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
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.
Fda Grants Full Approval To Keytruda For Urothelial Carcinoma Subset
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The FDA granted full approval to pembrolizumab for first-line treatment of certain patients with advanced urothelial carcinoma, according to the agents manufacturer.
The agency also approved a revised indication for pembrolizumab , an anti-PD-1 therapy, to include treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for platinum-containing chemotherapy.
the treatment landscape has evolved, an unmet need remains for appropriate patients newly diagnosed with certain types of advanced urothelial carcinoma who are not eligible for platinum-containing chemotherapy,Scot Ebbinghaus, MD, vice president of clinical research for Merck Research Laboratories, said in a company-issued press release. We are confident in the role Keytruda will continue to play for these patients, who have few other treatment options, and are working with urgency to advance studies to help more patients living with bladder and other types of cancer.
Earlier this year, the FDAs Oncologic Drugs Advisory Committee reviewed indications for several cancer drugs that received accelerated approval but subsequently failed to show clinical benefit in clinical trials.
In voting to maintain the approval, ODAC panel members noted the lack of therapies that otherwise would be available for patients ineligible for platinum-based chemotherapy.
Learning About Cancer And Tumor Mutational Burden
Having a TMB-H tumor is not a guarantee that pembrolizumab will be effective, but it is an opportunity, based on a robust evidence base that was developed in part by NCI-supported research and investigators.
Its also important to note that this is not the first tissue-agnostic FDA approval for pembrolizumab. In May 2017, it was approved to treat any cancer that has specific genetic alterations that affect a cells ability to repair damaged DNA, known as microsatellite instability high tumors. MSI-H and TMB-H are related, with most MSI-H tumors also showing increased TMB. The converse, however, is not truethat is, many TMB-H tumors are not MSI-H.
Moreover, MSI status does not necessarily need to be established through extensive tumor genomic testing, whereas TMB status generally does. So having a drug approval based on TMB is important, because it is more common in tumors than MSI-H, and thus should promote far greater adoption of tumor genomic testing.
Cancer cells that are MSI-H or TMB-H tend to produce a large number of mutant proteins, which are then often displayed on the cells’ surface as neoantigens. Since normal cells do not display such mutant proteins, the production of neoantigens can be a signal that draws the immune systems attention. That, in turn, can increase the likelihood that treatments like pembrolizumab, which strengthen the anti-tumor immune response, will help immune cells kill those tumors.
NCI Director Dr. Norman E. Sharpless
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Keytruda Approved To Treat Metastatic Small Cell Lung Cancer
The Food and Drug Administration has approved Keytruda for the treatment of patients with metastatic small cell lung cancer with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy.
The approval was based on data from 83 patients with SCLC who were enrolled in either the KEYNOTE-028 or KEYNOTE-158 trials. Patients received either Keytruda 200mg intravenously every 3 weeks or 10mg/kg IV every 2 weeks until disease progression, unacceptable toxicity, or a maximum of 24 months. The primary efficacy outcomes were objective response rate and duration of response .
Keytruda Approved For All Cancers With Specific Genetic Biomarker
Keytruda has been approved by the U.S. Food and Drug Administration to treat any cancer that has a certain genetic biomarker, regardless of where in the body the cancer originated.
The cancers targeted by this new drug have a biomarker referred to as microsatellite instability-high or mismatch repair deficient , the agency explained Tuesday in a news release. MSI-H/dMMR tumors are most often found in colorectal, endometrial, or gastrointestinal cancers, the FDA said. About 5% of patients with metastatic colorectal cancer have this biomarker.
Of 149 individuals with such tumors who took Keytruda in clinical trials, nearly 40% had a complete or partial remission. And for 78% of those patients, the drugs effects lasted 6 months or more, the FDA said. The drugs most common side effects included fatigue, pruritus, diarrhea, loss of appetite, rash, pyrexia, cough, and dyspnea.
Merck & Co.s Keytruda, first FDA-sanctioned in 2014, previously was approved to treat metastatic melanoma, metastatic non-small-cell lung cancer, recurrent or metastatic head and neck cancer, refractory classical Hodgkins lymphoma, and urothelial carcinoma.
New Combination Of Old Drugs Improves Survival In Patients With Prostate Cancer
Adding Zytiga plus prednisolone to standard therapy lengthened survival.
A novel combination of well-known drugs prolongs survival in patients with hormone/castration-sensitive prostate cancer, according to late breaking research presented at the European Society for Medical Oncology annual meeting .
