Modality
mAb
MOA
CDK2i
Target
BCMA
Pathway
PD-1/PD-L1
SMAFTDMM
Development Pipeline
Preclinical
~Aug 2009
→ ~Nov 2010
Phase 1
~Feb 2011
→ ~May 2012
Phase 2
~Aug 2012
→ ~Nov 2013
Phase 3
~Feb 2014
→ ~May 2015
NDA/BLA
~Aug 2015
→ ~Nov 2016
Approved
Feb 2017
→ Oct 2031
ApprovedCurrent
NCT05870906
1,541 pts·MM
2017-05→2028-12·Not yet recruiting
NCT03011209
1,272 pts·FTD
2023-03→2031-10·Terminated
NCT06591864
873 pts·FTD
2017-02→2031-10·Completed
3,686 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2028-12-022.7y awayPh3 Readout· MM
2031-10-245.6y awayPh3 Readout· FTD
2031-10-285.6y awayPh3 Readout· FTD
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Complet…
Approved
Not yet…
Approved
Termina…
Catalysts
Ph3 Readout
2028-12-02 · 2.7y away
MM
Ph3 Readout
2031-10-24 · 5.6y away
FTD
Ph3 Readout
2031-10-28 · 5.6y away
FTD
CompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05870906 | Approved | MM | Not yet recr... | 1541 | ORR |
| NCT03011209 | Approved | FTD | Terminated | 1272 | HbA1c |
| NCT06591864 | Approved | FTD | Completed | 873 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| ABB-8696 | AbbVie | Phase 3 | BCMA | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R | |
| DSN-3066 | Daiichi Sankyo | Phase 3 | IL-13 |