Regeneron-linked TOP2201 posts results; NeoSTOP-IT terminated, DEUTERON completed

Regeneron-linked trials saw three results or status updates this week, alongside continuing activity in the company's own MASLD and NSCLC programs.

• A Phase 2 trial of the PCSK9 inhibitor alirocumab plus the PD-1 inhibitor cemiplimab in metastatic NSCLC patients who progressed on prior anti-PD-1 therapy, sponsored by Duke University with Regeneron as collaborator, posted results on 2026-11-04. Of 60 enrolled participants, a protocol lists additional exclusion criteria¹ and the posted data show 5¹ participants with a complete or partial response and 29 of 60 with serious adverse events.
• A Phase 2 trial testing gemcitabine, cisplatin, and cemiplimab with or without fianlimab in muscle-invasive bladder cancer, sponsored by Columbia University with Regeneron as collaborator, is listed as terminated, evaluating doublet platinum-based chemotherapy plus cemiplimab with or without fianlimab for localized muscle-invasive bladder cancer², with the record citing a change in standard of care as the reason for stopping. The study enrolled only 1 participant.
• A Phase 4 pharmacokinetic study of high-dose aflibercept injected in both eyes of patients with diabetic macular edema or neovascular age-related macular degeneration, sponsored by Bayer with Regeneron as collaborator, is listed as completed. The study enrolled 51 participants³ and measured the maximum observed plasma concentration of free aflibercept for each participant during the regimen-specific semi-dense pharmacokinetic sampling period³.
• Regeneron's own Phase 3 trial of ALN-CIDEB in adults with metabolic dysfunction-associated steatotic liver disease remains listed as recruiting, with enrollment estimated at 1500 participants⁴ and primary completion estimated for 2029-03-03.
• A separate Regeneron-sponsored Phase 1/2a study of ALN-CIDEB in MASLD and MASH is listed as active, not recruiting, with 118 participants⁵ enrolled and primary completion estimated for 2027-08-17.
• A new Phase 2 pilot trial sponsored by the University of Maryland, Baltimore with Regeneron as collaborator opened for resectable Stage II, IIIA, or select IIIB NSCLC patients with high PD-L1 expression. The study is testing whether neoadjuvant single-agent cemiplimab for two cycles followed by radiographic and clinical reassessment⁶ can let some patients skip chemotherapy before surgery, with enrollment estimated at 30 participants.