In a head-to-head comparison between the immunotherapy drug pembrolizumab and standard chemotherapy as a first-line therapy for advanced nonsmall cell lung cancer, patients taking pembrolizumab had a 50 percent greater drop in the risk of death or disease progression and a four-month greater increase in progression-free survival compared with those who took chemotherapy.

JulieBrahmer2

Julie Brahmer

A report on these findings of an international clinical trial of 305 patients with stage 4 nonsmall cell lung cancer appeared Oct. 9 in The New England Journal of Medicine and is noted in today's Washington Post. What made the trial significant and novel, say the researchers, is that it included only people whose tumor cells were abundantly studded with so-called PD-L1 proteins.

“This is a group of patients we think should get anti-PD-1 therapy first before chemotherapy,” says Julie Brahmer, M.D., director of the Thoracic Oncology Program at the Johns Hopkins Kimmel Cancer Center co-director of the Upper Aerodigestive Program of the Bloomberg~Kimmel Institute for Cancer Immunotherapy. Pembrolizumab and another immunotherapy drug, nivolumab, are approved by the Food and Drug Administration to treat patients with advanced nonsmall cell lung cancer, but only after their cancers have progressed after treatment with chemotherapy.

Pembrolizumab, which is sold under the trade name Keytruda, blocks a molecular “handshake” between immune system T cells and cancer cells carrying PD-L1 proteins on their surface. With no handshake, T cells target the cancer cells for destruction.

Brahmer, who led the trial with a group of international scientists, says that another study showed little difference in progression-free survival of patients with nonsmall cell lung cancer who took a different PD-1 inhibitor compared with chemotherapy. “That study included nonsmall lung cancer patients with any level of PD-L1 protein on their tumors, but this study included only those with high levels of PD-L1 proteins on their tumor cells, whose tumors are more likely to respond,” says Brahmer. Some 23 to 28 percent of patients with advanced nonsmall cell lung cancer have high levels of PD-L1 proteins on their tumor cells. Nonsmall cell lung cancer accounts for more than 80 percent of an estimated 220,000 lung cancers diagnosed annually in the U.S.

For the study, funded by Merck, which makes pembrolizumab, tumor biopsy samples from 1,729 patients from 142 hospitals worldwide were evaluated by the researchers to determine which of them had more than 50 percent of tumor cells marked with PD-L1 proteins. From that group, 305 patients were randomly chosen to receive 35 intravenous doses of pembrolizumab over more than two years versus the standard treatment of four to six cycles over six months of one of five types of chemotherapy.

Among the two groups, 154 patients who received pembrolizumab had a median progression-free survival rate of 10.3 months, compared with six months for 151 patients on chemotherapy. Median follow-up was 11.2 months. The researchers estimated that patients who took pembrolizumab were 50 percent less likely to die from their cancer or have disease progression over the duration of the trial, which began in 2014. “Extending the time we can keep these patients’ cancer under control is an important step in creating more long-term survival,” says Brahmer.

The trial was stopped early because researchers’ interim analysis revealed the pembrolizumab’s benefit on progression-free survival. As a result, 66 patients who had received chemotherapy were switched to pembrolizumab, and more than half of them were still taking the drug at the end of the trial.

During the study, 108 patients died. One of the patients died after taking pembrolizumab potentially associated with that treatment, and three deaths were potentially caused by chemotherapy. The most common side effects in patients taking pembrolizumab were diarrhea, fatigue and fever. In patients taking chemotherapy, common side effects were anemia, nausea and fatigue.

“This study shows that immunotherapy can benefit some patients early on in their treatment, and our hope is that when we determine the best combinations of immunotherapy and targeted anticancer drugs, these patients may never need chemotherapy,” says Brahmer.

In her practice, Brahmer says treatment options for patients whose cancer progresses after taking pembrolizumab include clinical trials using combinations of immunotherapy drugs as well as chemotherapy.

Pembrolizumab’s cost can reach more than $100,000 annually for each patient, and Brahmer says her goal is to determine which groups of patients are more likely to benefit from it by itself. Plans are underway, she says, to study more closely the drug’s effectiveness in lung cancer patients whose cancers have lower levels of PD-L1 proteins.

Funding and materials for the study described in this press release were provided by Merck. Dr. Brahmer is also a paid consultant to Merck. This arrangement has been reviewed and approved by the Johns Hopkins University in accordance with its conflict of interest policies.

