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Is Keytruda Approved For Prostate Cancer

Feeling Or Being Sick

Keytruda For Prostate Cancer | Ask a Prostate Expert, Mark Scholz, MD

Feeling or being sick is usually well controlled with anti sickness medicines. Avoiding fatty or fried foods, eating small meals and snacks, drinking plenty of water, and relaxation techniques can all help.

It is important to take anti sickness medicines as prescribed even if you dont feel sick. It is easier to prevent sickness rather than treating it once it has started.

Zytiga May Be More Effective In Black Men Than White Men

ASCO also provided insight into how currently-approved prostate cancer drugs may interact with different population groups.

One trial, from Duke University in Durham, North Carolina, found black men were more likely to have a decline in an indicator of prostate cancer response than white men when treated with Zytiga. The study was the first prospective study to compare outcomes of Zytiga for advanced prostate cancer in black men and white men, the trial authors said. Their findings confirm previous retrospective observations suggesting a stronger cancer response to Zytiga in black men.

The study sought to address the issue of under-representation of ethnic minorities in clinical trials in most the percentage of minority participants, including black patients, is disproportionately lower than the representation of the same racial group in the general population. Black men were also under-represented in the trial that led to Zytigas approval in this indication, mCRPC.

Although time to radiographic progression was similar between the two groups, when researchers looked at prostate-specific antigen , a marker of cancer response and progression, they found differences by race.

Our research underscores the importance of specifically studying genetically diverse populations and raising awareness of these results, so that everyone who can benefit from abiraterone is offered this treatment.

Advaxis And Merck Announce Initiation Of Enrollment In The Phase 1/2 Study Of Adxs

KEYNOTE-046 is the second trial initiated to evaluate KEYTRUDA, and the first-in-human study of ADXS-PSA, for prostate cancer

Advaxis, Inc., a clinical-stage biotechnology company developing cancer immunotherapies, and Merck , known as MSD outside the U.S. and Canada, announced that enrollment has initiated in the Phase 1/2 clinical trial evaluating the combination of ADXS-PSA , an investigational Lm-LLO immunotherapy, and KEYTRUDA® , the first anti-PD-1 therapy approved in the United States, in patients with previously treated, metastatic castration-resistant prostate cancer . The clinical trial, KEYNOTE-046, is the first-in-human study of Advaxiss lead Lm-LLO immunotherapy candidate for prostate cancer. It is the second study initiated to evaluate the use of KEYTRUDA in the treatment of advanced prostate cancer.

ADXS-PSA and KEYTRUDA are members of a class of cancer treatments known as immuno-oncology therapies. Data from preclinical studies suggest that Advaxis Lm-LLO immunotherapies in combination with a PD-1 antibody may lead to an enhanced anti-tumor immune response. The results from KEYNOTE-046 will determine the future clinical development program for the combination.

About Prostate Cancer

About ADXS-PSA

About KEYTRUDA®

Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 70 clinical trials across more than 30 tumor types and over 8,000 patients both as a monotherapy and in combination with other therapies.

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Keytruda Benefits A Small Proportion Of Men With Late

HomeNews & MediaNewsKeytruda benefits a small proportion of men with late-stage metastatic prostate cancer

10 December 2019

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Keytruda is an immunotherapy drug that has revolutionised treatment for cancers such as melanoma and lung cancer. Unfortunately, the same level of success has not been seen for prostate cancer. Now a new study has some hopeful results, showing a small proportion of men with late-stage prostate cancer will benefit from Keytruda.

In May 2017, the US Food and Drug Administration for the first time approved a cancer treatment based on a common biomarker, rather than the location in the body where the tumour originated. The drug, Keytruda , was approved for use by patients who have tumours carrying a genetic defect that makes them susceptible to the drug. Keytruda is a very successful cancer drug that is now used to treat many different types of cancer in Australia.

How does Keytruda work?

Keytruda is called a checkpoint blockade inhibitor. It targets proteins called PD-1 receptors on the surface of immune cells. This receptor is responsible for stopping the immune system from fighting against the bodys own cells. Tumours make inhibitors that bind to this receptor, shutting down all immune responses from the cells with PD-1 receptors. By stopping this happening, Keytruda makes it easier for the immune cells to recognise cancer cells and fight against them.

The Keynote-199 study

Cohort 2 : tumour samples did not show inhibitors of PD-1.

When You Have Pembrolizumab

First Major Trial Of Keytruda For Prostate Cancer Shows It ...

You usually have pembrolizumab every 3 to 6 weeks. It takes about 30 minutes each time you have it. You have pembrolizumab for as long as it works and the side effects are not too bad. You usually have it for up to 2 years, but some people might have treatment for longer than 2 years.

Depending on your cancer type, you might have pembrolizumab on its own or with other cancer treatments.