For men with metastatic prostate cancer, androgen deprivation therapy was the standard of care for decades. In 2015, docetaxel was shown to improve survival when added to ADT and in 2017, abiraterone was also shown to improve survival when added to ADT. Until now, though, it was unknown whether one or both agents should be added to ADT to achieve the best outcomes. PEACE-1 found that using three drugs upfront is better than just two in men with metastatic prostate cancer, not only to postpone cancer progression, but also to prolong life. When AAP was added to ADT and docetaxel, men experienced an additional 25% reduction in the risk of death compared to ADT and docetaxel alone.
The trial found that at six years, men who had received standard treatment plus AAP for two years had an improvement in metastasis-free survival from 69% to 82%, an improvement in overall survival from 77% to 86% and an improvement in prostate cancer specific survival from 85% to 93%compared to standard treatment alone.
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
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.
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.
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Keytruda For Superior Prostate Most Cancers
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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.
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Feeling Or Being Sick
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.
Keytruda For Advanced Prostate Cancer
superior prostate most cancers prostate most cancers remedies. A new immunotherapy drug has been accredited for sufferers with a diffusion of cancers with a selected genetic signature. The fda ruling on keytruda opens the door to. Updated information for indoximod plus keytruda yahoo. Find out about keytruda might also treat, uses, dosage, facet effects, drug interactions, warnings, affected person labeling, reviews, and associated medicinal drugs. Discover new treatment for prostate most cancers at precision prostate center.
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A New Treatment For Advanced Prostate Cancer Improves Survival In Phase 3 Clinical Trial
- By Charlie Schmidt, Editor, Harvard Medical School Annual Report on Prostate Diseases
Radiation therapy is getting more precise, enabled by technologies that make it easier to kill tumors while sparing their surrounding tissues. Some newer therapies are even given intravenously instead of by machines, and they deliver radiation particles directly to the cancer cell itself. One of these new therapies a sort of smart bomb targeted at malignant cells is now generating promising data for men with the most aggressive prostate cancer.
In early June, investigators reported results from a phase 3 clinical trial showing that among men who received the experimental treatment, there was nearly a 40% reduction in deaths over the course of the study, compared to men who did not.
The treatment is called lutetium-177-PSMA-617, or LuPSMA, and it has two components: a compound that targets a cancer cell protein called prostate-specific membrane antigen, or PSMA, and a radioactive particle that destroys the cells. Healthy prostate cells don’t contain PSMA, or do at very low levels. And some men with prostate cancer have more of the protein than others. Doctors can detect the protein using a specialized imaging scan.
Results after 21 months showed that cancer progression was delayed for longer among the LuPSMA-treated men: 8.7 months on average versus 3.4 months among the controls. The treatment was also associated with better overall survival: 15.3 months versus 11.3 months.
Prostate Cancer Drug Keytruda Shows Positive Results In A Few Men During First Clinical Trial
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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Updates In Immune Checkpoint Inhibitors For Prostate Cancer
Journal of Clinical Oncology
- The prostate cancer tumor microenvironment has few T cells, thus activation of T cells by atezolizumab may not be expected to improve cancer control
- There may be multiple immunosuppressive pathways in the prostate cancer tumor microenvironment, thus targeting a single pathway may not yield a meaningful tumor biology response
- Since prostate cancer does not typically care a high mutation burden, T cells may not recognize and target prostate cancer sufficiently
- The impact of enzalutamide on the immune response in tumor microenvironment is unknown
Contribution Of Genomics Research
The role of NCI-supported research in helping to identify TMB as a biomarker of immunotherapy response is particularly gratifying.
For example, although TMB did not even exist as a concept at the time that The Cancer Genome Atlas was launched, researchers used TCGA data to perform wide-scale analyses of the relationship between tumor mutation numbers and immunotherapy response in the first place. The finding is another example of how building large, high-quality, and diverse sets of research data and making them publicly available can yield unexpected insights that lead to meaningful advances in treatment.
In addition, NCI has had a sustained and successful partnership with Foundation Medicine, the company that developed FoundationOne CDx, the test used to identify patients with TMB-H tumors for this approval. NCI-supported researchers made important contributions to the development of the technologies used by this test.
As should be expected, though, this is an extremely complicated area of research. Even with the best tests, measuring TMB and deciding what that measurement means for individual patientsin particular, estimating their likelihood of response to immunotherapyis far from straightforward.
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Merck Plans Trio Of Phase 3 Keytruda Studies In Prostate Cancer
- 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.