Researchers who contributed to the study include Martin Reck from the German Center for Lung Research; Delvys Rodriguez-Abreu from the Hospital Universitario Insular de Gran Canaria; Andrew Robinson from the Cancer Centre of Southeastern Ontario; Rina Hui from Westmead Hospital and the University of Sydney; Tibor Csoszi from the Jasz-Nagykun-Szolnok County Hospital; Andrea Fulop from Orszagos Koraanyi TBC es Pulmonologiai Intezet; Maya Gottfried from the Meir Medical Center; Nir Peled from the Davidoff Cancer Center; Ali Tafreshi from the Southern Medical Day Care Centre; Sinead Cuffe from the St. James’ Hospital and Cancer Trials Ireland; Mary O’Brien from the Royal Marsden Hospital; Suman Rao from MedStar Franklin Square Hospital; Katsuyuki Hotta from Okayama University Hospital; and Melanie Leiby, Gregory Lubiniecki, Yue Shentu and Reshma Rangwala from Merck.

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The University of Chicago and Johns Hopkins' Bloomberg~Kimmel Institute for Cancer Immunotherapy  have published a pair of studies looking at biomarkers involved in the immune system's response to tumors in the Nov. 7 issue of the Proceedings of the National Academy of Sciences.

The University of Chicago studies are explained here.

Janis Taube

Janis Taube

For the Johns Hopkins research, scientists studied 3500 tumor samples among nine cancer types recorded in The Cancer Genome Atlas to analyze five biomarkers of immune activity within tumors. They include: whether the microenvironment within a tumor is inflamed, the number of mutations present in tumor cells, and expression levels of immune-system related proteins called PD-1, PD-L1, and PD-L2, which can be coordinately expressed in the environment surrounding a tumor to ward off an immune system attack.

"Scientists have been looking at these markers independently, but we wanted to know how

they relate to each other and which was most influential in patients' survival," says Janis Taube, M.D., associate professor of dermatology and pathology at the Johns Hopkins University School of Medicine and member of the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Institute for Cancer Immunotherapy.

Taube and her team found that all five factors were important in predicting survival of patients with metastatic melanoma.  Four of the factors — PD-1, PD-L1, PD-L2 and inflammation — have very tight links, they say, and their research suggests that when expression levels of these factors are high, they are more important in predicting patients’ survival than the amount of mutations present in the tumor.  However, when these factors are low, mutational load plays an important role in predicting survival.

"This is an important step in understanding how to develop multifactorial-biomarkers for predicting patient outcomes," says Taube.

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Endocrinologists, or hormone doctors, are on your lung cancer treatment team “if it's clinically appropriate for them to be a part of it,” says radiation oncologist Russell K. Hales, M.D. of the Johns Hopkins Kimmel Cancer Center on the Johns Hopkins Bayview campus.

Hales notes that “Endocrinologists often look at hormone levels, and we use their expertise in patients who have underlying endocrine problems. We ask endocrinologists to evaluate some patients right after their therapy, patients whom we feel may be at risk for endocrine problems due to their radiation, chemo, or surgery. In that way, we can help these patients avoid some long-term side effects or manage them better.”

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“Every clinical trial is done in a way to try to get a very homogenous group of patients, so we can better draw conclusions about whether the innovation we’re testing is actually working,” says radiation oncologist Russell K. Hales, M.D. of the Johns Hopkins Kimmel Cancer Center on the Johns Hopkins Bayview campus.

“A patient can be evaluated for a clinical trial, and we would look carefully at the stage of their disease, at their overall health, and at other factors to determine whether they're appropriate candidates for a clinical trial,” Hales added. “Clinical trials are available for patients with all stages of disease, from early stage disease to very advanced disease, and for patients newly diagnosed, as well as for those with recurrent disease. Trials are not one-size-fits-all. They're custom made for patients at varying points on the continuum of lung cancer treatment.”

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Many lung cancer patients are concerned about the side effects lung cancer radiation can cause, such as heart or kidney damage, or fertility problems, says radiation oncologist Russell K. Hales, M.D. of the Johns Hopkins Kimmel Cancer Center on the Johns Hopkins Bayview campus.

“Any therapy can cause short-term or long-term problems, and side effects,” Hales notes. “When we look at the benefit of these therapies, though, they have to be taken in context of the risks. If your physician has recommended radiation as part of your lung cancer treatment, it is far more likely to be beneficial, than to be risky. New therapies that help us target our radiation treatment more precisely have helped lower the risks to nearby organs.”

