scholarly journals OR25-07 A Multi-Center, Open-Label, Pivotal Phase 2 Study of Azedra® (HSA I-131-MIBG) in Patients with Unresectable, Locally Advanced or Metastatic Pheochromocytoma or Paraganglioma: Updated Long-Term Survival and Safety

2020 ◽  
Vol 4 (Supplement_1) ◽  
Author(s):  
Camilo Jimenez ◽  
Bennett B Chin ◽  
Richard B Noto ◽  
Joseph Stephen Dillon ◽  
Lilja B Solnes ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Locally Advanced ◽  
Phase 2 ◽  
Pivotal Phase ◽  
Term Survival ◽  
Phase 2 Study ◽  
Therapeutic Doses

Abstract Background: Pheochromocytoma/Paraganglioma (PPGL) are rare neuroendocrine tumors with a 5-yr survival rate as low as 12%. There is a high unmet medical need for effective treatment options for patients with advanced disease. AZEDRA®, a high-specific-activity iodine-131 meta-iodobenzylguanidine (HSA I-131-MIBG), is the first and only FDA-approved therapeutic radiopharmaceutical agent indicated for the treatment of adult and pediatric patients with iobenguane scan positive, unresectable, locally advanced or metastatic PPGL who require systemic anticancer therapy. Methods: Patients with advanced PPGL who were heavily pre-treated and were ineligible for curative surgery or chemotherapy received a dosimetric dose followed by up to two therapeutic doses (each at 296 MBq/kg to a max of 18.5 GBq). The primary endpoint, defined as the proportion of patients with at least 50% reduction of all antihypertensive medication(s) lasting ≥6 months, was met and previously reported. Updated secondary endpoints including overall survival (OS) and safety are reported. Results: A dosimetric dose of HSA I-131-MIBG was administered to 74 patients. Of those, 68 patients received one therapeutic dose and 50 received two doses of HSA I-131-MIBG. Clinical benefit rates (objective tumor responses defined by RECIST 1.0 and stable disease) were observed in 71.4% and 98.0% of patients receiving one and two therapeutic doses, respectively. As of October 10, 2019, median survival time for all patients was 43.2 months (95% CI 31.4, >60). Median survival time was 19.3 months (95% CI 4.5, 32.4) and 49.1 months (95% CI 36.9, >60) in patients receiving one and two doses, respectively. The overall survival was 73.8% at 2 yrs, 47.5% at 4 yrs and 41.5% at 5 yrs. The most common (≥50%) adverse events were nausea, fatigue, and myelosuppression. Myelosuppressive events resolved within 4-8 wks without requiring stem cell transplantation. Late radiation toxicity included 7 patients with secondary malignancies (myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), colon cancer, and lung carcinoma) of which MDS, ALL and AML were considered related to I-131 radiotherapy. Conclusions: Results from this pivotal phase 2 study suggest that HSA I-131-MIBG is an efficacious and safe treatment for advanced PPGL.

Long-term survival and safety from a multi-center, open-label, pivotal phase 2 study of iobenguane I 131 in patients (Pts) with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (PPGL).

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 4108-4108
Author(s):  
Richard B. Noto ◽  
Camilo Jimenez ◽  
Bennett B. Chin ◽  
Joseph S. Dillon ◽  
Lilja Solnes ◽  
...  
Keyword(s):  
Lymphoblastic Leukemia ◽  
Locally Advanced ◽  
Unmet Need ◽  
High Specific Activity ◽  
Radiation Toxicity ◽  
Phase 2 ◽  
Pivotal Phase ◽  
Term Survival ◽  
Phase 2 Study ◽  
Therapeutic Doses

