Interferon alfa-2b treatment following therapeutic vaccination with mRNA electroporated dendritic cells results in skin depigmentation and tumor regression in patients with advanced melanoma

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 8537-8537 ◽  
Author(s):  
B. Neyns ◽  
J. Corthals ◽  
K. Thielemans
Keyword(s):  
Dendritic Cells ◽  
Tumor Regression ◽  
Advanced Melanoma ◽  
Interferon Alfa ◽  
Therapeutic Vaccination ◽  
Skin Reactions ◽  
Local Skin ◽  
Melanoma Patients ◽  
Disease Free

8537 Background: Therapeutic vaccination with autologous dendritic cells (DC) and Interferon alfa-2b (IFNa) both have low activity in patients with advanced melanoma. Combination therapy might be advantageous because of their complementary mechanism of action. Methods: We are investigating the safety and activity of an autologous DC-based melanoma vaccine in patients with advanced melanoma in a single institution phase IB clinical trial. Following leucapheresis and enrichment in a semi-closed culture system, adherent PBMC are cultured in IL-4 and GM-CSF supplemented medium for 6 days and cryo-preserved. Upon thawing, 15.106 DC are electroporated with synthetic mRNA that encodes a fusion protein between LAMP and one of 6 melanoma associated antigens (MAGE.A-1, MAGE.A-3, MAGE.C2, MELANA/MART1, Tyrosinase and gp100). DC vaccines are administered by 6 bi-weekly ID/SC injections and every 6–8w thereafter. Results: 15 pts (10M/5F; median age 52, range 27–72) with stage IIIC-IV melanoma have been recruited. Ten pts were able to receive ≥ 6 vaccinations. Toxicity was limited to grade 1 or 2 local skin reactions at the vaccine administration sites in all pts. Two pts had a regression of subcutaneous (sc) metastases during DC vaccination and one of these pts remains disease-free after 18 mths of follow-up (following the resection of a single residual metastasis). An additional pt remains disease-free following surgery of in transit metastases at 8 months of follow-up. Three out of four pts who were treated with IFNa-2b (5 106 U 3x/week sc) at progression developed skin depigmentation (leucoderma punctata) and in 2 of these pts an objective tumor response was documented (PR and CR, including complete regression of skin, lymph, liver and skeletal metastases). Both responses are ongoing at 9 and 11 months of follow-up. Conclusions: These preliminary observations indicate a potential for IFNa-2b to mediate auto-immune breakthrough and tumor regression in advanced melanoma patients vacinated with a mRNA electroporated DC-vaccine. Further investigation of this combination immunotherapy in advanced melanoma patients is ongoing. No significant financial relationships to disclose.

A cohort pilot study on therapeutic vaccination of advanced melanoma patients with dendritic cells loaded with multiple peptides or electroporated with mRNA

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 18011-18011
Author(s):  
B. Neyns ◽  
J. Corthals ◽  
J. De Grève ◽  
C. De Greef ◽  
P. G. Coulie ◽  
...  
Keyword(s):  
Dendritic Cell ◽  
Tumor Regression ◽  
Advanced Melanoma ◽  
Therapeutic Vaccination ◽  
Antigenic Peptides ◽  
Autologous Plasma ◽  
Skin Reactions ◽  
Local Skin ◽  
Cell Factories ◽  
Melanoma Patients

