Asset profile
Monalizumab
Monoclonal antibody
Evidence outlook · registrational
Non-Small Cell Lung Cancer: registrational readout pending
Entered Phase 3 on partial signal mid-stage evidence. The registry's posted readout date (2026-09-30) has passed without a status update. Check News for topline announcements.
COAST (NCT03822351): Participants were randomized among three treatment arms, including 62 receiving durvalumab plus monalizumab and 67 receiving durvalumab alone, but the study was open-label rather than blinded. The primary clinical endpoint, RECIST 1.1 objective response at 16 weeks, was 40.3% with monalizumab plus durvalumab versus 23.9% with durvalumab alone; because statistical significance for this comparison was not reported, the result is considered unclear.
Also in development:Head and Neck Squamous Cell Carcinoma
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Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
66 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 65 same-indication; 58 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Monalizumab: this drug | Phase 3 | Monoclonal antibody | NKG2A | ||
| BMS-986315 | Phase 2 | Monoclonal antibody | NKG2A | ||
| Afatinib (Gilotrif) | Approved | Small molecule | EGFR/HER1, HER2, HER4 | ||
| Alectinib (Alecensa) | Approved | Small molecule | ALK | ||
| Alymsys (bevacizumab-Maly) | Approved | Monoclonal antibody | VEGF-A | ||
| Amivantamab | Approved | Multispecific antibody | EGFR x c-MET | ||
| Atezolizumab | Approved | Monoclonal antibody | PD-L1 | ||
| BAT1706 (Avzivi) | Approved | Monoclonal antibody | VEGF-A | ||
| BAY2927088 (Hyrnuo) | Approved | Small molecule | HER2 (ERBB2) exon 20 insertions and point mutations; also mutant-selective EGFR | ||
| Bevacizumab | Approved | Monoclonal antibody | VEGF-A, Vascular Endothelial Growth Factor Inhibitor | ||
| Bevacizumab-Awwb (MVASI) | Approved | Monoclonal antibody | VEGF-A | ||
| Binimetinib | Approved | Small molecule | MEK1/2 | ||
| Brigatinib | Approved | Small molecule | ALK | ||
| Capmatinib | Approved | Small molecule | MET | ||
| Cemiplimab | Approved | Monoclonal antibody | PD-1 | ||
| Ceritinib | Approved | Small molecule | ALK |
…and 51 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Compare head-to-head
Upcoming events
(5 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2027 (1)
December 2027 (1)
What to watch
2028 (2)
April 2028 (1)
What to watch
December 2028 (1)
What to watch
2029 (1)
October 2029 (1)
What to watch
2030 (1)
May 2030 (1)
What to watch
All registered studies
Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.