4108 Background: PPGL, rare neuroendocrine tumors with a 5-yr survival rate as low as 12%, have a high unmet need for effective treatment options. AZEDRA, a high-specific-activity iodine-131 meta-iodobenzylguanidine (HSA I-131-MIBG), is the first and only FDA- approved therapeutic radiopharmaceutical agent indicated for the treatment of adult and pediatric pts with iobenguane scan positive, unresectable, locally advanced or metastatic PPGL who require systemic anticancer therapy. Methods: Pts with advanced disease who were heavily pre-treated and were ineligible for curative surgery or chemotherapy received a dosimetric dose followed by up to two therapeutic doses (each at 296 MBq/kg to a max of 18.5 GBq). The primary endpoint, defined as the proportion of pts with at least 50% reduction of all antihypertensive medication(s) lasting ≥6 months, was met and previously reported. Updated secondary endpoints including overall survival (OS) and safety are reported. Results: A dosimetric dose of HSA I-131-MIBG was administered to 74 pts. Of those, 68 pts received one therapeutic dose and 50 received two doses of HSA I-131-MIBG. Clinical benefit rates (objective tumor responses defined by RECIST 1.0 and stable disease) were observed in 71.4% and 98.0% of pts receiving one and two therapeutic doses, respectively. As of Jan 25, 2019, median OS for all pts was 41.1 months (95% CI 31.1, 91.2). Median OS was 17.5 months (95% CI 4.0, 31.5) and 48.7 months (95% CI 33.2, 91.2) in pts receiving one and two doses, respectively. A tail of survival was observed, with OS of 73.1% at 2 yrs and 44.2% at 4 yrs. The most common (≥50%) adverse events were nausea, fatigue, and myelosuppression. Myelosuppressive events resolved within 4-8 wks without requiring stem cell transplantation. Late radiation toxicity included 8 pts with secondary malignancies (myelodysplastic syndrome (MDS), acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), colon cancer, and lung carcinoma) of which MDS, ALL and AML were considered related to I-131 radiotherapy. Conclusions: Updated results from this pivotal phase 2 study suggest that HSA I-131-MIBG is an efficacious and safe treatment for advanced PPGL. Clinical trial information: NCT00874614.

Long-term survival in patients with metastatic renal cell carcinoma (mRCC) in the era of new targeted therapies: Five-year follow-up in a single Spanish medical institution (Genito-Urinary Tumor Unit, University Hospital 12 de Octubre).

2012 ◽  
Vol 30 (5_suppl) ◽  
pp. 376-376 ◽  
Author(s):  
G de Velasco Oria ◽  
J Sepulveda ◽  
F Villacampa ◽  
I Ghanem ◽  
Daniel E. Castellano
Keyword(s):  
Overall Survival ◽  
Targeted Therapy ◽  
Survival Time ◽  
Median Survival ◽  
Targeted Therapies ◽  
Median Survival Time ◽  
Progression Free Survival ◽  
Final Analysis ◽  
University Hospital ◽  
Term Survival

376 Background: Recently, new targeted therapies have proved the efficacy in patients with mRCC in terms of progression-free survival (PFS) and overall survival (OS). There is also growing evidence that successive targeted treatments has achieved objective responses and sustained time to progression. Here, we report data from our insitution analysing the OS benefit of continuing targeted therapy after disease progression. Methods: We identified 58 metastatic clear cell RCC patients who started targeted therapy between September 2005 and December 2008. The data were collected from our clinical trials registry. The patients were evaluated for differences in baseline characteristics and known prognostic factors (PFs) in metastatic RCC. We assessed overall survival for all patients. Results: We identified 58 pts, 24 are still alive (43%). Median age was 56 (range 31–78). ECOG PS 0/1/2: 33/24/1. 46% (27) had diagnosis to treatment intervals < 1 year. Sites of metastatic disease included: lung 46%(26), bone 32%(19), hepatic 29%(17) and retroperitoneal 24%(14). Nephrectomy was pesented in 90% of all pts. The number of metastases location was: 1/2/3: 32%/11%/7%. The drugs administered are listed in table. Median number of treatments: 3 (range 1–7). The median overall survival (OS) was 44 months and the 3- year OS was 60.4%. Pts by MSKCC risk-group were: favourable prognostic (FP) 19%, intermediate prognostic (IP) 63%, poor prognostic (PP) 18%. The overall survival for FP group was not reached, and 3-year OS was 81%; for IP group the median survival time was 44 months and 3-year OS was 59%; and for PP group the median survival time was 25 months. Conclusions: The survival for patients with mRCC who receive multiple lines of targeted therapy has increased to close to 4 years. These results indicate a clear shift in the evolution of mRCC but lack a great deal about what the best sequence. Final analysis of the best sequence of treatment will be presented at the meeting. [Table: see text]

scholarly journals A Clinicopathological Analysis on Diffuse Midline Glioma in Adults

