Libtayo (cemiplimab-rwlc)

P1/2, N=30, Not yet recruiting, Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

P2, N=39, Recruiting, University of Chicago | Not yet recruiting --> Recruiting

P1, N=60, Not yet recruiting, Memorial Sloan Kettering Cancer Center

With 5-year follow-up, cemiplimab plus chemotherapy continues to show durable long-term efficacy benefits versus chemotherapy with consistent safety profile, as first-line therapy for advanced NSCLC.

P1, N=30, Not yet recruiting, National Cancer Institute (NCI) | Initiation date: Jun 2026 --> Dec 2026

P2, N=70, Suspended, Thomas Jefferson University | Recruiting --> Suspended

Our findings support previous reports on the immune-privileged status of BCC. Contrary to the literature, we could not confirm PD-L1 expression on BCC cells, but rather on the intra- and peritumoral immune cells. Given these results and the literature suggesting a tendency of higher immunoreactivity compared to other BCC subtypes, basosquamous BCC might be a better target for anti-PD-1 therapy as opposed to other subtypes.

The ERAP1 inhibitor GRWD5769 combined with cemiplimab, a PD-1 inhibitor, has shown preliminary promise in overcoming resistance to PD-(L)1 blockade by targeting antigen processing. Another resistance-mitigating strategy is potentially IOS-1002, an antagonist of two immunosuppressive receptors, LILRB1/2 and KIR3DL1, combined with anti-PD-1 pembrolizumab. As well, an update on the recently published DART (NCI/SWOG S1609) study indicates that the classic combination of ipilimumab with nivolumab may benefit even more rare cancers, including gestational trophoblastic neoplasia.

P2, N=99, Not yet recruiting, Washington University School of Medicine

P1, N=105, Completed, Regeneron Pharmaceuticals | Active, not recruiting --> Completed

P2, N=35, Active, not recruiting, University of Southern California | Trial completion date: Jun 2027 --> Dec 2027 | Trial primary completion date: Nov 2025 --> Dec 2026

n this retrospective, non-randomized cohort, definitive-intent cemiplimab monotherapy was associated with durable disease control in selected patients with locally advanced resectable head and neck CSCC. This study provides a promising real-world organ preservation experience for patients with advanced head and neck CSCC treated with cemiplimab monotherapy that does not compromise oncologic outcomes.