Clinical Trials Test Treatments for High-Grade Brain Tumors


With a few exceptions, glioblastoma (GBM) remains largely incurable, and the U.S. Food and Drug Administration (FDA) has approved few treatments for the disease. Surgery (when feasible), radiation, and temozolomide are used in most patients. But even if a newly diagnosed tumor can be surgically excised, recurrences are too common.

In this blog post, I simply list some of the new treatments available in clinical trials for GBM and other high-grade brain tumors. Only drugs that have at least some preliminary results of activity are included, and the list is not meant to be fully comprehensive. The interested reader can judge for herself what might be of interest, keeping in mind that no single treatment is suitable or will work for all GBM patients. Continue reading…


Study Findings Show Role for Pembrolizumab and Durvalumab in GBM Treatment, Expert Says

Excerpt:

“Based on encouraging efficacy signals and safety data from separate trials exploring the PD-1 inhibitor pembrolizumab (Keytruda) and the PD-L1 inhibitor durvalumab (MEDI4736), there is a role for checkpoint inhibitors in the treatment of glioblastoma multiforme (GBM). Data from the studies were reported by David Reardon, MD, at the 21st Society for Neuro-Oncology (SNO) Annual Scientific Meeting.

“Reardon said that these results mark important firsts in the field: ‘There has been a lot of anticipation regarding the role of checkpoint inhibitors for glioblastoma and whether we’ll see results in any way similar to the exciting results that have been observed in other cancer indications with this new class of cancer therapeutics.’ ”

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Durvalumab Demonstrates Durable Responses in Recurrent GBM

Excerpt:

“Findings from a recent phase II study showed the PD-L1 inhibitor durvalumab generated durable responses in bevacizumab-naïve patients with recurrent glioblastoma multiforme (GBM). Findings of the study were presented at the 2016 Society for Neuro-Oncology Annual Meeting.

“In a 30-patient cohort, the 6-month progression-free survival (PFS) rate was 20.0% (6 patients; 90% CI, 9.7-33.0). The median PFS was 13.9 weeks (95% CI, 8.1-24.0). Of these 6 patients, 3 had wild-type IDH1 status and 3 had mutated IDH1.”

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Dual Biomarker Signature Holds Predictive Promise for Response to Anti-PD-L1 Therapy in NSCLC

Excerpt:

“Recent research suggests that the presence of PD-L1–positive and CD8+ cells may be useful for predicting responses in patients with non-small cell lung cancer (NSCLC) who have been treated with durvalumab (MEDI4736).

“Sonja Althammer, PhD, presented research on the association between improved survival rates to treatment with durvalumab and high CD8+ and PD-L1+ cell densities during a late-breaking abstract session at the Society for Immunotherapy of Cancer (SITC) 21st Annual Meeting & Associated Programs.”

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Gradalis®, Inc. Announces Dosing of First Patient in Pilot Study Combining Vigil® Engineered Autologous Tumor Cell Immunotherapy and Durvalumab in Advanced Breast Cancer

Excerpt:

“Gradalis®, Inc., a clinical-stage biopharmaceutical company, today announced that the first patient has been dosed in a pilot study combining Vigil® Engineered Autologous Tumor Cells (EATCs) with durvalumab in advanced breast cancer. This is an open-label, investigator-sponsored study supported partly by a grant from Gradalis, to evaluate the safety, tolerability, and efficacy of the combination of Vigil engineered autologous tumor cell immunotherapy and durvalumab (an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1)) in patients with no PD-L1 expression and locally advanced or metastatic triple negative breast cancer (TNBC), that have progressed following two prior lines of therapy.”

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ELCC 2016 News: Osimertinib Combined With Durvalumab in EGFR-mutant Non-Small-Cell Lung Cancer

Excerpt:

“Encouraging clinical activity was demonstrated by the combination of osimertinib plus durvalumab in patients with advanced non-small-cell lung cancer (NSCLC) that had received prior treatment with an epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) and also in EGFR-TKI naive patients that was offset by safety observations over the occurrence of interstitial lung disease (ILD) in some patients.

“Dr. Myung-Ju Ahn, Department of Medicine, Section of Hematology-Oncology, Samsung Medical Center, Sungkyunkwan University, Seoul, Republic of Korea, presented results during the ‘Best Abstracts’ session at the European Lung Cancer Conference (ELCC), held in Geneva, Switzerland, 13 to 16 April, 2016 from the TATTON trial.

“TATTON is a multi-arm phase Ib trial investigating osimertinib 80 mg in combination with durvalumab (anti-PD-L1 monoclonal antibody), savolitinib (MET inhibitor) or selumetinib (MEK 1/2 inhibitor) in patients with advanced EGFR-mutant lung cancer. The osimertinib and durvalumab combination is just one arm of the TATTON study, which has two parts: Part A was a dose escalation study in patients with advanced NSCLC that had received prior treatment with an EGFR-TKI. Part B was a dose expansion trial conducted in patients with advanced disease that were EGFR-TKI treatment-naive.”

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AstraZeneca Reports Top-Line Result of Tremelimumab Monotherapy Trial in Mesothelioma

“AstraZeneca and MedImmune, its global biologics research and development arm, today announced that DETERMINE, the Phase IIb clinical trial of 10 mg/kg tremelimumab monotherapy in second or third-line treatment of unresectable malignant mesothelioma, did not meet its primary endpoint of overall survival.

“Robert Iannone, Senior Vice President, Head of Immuno-Oncology, Global Medicines Development at AstraZeneca, said: ‘We are disappointed that tremelimumab monotherapy did not demonstrate a survival benefit in this patient population with no approved medicines beyond first-line treatment. However, we remain confident in tremelimumab’s clinical activity in combination, as shown in our recently published Study 006 trial of tremelimumab and durvalumab in non-small cell lung cancer.’ ”


AZ Cancer Immunotherapy Combo Impresses in Lung Cancer Trial

“Two immuno-oncology drugs in development at AstraZeneca (AZ) have shown potential as a dual therapy for non-small cell lung cancer, according to a new study.

“The phase II trial – reported in Lancet Oncology – found that combining anti-PD-L1 antibody durvalumab with anti-CTLA-4 antibody tremelimumab achieved an overall response rate (ORR) of 23%, significantly higher than has previously been seen with durvalumab alone in this setting.

“The trial was small and focused primarily on safety, but the preliminary efficacy signal – albeit in just 26 patients – is encouraging, according to an editorial accompanying the study by Edward Garon of the David Geffen School of Medicine at the University of California, Los Angeles.”


Putting Immune Checkpoint Blockade to the Test in Breast Cancer


About 10 months ago, we asked: Is There a Future for Immunotherapy in Breast Cancer? Now, we can answer this question with a qualified “yes.” The data show why:

Triple-negative breast cancer (TNBC)

TNBC has long been considered to be more amenable to immune system-based treatments than other types of breast cancer because it is more immunogenic; that is, relatively high levels of immune cells accumulate within or adjacent to TNBC tumors. These immune cells could be triggered to attack tumors if properly activated. TNBC tumors are also likely to have a higher mutational burden (number of genetic mutations). This is one of the predictors of sensitivity to a type of treatment called immune checkpoint blockade.  Drugs known as checkpoint inhibitors block the proteins PD-1 or PD-L1. In cancer, PD-L1 proteins on tumor cells bind to PD-1 proteins on immune T cells and inhibit their tumor-killing activity. Immune checkpoint drugs disable this interaction and enable activation of T cells. These drugs are actively being explored in TNBC in clinical trials.

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