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First-line immunotherapy treatment can improve survival for subset of lung cancer patients

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Results of phase III global clinical trial show that 75 percent of stage IV lung cancer patients with both complex tumor mutations and PDL-1 positive status respond to nivolumab.

Findings from a phase III clinical trial for advanced lung cancer patients could help oncologists better predict which patients are likely to receive the most benefit from immunotherapy as a first-line treatment based on the unique molecular characteristics of their tumor, according to a new study reported by a global team led by David Carbone, MD, PhD, of The Ohio State University Comprehensive Cancer — Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (OSUCCC — James).

In this study, researchers compared the effectiveness of the immunotherapy drug nivolumab (pronounced “nye VOL ue mab,” marketed at Opdivo), with standard-of-care chemotherapy in 541 patients with previously untreated or recurrent non-small cell lung cancer (NSCLC) that expressed PDL-1 antibodies.

Nivolumab is part of a class of immunotherapy drugs known as PD-1 blocking antibodies. These drugs work by targeting the PDL-1 receptor — a known immunotherapy biomarker for lung and other cancers — to boost immune responses to the cancer.

Patients were randomized to receive either immunotherapy or standard-of-care chemotherapy. About 60 percent of patients treated on the trial ultimately crossed over to the immunotherapy treatment arm due to disease progression.

Results from this new study showed that nivolumab did not result in longer progression-free survival compared with chemotherapy in the overall population. The response rate for patients receiving nivolumab was 26.1 percent, with a 12.1 month median duration of response before disease progression. The response rate for patients treated on the chemotherapy arm was 33.5 percent, but median duration of response was just 5.7 months before disease progression.

“The good news is that we discovered that a subset of patients who had both high tumor mutation burden and high PDL-1 positive status did experience a significant benefit from immunotherapy,” says Carbone.

Patients with both high tumor mutation burden and high PDL-1 positive status had a 75 percent response rate compared with a 16 percent response rate to immunotherapy among patients with low mutation burden and low PDL-1. These same two groups had 25 percent and 23 percent response rates, respectively, when treated with chemotherapy, showing that these markers were selective for immunotherapy.

Understanding a patient’s overall tumor burden through genomic testing, says Carbone, could help identify patients most likely to benefit from immunotherapy before therapy ever begins.

“This study is an important step toward understanding the impact of tumor mutation burden and PDL-1 in immunotherapy response. This data shows we should evaluate these two factors independently to most accurately define who will benefit from immunotherapy,” says Carbone.

The findings are reported in the June 22, 2017, issue of the New England Journal of Medicine.

Source: https://www.sciencedaily.com/releases/2017/06/170621190037.htm

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Immunotherapy found safe for type 1 diabetes in landmark trial

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Type 1 diabetes is believed to be an autoimmune disorder, so does this mean that immunotherapy could be used to treat it? A landmark trial has investigated the safety of such a therapeutic approach.
The Centers for Disease Control and Prevention (CDC) report that up to 1.05 million people in the United States – or 5 percent of the country’s diabetic population – have type 1 diabetes.

The condition is thought to be an autoimmune disorder in which the body’s immune system – its T cells, specifically – does not recognize the pancreas’ insulin-producing beta cells and mistakenly attacks them. At present, there are no treatments for preventing T cells from killing off the body’s beta cells.

Despite the belief that type 1 diabetes is an autoimmune condition, few studies have tested the possible benefits of immunotherapies in treating the condition, perhaps due to concerns that they might make it worse.

For type 1 diabetes, immunotherapies consist of molecules that imitate a proinsulin peptide. In this context, researchers based in the United Kingdom set out to examine the benefits of immunotherapy in a landmark trial that included a placebo control group.

The study’s first author is Dr. Mohammad Alhadj Ali, of the Cardiff University School of Medicine in the U.K., and the corresponding author is Mark Peakman, Ph.D., a professor of clinical immunology at King’s College London, also in the U.K.

The results were published in the journal Science Translational Medicine.

Proinsulin peptide immunotherapy is ‘safe’

Dr. Ali and team examined the effect of the peptide in 27 people who had been diagnosed with type 1 diabetes within the previous 100 days.
For 6 months, the participants received either shots of the immunotherapy or the placebo at 2- or 4-week intervals. Their C-peptide levels – which are markers of insulin – were tested at 3, 6, 9, and 12 months, and they were compared with baseline levels.

The trial found no evidence of toxicity or negative side effects, and beta cells were not impaired or reduced as a consequence of the therapy. The authors write, “Treatment was well tolerated with no systemic or local hypersensitivity,” which led the researchers to conclude that “proinsulin peptide immunotherapy is safe.”

