Health News & Tips: Glioblastoma

Showing posts with label Glioblastoma. Show all posts

Saturday, 21 September 2013

Could Agenus Vaccine For Glioblastoma Be Assigned Breakthrough Designation?

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Sep 18 2013, 17:18 by: Prohost Biotech | about: AGEN

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Agenus (AGEN) has extraordinary news. A recent analysis from a Phase 2 trial in patients with newly diagnosed glioblastoma multiforme (GBM) treated with Prophage Series G-100 (HSPPC-96) in combination with the current standard of care (radiation and temozolomide) showed an almost 18 month median progression free survival (PFS), which represents a 160% increase versus current standard of care alone. The results confirm continuation of the positive trends from the Phase 2 HSPPC-96 newly diagnosed GBM trial first reported at the 81st American Association of Neurological Surgeons (AANS) Annual Scientific Meeting in May 2013.

According to Andrew T. Parsa, MD, PhD, Lead Clinical Investigator and Chair of Neurosurgery at Northwestern Memorial Hospital and Northwestern University Feinberg School of Medicine, the results are extremely encouraging and justify a definitive randomized study. The patient-specificity and lack of toxicity, combined with patient selection to optimize immunotherapy efficacy, could position this vaccine as a breakthrough treatment for newly diagnosed GBM patients in the years ahead.

Agenus plans to hold an end of Phase 2 meeting with the FDA to discuss a Phase 3 trial that could potentially lead to marketing approval of the HSPPC-96 vaccine as a treatment for patients with newly diagnosed GBM.

The Trial

The Phase 2 trial includes 46 patients treated with radiation and temozolomide as the standard of care in addition to HSPPC-96 vaccination. Data analysis demonstrates a median PFS of 17.8 months with 63% of the patients progression free at twelve months and 20% progression free at 24 months. These results score a considerable improvement when compared to patients treated with the standard of care (radiation plus temozolomide), which is 6.9 months.

The primary endpoint of the trial - Median overall survival (OS) - is 23.3 months and remained durable in patients treated with HSPPC-96. The 12 months survival rate is 85% with 50% of patients still alive and being followed, with many surviving beyond the 24 month study period. For the standard of care alone, median OS survival rate is 14.6 months.

The Phase 2 recurrent and newly diagnosed trials are being sponsored by Dr. Parsa and are primarily supported through funding from the American Brain Tumor Association, Accelerated Brain Cancer Cure, National Brain Tumor Society and National Cancer Institute Special Programs of Research Excellence. Dr. Parsa has not received any financial support or expense reimbursement for this work or for consulting activities on behalf of Agenus. He does not have an equity interest in Agenus or a financial relationship with the company.

In addition to the Phase 2 newly diagnosed GBM trial, the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI) is supporting a study of the HSPPC-96 vaccine in a large, randomized Phase 2 trial in combination with bevacizumab (Avastin) in patients with surgically resectable recurrent GBM. Patients have already been randomized into this trial and active recruitment is underway at multiple centers in the US. The study is being sponsored by the Alliance for Clinical Trials in Oncology (ALLIANCE), a cooperative group of the NCI. This trial is the largest brain tumor trial ever funded by the NCI and the largest vaccine study ever conducted with Avastin.

The ALLIANCE trial is investigating the potential benefits of treatment with a combination of HSPPC-96 and bevacizumab in a three-arm study of approximately 222 patients with surgically resectable recurrent GBM using a primary endpoint of overall survival. The study will compare efficacy of the HSPPC-96 vaccine administered with bevacizumab either concomitantly or at progression, versus treatment with bevacizumab alone. This study design is supported in part by previous research indicating a potential synergistic effect between the mechanisms of action behind both HSPPC-96 and bevacizumab.

The ALLIANCE is composed of three NCI funded cooperative groups (American College of Surgeons Oncology Group [ACOSOG], Cancer and Leukemia Group B [CALGB], and North Central Cancer Treatment Group [NCCTG]). These three groups have been integrated in an effort to develop and conduct more efficient clinical research studies to bring clinical trial results to patients more quickly.

