Tazemetostat Expanded Access Program for Adults With Epitheliloid Sarcoma

2020 ◽  
Author(s):  
Keyword(s):  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

IPILIMUMAB IN PATIENTS WITH DISSEMINATED MELANOMA: THE N.N. PETROV NATIONAL MEDICAL RESEARCH CENTER OF ONCOLOGY EXPANDED ACCESS PROGRAM EXPERIENCE

2018 ◽  
Vol 64 (3) ◽  
pp. 388-393
Author(s):  
Yekaterina Anokhina ◽  
V. Rubinchik ◽  
Yekaterina Yaremenko ◽  
Gulfiya Teletaeva ◽  
Dilorom Latipova ◽  
...  
Keyword(s):  
Overall Survival ◽  
Adverse Events ◽  
Medical Research ◽  
Research Center ◽  
Expanded Access ◽  
Risk Of Death ◽  
National Medical ◽  
Expanded Access Program ◽  
Access Program

Ipilimumab (IPI) provides a ten-year overall survival in almost 20 % of selected patients participated in several phase II-III trials. However, the expanded access program (EAP) looks more like routine practice than like clinical trials& This is why the results of such application could be different. Here we present the long-term follow-up data of single center EAP. Ninety-six patients with disseminated melanoma progressing after at least one lines of drug therapy were included at the N.N. Petrov National Medical Research Center of Oncology. Sixty-seven (70 %) patients had stage IV M1c, 35 patients (36 %) had elevated LDH before initiating IPI therapy. All patients received IPI 3 mg / kg IV every 3 weeks for a maximum of 4 cycles. Totally, 320 cycles (mean - 3.3 per patient) were conducted. Grade 3-4 immuno-mediated adverse events (imAE) observed in 18 (19 %) patients. Three patients died of adverse events, possibly associated with ongoing therapy. The median time to progression was 3 (95 % CI, 2.4 to 3.5) mo., the median overall survival was 13 (95 % CI, 8.3 to17.6) mo. Previous immunotherapy with dendritic cell vaccines decreased the risk of death by 48 % (Log-rank p = 0.049). The wild type BRAF status increased three-year overall survival from 29 to 68 % (p = 0.042). Our data confirms long-term safety and efficacy of IPI in patients with pretreated disseminated melanoma in the close to real practice setting.

scholarly journals Avelumab expanded access program in metastatic Merkel cell carcinoma: efficacy and safety findings from patients in Europe and the Middle East

2021 ◽  
Author(s):  
Paolo Antonio Ascierto ◽  
Kristina Orlova ◽  
Giovanni Grignani ◽  
Monika Dudzisz‐Śledź ◽  
Eyal Fenig ◽  
...  
Keyword(s):  
Middle East ◽  
Cell Carcinoma ◽  
Merkel Cell Carcinoma ◽  
Merkel Cell ◽  
Efficacy And Safety ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

scholarly journals 407P Pembrolizumab Expanded Access Program (EAP) in Taiwan for patients with progressive advanced melanoma after prior ipilimumab treatment

2016 ◽  
Vol 27 ◽  
pp. ix127
Author(s):  
C.-K. Yang ◽  
J.-H. Liu ◽  
C.-C. Lin ◽  
T.-C. Liu ◽  
P.-T. Cheng ◽  
...  
Keyword(s):  
Advanced Melanoma ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

Efficacy and safety of infliximab treatment for refractory and fistulizing Crohn's disease in a dutch expanded access program

2000 ◽  
Vol 118 (4) ◽  
pp. A588
Author(s):  
Ruud A. van Hogezand ◽  
Maurice G. Russel ◽  
Anton Naber ◽  
Bas Oldenburg ◽  
Ad A. Bodegraven ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Infliximab Treatment ◽  
Efficacy And Safety ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

scholarly journals Pemetrexed in the treatment of malignant mesothelioma: Results from an expanded access program in Germany