Additionally, “Placebo subjects showed a significant decline in stimulated C-peptide (measuring insulin reserve) at 3, 6, 9, and 12 months versus baseline, whereas no significant change was seen in the 4-weekly peptide group at these time points,” say the researchers.

Importantly, over a period of 12 months, the daily insulin intake in the placebo group increased by 50 percent, whereas the treatment group kept stable levels of insulin use.

Although the effects of immunotherapies need to be tested in larger cohorts, the trial offers an encouraging safety profile for the treatment. Speaking to Medical News Today about the clinical implications of such results, Prof. Peakman broke down the findings.

The good safety profile means 3 things:

(i) that we can progress to the next stage, which is to perform an efficacy trial and we hope to start this in 2018;

(ii) that this therapy may be acceptable in children, which is the main group developing type 1 diabetes;

(iii) that we may be able to give the peptide repeatedly over long periods, which may be required to gain full effects.
– Mark Peakman, Ph.D.

Regarding the limitations of the research, Prof. Peakman told us that the small sample size meant that the researchers could not examine how efficacious the treatment was. Consequently, in the future, the researchers plan to conduct a larger study in order to investigate the immunotherapies’ effect on disease progression.

Source: http://www.medicalnewstoday.com/articles/318899.php

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Immunotherapy found safe for type 1 diabetes in landmark trial

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Type 1 diabetes is believed to be an autoimmune disorder, so does this mean that immunotherapy could be used to treat it? A landmark trial has investigated the safety of such a therapeutic approach.


The Centers for Disease Control and Prevention (CDC) report that up to 1.05 million people in the United States – or 5 percent of the country’s diabetic population – have type 1 diabetes.

The condition is thought to be an autoimmune disorder in which the body’s immune system – its T cells, specifically – does not recognize the pancreas’ insulin-producing beta cells and mistakenly attacks them. At present, there are no treatments for preventing T cells from killing off the body’s beta cells.

Despite the belief that type 1 diabetes is an autoimmune condition, few studies have tested the possible benefits of immunotherapies in treating the condition, perhaps due to concerns that they might make it worse.

For type 1 diabetes, immunotherapies consist of molecules that imitate a proinsulin peptide. In this context, researchers based in the United Kingdom set out to examine the benefits of immunotherapy in a landmark trial that included a placebo control group.

The study’s first author is Dr. Mohammad Alhadj Ali, of the Cardiff University School of Medicine in the U.K., and the corresponding author is Mark Peakman, Ph.D., a professor of clinical immunology at King’s College London, also in the U.K.

The results were published in the journal Science Translational Medicine.

Proinsulin peptide immunotherapy is ‘safe’

Dr. Ali and team examined the effect of the peptide in 27 people who had been diagnosed with type 1 diabetes within the previous 100 days.
For 6 months, the participants received either shots of the immunotherapy or the placebo at 2- or 4-week intervals. Their C-peptide levels – which are markers of insulin – were tested at 3, 6, 9, and 12 months, and they were compared with baseline levels.

The trial found no evidence of toxicity or negative side effects, and beta cells were not impaired or reduced as a consequence of the therapy. The authors write, “Treatment was well tolerated with no systemic or local hypersensitivity,” which led the researchers to conclude that “proinsulin peptide immunotherapy is safe.”

Additionally, “Placebo subjects showed a significant decline in stimulated C-peptide (measuring insulin reserve) at 3, 6, 9, and 12 months versus baseline, whereas no significant change was seen in the 4-weekly peptide group at these time points,” say the researchers.

Importantly, over a period of 12 months, the daily insulin intake in the placebo group increased by 50 percent, whereas the treatment group kept stable levels of insulin use.

Although the effects of immunotherapies need to be tested in larger cohorts, the trial offers an encouraging safety profile for the treatment. Speaking to Medical News Today about the clinical implications of such results, Prof. Peakman broke down the findings.

The good safety profile means 3 things:

(i) that we can progress to the next stage, which is to perform an efficacy trial and we hope to start this in 2018;

(ii) that this therapy may be acceptable in children, which is the main group developing type 1 diabetes;

(iii) that we may be able to give the peptide repeatedly over long periods, which may be required to gain full effects.
– Mark Peakman, Ph.D.

Regarding the limitations of the research, Prof. Peakman told us that the small sample size meant that the researchers could not examine how efficacious the treatment was. Consequently, in the future, the researchers plan to conduct a larger study in order to investigate the immunotherapies’ effect on disease progression.

Source: http://www.medicalnewstoday.com/articles/318899.php

iMedWorks Ask Platform Links below:

1.  Get a Medical Second Opinion
2.  Search doctors and Request Appointment