Modality
Bispecific Ab
MOA
HER2
Target
FGFR
Pathway
Lipid Met
Melanoma
Development Pipeline
Preclinical
~Jun 2010
→ ~Sep 2011
Phase 1
~Dec 2011
→ ~Mar 2013
Phase 2
~Jun 2013
→ ~Sep 2014
Phase 3
~Dec 2014
→ ~Mar 2016
NDA/BLA
~Jun 2016
→ ~Sep 2017
Approved
Dec 2017
→ Dec 2028
ApprovedCurrent
NCT04483308
2,889 pts·Melanoma
2017-12→2025-12·Active
NCT04316660
2,799 pts·Melanoma
2019-09→2027-07·Completed
NCT08784425
1,698 pts·Melanoma
2024-10→2028-12·Terminated
+1 more trial
7,818 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2025-12-144mo agoPh3 Readout· Melanoma
2027-07-111.3y awayPh3 Readout· Melanoma
2028-12-152.7y awayPh3 Readout· Melanoma
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
Approved
Active
Approved
Complet…
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2025-12-14 · 4mo ago
Melanoma
Ph3 Readout
2027-07-11 · 1.3y away
Melanoma
Ph3 Readout
2028-12-15 · 2.7y away
Melanoma
ActiveCompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04483308 | Approved | Melanoma | Active | 2889 | OS |
| NCT04316660 | Approved | Melanoma | Completed | 2799 | ORR |
| NCT08784425 | Approved | Melanoma | Terminated | 1698 | UPDRS |
| NCT05293699 | Approved | Melanoma | Active | 432 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| Voxaderotide | Viking Therapeutics | Approved | PD-L1 |