Abstract 553P
Background
Dostarlimab is an anti-PD-1 antibody approved by the EMA in April 2021 as monotherapy for patients (pts) with dMMR/MSI-H A/R endometrial cancer (EC) that have progressed on/after platinum-based therapy, based on the results of the GARNET trial1 (NCT02715284). The French Health Authorities granted early access for dostarlimab in this setting in Oct 2020.
Methods
We report pt characteristics and safety of dostarlimab for dMMR/MSI-H A/R EC pts enrolled in the early access dostarlimab ATU program in France from Nov 3, 2020 to Jun 30, 2021. Physicians could complete follow-up forms at each cycle to report clinical follow-up information, safety, and efficacy; safety was also captured through pharmacovigilance reports.
Results
95 ATU requests were made by 80 oncologists in 59 French hospitals; 87 pts were eligible and 80 received ≥1 dose of dostarlimab. Follow-up forms (≥1) were completed for 62.5% (n=50) of pts. Mean age at time of ATU request was 69.1 years (SD: 10.4) and mean weight was 72.5 kg (SD: 17.8); 73% (n=58) and 28% (n=22) of pts had ECOG performance status of 1 and 0, respectively. Overall, 81% (n=65) of pts had endometrioid histology, 8% (n=6) papillary serous, 4% (n=3) clear cell, and 8% (n=6) other; 9% (n=7) had a Lynch syndrome diagnosis. Most pts (87%; n=20/23) were FIGO Stage IV at relapse and 13% (n=3/23) were Stage III; 86% (n=69) had metastases. Previous treatment (tx) included surgery (73%; n=58), radiotherapy (54%; n=43), brachytherapy (41%; n=32), and chemotherapy (chemo; 100%): neoadjuvant chemo (15%; n=12), adjuvant chemo (35%; n=28), chemo-radiotherapy (5%; n=4), and chemo for metastatic disease (43%; n=34). Median tx duration for pts who started tx on the ATU was 16.1 weeks. No new safety signal was reported. Efficacy data to be presented.
Conclusions
The enrollment of 80 pts in 8 months highlights the need for access to novel tx regimens for post-platinum pts with A/R dMMR/MSI-H EC in France. Funding: GSK. Editorial support provided by Fishawack Health, funded by GSK. 1. Oaknin A, et al. JAMA Oncol 2020;6(11):1766–72.
Clinical trial identification
Editorial acknowledgement
Editorial support provided by Fishawack Health.
Legal entity responsible for the study
GlaxoSmithKline.
Funding
GlaxoSmithKline.
Disclosure
M.J. Rodrigues: Financial Interests, Personal, Other, Experts board & lectures: AstraZeneca, Merck, GSK; Financial Interests, Personal, Other, Lectures: Immunocore; Financial Interests, Institutional, Research Grant: Bristol-Myers Squibb, Merck. P. Follana: Financial Interests, Personal, Advisory Role: AstraZeneca; Financial Interests, Personal, Expert Testimony: Clovis, Novartis; Financial Interests, Personal, Invited Speaker: Eisai, GlaxoSmithKline, MSD; Financial Interests, Personal, Other, Congress invitation: Gilead. V. Brunel: Financial Interests, Personal, Other, Experts board: Novartis. L. Gauthier: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. V.J. Jacquemin: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline. C. Tessier: Financial Interests, Personal, Full or part-time Employment: GlaxoSmithKline; Financial Interests, Personal, Stocks/Shares: GlaxoSmithKline. N. El Mouaddin: Financial Interests, Personal, Full or part-time Employment: GSK France. F. Fiteni: Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis, GSK, Lilly, Novartis, Pfizer. E. Angeli: Non-Financial Interests, Personal, Other, Reviewer: APHP- Avicenne Hospital. N. Delanoy: Financial Interests, Personal, Other, Advisory board, hospitality: GSK; Financial Interests, Personal, Advisory Board: AstraZeneca, Clovis Oncology; Financial Interests, Personal, Other, Conference: MSD. R. Sabatier: Financial Interests, Personal, Other, Consulting: GSK; Financial Interests, Personal, Other, Lectures: GSK, Novartis; Non-Financial Interests, Personal, Other: GSK, BMS, AstraZeneca; Financial Interests, Institutional, Research Grant: AstraZeneca; Financial Interests, Personal, Invited Speaker, Lectures: Clovis. R. Flippot: Financial Interests, Personal, Other, Honoraria/consulting: IPSEN, Bayer, MSD, Janssen. T. De La Motte Rouge: Financial Interests, Personal, Advisory Board: Pfizer, AstraZeneca, GSK, Clovis Oncology, Roche, MSD, MYLAN, TESARO; Financial Interests, Institutional, Research Grant: Novartis, Pfizer, MSD, Seagen; Financial Interests, Institutional, Principal Investigator: Roche, AstraZeneca, GSK, MSD, Pfizer, Netris Pharma; Non-Financial Interests, Personal, Advisory Role: French National Cancer Institute, Unicancer; Non-Financial Interests, Personal, Principal Investigator: ARCAGY. All other authors have declared no conflicts of interest.