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Keytruda For Superior Prostate Most Cancers

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Keytruda In Clinical Trials For Prostate Cancer

Keytruda has been and is being tested in several completed and ongoing clinical trials for prostate cancer, alone and in combination with other drugs.

Results from a Phase 2 trial carried out by the OHSU Knight Cancer Institute demonstrated that Keytruda could be effective in advanced prostate cancer patients treated with Xtandi . The trial, which is still recruiting patients at a site in Oregon, aims to treat 58 patients.

Patients will receive Keytruda once every three weeks for four treatment cycles, along with standard-of-care Xtandi. Following a monitoring phase, patients will receive four more doses of Keytruda, then will be followed for up to two and a half years.

Data from the first 10 men, whose cancer was continuing to progress on Xtandi but who were treated as part of the trial, were published in the medical journal Oncotarget. Three of these 10 men responded to Keytruda, with a decrease in prostate-specific antigen , a marker associated with prostate cancer, to almost undetectable levels in their blood. One patients PSA levels decreased from 2,503 to 0.1 ng/ml, an unprecedented reduction. All three of these patients remained free of progression at their last reported follow-up. Two of them also saw a reduction in their tumor size and symptoms.

However, not all patients responded to the drug, and researchers are uncertain which factors could influence this. Future studies are being planned by OHSU.

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Keytruda For Prostate Cancer

Home» Keytruda for Prostate Cancer

Keytruda is a cancer immunotherapy drug developed by Merck .

On May 23, 2017, Keytruda was granted accelerated approval by the U.S. Food and Drug Administration for the treatment of solid tumors with a specific genetic marker, including prostate cancer.

The drug is still under investigation for other types of prostate cancer.

Good News But More To Learn

Prostate Cancer Treatments Keytruda

This new approval is exciting, and it will have an immediate impact on patient care. However, its important to stress that TMB status is just one piece of information about a tumor. Its relevance to treatment may depend on a number of factors, including a patients physical ability and willingness to tolerate further treatment.

In KEYNOTE-158, most patients with TMB-H tumors didnt benefit from pembrolizumab, and a small percentage of patients whose tumors had a low TMB did respond to treatment. This suggests we still have more to learn in order to predict who will respond to immunotherapy drugs.

There is evidence, for example, that the extent of TMB required to improve the likelihood of responding to immunotherapy may vary from cancer to cancer. Information such as whether cancer type influences treatment response is important, because no cancer treatment comes without side effects, including financial toxicity.

Larger studies of pembrolizumab, which are required by FDA as part of an accelerated approval, and other research being supported by NCI can hopefully provide answers to these questions. Those answers can then help patients and their doctors have informed discussions and engage in a true process of . For patients with advanced cancer and their families, such discussions are vital.

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Keytruda Approved For Patients With Previously Treated Metastatic Small

Lung cancer is the second most frequently diagnosed malignancy in both men and women , and the leading cause of cancer deaths overall. Nonsmall-cell lung cancer is the most common type, with the more aggressive small-cell lung cancer making up approximately 10% to 15% of cases.

On June 17, 2019, the US Food and Drug Administration granted accelerated approval to pembrolizumab for the treatment of patients with metastatic SCLC who have progressive disease following platinum-based chemotherapy and at least 1 other previous line of therapy. This approval marks the first time the immunotherapeutic agent has been indicated for the treatment of patients with SCLC.

Pembrolizumab, an antiPD-1 therapy, was previously approved as monotherapy for first-line treatment of patients with metastatic NSCLC whose tumors had a PD-L1 tumor proportion score of 50%. In April 2019, the FDA expanded pembrolizumabs indication to include the first-line treatment of patients with unresectable stage III NSCLC and for patients who are ineligible to undergo definitive chemoradiation, as well as those with metastatic disease. Patients who are eligible to receive pembrolizumab must have tumors that express PD-L1, a TPS of 1% as determined by an FDA-approved test, and no EGFR or ALK mutations.

Finding Prostate Cancer Patients Who Respond To Immunotherapy A Challenge Expert Cautions

byKristin Jenkins, Contributing Writer, MedPage Today December 10, 2019

Pembrolizumab monotherapy demonstrated antitumor activity with manageable safety in a small subgroup of men with previously treated metastatic castrate-resistant prostate cancer , researchers found.

Results from the first three cohorts in the five-cohort phase II, open-label, multi-center KEYNOTE-199 trial showed a combined overall response rate to pembrolizumab monotherapy in nine patients out of 199 in cohorts 1 and 2 combined. The combined median duration of response was 16.8 months, said Johann Sebastian de Bono, MD, PhD, of the Institute of Cancer Research and the Royal Marsden Hospital in London, and colleagues.

