Novel PD-1 inhibitor prolgolimab: expanding non-resectable/metastatic melanoma therapy choice

• DOI: 10.1016/j.ejca.2021.02.030
• Publication Date: 2021-04-19T00:53:24Z
• Authors: Sergey Tjulandin; Lev Demidov; Vladimir Moiseyenko; Svetlana Protsenko; Tatiana Semiglazova; Svetlana Odintsova; Ruslan Zukov; Sergey Lazarev; Yuliya Makarova; Marina Nechaeva; Dina Sakaeva; Aleksey Andreev; Anna Tarasova; Natalya Fadeyeva; Mariia Shustova; Ivan Kuryshev
• Keywords: Adult; Aged, 80 and over; Male; Skin Neoplasms; Time Factors; Programmed Cell Death 1 Receptor; Middle Aged; Drug Administration Schedule; Progression-Free Survival; Russia; 3. Good health; 03 medical and health sciences; 0302 clinical medicine; Disease Progression; Humans; Female; Immune Checkpoint Inhibitors; Melanoma; Aged

BackgroundProlgolimab is an IgG1 anti–PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation. We assessed efficacy and safety of two dosing regimens prolgolimab in patients with advanced melanoma a multicenter open-label parallel-arm phase II trial (MIRACULUM). present final analysis after 1 year follow-up additional results from 2 years follow-up.MethodsPatients cutaneous or non-cutaneous melanoma, including stable brain metastasis, without autoimmune disease who underwent no prior targeted therapy, anti–PD-(L)1 anti–CTLA-4 (cytotoxic T-lymphocyte-associated 4) therapy were randomly assigned (1:1) to receive regimens, mg/kg every weeks (arm 3 2), until progression intolerable toxicity. Randomisation was stratified based on performance status (Eastern Cooperative Oncology Group 0 1), lactate dehydrogenase levels (elevated normal) systemic (naive previously treated). The primary outcome objective response rate, as per immune-related Response Evaluation Criteria Solid Tumours by independent central review. hypothesis that each regimen has overall rate >28% tested independently for study arm comprising all received at least one dose prolgolimab. Exploratory assessment efficacy, subgroup analysis, not specified protocol. This registered withClinicalTrials.gov(NCT03269565).ResultsBetween August 2017 March 2018, 126 enrolled. At main 1-year data cut-off, median 13.8 14.5 months 2, respectively. An observed 38.1% 28.6% 2). Grade III–IV treatment-related adverse events occurred 12.7% 3.2% For exploratory 25.4 25.7 2-year progression-free survival 33.3% 30.2% 57.1% 46.0%, respectively.ConclusionsThe MIRACULUM met its end-point both arms. Prolgolimab showed significant antitumour activity manageable profile melanoma.