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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 small molecule being studied for the treatment of non-small cell lung cancer (NSCLC), including metastatic NSCLC, and gastric cancer. It is also being evaluated in patients with esophagogastric junction adenocarcinoma. The drug is in clinical development and has not been approved by the FDA.
Savolitinib is a kinase inhibitor, belonging to the -tinib class of drugs. It targets specific kinases involved in cancer growth. In clinical trials, it is being studied in biomarker-selected patients, including those with MET amplification or MET alterations, particularly in combination with osimertinib for EGFR-mutant NSCLC.
Savolitinib is being developed by HUTCHMED (China) Limited, a biopharmaceutical company listed on the stock exchange under the ticker HCM. The company is conducting clinical trials of Savolitinib in China for multiple oncology indications.
Savolitinib is in Phase 2 and Phase 3 clinical trials. It has received FDA designations including Breakthrough Therapy, Fast Track, and Priority Review, indicating its potential importance in treating serious conditions. However, it remains investigational and is not yet approved for any indication.
Savolitinib is being studied in several clinical trials. NCT04923932 is a completed Phase 2 trial in gastric cancer and esophagogastric junction adenocarcinoma. NCT04923945 is a completed Phase 3 trial in metastatic NSCLC. NCT05009836 is an active Phase 3 trial combining Savolitinib with osimertinib in EGFRm+/MET+ NSCLC, and NCT05015608 is a completed Phase 3 trial in NSCLC with MET amplification.
Savolitinib is a distinct investigational drug and is not the same as other approved kinase inhibitors. It is being studied alone and in combination with osimertinib, which is a separate EGFR inhibitor. Savolitinib's unique target profile and development program differentiate it from other therapies.