The dataset from this Phase II study is compelling, with a very clear efficacy signal in MET-driven patients and an encouraging long duration of response, while remaining very well tolerated. |
All press releases naming this drug 62 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 51 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Savolitinib | “Phase 1 safety data of savolitinib (also known as AZD6094, HMPL-504, volitinib), a potent, selective MET TKI, plus osimertinib, a third-generation EGFR TKI, have provided...” PMID 32027846 ↗ Feb 202039“Savolitinib (AZD6094, HMPL-504, volitinib) is an oral, bioavailable, selective MET-tyrosine kinase inhibitor.” PMID 33400845 ↗ Jan 2021 “Savolitinib (volitinib, HMPL-504, AZD6094) is an oral, potent, and highly selective MET-TKI.” PMID 33052556 ↗ Oct 2020 “Savolitinib 300mg po, qd.” NCT04322578 ↗ “Drug: Savolitinib” NCT03091192 ↗ |
| Known as | AZD6094 | “Phase 1 safety data of savolitinib (also known as AZD6094, HMPL-504, volitinib), a potent, selective MET TKI, plus osimertinib, a third-generation EGFR TKI, have provided...” PMID 32027846 ↗ Feb 20206“Savolitinib (AZD6094, HMPL-504) is a highly selective MET-TKI which has demonstrated anti-tumor activity in various cancers with MET alterations.” PMID 36333268 ↗ Sep 2022 “The Sponsor is developing the test medicine, AZD6094 (Savolitinib) for the potential treatment of cancer.” NCT04675021 ↗ |
| Known as | HMPL-504 | “Phase 1 safety data of savolitinib (also known as AZD6094, HMPL-504, volitinib), a potent, selective MET TKI, plus osimertinib, a third-generation EGFR TKI, have provided...” PMID 32027846 ↗ Feb 20202“Savolitinib (AZD6094, HMPL-504, volitinib) is an oral, bioavailable, selective MET-tyrosine kinase inhibitor.” PMID 33400845 ↗ Jan 2021 “Volitinib(HMPL-504)” NCT01985555 ↗ |
| Known as | volitinib | “Phase Ib, Single-arm Study of AZD6094 (Volitinib) in Combination With Docetaxel, in Any Solid Cancer and Sequential Phase II, Single-arm Study of AZD6094 (Volitinib) in...” NCT02447406 ↗8“Phase 1 safety data of savolitinib (also known as AZD6094, HMPL-504, volitinib), a potent, selective MET TKI, plus osimertinib, a third-generation EGFR TKI, have provided...” PMID 32027846 ↗ Feb 2020 “Savolitinib (AZD6094, HMPL-504, volitinib) is an oral, bioavailable, selective MET-tyrosine kinase inhibitor.” PMID 33400845 ↗ Jan 2021 |
| Action | Inhibit | “inhibitor of c-Met kinase” NCT01773018 ↗ |
| Modality | Small molecule | “small molecule inhibitor of c-Met kinase” NCT01773018 ↗ |
| Route | Oral | “administered orally” NCT01773018 ↗ |
| Target | MET | “small molecule inhibitor of c-Met kinase” NCT01773018 ↗ |