Replies to post #545049 on NorthWest Biotherapeutics Inc (NWBO)

[antihama]

The article discusses a lot of what was discussed in other articles but I'll paste the part where they ask 2 docs not affiliated w the trial what they think since you have to sign up to read it I believe. One is excited and the other, a radiation oncologist, not as much but even he is somewhat excited about the outcome in rGBM.

"The results of our trial will allow for further study in the immuno-oncology space," said Liau. "The reality is that we don't have enough treatments for our patients, and different groups will respond to different treatments."

Weighing In
Two experts not involved in the trial were approached by Medscape Medical News for an independent comment.

"The data is compelling and I am a strong advocate for stimulating the body's own immune system to treat these tumors," said Joseph C. Landolfi, DO, CPE, Division Chief, Neuro-Oncology and Radiosurgery at Hackensack Meridian Health JFK University Medical Center, Edison, New Jersey. "Any significant improvement in survival for this patient population is a benefit as for some it means being present for significant life events [like] weddings, births, etc."

Overall, it's a good study, he said. "This will be another treatment option for those patients who have a newly diagnosed or recurrent glioblastoma should it obtain approval," he added.

However, Jonathan Lischalk, MD, a radiation oncologist at NYU Langone's Perlmutter Cancer Center and assistant professor of radiation oncology at NYU Long Island School of Medicine, New York City, was cautious in reacting to the results.

Although the authors utilized a sound primary endpoint, a major criticism of this trial is its externally controlled cohort due to extensive crossover of the control group, he commented. "This certainly makes interpretation of the results more challenging relative to a standard randomized control trial," he said. "Given that benefits of treatment are measured on the order of months, any biases reflected in the external control group could result in problematic interpretation of the data."

He also pointed out another issue: this trial was initiated in 2007 and it underwent a 3-year hiatus, and in the meantime there have been a "number of changes in our understanding of glioblastoma multiforme [GBM] and its management."

"For example, the WHO classification of glioblastoma now reflects prespecified molecular markers including IDH [isocitrate dehydrogenase], though it is unclear from the manuscript how this was handled by the investigators," said Lischalk.

"In addition, the only landmark GBM trial during this timeframe, published by Stupp et al in 2017, changed standard of care for primary GBM to include tumor-treating fields. This device was only utilized in eight patients within this trial, so it is unclear how these two methods of treatment interact," he commented.

Despite these concerns, Lischalk emphasized that this trial explores a very novel method of drug therapy for a cancer that continues to pose momentous challenges for patients and oncologists.

"More research is required to explore the resulting immunogenicity from such a vaccine and how it interacts with newer forms of GBM treatment, including tumor-treating fields while stratifying for modern molecular markers," he said.

"Although the cohort with recurrent GBM in this trial was relatively small, the survival improvement was pronounced, and given the lack of clear standard of care in the recurrent setting, this vaccine may be a good option and should be explored by regulators," Lischalk added.

However, given the limitations of the trial, and particularly the lack of randomization and internal control, "I do not think a change in standard of care in the upfront setting is warranted at this time," he said.