In addition to the newly diagnosed GBM study in Prophage Series G-100 and the ALLIANCE trial, a Phase 2 study testing the Prophage Series G-200 in patients with recurrent glioma has been completed. Agenus expects the final trial results of this study to be published in a scientific journal in 2014.

Our Comments

The above results bring news that many are hoping for, but were not expecting soon and from a small firm. Here we are, the good news has come at the hands of Agenus' Prophage Series vaccines. The vaccines contain a precise antigenic "fingerprint" of a patient's particular cancer and are designed to reprogram the body's immune system to target only those cells that bear this fingerprint, reducing the risk of affecting healthy tissue, causing debilitating adverse effects. The Prophage Series G vaccines are currently being studied in two different settings of newly diagnosed and recurrent glioblastoma.

This is great news as Glioblastoma is a vicious brain cancer that has poor prognosis and no effective treatment. The incidence rate has risen the past three decades. The current standard of care for patients with newly diagnosed GBM is surgical resection followed by fractionated external beam radiotherapy and systemic temozolomide resulting in a median OS of 14.6 months. No cure has been provided yet and most patients with GBM experience cancer recurrence with a median time to recurrence of seven months. There is no standard treatment for patients with recurrent GBM.

The American Cancer Society estimates that more than 23,000 malignant tumors of the brain or spinal cord will be diagnosed during 2013 in the US, and that more than 14,000 people will die from these tumors.

This is, indeed, good news.

Disclosure: Long AGEN.

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Agenus: Thoughts On Phase II Results For Prophage In Glioblastoma

Reason for This Report

Agenus (AGEN) just issued an update on a Phase II trial of Prophage G-100 combined with current standard of care in newly diagnosed glioblastoma patients that showed median overall survival (OS) of 23.3 months. There was no control group in the study but data from recent trials suggests that OS with standard of care (SOC) approximates 16.2 months. Standard of care is surgical resection followed by regimen made up of the cancer drug temozolomide and radiation.

This data suggests an improvement of 7.1 months in OS with Prophage G-100 versus SOC. As discussed in this report, an improvement in OS of four to five months is considered a significant advance for drugs like Prophage that are being tested in aggressive cancers such as glioblastoma. Importantly, temozolomide was approved for newly diagnosed glioblastoma on the basis of only a 2.5 month improvement in OS.

This was a small, non-randomized multi-center Phase II trial with 46 patients and it is not infrequently the case that promising results in small Phase II trials are not replicated in larger Phase III trials. Despite this caveat, this is a very encouraging signal of efficacy. Also, it is important for investors to understand that the Phase III trial in newly diagnosed glioblastoma is still in the planning stages so that results are several years away.

There has previously been a similar strong signal of efficacy in a trial of Prophage G-200 in recurrent glioblastoma; almost all patients die or have their disease recur in a three to four year period and about one-half die within 18 months. This earlier trial showed an improvement in OS of 2.5 months. Avastin was approved in the recurrent setting even though it showed no improvement in OS; the basis of its approval was shrinkage in tumor size in a small number of patients. A NCI sponsored randomized, placebo-controlled Phase II trial involving 222 patients is now underway in recurrent glioblastoma. If results substantiate a meaningful improvement in OS, this could be the basis for approval as early as 2015 or 2016.

The conventional wisdom on Wall Street is that cancer vaccines don't work. This is based on a long string of failed attempts to develop such products. The only cancer vaccine that has been approved is Provenge, which showed a 4.5 month improvement in OS in metastatic prostate cancer. I sometimes feel like Don Quixote tilting at windmills when I write positively on cancer vaccines. Others are enormously skeptical.

However, I remain undaunted. We have seen signals of efficacy similar to Prophage in three other glioblastoma cancer vaccines: Northwest Biotherapeutics (NWBO) DC Vax-L, ImmunoCellular's (IMUC) ICT-107 and Celldex's (CLDX) rindopepimut. It may be the case that encouraging findings in these three other products occurred by chance and that each product will fail in Phase III trials. This seems to be what most people think, but I am much more hopeful.

