Jemperli (dostarlimab-gxly)

P4, N=100, Not yet recruiting, GlaxoSmithKline

P2, N=134, Active, not recruiting, Grupo Español de Investigación en Cáncer de Ovario | Trial primary completion date: Dec 2025 --> Jul 2028 | Trial completion date: Dec 2025 --> Jul 2028

P3, N=88, Active, not recruiting, GlaxoSmithKline | Trial completion date: Feb 2027 --> Aug 2027 | Trial primary completion date: Feb 2027 --> Jun 2026

P2, N=351, Active, not recruiting, GlaxoSmithKline | Trial completion date: Feb 2027 --> Dec 2027 | Trial primary completion date: Feb 2027 --> Nov 2026

Genetic testing confirmed sensitivity to dostarlimab-gxly and pembrolizumab, leading to the initiation of pembrolizumab (200 mg Q3W) and lenvatinib (20 mg QD) in June 2024 after spine surgery. We present a 57-year-old female patient initially diagnosed with FIGO Stage 2 EC, who subsequently developed distant metastases and was restaged as FIGO Stage 4B recurrent disease. The management of this patient illustrates the multimodal treatment approach and the critical role of molecular subtyping in guiding immunotherapeutic strategies for recurrent advanced EC.

Results from the RUBY and NRG-GY018 trials show that combining dostarlimab or pembrolizumab with platinum-based chemotherapy improves survival in patients with untreated advanced disease...Overcoming this resistance requires combination strategies, such as using anti-angiogenic agents like lenvatinib with immune checkpoint inhibitors, as shown in the KEYNOTE-775 trial...As molecular monitoring via liquid biopsy and the use of antibody-drug conjugates (ADCs) evolve, the personalization of immunotherapy continues to progress. This review examines current clinical evidence and the mechanisms of resistance to define the future of precision medicine in endometrial cancer.

P1/2, N=34, Active, not recruiting, Grupo Español de Tratamiento de Tumores de Cabeza y Cuello | Recruiting --> Active, not recruiting | Trial primary completion date: Sep 2027 --> Mar 2027

At 4 years, RUBY demonstrated sustained remission and long-term survival benefit, suggesting the potential for curative intent with dostarlimab+CP in patients with dMMR/MSI-H primary advanced or recurrent EC.

P1/2, N=1000, Recruiting, Oslo University Hospital HF | N=6000 --> 1000

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.

P1, N=845, Recruiting, GlaxoSmithKline | N=590 --> 845 | Trial completion date: May 2027 --> Jun 2029 | Trial primary completion date: Sep 2026 --> Oct 2028

P1/2, N=305, Recruiting, GlaxoSmithKline | Trial completion date: Apr 2028 --> Oct 2028 | Trial primary completion date: Dec 2027 --> Jun 2027