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This blog post was written by Kristina Baum, who has melanoma and is participating in a clinical trial on immunotherapy at the Johns Hopkins Kimmel Cancer Center. For more information on Kristina's story, watch her interview with Denise Grady on the New York Times' Facebook page or follow her on Twitter at @kristinabaum. For the post, we asked Kristina to discuss what led her to join an immunotherapy clinical trial. 

When I was first diagnosed with melanoma in September 2012, cancer research was light years behind what it is now. When I was diagnosed this second time in June 2016 with metastatic melanoma, my oncologist, Dr. Evan Lipson, mentioned a clinical trial as my first option. Admittedly, the words “clinical trial” scared me. As I weathered cancer the first time, I remember patients going on clinical trials simply when they had no other options to consider. Clinical trials seemed like a last resort, or a type of lab rat experience when there was no other hope. However, as I gathered myself in the midst of the diagnosis conversation, I knew that Dr. Lipson and the team at Johns Hopkins were ones I trusted. Therefore, I knew there must be a good reason for their suggestion – and there was.

Kristina Baum

Kristina Baum

By going with an immunotherapy clinical trial, I ended up having more treatment options than I had initially anticipated. We pursued a trial with Opdivo and an experimental drug known as a LAG-3 monoclonal antibody made by Bristol-Myers Squibb. There were a limited number of slots on the clinical trial provided to patients at Johns Hopkins and I received one of them, which was a miracle because that spot was not available the week before I was diagnosed. I eagerly learned about the trial, and quickly heard about the many successes patients were having with immunotherapies. Dr. Lipson, my family, and I were all very optimistic.

However, bumps in the road occurred.

As I went in for my third infusion, I experienced a side effect that occurs in less than one percent of patients known as auto-immune meningitis. Basically, I had a terrible headache and was completely oblivious to the seriousness of what was happening. I was admitted to the hospital and carefully watched by a team of doctors, including Dr. Lipson, and was later released on a strict regimen of steroids. The inflammation quieted, and I resumed normal life at work. Each week, I get lab work done to watch my numbers and to keep track of my progress. Then, on August 1, great news emerged. My very first CT scan since being diagnosed the second time revealed that the tumor in my left kidney shrank from 2cm to a smaller 7mm! No other metastasis were present either.

The immunotherapy clinical trial was working!

Pursuing the experience of an immunotherapy clinical trial no longer has the frightening stigma I feel that it once had. I would encourage any patient to pursue an immunotherapy clinical trial for a number of reasons with one being that a clinical trial might allow you to receive medications based on the most cutting edge, up-to-date, freshly researched cancer developments.

One person encouraged me to not Google my cancer, as any cancer patient already knows, but for a different reason. Developments are being made in cancer research, especially at places like Johns Hopkins, at such a rapid speed that some articles or information that’s more than a few months old might well be out-of-date. Research in cancer immunotherapy is not only developing and growing quickly, but the word about its successes is spreading like wildfire. And I noticed that this “wildfire effect” is usually from the patients’ stories themselves. In other words, I was seeing that there were people out there with stage four cancer, just like me, who were achieving "No Evidence of Disease" results rather quickly through immunotherapy clinical trials. I was so encouraged, so hopeful, so inspired, and so sure that I had made the right decision. I also thought that in some small way, I could be a part of a choice group of people that hopefully help other patients that were like me, too.

I imagined another young woman in her early 30’s receiving the news of a metastatic melanoma diagnosis. I imagined her, just as I had been, as scared, unsure of next steps, her family and career somehow unfathomably having to go on hold and the overwhelming thought of “how do you even tell your loved ones?” I imagined her flooded with emotions from the news of the word “it’s cancer” and the swirling survival statistics doing gymnastics in her mind. The truth is, with an immunotherapy clinical trial, there is hope. Your life doesn’t have to go on hold, but you do need to be careful and listen to your oncologist. And the support I received from not just loved ones but also the Hopkins family has made this road an easier one to walk down. It’s not a “cure” but it sure is evidence to me that we’re moving in the right direction.

--Kristina Baum

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“The best way to prevent lung cancer now is to make sure you're not currently smoking,” says Russell K. Hales, M.D.

Hales, who is a radiation oncologist at the Johns Hopkins Kimmel Cancer Center on the Johns Hopkins Bayview campus, notes that smoking, even as late as when you’ve had a lung cancer diagnosis, can improve the outcome of your treatment, in part because you can better tolerate therapy.