18011 Background: Therapeutic vaccination of melanoma patients with tumor specific antigenic peptides has been associated with increased frequency of anti-vaccine CTL precursor frequencies in peripheral blood and objective tumor regression in a low percentage of patients. Methods: We investigated the safety and activity of two autologous dendritic cell-based vaccines in 2 sequential cohorts of advanced melanoma patients. Patients first underwent a leucapheresis. Following enrichment in a semi-closed culture system using Cell Factories (Nunc), adherent cells were cultured in RPMI 1640 medium supplemented with 1% heat-inactivated autologous plasma, 500U/ml IL-4 and 1000 U/ml GM-CSF for 6 days and cryo-preserved. Upon thawing, DC were pulsed with 8 peptides or electroporated with synthetic mRNA encoding 7 antigens. Dendritic cell vaccines were administered by intradermal and subcutaneous biweekly injections for a total of 6 times (= cycle 1). Thereafter vaccination was repeated every 6w until clinical deterioration or patient refusal. Frequencies of blood anti-vaccine CTL were estimated by in vitro restimulation in limiting dilution conditions followed by detection with tetramer assay. Results: Fifteen patients were recruited (9M/6F; median age was 49 y, range 28–81). Seven HLA-A2 patients were treated with peptide pulsed DC (cohort A) and 7 patients (4 HLA-A2 and 3 HLA-A1) with mRNA electroporated DC (cohort B). One patient was sequentially treated with both vaccines. Five patients in cohort A and 3 patients in cohort B completed the first treatment cycle of 6 bi-weekly vaccinations (cycle 1 is ongoing in 3 patients of cohort B). Toxicity was limited to grade 1 or 2 local skin reactions at the vaccine administration sites in all patients. In cohort B one patient qualified for stable disease and 2 other patients with progressive disease displayed regression of individual metastases. A >10-fold increase in CTL precursor frequency was observed in 2 out of 3 patients of cohort A that have been analyzed at present. Conclusions: Vaccination of melanoma patients with peptide pulsed or mRNA electroporated autologous DC vaccines was found to be feasible and safe. Updated results will be presented at the meeting. [Table: see text]

scholarly journals P865 Safety & efficacy of lifileucel (LN-144) tumor infiltrating lymphocyte therapy in metastatic melanoma patients after progression on multiple therapies – independent review committee data update

2020 ◽  
Vol 8 (Suppl 1) ◽  
pp. A12-A12
Author(s):  
Amod Sarnaik ◽  
Nikhil Khushalani ◽  
Jason Chesney ◽  
Harriet Kluger ◽  
Brendan Curti ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Advanced Melanoma ◽  
Review Committee ◽  
Safety And Efficacy ◽  
Mek Inhibitors ◽  
Tumor Infiltrating Lymphocyte ◽  
Heavily Pretreated ◽  
Independent Review ◽  
Melanoma Patients

BackgroundTreatment options are limited for patients with advanced melanoma who have progressed on checkpoint inhibitors and targeted therapies such as BRAF/MEK inhibitors (if BRAF-V600E mutated). Adoptive cell therapy utilizing tumor-infiltrating lymphocytes (TIL) has shown antitumor efficacy with durable responses in heavily pretreated melanoma patients. Safety and efficacy of lifileucel, a centrally manufactured cryopreserved autologous TIL therapy assessed by both investigator and an independent review committee (IRC), are presented.MethodsC-144-01 is a global Phase 2 open-label, multicenter study of the safety and efficacy of lifileucel in patients with unresectable metastatic melanoma. We report on Cohort 2 (N = 66) patients with Stage IIIC/IV unresectable melanoma who received lifileucel. Tumors resected at local institutions were processed in central GMP facilities for TIL production in a 22-day process. Final TIL infusion product was cryopreserved and shipped to sites. Patients received one week of cyclophosphamide/fludarabine preconditioning lymphodepletion, a single lifileucel infusion, followed by up to 6 doses of IL-2. All responses were assessed by RECIST 1.1.Results66 patients had the following baseline characteristics: 3.3 mean prior therapies (anti-PD1 100%; anti-CTLA-4 80%; BRAF/MEK inhibitor 23%), relatively high tumor burden (106 mm mean target lesion sum of diameters), 44% with liver and/or brain lesions, median LDH 244 U/L. Objective Response Rate (ORR) by investigator was 36.4% (2 CR, 22 PR, 1 previously confirmed PR is now changed to SD) and Disease Control Rate (DCR) of 80.3%. At a median follow up of 9.7 months, median Duration of Response (DOR) has not been reached. The adverse event profile was generally consistent with the underlying advanced disease and the profile of the lymphodepletion and IL-2 regimens.The ORR per IRC was 34.8% (2 CR, 21 PR) and DCR was 72.7%. At a median follow up of 6.9 months, the median IRC DOR has not been reached. Overall concordance rate of investigator and IRC read of response was 89.4%. The concordance compares favorably with literature reports in a metastatic disease.1ConclusionsLifileucel treatment resulted in a 36.4% ORR in heavily pretreated metastatic melanoma patients with high baseline disease burden who had received prior anti-PD1 and BRAF/MEK inhibitors, if tumor BRAF mutated. The high concordance of 89.4% between investigator and IRC confirms the original assessment of lifileucel efficacy in metastatic melanoma.2AcknowledgementsThe authors would like to thank the patients and their families for participation in the study.The authors would also like to acknowledge the support and dedication of all investigators and site team members from all participating clinical trial institutions.Trial RegistrationClinicalTrials. gov Identifier: NCT02360579Ethics ApprovalEthics Approval This trial was approved by Western Institutional Review Board - IRB Tracking Number: 20160198.ReferencesGhiorghiu DC, et al. Comparison of central and site review of RECIST data in an open randomised phase II trial in advanced melanoma. 10.1594.ecr 2009/C-075.Sarnaik A, et al. Safety and efficacy of cryopreserved autologous tumor infiltrating lymphocyte therapy (LN-144, lifileucel) in advanced metastatic melanoma patients who progressed on multiple prior therapies including anti-PD-1. J Clin Oncol 2019;37:2518–2518.

