EGFR exon 20 insertion TKI · small molecule
mobocertinib
2 active trials across 3 of our biomarkers, targeting EGFR exon 20. Not approved for any biomarker on marked.bio yet.
Also known as TAK-788, Exkivity.
Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.
Approvals and pivotal results
Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.
| Therapy | Biomarker | Tumour | United States | European Union |
|---|---|---|---|---|
mobocertinib
|
EGFR exon 20 insertion | NSCLC | Withdrawn approved 2021 | Not approved |
Biomarkers
| Biomarker | Active trials | All trials | Furthest active phase |
|---|---|---|---|
| EGFR exon 20 insertion | 2 | 4 | Phase 1/2 |
| EGFR exon 19 deletion / L858R | 1 | 3 | Phase 1/2 |
| HER2 (ERBB2) activating mutation | 1 | 2 | Phase 1/2 |
Sponsors
Industry sponsors leading active biomarker-selected trials of mobocertinib.
- Takeda 2
Trials
2 of 4 trials shown
-
A Study of TAK-788 in Adults With Non-Small Cell Lung Cancer
…one of the following documented by a local test: an activating mutation in EGFR including exon 19 deletions or exon 21 L858R substitution (with or without T790M), or an uncommon activating mutatio…
EGFR exon 19 deletion / L858REGFR exon 20 insertionHER2 (ERBB2) activating mutationCarcinoma, Non-Small-Cell Lung
-
A Study of Mobocertinib in Japanese Adults With Non-Small Cell Lung Cancer
A documented EGFR in-frame exon 20 insertion (including A763\_Y764insFQEA, V769\_D770insASV, D770\_N771insNPG, D770\_N771insSVD, H773\…
EGFR exon 20 insertionNon-Small Cell Lung Cancer
-
TAK-788 as First-Line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations
mobocertinibpemetrexedcisplatincarboplatin
…mutations for which there are approved anti-EGFR tyrosine kinase inhibitors \[TKIs\] (ie, exon 19 del, L858R, T790M, L861Q, G719X, or S768I, where X is any other amino acid)
EGFR exon 19 deletion / L858REGFR exon 20 insertionHER2 (ERBB2) activating mutationAdvanced/Metastatic Non-Small Cell Lung Cancer (NSCLC)
-
A Study to Evaluate the Impact of Management Strategies on Gastrointestinal-Related Adverse Events in Participants With Non-Small Cell Lung Cancer Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations Receiving TAK-788
mobocertinibAntidiarrheal prophylaxis
A documented epidermal growth factor receptor (EGFR) mutation with in-frame exon 20 insertion, confirmed as follows:
EGFR exon 19 deletion / L858REGFR exon 20 insertionNon-Small Cell Lung Cancer (NSCLC)
No trials match these filters.