Is there anything that you can do to reduce your risk more, now? Hales says, “Lung cancer screening may be appropriate, although the benefits of screening have only been established for lung cancer patients who smoked for 30 years or more. Screening is also more than just a CT scan. We have other tests that we look at, markers in the blood, or in a patient's sputum, that can help us better identify which patients are likely to be at risk for lung cancer. Call 410-955-LUNG to find out more about screening.

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“When I meet with patients, I tell them that there are three critical parts to their therapy. The first is local therapy, such as surgery or radiation. The second is chemotherapy, or systemic therapy. And the third is their overall well-being, such as nutrition,” says Russell K. Hales, M.D.

Hales, a radiation oncologist at the Johns Hopkins Kimmel Cancer Center on the Johns Hopkins Bayview campus, says, “It's critical, that lung cancer patients stay healthy and avoid weight loss as they go through treatment. Your stamina through treatment will affect your ability to get all the treatment that we need to give. As a result, we use nutritionists early on in treatment, because we know that a patient's stamina will drive their overall outcome, and their ability to tolerate the therapies that we'd like for them.”

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Brian Boyle on FOX45 TV

Brian Boyle on FOX45 TV

Master of Health Communications student Brian Boyle will participate in this weekend's Swim Across America Baltimore event, which benefits the Johns Hopkins Kimmel Cancer Center. His father recently celebrated 25 years free of cancer and will be kayaking alongside his son in Sunday's swim event.  "Cancer has impacted our family many times, as it has for millions of people all over the world. I’ve lost childhood friends to cancer. Both of my grandparents on my dad’s side died of cancer (prostate and pancreatic), my uncle passed away (pancreatic) from it last year, and it almost took my dad’s life. I want to do all I possibly can to help find a cure and prevent it," says Boyle.

After his father was treated for cancer, Brian survived his own health crisis after a horrific car accident. But he rebounded with fierce energy that helped him rediscover his passion for swimming. Read Brian's story in the Huffington Post and watch his interview on Fox 45 Baltimore.

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IMG_0764We've heard much about the national Cancer Moonshot led by Vice President Joe Biden aimed at galvanizing resources across the nation to speed the rate of cancer discoveries. The Kimmel Cancer Center’s own deputy director, Elizabeth Jaffee, M.D., is co-chair of the national Cancer Moonshot’s Blue Ribbon Panel that has provided recommendations for the initiative. But on the local level, Maryland hospitals, health experts and community organizers have a long history of working together to help curb cancer.

Every five years, the Maryland Comprehensive Cancer Control Plan defines goals and strategies to help Marylanders reduce cancer risk and improve early detection, treatment and survivorship. The cancer plan is coordinated through Maryland’s Department of Health and Mental Hygiene and funded by the Centers for Disease Control and Prevention. The plan receives input from health professionals, individuals and community leaders throughout the state, and Johns Hopkins experts participate in work groups to update and implement it. Johns Hopkins experts also create reports about implementation of the plan in Maryland and at Johns Hopkins, and host statewide meetings about the plan.

“The current plan includes integration of goals and strategies across many types of cancer,” says Elizabeth Platz, Sc.D., M.P.H., the Kimmel Cancer Center’s co-leader of cancer prevention and control and a professor in the Johns Hopkins Bloomberg School of Public Health.

Platz leads the Maryland Cancer Collaborative, a volunteer group of individuals and organizations charged with prioritizing its strategies and implementing Maryland’s cancer plan. “Most Maryland residents may not know that such a plan exists,” she says. “But work is being done by many of the plan’s collaborators and other stakeholders every day to complete its goals and objectives.”

Maryland’s cancer plan aims to tackle three main areas over the next five years: cancer prevention, reducing the high burden of cancer in Marylanders, and improving cancer survivorship, palliative care and hospice care.

Platz says the plan includes strategies to improve HPV vaccination rates among Maryland adolescents, further enhance tobacco control, promote education regarding familial risk of cancer, and develop systems to track and monitor hospice use.

Among the results from the past five years of implementing Maryland’s previous cancer plan are comprehensive materials for cancer survivors about support groups and resources, as well as surveys of Maryland colleges and universities on tobacco policies and smoking cessation services.

“This is an opportunity for organizations and individuals to come together and work efficiently on a common goal,” says Platz. “With the cancer plan, we're better organized and able to help Marylanders.”

Read about Maryland’s cancer plan.

Outcomes from previous Maryland cancer plans.

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