scholarly journals Successful treatment of an adult with Kasabach-Merritt syndrome using thalidomide, vincristine, and prednisone

2019 ◽  
Vol 47 (4) ◽  
pp. 1810-1814
Author(s):  
Yue-Hua Huang ◽  
Dao-Bin Zhou ◽  
Bing Han ◽  
Tian Li ◽  
Shu-Jie Wang
Keyword(s):  
Treatment Regimen ◽  
Disseminated Intravascular Coagulation ◽  
Tumor Regression ◽  
Severe Bleeding ◽  
Intravascular Coagulation ◽  
Subcutaneous Mass ◽  
Low Incidence ◽  
Disease Free ◽  
Novel Therapeutic

Objective Kasabach-Merritt syndrome is a rare disease that mainly occurs in infants and adolescents. It usually manifests as disseminated intravascular coagulation and severe bleeding, and is associated with high mortality. However, its low incidence and clinical rarity in adults mean that there is currently no well-verified treatment regimen for this disease. We report on an effective novel therapeutic regimen in a patient with Kasabach-Merritt syndrome. Methods A woman with Kasabach-Merritt syndrome presented with a recurrent subcutaneous mass and disseminated intravascular coagulation, and was treated with prednisone, vincristine and thalidomide. Results This treatment regimen successfully resolved the patient’s symptoms, with tumor regression. The patient remained disease-free after 6 years of follow-up. Conclusions Prednisone combined with vincristine and thalidomide may be an effective treatment for Kasabach-Merritt syndrome, but further studies are needed to verify the use of this regimen.

Single-Step Antigen Loading and Activation of Dendritic Cells by mRNA Electroporation for the Purpose of Therapeutic Vaccination in Melanoma Patients

2009 ◽  
Vol 15 (10) ◽  
pp. 3366-3375 ◽  
Author(s):  
Aude Bonehill ◽  
An M.T. Van Nuffel ◽  
Jurgen Corthals ◽  
Sandra Tuyaerts ◽  
Carlo Heirman ◽  
...  
Keyword(s):  
Dendritic Cells ◽  
Single Step ◽  
Therapeutic Vaccination ◽  
Melanoma Patients ◽  
Mrna Electroporation

Phase I/II trial of a PrimeBoost therapeutic vaccine in stage III/IV metastatic melanoma

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8030-8030 ◽  
Author(s):  
R. E. Hawkins ◽  
A. Dangoor ◽  
U. Keilholz ◽  
D. Schadendorf ◽  
A. Harris ◽  
...  
Keyword(s):  
Immune Responses ◽  
Metastatic Melanoma ◽  
Elispot Assay ◽  
Viral Vector ◽  
Stage Iii ◽  
High Dose ◽  
Skin Reactions ◽  
Local Skin ◽  
Tumour Control ◽  
Melanoma Patients