2021 ◽  
Author(s):  
Xiao Mu Hu ◽  
Xiao Yu Nie ◽  
Kai Lun Xu ◽  
Yin Wang ◽  
Feng Tang ◽  
...  
Keyword(s):  
Overall Survival ◽  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Age Groups ◽  
Young Patients ◽  
Imaging Data ◽  
Wild Type ◽  
Old Patients ◽  
Diffuse Midline Glioma

Abstract Purpose: Diffuse midline glioma (DMG), H3K27M mutant is a new entity that has become widely recognized. However, studies concerning DMG in adult patients remains rare. We did a retrospective study covering the largest amount of patients to date to analyze the clinicopathological characteristics of DMG in adult. Methods: We reviewed 117 cases of adult DMG, collected their clinical and imaging data along with pathological results including H3K27M. Summarized their features and the connection with overall survival in different age groups.Results: Among 117 cases, most tumors were located at the thalamus, 39 patients had H3K27M mutation, of whom 38 demonstrated down regulation of H3K27me3. The average overall survival of H3K27M-mutant gliomas was 13 months, while that of 78 H3K27M wild-type gliomas were 11.8 months. For young patients (age＜35), The median survival time of the H3K27M-mutant was 20.1 months, while that of the H3K27M wild-type was 39.5 months. For older patients (age≥35), the median survival time of the H3K27M-mutant was 22.3 months, while that of the H3K27M wild-type was 17.1 months. The OS of patients who received biopsies, subtotal resections, and total resections were 15.8, 17.6, and 11.6 months respectively. Conclusion: The DMG in adults mainly occurred in the thalamus. H3K27M mutations tend to happen more frequently in young adults, and this genetic alteration results in a worse outcome only in young patients. For old patients, age and the approach of surgery are independent prognostic factors. Patients received biopsy instead of total resection had a better prognosis.

scholarly journals Controlling Nutritional Status (CONUT) Score is Associated with Overall Survival in Patients with Unresectable Hepatocellular Carcinoma Treated with Lenvatinib: A Multicenter Cohort Study

Nutrients ◽  
2020 ◽  
Vol 12 (4) ◽  
pp. 1076 ◽  
Author(s):  
Shigeo Shimose ◽  
Takumi Kawaguchi ◽  
Hideki Iwamoto ◽  
Masatoshi Tanaka ◽  
Ken Miyazaki ◽  
...  
Keyword(s):  
Hepatocellular Carcinoma ◽  
Overall Survival ◽  
Nutritional Status ◽  
Survival Time ◽  
Median Survival ◽  
Median Survival Time ◽  
Rank Test ◽  
Multicenter Cohort Study ◽  
The Impact ◽  
Conut Score

We aimed to investigate the impact of the controlling nutritional status (CONUT) score, an immuno-nutritional biomarker, on the prognosis of patients with hepatocellular carcinoma (HCC) treated with lenvatinib (LEN). This retrospective study enrolled 164 patients with HCC and treated with LEN (median age 73 years, Barcelona Clinic Liver Cancer (BCLC) stage B/C 93/71). Factors associated with overall survival (OS) were evaluated using multivariate and decision tree analyses. OS was calculated using the Kaplan–Meier method and analyzed using the log–rank test. Independent factors for OS were albumin–bilirubin grade 1, BCLC stage B, and CONUT score <5 (hazard ratio (HR) 2.9, 95% confidence interval (CI) 1.58–5.31, p < 0.001). The CONUT score was the most important variable for OS, with OS rates of 70.0% and 29.0% in the low and high CONUT groups, respectively. Additionally, the median survival time was longer in the low CONUT group than in the high CONUT group (median survival time not reached vs. 11.3 months, p < 0.001). The CONUT score was the most important prognostic variable, rather than albumin–bilirubin grade and BCLC stage, in patients with HCC treated with LEN. Accordingly, immuno-nutritional status may be an important factor in the management of patients with HCC treated with LEN.

