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…


Some Glioblastoma Patients Benefit from ‘Ineffective’ Treatment

Excerpt:

“A subgroup of patients with a devastating brain tumor called glioblastoma multiforme benefited from treatment with a class of chemotherapy drugs that two previous large clinical trials indicated was ineffective against the disease, according to a study at the Stanford University School of Medicine.

“Specifically, patients in the subgroup who were treated with chemotherapy drugs that block the growth of new blood vessels in the tumor lived an average of about one year longer than those who were given other classes of chemotherapy drugs, the researchers found.”

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Addition of Bevacizumab Shows No Survival Advantage Over Cisplatin Pemetrexed Alone in Non-Squamous NSCLC

Excerpt:

“Preliminary data from the SAKK19/09 trial shows no overall survival difference between two cohorts of patients with non-squamous non-small cell lung cancer (NSCLC) receiving similar cisplatin pemetrexed-based regimens.

“The SAKK19/09 trial examined a total of 77 patients with EGFR wild type non-squamous NSCLC. Both cohorts received cisplatin pemetrexed in the frontline, while one cohort had the addition of bevacizumab. In an interview with Targeted Oncology, Oliver Gautschi, MD, Assistant Professor, University of Bern, President, SAKK Lung Cancer Group, discusses the lack of differences in overall survival, where the field is going as a whole, and why combination maintenance therapy is not better than a single agent.”

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Bevacizumab/Erlotinib Combo Approved in Europe for NSCLC

Excerpt:

“The European Commission approved bevacizumab (Avastin) in combination with erlotinib (Tarceva) as a frontline treatment for patients with unresectable advanced, metastatic, or recurrent EGFR-mutant non–small cell lung cancer (NSCLC).

“The approval was based on findings from the phase II JO25567 study, which showed a 46% reduction in the risk of progression or death with the combination versus single-agent erlotinib. The median progression-free survival (PFS) with the addition of bevacizumab was 16 versus 9.7 months with erlotinib alone (HR, 0.54; 95% CI, 0.36-0.79; P = .0015).

“ ‘The combination of Avastin and Tarceva represents a new standard of care for patients with this type of lung cancer,’ Sandra Horning, MD, chief medical officer and Global Head of Product Development at Roche, the company developing the combination, said in a statement. ‘This approval provides physicians in Europe with a powerful combination therapy that can significantly extend progression-free survival beyond 1 year, representing important progress for a group of patients who typically face a poor prognosis.’ ”

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New Data Evaluating KEYTRUDA® (pembrolizumab) in Combination with Chemotherapy for First-Line Treatment of Non-Small Cell Lung Cancer Demonstrate Response Rates Ranging from 48 to 71 Percent

Excerpt:

“Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced findings from an initial proof-of-concept study of KEYTRUDA®(pembrolizumab), the company’s anti-PD-1 therapy, combined with standard treatments, one with bevacizumab and others without, in non-small cell lung cancer (NSCLC) including chemotherapy in previously untreated patients with NSCLC; the study showed overall response rates (ORR) ranging from 48 to 71 percent, depending on the therapy used. These data, from the phase 1/2 KEYNOTE-021 trial, will be presented today at the 52nd Annual Meeting of the American Society of Clinical Oncology (ASCO) by Dr. Shirish Gadgeel of the Barbara Ann Karmanos Cancer Institute (Abstract #9016) from 8:00 – 11:30 a.m. CDT (Location: Hall A) and in a poster discussion from 3:00 – 4:15 p.m. CDT (Location: E354b).

“ ‘Combining KEYTRUDA and chemotherapy in the first-line lung cancer treatment setting is an important part of our effort to develop more treatment options for patients with non-small cell lung cancer,’ said Dr. Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. ‘This study has helped us to identify chemotherapy options for combination with KEYTRUDA regardless of PD-L1 expression to take forward in phase 3 trials.’ ”

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Advanced Breast Cancer Slowed with Avastin Combo (CME/CE)

Excerpt:

“Adding bevacizumab (Avastin) to letrozole (Femara) improved progression-free survival (PFS) in estrogen receptor-positive metastatic breast cancer (ER+MBC) but not other outcomes, an open-label, multicenter phase III trial showed.

“While median PFS increased by 4.6 months in patients who received combined therapy versus letrozole alone, there was no significant difference in overall survival (hazard ratio 0.87; 95% CI 0.65-1.18; P=0.188), Maura N. Dickler, MD, of Memorial Sloan Kettering Cancer Center in New York City, and colleagues reported online in the Journal of Clinical Oncology.

“In addition, there was a marked increase in grade 3 to 4 toxicities, particularly hypertension (24% versus 2%) and proteinuria (11% versus 0%), the researchers said, emphasizing that the role of bevacizumab in this setting will need to be clarified with research on predictive markers.”

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CHMP Recommends EU Approval for Roche's Avastin in Combination With Tarceva for Patients With a Specific Type of Advanced Lung Cancer

Excerpt:

“Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Union’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for the use of Avastin® (bevacizumab) in combination with Tarceva® (erlotinib) for the first-line treatment of adult patients with unresectable advanced, metastatic or recurrent non-squamous non-small cell lung cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) activating mutations. NSCLC is the most common type of lung cancer, the leading cause of cancer-related death in Europe and across the world. Approximately 10-15 percent of Europeans with NSCLC will have tumours with EGFR-activating mutations, representing an estimated 33,000 cases in Europe per year or 90 every day.”

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Expert Discusses Emerging Treatments, Immunotherapy Potential in pNETs

“Several recent studies have shown promise for the treatment of pancreatic NETs (pNETs). In the phase II CALGB-80701, which investigated the addition of bevacizumab (Avastin) to a treatment paradigm of everolimus and octreotide (Sandostatin) LAR in patients with locally advanced or metastatic pNETs, bevacizumab extended progression-free survival (PFS) by more than 3 months compared with everolimus and octreotide LAR alone.

“Response rate was also higher in the bevacizumab arm, with a 31% response to everolimus plus bevacizumab versus a 12% response in the control arm. Toxicity, however, was significantly higher in the bevacizumab arm.”


Antiangiogenic Breast Cancer Treatment May Benefit Only Patients with Well-Perfused Tumors

“A Massachusetts General Hospital (MGH) research team, in collaboration with investigators at the Dana-Farber Cancer Institute, may have found a reason why the use of antiangiogenesis drugs – which has improved outcomes for patients with several types of cancer – fails to benefit some breast cancer patients. In their report published online in PNAS Early Edition, the investigators describe how preoperative treatment with the antiangiogenic drug bevacizumab primarily benefited patients whose tumors were highly perfused with blood vessels prior to treatment.

” ‘As expected, bevacizumab treatment did reduce pressure within tumors and the density of  vasculature, but the pathologic response to therapy – whether or not it actually eradicated the tumor – appears to depend on the microvascular density of the tumor before treatment,’ says Rakesh K. Jain, PhD, director of the Steele Laboratory of Tumor Biology in the MGH Radiation Oncology Department and co-senior author of the current report. ‘In other words, our results indicate that a significant percentage of breast cancers do not have a blood supply sufficient to benefit from the vascular normalization provided by antiangiogenic drugs.’ “