8030 Background: This trialevaluated the safety, immunogenicity and tumour response of increasing doses of DNA plasmid (DNA.Mel3) and MVA viral vector (MVA.Mel3), containing 7 melanoma epitopes. Methods: 41 HLA-A2 positive stage III/IV melanoma patients with unresectable measurable disease were enrolled. Immunisations were administered three weeks apart with continued MVA.Mel3 boosting in patients with tumour control. Epitope-specific CD8+ T cell responses were evaluated using ex vivo tetramer staining and interferon gamma (IFN-γ) ELISPOT assay. Results: DNA.Mel3 was well tolerated at all doses. Dose-related grade 3 local skin reactions and systemic immune-associated reactions were observed following MVA.Mel3, no reactions led to early study discontinuation. Melan-A tetramer responses were observed in 23/36 (64%) evaluable patients, of which 9/36 showed an IFNγ response to at least one epitope in ELISPOT assay. Seven patients (17%) showed tumour control (PR, MR, or SD >6 months), of which 3/7 patients had associated immune responses, including one with PR > 21 months who underwent extended MVA.Mel3 boosting. Overall median progression free survival was 9 weeks (16 weeks for immune responders). Median overall survival for the intention-to-treat population is 11.7 months with follow up of 16 patients continuing. Conclusions: High dose heterologous PrimeBoost immunisation was safe and stimulated immune responses in >50% of late stage metastatic melanoma patients treated. Tumour control was observed with some evidence of association with immune response. [Table: see text] [Table: see text]

Patient Preferences for Adjuvant Interferon Alfa-2b Treatment

2001 ◽  
Vol 19 (3) ◽  
pp. 812-823 ◽  
Author(s):  
Kerry L. Kilbridge ◽  
Jane C. Weeks ◽  
Arthur J. Sober ◽  
Frank G. Haluska ◽  
Craig L. Slingluff ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Disease Free Survival ◽  
Interferon Alfa ◽  
Health States ◽  
Free Survival ◽  
Risk Melanoma ◽  
Melanoma Patients ◽  
Disease Free ◽  
Adjuvant Interferon

PURPOSE: Although trials of adjuvant interferon alfa-2b (IFNα-2b) in high-risk melanoma patients suggest improvement in disease-free survival, it is unclear whether treatment offers improvement in overall survival. Widespread use of adjuvant IFNα-2b has been tempered by its significant toxicity. To quantify the trade-offs between IFNα-2b toxicity and survival, we assessed patient utilities for health states associated with IFN therapy. Utilities are measures of preference for a particular health state on a scale of 0 (death) to 1 (perfect health).PATIENTS AND METHODS: We assessed utilities for health states associated with adjuvant IFN among 107 low-risk melanoma patients using the standard gamble technique. Health states described four IFNα-2b toxicity scenarios and the following three posttreatment outcomes: disease-free health and melanoma recurrence (with or without IFNα-2b) leading to cancer death. We also asked patients the improvement in 5-year disease-free survival they would require to tolerate IFN.RESULTS: Utilities for melanoma recurrence with or without IFNα-2b were significantly lower than utilities for all IFNα-2b toxicities but were not significantly different from each other. At least half of the patients were willing to tolerate mild-moderate and severe IFNα-2b toxicity for 4% and 10% improvements, respectively, in 5-year disease-free survival.CONCLUSION: On average, patients rate quality of life with melanoma recurrence much lower than even severe IFNα-2b toxicity. These results suggest that recurrence-free survival is highly valued by patients. The utilities measured in our study can be applied directly to quality-of-life determinations in clinical trials of adjuvant IFNα-2b to measure the net benefit of therapy.

Imiquimod, a Patient-Applied Immune-Response Modifier for Treatment of External Genital Warts

1998 ◽  
Vol 42 (4) ◽  
pp. 789-794 ◽  
Author(s):  
Karl R. Beutner ◽  
Stephen K. Tyring ◽  
Kenneth F. Trofatter ◽  
John M. Douglas ◽  
Spotswood Spruance ◽  
...  
Keyword(s):  
Immune Response ◽  
Genital Warts ◽  
Response Modifier ◽  
Imiquimod Cream ◽  
Antitumor Effects ◽  
Skin Reactions ◽  
Local Skin ◽  
External Genital Warts ◽  
Immune Response Modifier