Let me anticipate the next question. Which of these products will win out if all are successfully developed in glioblastoma and approved? There is not enough data for me to try to answer this question. However, I think that past experience suggests that each product might work in some patients and not in others and that they would be used sequentially or in combination. I think that they would likely all do well in glioblastoma from a commercial standpoint if they are approved.

The really important point, however, is that cancer vaccine technology would be validated and would suggest applications in a broad, broad range of tumors. Cancer vaccines might be seen as a major advance in cancer therapy and each of these small companies would be viewed as leaders in the field. It is possible/probable that each would be acquired by Big Pharma companies before their products were ever introduced.

Investment Thesis for Agenus

Let me touch now on the investment thesis for Agenus. In my initiation report, I pointed out that Agenus has a broad portfolio of products in development. One of the two most important in the near term is the MAGE A-3 vaccine for metastatic melanoma and non-small cell lung cancer. This is a Glaxo (GSK) product that used Agenus's QS-21 as an adjuvant. However, the most important Agenus asset is probably the Prophage programs in newly diagnosed and recurrent glioblastoma, which remain wholly owned by Agenus.

The recent failure of the MAGE A-3 vaccine to reach one of its co-primary endpoints of disease free survival in metastatic melanoma touched off a sharp decrease in the price of Agenus. I pointed out at the time that there are several ways for investors to win with Agenus and I think that the recent news on Prophage in newly diagnosed glioblastoma illustrates this as the previous price decline was essentially reversed with the news on Prophage. The stock closed at $3.71 before the news on MAGE A-3 on September 5, 2013 was announced and the news caused the stock to decline to close at $2.84 the next day. The report on Prophage on September 17 led to an inter-day high of $3.68. However, the announcement later that day of a financing then drove the stock back to $2.98 or so.

I think that the potential for Prophage more than justifies buying the stock at current prices. However, there is also the potential that new data from the RTS,S malaria trial and the Phase II trial of HerpV in genital herpes could provide a new boost to the stock as results are expected before the end of the year.

I also advised in my last note not to write off the MAGE A-3 vaccine just yet. The trial in metastatic melanoma did not hit one of the two co-primary endpoints of disease free survival. However, the Independent Data Monitoring Committee unanimously recommended that the trial continue to the second co-primary endpoint. This is PFS in a prospectively identified sub-population in the trial that has a unique gene signature or profile. Results in this sub-population will be reported in 2015. There will also be OS data from the melanoma trial and results from the use of MAGE A-3 in non-small cell lung cancer reported in 2014. There are good arguments that PFS could be reached in non-small cell lung cancer. Refer to my report written on September 5, 2013 for a more detailed discussion.

Late Breaking News on Financing

Agenus just announced that it has issued 2.2 million shares and 650,000 warrants exercisable at $3.75 to raise $6.5 million. The Company had $13 million at the end of 2Q 2013 and has a current burn rate of $4 to $5 million per quarter. This new cash infusion suggests a year end cash balance of about $9 million assuming no new cash infusions. Agenus is clearly looking at the prospects for partnering HerpV or Prophage in late 2013 or early 2014 to make a meaningful contribution to covering the cash burn in 2014 and beyond.

Agenus now has 30.0 million shares outstanding, 3.7 million options, 3.3 million warrants and 0.5 million shares underlying non-vested shares and convertible preferred stock. Not all of the options and warrants are likely to be exercised, but for the sake of conservatism, let's assume that they are. In this case, Agenus would have 37.5 million fully diluted shares outstanding. Based on this and the recent price of $2.98 the fully diluted market capitalization is $112 million.

Update on Trial of Prophage in Newly Diagnosed Glioblastoma

Agenus reported updated data from a Phase II trial in 46 patients with newly diagnosed glioblastoma treated with a combination of Prophage G-100 and standard of care. The principal endpoints of the trial that investors focus on are median overall survival (OS) and median progression free survival (PFS). For those not familiar with statistics, the median is the numerical value separating the higher half of a data sample from the lower half. The median of a finite list of numbers can be found by arranging all the observations from lowest value to highest value and determining the middle number, e.g., the median of the series of five numbers 1, 4, 5, 8 and 9 is 5.

