What's Intriguing And Concerning About Early Results For Keytruda In Breast Cancer

Note: This is an opinion piece about the recent news that the drug Keytruda has shown promise for treating triple-negative breast cancer (TNBC). It does not necessarily reflect the views of Cancer Commons.

“At first glance, it’s hard to get excited about the preliminary results of an early phase trial study of pembrolizumab (Keytruda, MK-3475) in women with triple-negative breast cancer (TNBC). The non-randomized study has, so far, yielded an overall response rate of 18.5 percent – only 5 among 27 evaluable patients.

“The findings drew attention at the San Antonio Breast Cancer Symposium, in part because TNBC is a notoriously hard-to-treat form of the disease. The work* was presented by Dr. Rita Nanda, of the University of Chicago, who led a multinational list of authors including academics and several Merck employees.

“Keytruda is a monoclonal antibody given by infusion. When it binds PD-1, as it’s engineered to do with high affinity, it can unleash the body’s normal immune cells to fight a tumor. Recently, the FDA approved Keytruda for use in advanced melanoma. Last week, at the annual meeting of the American Society of Hematology, investigators reported preliminary findings that the drug is well-tolerated and may be helpful in Hodgkin’s lymphoma.”


Early Trial of New Drug Shows Promise for Patients with Triple-Negative Breast Cancer

The gist: A drug called pembrolizumab (aka Keytruda or MK-3475) has shown promise for people with metastatic triple-negative breast cancer (TNBC) whose tumors have high levels of a protein called PD-L1.  It was recently tested in patients in a clinical trialPembrolizumab is already approved by the U.S. Food and Drug Administration (FDA) for treating melanoma. It is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer. More research will determine just how well pembrolizumab might work for TNBC.

“In patients with metastatic triple-negative breast cancer—a disease with no approved targeted therapies—infusion of pembrolizumab produced durable responses in almost one out of five patients enrolled in a phase-Ib clinical trial, according to data presented Dec. 10, at the 2014 San Antonio Breast Cancer Symposium.

“The multi-center, non-randomized trial was designed to evaluate the safety, tolerability and antitumor activity of bi-weekly infusions of pembrolizumab (MK-3475, marketed as Keytruda®). The researchers enrolled 27 patients, aged 29 to 72 years, who had metastatic triple-negative breast cancer that either relapsed after treatment for early stage disease or progressed on therapy for advanced disease.

” ‘For this group of patients our treatment options are limited to chemotherapy,’ said study director Rita Nanda, MD, assistant professor of medicine and associate director of the breast medical oncology program at the University of Chicago.

“All patients in the study had triple-negative tumors with high levels of a protein called programmed death-ligand 1 (PD-L1). This protein can suppress the immune system’s efforts to eliminate cancer cells. Pembrolizumab is a monoclonal antibody designed to help reactivate a person’s own immune system to help fight the tumor.”


ASCO 2014 Lung Cancer Roundup


Every year, thousands of people gather in Chicago, Illinois, for the American Society of Clinical Oncology (ASCO) Annual Meeting. The largest meeting of its kind, ASCO brings together doctors, researchers, nurses, patient advocates, pharmaceutical company representatives, and more to discuss the latest in cancer research. Here are some of the most exciting new developments in lung cancer research presented last week at ASCO 2014: Continue reading…


ASCO: Targeting PD-1 Works in Advanced Melanoma

“Two studies indicate that using investigative immunotherapy drugs improves survival and response in patients with metastatic melanoma, researchers said here.

“In one study, the agent pembrolizumab (MK-3475) which targets the programmed death (PD-1) pathway produced a 1-year 69% survival rate, said Antoni Ribas, MD, PhD, professor of medicine at the UCLA Jonsson Comprehensive Cancer Center in Los Angeles.

“In a second study reported in a press conference at the annual meeting of the American Society of Clinical Oncology, Mario Sznol, MD, professor of medicine at the Yale Cancer Center, demonstrated that a combination of the investigative PD-1 inhibitor nivolumab in combination with another targeted agent ipilimumab (Yervoy) produced a 1-year survival rate of 85% and 2-year survival rate of 79% for advanced melanoma patients.”

Editor’s note: Immunotherapy drugs boost a patient’s own immune system to fight cancer. Promising research into new immunotherapy drugs for melanoma was recently presented at the American Society of Clinical Oncology (ASCO) Annual Meeting. Two treatments that received special attention were MK-3475 (aka pembrolizumab) and a combination of the drugs ipilimumab (Yervoy) and nivolumab.