ABSTRACT Genital human papillomavirus infection is one of the most common sexually transmitted diseases. Imiquimod is a new agent, an immune-response modifier, that has been demonstrated to have potent in vivo antiviral and antitumor effects in animal models. The present prospective, multicenter, double-blind, randomized, vehicle-controlled trial evaluated the efficacy and safety of daily patient-applied imiquimod for up to 16 weeks for the treatment of external genital warts. Wart recurrence was investigated during a 12-week treatment-free follow-up period. In the intent-to-treat analysis, baseline warts cleared from 49 of 94 (52%) patients treated with 5% imiquimod cream, 13 of 90 (14%) patients treated with 1% imiquimod cream, and 3 of 95 (4%) vehicle-treated patients; the differences between the groups treated with vehicle and imiquimod were significant (P< 0.0001). For subjects who completed the follow-up period, recurrence rates after a complete response were 19% (9 of 48 patients) in the 5% imiquimod cream group, 17% (2 of 12) in the 1% imiquimod cream group, and 0% (0 of 3) in the vehicle-treated group. There were no systemic reactions, although local skin reactions (generally of mild or moderate severity) were common, particularly in the 5% imiquimod cream group. Local reactions caused two patients to discontinue treatment. The most frequently reported local skin reactions were erythema, excoriation or flaking, and erosion. Patient-applied 5% imiquimod cream is effective for the treatment of external genital warts and has a favorable safety profile.

Long-term follow up of lifileucel (LN-144) cryopreserved autologous tumor infiltrating lymphocyte therapy in patients with advanced melanoma progressed on multiple prior therapies.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 10006-10006 ◽  
Author(s):  
Amod Sarnaik ◽  
Nikhil I. Khushalani ◽  
Jason Alan Chesney ◽  
Karl D. Lewis ◽  
Theresa Michelle Medina ◽  
...  
Keyword(s):  
Metastatic Melanoma ◽  
Checkpoint Inhibitors ◽  
Adoptive Cell Therapy ◽  
Advanced Melanoma ◽  
Autologous Tumor ◽  
Mek Inhibitors ◽  
High Baseline ◽  
Heavily Pretreated ◽  
Melanoma Patients

10006 Background: Treatment options are limited for patients with advanced melanoma who have progressed on checkpoint inhibitors and targeted therapies. Adoptive cell therapy using tumor-infiltrating lymphocytes (TIL) leverages and enhances the body’s natural defense against cancer and has shown durable responses in heavily pretreated melanoma patients. Methods: C-144-01 is a global Phase 2 open-label, multicenter study of efficacy & safety of lifileucel in patients with unresectable metastatic melanoma who have progressed on checkpoint inhibitors and BRAF/MEK inhibitors, if BRAFv600 mutant. We report on Cohort 2 (N = 66) patients who have received TIL. Tumors were resected at local institutions, processed in central GMP facilities for TIL production, manufactured, cryopreserved & shipped back to sites in a 22-day process. Therapy consisted of one week of lymphodepletion, a single lifileucel infusion, and up to 6 IL-2 doses. ORR was based on RECIST v1.1 by investigator assessment. Data cutoff was Feb 2, 2020. Results: Baseline characteristics: 3.3 mean prior therapies (anti-PD1 100%; anti-CTLA-4 80%; BRAF/MEK inhibitor 23%), high baseline tumor burden (106 mm mean target lesion sum of diameters), 44% liver/brain lesions, 40.9% LDH > ULN. ORR by investigator was 36.4% (2 CR, 22 PR) and DCR was 80.3%. Mean time to response was 1.9 months (range: 1.3-5.6). After a median study follow-up of 17.0 months, median DOR (mDOR) was still not reached. Six responders have progressed, 2 have died and 2 started other anti-cancer therapy without progression. The adverse event profile was consistent with the underlying advanced disease and the lymphodepletion and IL-2 regimens. Additional follow-up data will be available for presentation. Conclusions: Lifileucel treatment results in a 36.4% ORR and mDOR was not reached at 17.0 months of median study follow up in a heavily pretreated metastatic melanoma patients with high baseline disease burden who progressed on multiple prior therapies, including anti-PD1 and BRAF/MEK inhibitors, if BRAFv600 mutant. Clinical trial information: NCT02360579.

Four-year survival follow-up of toripalimab (JS001) as salvage therapy in Chinese melanoma patients.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e21522-e21522
Author(s):  
Bixia Tang ◽  
Zhihong Chi ◽  
Yingbo Chen ◽  
Xiufeng Liu ◽  
Di Wu ◽  
...  
Keyword(s):  
Salvage Therapy ◽  
Advanced Melanoma ◽  
Extension Study ◽  
Unknown Primary ◽  
Term Survival ◽  
Long Term Survival ◽  
Systemic Treatments ◽  
Melanoma Patients