Quizartinib Significantly Improves Overall Survival in FLT3-ITD Positive AML Patients Relapsed after Stem Cell Transplantation or after Failure of Salvage Chemotherapy: A Comparison with Historical AML Database (UK NCRI data)

Blood ◽  
2015 ◽  
Vol 126 (23) ◽  
pp. 2557-2557 ◽  
Author(s):  
Robert K Hills ◽  
Guy Gammon ◽  
Denise Trone ◽  
Alan K. Burnett
Keyword(s):  
Overall Survival ◽  
Median Survival ◽  
Salvage Chemotherapy ◽  
Sensitivity Analyses ◽  
Intensive Chemotherapy ◽  
Phase 2 ◽  
Eligibility Criteria ◽  
Historical Cohort ◽  
Phase 2 Study ◽  
The Uk

Abstract Introduction: The prognosis of patients with a FLT3-ITD mutation in acute myeloid leukemia (AML) is worse than FLT3 wild type patients, with increased early relapse including after allogeneic stem cell transplantation (SCT) and with a poor response to salvage. FLT3-ITD mutant patients who relapse after SCT or fail salvage chemotherapy have a dismal prognosis with no approved treatment options. Quizartinib (AC220), an oral FLT3 receptor tyrosine kinase inhibitor, has shown a remission rate of 44%, and median overall survival of 23 weeks in FLT3-ITD mutant patients who were relapsed or refractory to 2nd line treatment, or relapsed following SCT in a non-randomised phase 2 study [1]. While these outcomes compare favourably to published data, which give a median survival of 1.5 months in all comers [2], and median survival in FLT3-ITD mutant patients of 13 weeks following first relapse [3], there is an overall paucity of data available for the FLT3-ITD+ subpopulation examined in the quizartinib studies . The UK NCRI database is the largest dataset for FLT3-ITD+ AML patients, containing 6872 patients with ITD status (1388 mutant) and systematic collection of data from diagnosis with follow-up for at least 5 years or to death. Methods: 97 FLT3-ITD+ patients from the AC220-002 study who had received intensive chemotherapy, and had either relapsed following SCT (n=39); or were relapsed (n=53) or refractory (n=5) following salvage therapy prior to enrolment were identified. The equivalent eligibility criteria were applied to the UK MRC/NCRI database of AML trial patients treated intensively from 1988-2013 who had confirmed FLT3-ITD mutation: 183 patients matching the same criteria were identified (post-SCT n= 65; relapsed n=99; refractory n=19). Patients in this group received only recognised intensive chemotherapy regimens prior to fulfilling the eligibility criteria. To reflect the screening period in AC220-002, patients in the MRC/NCRI cohort entered the analysis 14 days following being identified as relapsed/refractory. The primary endpoint was overall survival. Multivariable Cox/logistic regression was performed stratified for known prognostic factors, including route to eligibility (post SCT/relapsed/refractory). Sensitivity analyses were performed excluding deaths within 14 and 28 days from eligibility from the MRC/NCRI cohort only to allow for patients who might not have been considered for quizartinib treatment on grounds of fitness. Results: There was no significant difference in the ages of the two cohorts (median age AC220-002 47y vs. MRC 48y). Outcomes in the MRC/NCRI cohort did not improve over time from 1988-2013 (p=0.7). Analyses were performed adjusted for route to eligibility, ITD allelic ratio, duration of remission (in relapsed patients), and cytogenetics. Overall survival was improved in the Quizartinib patients (adjusted hazard ratio (HR) 0.40 (0.29-0.55) p<.0001), with no interaction with route to eligibility (p=0.4). Median survival was 231 vs 60 d for relapse post SCT, 128 vs 53 d in relapsed patients, and 146 vs 61 d in refractory patients. Response rates (CRc) overall were 43% vs 11% (adjusted OR 0.24 (0.10-0.61) p=0.002). In sensitivity analyses excluding deaths within 14 days (HR 0.50 (0.36-0.69), p<.0001) and 28 days (HR 0.5 (0.38-0.76) p=0.0004) within the MRC/NCRI cohorts quizartinib retained superiority. Discussion: Quizartinib has previously shown activity in relapsed/refractory patients in a large Phase 2 single arm study, and is currently being studied in a randomized Phase 3 study vs. standard salvage chemotherapy. This analysis examines a patient population that has failed salvage therapy or SCT and for whom there is no standard therapy. It confirms the prolonged overall survival seen in the Phase 2 study when compared to an equivalent large historical cohort of previously intensively treated patients from the UK MRC/NCRI trials, with median survival in quizartinib patients was 159 days compared to 56 days in the historical cohort. Even if deaths within 28 days are excluded entirely from the MRC/NCRI group, there is a highly significant survival benefit for quizartinib. Overall, the activity seen in the AC220-002 Phase 2 study is greater than that seen in comparable patients in a large historical cohort. [1] Levis M et al. ASH meeting Abstr 615, 2014. [2] Giles F et al. Cancer 104 (3), p547, 2005. [3] Ravandi F et al. Leukemia Research 34, p752, 2010. Figure 1. Figure 1. Disclosures Off Label Use: Quizartinib for AML. Gammon:Ambit: Employment. Trone:Ambit: Employment.

