EURACTIV Health
halama_immunoRare #cancer treated with #Immunotherapy : new data for #sarcoma subtype angiosarcoma, treated with double #checkpointinhibitors and showing clinical effects. But we still need better #biomarkers for #precisionmedicine in #immunology ... @chfloudas @cyrilpedia #rarecancers
https://jitc.bmj.com/content/9/8/e002990
Multicenter phase II trial (SWOG S1609, cohort 51) of ipilimumab and nivolumab in metastatic or unresectable angiosarcoma: a substudy of dual anti-CTLA-4 and anti-PD-1 blockade in rare tumors (DART)
Purpose Angiosarcoma is a rare aggressive endothelial cell cancer with high mortality. Isolated reports suggest immune checkpoint inhibition efficacy in angiosarcoma, but no prospective studies have been published. We report results for angiosarcoma treated with ipilimumab and nivolumab as a cohort of an ongoing rare cancer study. Methods This is a prospective, open-label, multicenter phase II clinical trial of ipilimumab (1 mg/kg intravenously every 6 weeks) plus nivolumab (240 mg intravenously every 2 weeks) for metastatic or unresectable angiosarcoma. Primary endpoint was objective response rate (ORR) per RECIST 1.1. Secondary endpoints include progression-free (PFS) and overall survival, and toxicity. A two-stage design was used. Results Overall, there were 16 evaluable patients. Median age was 68 years (range, 25–81); median number of prior lines of therapy, 2. Nine patients had cutaneous and seven non-cutaneous primary tumors. ORR was 25% (4/16). Sixty per cent of patients (3/5) with primary cutaneous scalp or face tumors attained a confirmed response. Six-month PFS was 38%. Altogether, 75% of patients experienced an adverse event (AE) (at least possibly related to drug) (25% grade 3–4 AE); 68.8%, an immune-related AE (irAE) (2 (12.5%), grade 3 or 4 irAEs (alanine aminotransferase/aspartate aminotransferase increase and diarrhea)). There were no grade 5 toxicities. One of seven patients in whom tumor mutation burden (TMB) was assessed showed a high TMB (24 mutations/mb); that patient achieved a partial response (PR). Two of three patients with PDL1 immunohistochemistry assessed had high PDL1 expression; one achieved a PR. Conclusion The combination of ipilimumab and nivolumab demonstrated an ORR of 25% in angiosarcoma, with three of five patients with cutaneous tumors of the scalp or face responding. Ipilimumab and nivolumab warrant further investigation in angiosarcoma. Trial registration number [NCT02834013][1]. Data are available on reasonable request. All data relevant to the study are included in the article or uploaded as online supplemental information. Data are currently stored at the centralized SWOG Statistics and Data Management Center, housed at the Fred Hutchinson Cancer Research Center in Seattle, Washington, USA. All relevant data for the angiosarcoma cohort of S1609 are presented in this manuscript. Full protocol and underlying data is available on request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT02834013&atom=%2Fjitc%2F9%2F8%2Fe002990.atom
MediPaCe#DidYouKnow that 72% of #RareDiseases are genetic whilst the rest are a result of infections, allergies, environmental causes or are #RareCancers?
Support #RareDiseaseDay and join the discussion to raise awareness!
Soragni:LabIf you are at #CTOS2022 tonight stop by our posters to hear all about our landscape analyses of sarcoma drug response from Dr. Tebon!
Posters 183-184, today from 5-7pm