2010 ◽  
Vol 104 (1) ◽  
pp. 142-148 ◽  
Author(s):  
Martin Reck ◽  
Rolf A. Stahel ◽  
Joachim von Pawel ◽  
Meinolf Karthaus ◽  
Soenke Korfee ◽  
...  
Keyword(s):  
Malignant Mesothelioma ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

scholarly journals Nivolumab in never-smokers with advanced squamous non-small cell lung cancer: Results from the Italian cohort of an expanded access program

Tumor Biology ◽  
2018 ◽  
Vol 40 (11) ◽  
pp. 101042831881504 ◽  
Author(s):  
Marina Chiara Garassino ◽  
Lucio Crinò ◽  
Annamaria Catino ◽  
Andrea Ardizzoni ◽  
Enrico Cortesi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Adverse Events ◽  
Small Cell Lung Cancer ◽  
Cell Lung Cancer ◽  
Small Cell ◽  
Small Cell Lung ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Never Smokers ◽  
Access Program

Objectives: Never-smokers may be a distinct subgroup among patients with advanced non-small cell lung cancer, appearing to benefit less from immunotherapy than smokers. We report results from never-smokers enrolled in the Italian cohort of the nivolumab expanded access program in pre-treated patients with advanced squamous non-small cell lung cancer. Materials and methods: Nivolumab (3 mg/kg every 2 weeks for ≤24 months) was available on physician request. Efficacy data included objective tumor response, date of progression, and survival information. Safety was monitored. Results: Overall, 371 patients received at least one dose of nivolumab, including 31 never-smokers (8%). Objective response rate, disease-control rate, and median overall survival were 23%, 45%, and 12.1 months (95% confidence interval: 3.7–20.4), respectively, in never-smokers, and 18%, 47%, and 7.9 months (95% confidence interval: 6.2–9.6), respectively, in the overall expanded access program population. Any-grade and grade 3–4 treatment-related adverse events were reported in 12 (39%) and 3 (10%) never-smokers, respectively, and in 109 (29%) and 21 (6%) patients, respectively, in the overall expanded access program population. Grade 3–4 treatment-related adverse events in non-smokers were increased transaminases (n = 2; 6%) and diarrhea (n = 1; 3%). Treatment-related adverse events led to treatment discontinuation in 4 non-smokers (17%) and in 26 patients (9%) overall. Conclusion: Pre-treated never-smokers with advanced squamous non-small cell lung cancer in this Italian expanded access program demonstrated efficacy and safety that were consistent with those in the overall expanded access program population and clinical trials. These results suggest that a proportion of never-smoker patients with squamous non-small cell lung cancer may be responsive to immunotherapy. Other factors, such as the tumor mutational load and the status of programmed death-ligand 1, anaplastic lymphoma kinase, and epidermal growth factor receptor, might play a potential key role.

scholarly journals Avelumab in European patients (pts) with metastatic Merkel cell carcinoma (mMCC): Experience from an ad-hoc expanded access program (EAP)

2018 ◽  
Vol 29 ◽  
pp. viii460-viii461
Author(s):  
P. Nathan ◽  
V. Kasturi ◽  
L. Dirix ◽  
E. Fenig ◽  
P.A. Ascierto ◽  
...  
Keyword(s):  
Cell Carcinoma ◽  
Merkel Cell Carcinoma ◽  
Ad Hoc ◽  
Merkel Cell ◽  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program

scholarly journals Evaluation of Children with SMA Type 1 Under Treatment with Nusinersen within the Expanded Access Program in Germany

2018 ◽  
Vol 5 (2) ◽  
pp. 135-143 ◽  
Author(s):  
Astrid Pechmann ◽  
Thorsten Langer ◽  
David Schorling ◽  
Sabine Stein ◽  
Sibylle Vogt ◽  
...  
Keyword(s):  
Expanded Access ◽  
Expanded Access Program ◽  
Access Program
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