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Also known as HMPL-504
Savolitinib · 4 trials · 4 indications
Progression-free survival (PFS) using Investigator assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1).
To evaluate the efficacy of Savolitinib in the treatment of locally advanced or metastatic NSCLC patients with MET exon 14 mutations
| Arm | Type | Description |
|---|---|---|
| Savolitinib + Osimertinib | EXPERIMENTAL | Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) |
| Pemetrexed combined with platinum | ACTIVE_COMPARATOR | Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks) |
| Savolitinib | EXPERIMENTAL | Savolitinib 600 mg or 400 mg QD orally +Osimertinib 80 mg QD orally ( every 3 weeks) |
| placebo | PLACEBO_COMPARATOR | placebo 600 mg or 400 mg QD orally+ Osimertinib 80 mg QD orally ( every 3 weeks) |
| Name | Type | Description |
|---|---|---|
| Savolitinib + Osimertinib | DRUG | Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
| Pemetrexed + Cisplatin /Carboplatin | DRUG | Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks) |
| Savolitinib | DRUG | Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent. |
| Placebo | DRUG | Subjects will receive placebo orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse |
Inclusion Criteria: 1. Fully aware this study and voluntary to sign the informed consent form, and willing and able to comply with the study procedure; 2. Age ≥ 18 and ≤75 years; 3. In accordance with the 8th Edition of TNM staging for lung cancers by International Association for the Study of Lung...
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Savolitinib is an investigational oral medicine being studied in gastric cancer and non-small cell lung cancer, including metastatic NSCLC. It is also being tested in combination with osimertinib in EGFR-mutant, MET-positive advanced NSCLC. It is not yet approved for commercial use and remains in clinical development.
Savolitinib targets MET, a receptor tyrosine kinase. As a small-molecule MET inhibitor, it blocks MET signaling, which is relevant in tumors with MET amplification or dysregulation. This targeted approach is being explored in biomarker-selected patient populations, particularly in NSCLC and gastric cancer.
Savolitinib is being developed by HUTCHMED (China) Limited, which trades under the ticker HCM. The company is the sponsor of the clinical trials evaluating savolitinib in oncology indications, including combinations with osimertinib.
Savolitinib is in Phase 2 development overall, though several trials have been conducted at Phase 3. It is investigational and has not been approved by the FDA. The program has received FDA designations including Breakthrough Therapy, Fast Track, and Priority Review for certain indications.
Savolitinib has been studied in trials including NCT05015608, NCT05009836, NCT04923945, and NCT04923932. These trials evaluated savolitinib alone or with osimertinib in non-small cell lung cancer and gastric cancer, primarily in China. One trial is active but not recruiting, while others are completed.