Oxaliplatin/CF/5-FU versus paclitaxel/CF/5-FU in patients with advanced gastric cancer: A phase II clinical trial

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 14014-14014
Author(s):  
T. Lin ◽  
F. Xu ◽  
S. Wang ◽  
Y. He ◽  
W. Tian ◽  
...  
Keyword(s):  
Gastric Cancer ◽  
Survival Time ◽  
Advanced Gastric Cancer ◽  
Median Survival ◽  
Median Survival Time ◽  
Performance Status ◽  
Locally Advanced ◽  
Metastatic Gastric Cancer ◽  
Tumor Control ◽  
Tumor Control Rate

14014 Background: Although many randomized trials of chemotherapy for advanced gastric cancer have been reported during the past two decades, no standard regimens worldwide have been established yet. Now Paclitaxel and Oxaliplatin have shown promising activity in advanced gastric cancer. We prospectively evaluated toxicity, efficacy and survival of Oxaliplatin /CF/5-FU versus Paclitaxel/CF/5-FU. Methods: Metastatic or locally advanced gastric cancer; performance status (PS) 0–2. Patients (pts) were enrolled and randomized into arm A with Oxaliplatin 100mg/m2, 5-FU 400 mg/m2 bolus, FA 200 mg/m2 2h, 5-FU 2500 mg/m2 46h, q2w or into arm B with Paclitaxel 80 mg/m2, 5-FU 400 mg/m2 bolus, FA 200 mg/m2 2h, 5-FU 2500 mg/m2 46h, q2w. Results: From 2000 to 2005, (A/B) 46/43 pts were enrolled into this study. Median age (52/50 y), gender, PS, localization and numbers of metastatic sites were comparable for both arms. Pts who were not chemotherapy naive in A/B (% of pts) were 41.3/33.3. All pts were eligible and evaluable for toxicity and response. Overall response (CR+PR) rate for A/B (% of pts): 37.0/47.2 (p<0.05), tumor control rate (CR+PR+SD) 76.1/69.4(p<0.05). Median time to progression (TTP) were for A/B: 6.0 and 3.2 months. And median survival time for A/B were 13.4 and 13.8 months. Grade 3/4 toxicities were for A/B (% of pts): neutropenia 10.9/5.6, thrombocytopenia 4.3/2.8, anemia 0/2.8, vomiting 8.7/2.8, neurotoxic 0/2. No treatment-related death occurred in A/B. Conclusions: Oxaliplatin /CF/5-FU and Paclitaxel/CF/5-FU are both effective and safe in advanced or metastatic gastric cancer. Though Oxaliplatin /CF/5-FU had better tumor control rate and median TTP, there was no difference between the arms in the median survival time. No significant financial relationships to disclose.

scholarly journals A 10-year Retrospective Study of Lung Cancer in Uganda

2021 ◽  
Author(s):  
Naghib Bogere ◽  
Felix Bongomin ◽  
Andrew Katende ◽  
Blair Andrew Omaido ◽  
Elizabeth Namukwaya ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Overall Survival ◽  
Survival Time ◽  
Median Survival ◽  
Medical Records ◽  
Median Survival Time ◽  
Histological Diagnosis ◽  
Histologic Subtype ◽  
Vital Status ◽  
Phone Calls

