Libtayo (cemiplimab-rwlc)

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.

P1/2, N=61, Active, not recruiting, EMD Serono Research & Development Institute, Inc. | Trial completion date: Mar 2026 --> Sep 2026 | Trial primary completion date: Mar 2026 --> Sep 2026

P1, N=36, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Active, not recruiting --> Recruiting

P1/2, N=175, Recruiting, Grey Wolf Therapeutics Limited | N=130 --> 175

The largest adequately powered signals were observed for pembrolizumab (ROR 18.34, n = 258), nivolumab (ROR 18.65, n = 256), atezolizumab (ROR 22.22, n = 132), and ipilimumab (ROR 15.11, n = 73); cemiplimab (ROR 46.89), relatlimab (ROR 44.68), and dostarlimab (ROR 33.48) produced high-magnitude estimates with smaller case counts. The DM phenotype is more consistently disproportionate than PM across classes, with mechanistic plausibility given PD-L1's role in restraining interferon-producing plasmacytoid dendritic cells. The immune-mediated myositis MedDRA term captures the most statistically robust signal, reflecting a distinct ICI-associated coding pattern in spontaneous reporting.

Pegenzileukin in combination with cemiplimab at the RP2D of 16 µg/kg showed a manageable safety profile and promising translational data supporting its mechanism of action.

P2, N=39, Not yet recruiting, University of Chicago