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588 TROPHIMMUN, cohort a: maintained benefit from second-line avelumab after failure to monochemotherapy in low-risk gestational trophoblastic tumor, with a 4 year-follow-up
  1. Benoit You1,
  2. Adrien Msika2,
  3. Jean Pierre Lotz3,
  4. Laurence Gladieff4,
  5. Coriolan Lebreton5,
  6. Touria Hajri6,
  7. Pierre Descargues6,
  8. Jérôme Massardier6,
  9. Carole Langlois Jacques7,
  10. Sylvie Bin7,
  11. Laurent Villeneuve8,
  12. Adeline Roux7,
  13. Marine Alves Ferreira7,
  14. Pascal Rousset1,
  15. Gilles Freyer9,
  16. François Golfier1 and
  17. Pierre-Adrien Bolze1
  1. 1Université Lyon 1 – Hospices Civils de Lyon – Centre Français de Référence des Maladies Trophoblastiques – CICLY EA3738, Lyon, France
  2. 2Université Lyon 1 – Hospices Civils de Lyon – Centre Français de Référence des Maladies Trophoblastiques, Lyon, France
  3. 3Sorbonne Université – APHP – Centre Français de Référence des Maladies Trophoblastiques, Paris, France
  4. 4IUCT – oncopole, Toulouse, France
  5. 5Institut Bergonié, Bordeaux, France
  6. 6Hospices Civils de Lyon – Centre Français de Référence des Maladies Trophoblastiques, Lyon, France
  7. 7Hospices Civils de Lyon, Lyon, France
  8. 8Hospices Civils de Lyon – CICLY EA3738, Lyon, France
  9. 9Université Lyon 1 – Hospices Civils de Lyon, Lyon, France


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 < 45 years old (n=9) and after exclusion of those who underwent hysterectomy before having completed their childbearing wish (n=2), 4 out of 7 patients initiated a pregnancy, and 3 of them gave birth to 4 healthy newborns (1 patient delivered twice).

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.

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