Abstract Background: Lung cancer is a leading cause of cancer-related deaths in Uganda. In this study, we aimed to describe the baseline characteristics and survival of patients with lung cancer at Uganda Cancer Institute (UCI). Methodology: We retrospectively reviewed medical records of all patients with a histological diagnosis of lung cancer registered at UCI between January 2008 and August 2018. Data on demographic, clinical, and treatment characteristics, and vital status were abstracted and analyzed. Patients with undocumented vital status on the medical records were contacted through phone calls. We determined survival as time from histological diagnosis to death. The Kaplan-Meier survival analysis was performed to estimate the median survival time and the 5-year overall survival rate. Results: Of the 207 patients enrolled, 56.5% (n=117) were female, median age was 60 years (range: 20-94), 78.7% (n=163) were never-smokers and 18 (8.7%) were living with HIV. Presumptive anti-tuberculosis treatment was given to 23.2% (n=48). Majority had non-small cell lung cancer (96.6%, n=200) with 74.5% (n=149) adenocarcinoma and 19% (n=38) squamous cell carcinoma. All had advanced (stage III or IV) disease with 96.1% (n=199) in stage IV. Chemotherapy (44.9%, n=93) and biological therapy (34.8%, n=72) were the commonest treatments used. Overall survival at 6 months, 1-, 2- and 5-years was 41.7%, 29.7%, 11.8% and 1.7% respectively. The median survival time was 4.4 months and was not different between NSCLC and SCLC (4.5 vs. 3.9 months respectively, p=.335). Conclusion: In Uganda, adenocarcinoma is the predominant histologic subtype of lung cancer predominantly occurring in females and non-smokers. Patients present late with advanced disease and poor overall survival. Public awareness should be heightened to facilitate early screening and improve outcomes.

Clinical trials of VAL-083 in patients with chemo-resistant glioblastoma.

2017 ◽  
Vol 35 (15_suppl) ◽  
pp. TPS2082-TPS2082
Author(s):  
Jeffrey A. Bacha ◽  
Anne Steino ◽  
Richard Stephen Schwartz ◽  
John Langlands ◽  
Sarath Kanekal ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Overall Survival ◽  
Dna Methyltransferase ◽  
Drug Application ◽  
Phase 2 ◽  
Current Standard ◽  
Pivotal Phase ◽  
Phase 2 Study ◽  
Recurrent Gbm

TPS2082 Background: Glioblastoma (GBM) is the most common and aggressive primary brain cancer. Current standard of care includes surgery, radiation and treatment with temozolomide (TMZ), however nearly all tumors recur and the prognosis for recurrent GBM is dismal. Most GBM tumors have unmethylated promoter status for O6-methylguanine-DNA-methyltransferase (MGMT); a validated biomarker for TMZ-resistance. Second-line treatment with anti-angiogenic agent bevacizumab has not improved overall survival (OS) and 5-year survival is less than 3%. Dianhydrogalactitol (VAL-083) is a bi-functional alkylating agent targeting N7-Guanine and inducing interstrand DNA cross-links, double-strand breaks and cell death in GBM cell lines and GBM cancer stem cells, independent of MGMT status in vitro. VAL-083 readily crosses the blood-brain barrier and accumulates in brain tumor tissue. Our recent phase I/II clinical trial in recurrent GBM patients failing both TMZ and bevacizumab, suggested that VAL-083 offers clinically meaningful survival benefits for patients with recurrent GBM and pinpointed a new dosing regimen (40 mg/m2/d on days 1,2,3 of a 21-day cycle) which was well-tolerated and was selected for study in subsequent GBM trials. Methods: These trials include i) an ongoing single-arm, biomarker driven, Phase 2 study to determine if VAL-083 treatment of MGMT-unmethylated adult GBM patients at first recurrence/progression, prior to bevacizumab improves overall survival at 9 months, compared to historical control with lomustine (clinicaltrials.gov identifier: NCT02717962). ii) A pivotal Phase 3 study in recurrent GBM after failing both TMZ and bevacizumab. The control arm will consist of a limited number of salvage chemotherapies currently used in bevacizumab-failed GBM. If successful, this study will serve as the basis for a New Drug Application (NDA) submission for VAL-083. iii) A single arm, biomarker driven, Phase 2 study to confirm the tolerability and efficacy of VAL-083 in combination with radiotherapy in newly diagnosed MGMT-unmethylated GBM patients whose tumors are known to express high MGMT levels. The results of these studies may support a new treatment paradigm in chemotherapeutic regimens for the treatment of GBM. Clinical trial information: NCT02717962.

Sign in / Sign up

Export Citation Format

Share Document