e21522 Background: Toripalimab, a PD-1 monoclonal antibody received conditionally approval in China as a salvage therapy for metastatic melanoma in 2018 based on a phase II trial with confirmed objective response rate of 17.3%. With four-year survival follow-up, here we report long-term survival results and related predictive biomarkers (NCT03013101). Methods: Patients with advanced melanoma who had failed prior systemic treatments were given toripalimab at 3 mg/kg i.v. Q2W until disease progression, intolerable toxicity or 2-year of treatment. Pts were followed for survival every 3 mo after discontinuation of treatment. Pts were transferred to an extension study after 2-year treatment. The Primary endpoint for the extension study was overall survival (OS). Results: 127 pts were enrolled, including50 (39.4%) acral, 22 (17.3%) mucosal, 29 (22.9%) nonacral cutaneous, and 26 (20.5%) unknown primary subtypes. After a median follow-up of 16.5 mo (range, 0.9-48.8), 74 (58%) pts had died. Median duration of response was 25.6 mo (95%CI:12.8-NE). Median OS was 22.0 mo (95%CI: 15.3-32.5). The OS rates for year 1 to 4 were 67.1%, 48.2%, 38.0% and 31.7% respectively. The median OS of complete response (CR)/ partial response (PR) (n = 22), stable disease (SD) (n = 51), progression disease (PD) (n = 54) were not reached, 34.0 mo and 9.7 mo, respectively. The median OS of non-acral cutaneous, unknown primary, acral and mucosal melanoma subtypes were 46.1, 37.3, 16.9 and 10.3 mo, respectively. The median OS of PD-L1+ (n = 26) and PD-L1- (n = 84) patients were 46.1 and 14.4 mo (P = 0.026, HR = 0.45, 95%CI 0.26-0.76). The median OS of TMB high (n = 20), TMB low (n = 78) was 16.0 and 22.3 mo with no statistically significance (P = 0.49, HR = 1.28, 95%CI 0.63-2.58). Conclusions: Salvage treatment with toripalimab leads to long-term survival benefit in advanced melanoma patients, especially for those with non-acral cutaneous and unknown primary subtypes, CR/PR/SD as best response or PD-L1+.

scholarly journals Audencel Immunotherapy Based on Dendritic Cells Has No Effect on Overall and Progression-Free Survival in Newly Diagnosed Glioblastoma: A Phase II Randomized Trial

Cancers ◽  
2018 ◽  
Vol 10 (10) ◽  
pp. 372 ◽  
Author(s):  
Johanna Buchroithner ◽  
Friedrich Erhart ◽  
Josef Pichler ◽  
Georg Widhalm ◽  
Matthias Preusser ◽  
...  
Keyword(s):  
Overall Survival ◽  
Dendritic Cells ◽  
Phase Ii ◽  
Progression Free Survival ◽  
Severe Toxicity ◽  
Newly Diagnosed ◽  
Skin Reactions ◽  
Local Skin ◽  
Free Survival ◽  
Newly Diagnosed Glioblastoma

Dendritic cells (DCs) are antigen-presenting cells that are capable of priming anti-tumor immune responses, thus serving as attractive tools to generate tumor vaccines. In this multicentric randomized open-label phase II study, we investigated the efficacy of vaccination with tumor lysate-charged autologous DCs (Audencel) in newly diagnosed glioblastoma multiforme (GBM). Patients aged 18 to 70 years with histologically proven primary GBM and resection of at least 70% were randomized 1:1 to standard of care (SOC) or SOC plus vaccination (weekly intranodal application in weeks seven to 10, followed by monthly intervals). The primary endpoint was progression-free survival at 12 months. Secondary endpoints were overall survival, safety, and toxicity. Seventy-six adult patients were analyzed in this study. Vaccinations were given for seven (3–20) months on average. No severe toxicity was attributable to vaccination. Seven patients showed flu-like symptoms, and six patients developed local skin reactions. Progression-free survival at 12 months did not differ significantly between the control and vaccine groups (28.4% versus 24.5%, p = 0.9975). Median overall survival was similar with 18.3 months (vaccine: 564 days, 95% CI: 436–671 versus control: 568 days, 95% CI: 349–680; p = 0.89, harzard ratio (HR) 0.99). Hence, in this trial, the clinical outcomes of patients with primary GBM could not be improved by the addition of Audencel to SOC.

Sign in / Sign up

Export Citation Format

Share Document