Tumor Size is Defining Factor to Response from Promising Melanoma Drug

“In examining why some advanced melanoma patients respond so well to the experimental immunotherapy MK-3475, while others have a less robust response, researchers at Mayo Clinic in Florida found that the size of tumors before treatment was the strongest variable.

“They say their findings, being presented June 2 at the 50th annual meeting of the American Society of Clinical Oncology (ASCO), offered several clinical insights that could lead to different treatment strategies and perhaps influence staging of advanced melanoma.”

Editor’s note: MK-3475 is a promising new immunotherapy drug that boosts a patient’s own immune system to fight cancer. It works very well for some patients, and not so well for others. New research shows that doctors may be able to predict whether MK-3475 will work well or not based on the size of a patient’s tumors before treatment. In the study, patients who had a large total volume of tumors were less likely to respond well to the drug, no matter where in the body those tumors were found.


Business: Washington Post Business Page, Business News

“Kim Sherman was in bad shape a year ago after a lemon-sized melanoma tumor in her pelvis stopped responding to standard targeted therapy. By late June 2013, the pain from the mass pressing on her hamstring became so bad she could hardly sleep, walk, or even sit down.

“Then she joined a trial on an experimental drug from Bristol-Myers Squibb Co. designed to boost the immune system against her tumor when used in combination with the company’s existing immune enhancing drug Yervoy. Within three weeks the pain started to subside, and within three months later the tumor disappeared. Her doctor at Yale Cancer Center in New Haven may stop therapy entirely in a few weeks, she said.”

Editor’s note: This article discusses immunotherapy treatments, which boost a patient’s own immune system to fight cancer. Learn more about immunotherapy for melanoma in The Basics.


MK3475 Induced High Rates of Durable Responses in Advanced Melanoma

“A majority of patients with advanced melanoma who had and had not received previous ipilimumab demonstrated durable responses with the PD-1 targeted antibody MK-3475, according to study results presented at the ASCO Annual Meeting.

“ ‘This is the largest phase 1 clinical trial ever conducted in this disease, and together with a lung cancer cohort, this is the largest phase 1 trial ever done in oncology,’ study investigator Antoni Ribas, MD, PhD, professor of medicine at the David Geffen School of Medicine at the University of California in Los Angeles, said during a press conference. ‘These are early data, but they tell us we are on to something really important.’ ”

Editor’s note: The cancer drug MK-3475 is an immunotherapy, meaning that it boosts a patient’s own immune system to fight cancer. This story describes a clinical trial that tested MK-3475 on volunteer patients with advanced melanoma, and found good results for a majority of the patients. Some of the patients had previously been treated with the drug ipilimumab (Yervoy) and some had not; both kinds of patients benefited from MK-3475 in the trial.


Immunotherapy Shows Promise Against Melanoma

“By unleashing the immune system to attack skin cancer, researchers have made important strides against melanoma, according to the results of three clinical trials released Monday.

“The first study presented at the American Society of Clinical Oncology annual meeting showed patients given a drug called Yervoy (ipilimumab), made by Bristol Myers-Squibb, saw a 25 percent reduced risk of the cancer coming back when compared to a placebo.”

Editor’s note: Immunotherapy treatments, which boost a patient’s own immune system to fight cancer, were a big topic this past weekend at the American Society of Clinical Oncology (ASCO) Annual Meeting. This article provides an overview of some new findings in immunotherapy for melanoma.


New Therapies Harness Power of the Immune System Against Cancer

“New research on innovative immunotherapies for advanced or high-risk melanoma and cervical cancer were presented today at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO). These treatments – used alone or in combination – fight cancer by activating and amplifying the body’s immune response to the disease.

“The new studies find high activity with investigative drugs for advanced melanoma, and show for the first time that ipilimumab, a treatment already approved for advanced melanoma, can substantially decrease the risk of melanoma recurrence in certain patients with earlier-stage disease. In addition, another small trial reports that a one-time, personalized immunotherapy treatment induces complete and long-lasting remissions in a small number of women with advanced cervical cancer – a disease with little to no effective treatment options.”

Editor’s note: Immunotherapies are treatments that boost a patient’s own immune system to fight cancer. Learn more.