This Phase II trial included 46 patients and the primary endpoint is median overall survival (OS). At this most recent look, the median overall survival was 23.3 months and the median progression free survival was 17.8 months. In this report I focus on OS because this is the primary endpoint of this trial and will almost certainly be the primary endpoint if a Phase III trial is conducted. Because this trial was not randomized with some patients given standard of care, patients treated with Prophage cannot be directly compared to a control group receiving standard of care. To put the results in perspective, we must look at results obtained with standard of care in other trials.

The standard of care in glioblastoma is surgical resection followed by a regimen of radiation and temozolomide. This was first defined in the Stupp trial whose results were published in the March 10, 2005 issue of the New England Journal of Medicine. The data from that trial showed that median overall survival for surgery followed by radiation and temozolomide was 14.6 months. This compared to 12.1 months in the group that only received surgery followed by radiation, the previous SOC. The accepted OS for SOC became 14.6 months, but this has since been revised upward.

In a May 9, 2009 issue of the Lancet, data on a subset of patients in the Stupp trial was presented. These were patients who underwent gross total resection that was enhanced by gadolinium imaging followed by radiation and temozolomide. In this group, OS was 18.8 months and this became accepted as the expected result for standard of care. Quite recently, Roche (RHHBY.OB) and the RTOG completed two large trials comparing Avastin added to standard of care in glioblastoma (more of this later). The median overall survival was 15.7 and 16.7 months for standard of care in these trials. Because the Avastin trials were very large trials that enrolled 637 patients in one trial and 921 in a second, I think that they are more accurate in defining OS for standard of care.

How Good are the Results?

I think that with some confidence we can assume that SOC or surgical resection followed by radiation and temozolomide leads to OS of about 16.2 months, which is the average shown in the two Avastin trials. Prophage G-100 is showing OS of 23.3 months which is a 7.1 month improvement in OS relative to standard of care. So, is that good or bad? Investigators generally consider a 4 to 5 month improvement in OS as being a significant advance. For example, the recently introduced Zytiga and Xtandi showed a 4 to 5 month improvement in OS in metastatic prostate cancer. In the previously reported Stupp trial, the improvement in OS attributable to temozolomide in glioblastoma was 2.5 months.

Viewed against these drugs, the 7.1 month improvement in OS demonstrated by Prophage in this patient group was extremely impressive. Of course, the next question is what this might mean in terms of commercial success? Following their introduction less than three years ago, Zytiga and Xtandi sales should reach about $1.5 billion and $400 million respectively in 2013. Because prostate cancer is more prevalent than glioblastoma, this only means that clinicians considered the OS results as significant and quickly incorporated them into their practices. However, temozolomide with a meager OS improvement of 2.5 months in glioblastoma went on to achieve peak sales of over $1 billion. This provides more insight on potential in glioblastoma.

Reported OS for Prophage Could Improve from 23.3 Months

In the current trial of 46 patients, 13 patients have died. Of the remaining patients who are alive, 9 are beyond 23.3 months of survival and 24 have not yet reached 24 months. Remember that median overall survival of 23.3 months means that of the 13 patients who have died, the median patient died at 23.3 months. This statistic changes with each additional death in the trial.

The history of immunotherapy is that it takes a while to take effect. It also seems to be the case that patients who respond to the therapy can experience some very long survivals. This was shown in the Phase I trials of Northwest Biotherapeutics' DC Vax-L and ImmunoCellular's ICT-107 in their Phase I trials. This was also seen with Bristol-Myers Squibb's (BMY) checkpoint inhibitor Yervoy. If this holds true with Prophage, I would expect to see the OS improve as more patients in the trial die. My expectation is that OS will improve from 23.3 months.

