Modality
ERT
MOA
KRASG12Ci
Target
PARP
Pathway
PD-1/PD-L1
Melanoma
Development Pipeline
Preclinical
~Mar 2012
→ ~Jun 2013
Phase 1
~Sep 2013
→ ~Dec 2014
Phase 2
~Mar 2015
→ ~Jun 2016
Phase 3
~Sep 2016
→ ~Dec 2017
NDA/BLA
~Mar 2018
→ ~Jun 2019
Approved
Sep 2019
→ Oct 2027
ApprovedCurrent
NCT04279290
1,816 pts·Melanoma
2025-02→2027-05·Completed
NCT03285821
1,757 pts·Melanoma
2025-08→2027-10·Not yet recruiting
NCT03992713
2,324 pts·Melanoma
2019-09→TBD·Recruiting
+1 more trial
7,428 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2025-12-064mo agoPh3 Readout· Melanoma
2027-05-041.1y awayPh3 Readout· Melanoma
2027-10-031.5y awayPh3 Readout· Melanoma
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
Approved
Recruit…
Approved
Complet…
Approved
Termina…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-12-06 · 4mo ago
Melanoma
Ph3 Readout
2027-05-04 · 1.1y away
Melanoma
Ph3 Readout
2027-10-03 · 1.5y away
Melanoma
RecruitingCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04279290 | Approved | Melanoma | Completed | 1816 | Safety |
| NCT03285821 | Approved | Melanoma | Not yet recr... | 1757 | LiverFat |
| NCT03992713 | Approved | Melanoma | Recruiting | 2324 | EASI-75 |
| NCT03546795 | Approved | Melanoma | Terminated | 1531 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Miriosocimab | Pfizer | Phase 1 | PARP | |
| Lisolucimab | Novartis | Approved | CD20 | |
| Gozelemzoparlimab | Merck & Co | Phase 2 | FXIa | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Pexazasiran | Sanofi | Preclinical | FXIa | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| Semainavolisib | Gilead Sciences | Phase 2 | PARP | |
| REG-861 | Regeneron | Phase 2 | PARP | |
| ALN-6288 | Alnylam | Approved | LAG-3 |