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Introduction/Background In 2020, the TROPHIMMUN trial (NCT03135769), single agent avelumab (anti PD-L1) yielded a 53% response rate in women with gestational trophoblastic tumors (GTT) who experienced disease progression after single-agent chemotherapy (You et al, JCO 2020). Grade 1–2 treatment-related adverse events occurred in 93% of patients, most commonly (≥ 25%) fatigue (33.3%), nausea/vomiting (33.3%), and infusion-related reaction (26.7%). One patient had grade 3 uterine bleeding (treatment unrelated). One patient started a normal pregnancy one year after treatment success and delivered a healthy newborn before the trial ended. Here, we report updated recurrence-free (RFS) and overall (OS) survivals. Methodology In this phase II trial, women with resistance or relapse after single-agent chemotherapy for low-risk GTT were treated with single-agent avelumab (10mg/kg) every 2 weeks until human chorionic gonadotropin (hCG) normalization, followed by 3 consolidated cycles of avelumab. All enrolled patients were registered to the French Reference Center for Trophoblastic Diseases and their serum hCG was followed monthly during at least 3 years after treatment discontinuation. Update analysis of RFS and OS was performed, and pregnancy outcomes during follow-up were reported. Results After a median 52.6-month follow-up post-hCG normalization, all the 8 cured patients have remained relapse-free. The overall survival of the entire cohort (n=15) was 100%. Among the patients Conclusion Single-agent avelumab provided sustained a ~50% disease cure rate, as a salvage alternative to second-line single-agent chemotherapy, surgery, or multiple-agent chemotherapy for GTT patients who failed first-line single-agent chemotherapy. The fertility outcomes after anti PD-L1 treatment are reassuring, although further analyses on larger cohorts are needed. Disclosures This study was supported by Merck (CrossRef Funder ID: 10.13039/100009945) and was previously conducted under an alliance between Merck and Pfizer.
You et al. (Fri,) studied this question.