Prophage Results in Recurrent Glioblastoma are Also Encouraging

Agenus has previously reported encouraging results for Prophage G-200 in recurrent glioblastoma. In 2012, results from a trial of 40 patients given Prophage were reported. There was no control group in the trial, but results were compared to that for 86 consecutive patients not enrolled in the Prophage G-200 trial who were treated with alternative therapies during the study period.

The OS for Prophage was 10.9 months and the OS for the surrogate control group was 7.5 months for an improvement of 2.4 months. How good is this? One way of looking at this is that temozolomide only produced a 2.5 month improvement in newly diagnosed glioblastoma in which patients have a much longer expected survival time than those who suffer recurrences.

Another way of viewing these results is to look at Avastin, which is approved for recurrent glioblastoma. The package label for Avastin for recurrent glioblastoma states the following. The effectiveness of Avastin is based on improvement in the objective response (shrinking the size of the tumor). There is no data showing improvement in OS or PFS. There were two trials that supported approval; one showed an objective response of 19.6% in patients and the other showed 25.9%.

If the Prophage Phase II results in recurrent glioblastoma hold up, the improvement in OS of 2.5 months would be a major advance over Avastin, which has shown no improvement. Prophage G-200 is currently in a Phase II trial involving 222 patients. If the results are positive, this could be the basis for approval in 2015 or 2016 and would likely be the first cancer vaccine approved in glioblastoma.

More on the Recent Avastin Trials in Newly Diagnosed Glioblastoma

Roche recently reported results in two large Phase III trials of Avastin in newly diagnosed glioblastoma. RTOG 0825 was a 978 patient trial with 637 randomized patients. There was no improvement of OS, which was 15.7 months for Avastin as compared to 16.1 months for SOC. PFS of 10.7 months was an improvement versus 7.3 months for SOC. In the second trial, AVAglia there were 921 patients enrolled. The OS of 16.7 months for Avastin was the same as the 16.7 months seen with SOC. PFS was 10.6 months for Avastin versus 6.2 months for SCO.

Avastin has shown very modest efficacy, if any, first in recurrent glioblastoma and now in newly diagnosed glioblastoma. I would be shocked if the FDA approves it for newly diagnosed glioblastoma.

Disclosure: I am long AGEN, BMY, NWBO, IMUC. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article. (More...)

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Tuesday, 20 August 2013

Glioblastoma response to anti-angiogenesis therapy revealed by new MR analysis technique

Main Category: Cancer / Oncology
Also Included In: MRI / PET / Ultrasound; Neurology / Neuroscience
Article Date: 20 Aug 2013 - 1:00 PDT Current ratings for:
Glioblastoma response to anti-angiogenesis therapy revealed by new MR analysis technique
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A new way of analyzing data acquired in MR imaging appears to be able to identify whether or not tumors are responding to anti-angiogenesis therapy, information that can help physicians determine the most appropriate treatments and discontinue ones that are ineffective. In their report receiving online publication in Nature Medicine, investigators from the Martinos Center for Biomedical Imaging at Massachusetts General Hospital (MGH), describe how their technique, called vessel architectural imaging (VAI), was able to identify changes in brain tumor blood vessels within days of the initiation of anti-angiogenesis therapy.

"Until now the only ways of obtaining similar data on the blood vessels in patients' tumors were either taking a biopsy, which is a surgical procedure that can harm the patients and often cannot be repeated, or PET scanning, which provides limited information and exposes patients to a dose of radiation," says Kyrre Emblem, PhD, of the Martinos Center, lead and corresponding author of the report. "VAI can acquire all of this information in a single MR exam that takes less than two minutes and can be safely repeated many times."

Previous studies in animals and in human patients have shown that the ability of anti-angiogenesis drugs to improve survival in cancer therapy stems from their ability to "normalize" the abnormal, leaky blood vessels that usually develop in a tumor, improving the perfusion of blood throughout a tumor and the effectiveness of chemotherapy and radiation. In the deadly brain tumor glioblastoma, MGH investigators found that anti-angiogenesis treatment alone significantly extends the survival of some patients by reducing edema, the swelling of brain tissue. In the current report, the MGH team uses VAI to investigate how these drugs produce their effects and which patients benefit.