An ongoing response was observed in five patients at data cutoff with four responders remaining on treatment after 21.8 months, they reported in the Journal of Clinical Oncology.

“These data add to the growing body of evidence that suggests that, despite its more immunosuppressive microenvironment, a small number of select patients with mCRPC may benefit from pembrolizumab,” the authors wrote.

Patients with DNA repair mutations appeared to respond particularly well to immunotherapy, said de Bono, who added that two of his own patients have been on pembrolizumab for more than 2 years. Local biomarker testing by immunohistochemistry revealed a mismatch repair defect that was below the cutoff for high microsatellite instability by mSINGS assay.

Disclosures

Primary Source

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Breast Cancer Data Vs Myths

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Prostate Cancer Drug Keytruda Shows Positive Results In A Few Men During First Clinical Trial

Keytruda  a new hope for oncology.

New prostate cancer drug Keytruda showed promising results in its first major clinical trial to test immunotherapy in some men with advanced prostate cancer.

Researchers from The Institute of Cancer Research and The Royal Marsden NHS Foundation Trust in London gave 258 men with the otherwise untreatable cancer the immunotherapy agent Keytruda . After a year, 38% of the men were still alive and 11% are still receiving the antibody, because their cancer stopped growing. Only 5% of men in the trial saw their tumors shrink or go away after treatment.

Prostate cancer affects 1 in 9 men and is the most common non-skin cancer in America, according to the Prostate Cancer Foundation. The one-year survival rate for men diagnosed with late-stage prostate cancer is 75%, according to National Cancer Institute data. That percentage drops to about 26% at five years.

Immunotherapy, which personalizes treatment based on the genetic make-up of tumors, is only successful for a minority of patients, professor Paul Workman, chief executive of the ICR, said in a statement.

“One of the major challenges with immunotherapy is that we dont have many reliable tests to pick out who will benefit,” Workman said. “This new trial has found that testing for mutations in DNA repair genes could be valuable marker of who will respond.”

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Keytruda For Advanced Prostate Cancer

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Immunotherapy For Prostate Cancer

Immunotherapy for prostate cancer works by helping a patients own immune system fight back against cancer cells. One immune therapy that has been approved by the FDA is a vaccine called sipuleucel-T , which spurs a patients immune system to attack prostate cancer cells. The vaccine is tailored to match each patients own immune system using the following process:

  • Using a special machine, white blood cells are removed from the patient over the course of a few hours.
  • In the lab, the white blood cells are exposed to a protein from prostate cancer cells called prostatic acid phosphatase. This exposure trains the white blood cells to recognize prostate cancer cells.
  • The trained cells are infused back into the patients body. The infused cells help other immune system cells attack the prostate cancer.
  • While sipuleucel-T does not appear to reduce PSA levels or stop prostate cancer growth, it may increase survival in patients with metastatic castration-resistant cancer who show few or no symptoms.

    Common side effects of the vaccine include fever, fatigue, chills, back and joint pain, headache and nausea. They are associated with the infusion period and usually only last for a few days.

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    When To Contact Your Team

    Your doctor or nurse will go through the possible side effects. They will monitor you closely during treatment and check how you are at your appointments. Contact your advice line as soon as possible if:

    • you have severe side effects
    • your side effects arent getting any better
    • your side effects are getting worse

    Early treatment can help manage side effects better.

    Merck Plans Trio Of Phase 3 Keytruda Studies In Prostate Cancer

    Immunotherapy for Prostate Cancer – Provenge or Keytruda?
    • Merck & Co. said Thursday it plans to launch three pivotal Phase 3 studies testing different combination therapies involving its blockbuster immunotherapy Keytruda in patients with a difficult-to-treat form of prostate cancer.
    • The big pharmasdecision stemmed from Phase 1b/2 data out of an umbrella study of Keytruda in metastatic, castration-resistant prostate cancer , said Roy Baynes, chief medical officer at Merck Research Laboratories, in a statement. The results were presented at an oncology conference Thursday.
    • The three pivotal Phase 3 studies will all assess overall survival as a co-primary endpoint, and the new studies give Merck the largest clinical program for an anti-PD-1 therapy in prostate cancer, the company claimed.

    Checkpoint inhibitors like Mercks Keytruda have changed cancer care across a number of tumor types, but none are currently approved for prostate cancer. Neither are any of three PARP inhibitors currently on the U.S. market for ovarian and breast cancers.

    Merck hopes to change that through these late-stage studies, pairing Keytruda with the PARP inhibitor Lynparza , chemotherapy and approved prostate cancer agent Xtandi .

    Patients with mCRPC pose a particular challenge to treat. Metastatic cancer has spread to other parts of the body, while castration-resistant tumors have continued to grow despite surgery or treatment to lower the amount of male sex hormones, or androgens, that typically drive prostate cancer.

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