Advanced MR techniques developed in recent years can determine factors like the size, radius and capacity of blood vessels. VAI combines information from two types of advanced MR images and analyzes them in a way that distinguishes among small arteries, veins and capillaries; determines the radius of these vessels and shows how much oxygen is being delivered to tissues. The MGH team used VAI to analyze MR data acquired in a phase 2 clinical trial - led by Tracy Batchelor, MD, director of Pappas Center for Neuro-Oncology at MGH and a co-author of the current paper - of the anti-angiogenesis drug cediranib in patients with recurrent glioblastoma. The images had been taken before treatment started and then 1, 28, 56, and 112 days after it was initiated.

In some patients, VAI identified changes reflecting vascular normalization within the tumors - particularly changes in the shape of blood vessels - after 28 days of cediranib therapy and sometimes as early as the next day. Of the 30 patients whose data was analyzed, VAI indicated that 10 were true responders to cediranib, whereas 12 who had a worsening of disease were characterized as non-responders. Data from the remaining 8 patients suggested stabilization of their tumors. Responding patients ended up surviving six months longer than non-responders, a significant difference for patients with an expected survival of less than two years, Emblem notes. He adds that quickly identifying those whose tumors don't respond would allow discontinuation of the ineffective therapy and exploration of other options.

Gregory Sorensen, MD, senior author of the Nature Medicine report, explains, "One of the biggest problems in cancer today is that we do not know who will benefit from a particular drug. Since only about half the patients who receive a typical anti-cancer drug benefit and the others just suffer side effects, knowing whether or not a patient's tumor is responding to a drug can bring us one step closer to truly personalized medicine - tailoring therapies to the patients who will benefit and not wasting time and resources on treatments that will be ineffective." Formerly with the Martinos Center, Sorensen is now with Siemens Healthcare.

Study co-author Rakesh Jain, PhD, director of the Steele Laboratory in the MGH Department of Radiation Oncology, adds, "This is the most compelling evidence yet of vascular normalization with anti-angiogenic therapy in cancer patients and how this concept can be used to select patients likely to benefit from these therapies."

Lead author Emblem notes that VAI may help further improve understanding of how abnormal tumor blood vessels change during anti-angiogenesis treatment and could be useful in the treatment of other types of cancer and in vascular conditions like stroke. He and his colleagues are also exploring whether VAI can identify which glioblastoma patients are likely to respond to anti-angiogenesis drugs even before therapy is initiated, potentially eliminating treatment destined to be ineffective. A postdoctoral research fellow at the Martinos Center at the time of the study, Emblem is now a principal investigator at Oslo University Hospital in Norway and maintains an affiliation with the Martinos Center.

Article adapted by Medical News Today from original press release. Click 'references' tab above for source.
Visit our cancer / oncology section for the latest news on this subject.

Additional co-authors of the Nature Medicine paper are Kim Mouridsen, PhD, Christian Farrar, PhD, Dominique Jennings, Ronald Borra, PhD, and Bruce Rosen, MD, PhD, Martinos Center at MGH; Rakesh Jain, PhD, Steele Laboratory of Tumor Biology, MGH Radiation Oncology; Atle Bjornerud, PhD, University of Oslo, Norway; Patrick Wen, MD, Dana-Farber Cancer Institute; and Percy Ivy, MD, National Cancer Institute. Support for the study includes numerous grants from the U.S. Public Health Service, the National Cancer Institute and other funders.

Vessel architectural imaging identifies cancer patient responders to anti-angiogenic therapy

Kyrre E Emblem, Kim Mouridsen, Atle Bjornerud, Christian T Farrar, Dominique Jennings, Ronald J H Borra, Patrick Y Wen, Percy Ivy, Tracy T Batchelor, Bruce R Rosen, Rakesh K Jain & A Gregory Sorensen; Nature Medicine (2013) doi:10.1038/nm.3289

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