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Notable News | April 2019

You may want to do some yoga, especially if you are experiencing chronic stress. However, you can breath a sigh of relief about the positive research in bladder and prostate cancers reported this month. There’s even some super cool research that involves containing, rather than killing, cancer cells. Check it out.

Chronic stress is not good for anybody, but as livescience.com reports, it may be even more detrimental for cancer patients. Acute stress is normal on occasion to help us avoid danger, but chronic stress, which weakens the immune system, leads to changes in the body that could then lead to the development and progression of cancer. However, experts say we can’t be so fast to draw a link between stress and cancer because of the ways different people respond to stress. Some people are motivated by it; others sickened by it. Some experts believe it may not be the stress that leads to cancer, but rather the poor habits people adopt to cope with stress. While experts don’t yet agree that there is a clear and definitive line between chronic stress and cancer, there is evidence that taking measures to reduce stress is best for overall health. Find out more here.

Speaking of stress, cancer can be stressful. Many patients turn to alternative forms of healing to manage the affects of cancer or treatment, but medicalnewstoday.com says, that may be doing more harm than good. As many as one third of people living with cancer are using alternative or complementary therapies. The most common form of alternative therapies is the use of herbal supplements, which researchers found could be a problem because the ingredients of herbal supplements are not always known, and there is a concern that supplement ingredients could negatively interact with the medicines they are taking. For example, high levels of antioxidants may make radiation less effective. Yoga, however, is the one complementary method of treatment that seemed to help patients. You can learn more about the research involving alternative and complementary therapies here, and decide whether or not those methods are right for you.

Researchers are starting to decide that maybe killing all the cancer cells isn’t the best option for combating cancer, reports medicalnewstoday.com. Cancer cells evolve really fast, and some studies show that there is no way of killing them all. Researchers are looking at a new approach of treating cancer that involves preventing it from developing and spreading by containing it. They hope to use medication to make the cancer cells dormant and keep them that way, which could be useful in cancers, such as breast cancer, which is now considered a chronic cancer because it can come back many years later with secondary tumors. You can learn more about this unique approach here.

Other findings this month bring good news for bladder cancer patients, reports seekingalpha.com. The FDA has approved the Johnson & Johnson drug, Balversa, for patients with metastatic bladder cancer. The approval was based on a trial that resulted in a 32 percent overall response rate. The patients who are eligible for Balversa, have metastatic bladder cancer with specific genetic alterations, but there is hope that it will eventually be tested on other types of cancers. Learn more here.

More good news comes from British scientists who have discovered 17 genes for diagnosing prostate cancer, reports dailymail.co.uk. Combined with the six genes already known to be linked to prostate cancer, there are now 23 genes that can be screened through a spit or blood test. Find more information about the research and what it means for diagnosis and treatment of prostate cancer here.

The not-so-good news reported this month is the increase in lung cancer among non-smokers — especially women. An in depth look at this growing issue can be found at theguardian.com here.

The ups and downs of cancer research news can be stressful for anyone, so to alleviate that stress, let’s all stay informed, and maybe take to our yoga mats. Until next month, namaste.

Astellas Press Release

Astellas and Seattle Genetics Initiate Pivotal Trial of Enfortumab Vedotin for Patients with Locally Advanced or Metastatic Urothelial Cancer

Solid Tumor Antibody-Drug Conjugate (ADC) Enfortumab Vedotin to be Evaluated as a Monotherapy in Patients Previously Treated with a Checkpoint Inhibitor

TOKYO and BOTHELL, Wash.Oct. 10, 2017 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, “Astellas”) and Seattle Genetics Inc., (NASDAQ: SGEN) today announced dosing of the first patient in EV-201, a registrational phase 2 clinical trial of enfortumab vedotin for patients with locally advanced or metastatic urothelial cancer who have been previously treated with checkpoint inhibitor (CPI) therapy. The EV-201 study will assess the antitumor activity and safety of enfortumab vedotin to support potential registration under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations.

Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)

“Locally advanced or metastatic urothelial cancers are often aggressive and treatment-resistant. Treatment options are limited for those many patients who do not respond to chemotherapy and checkpoint inhibitors, or CPIs. In addition, there are no FDA-approved therapies for patients who progress following CPI treatment,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “Initiation of this pivotal phase 2 trial of enfortumab vedotin is a significant advance toward our goal of providing a new treatment option for patients with locally advanced or metastatic urothelial cancer.”

The primary endpoint of the single-arm, open-label trial is confirmed objective response rate (ORR), per independent review. Secondary endpoints include assessments of overall survival, progression free-survival, safety and tolerability. The study will enroll approximately 120 patients at multiple centers globally, and enfortumab vedotin will be administered three of every four weeks for the duration of treatment.

“The initiation of the EV-201 clinical trial demonstrates our continued commitment to patients living with locally advanced or metastatic urothelial cancer,” said Steven Benner, M.D., Senior Vice President and Global Therapeutic Area Head, Oncology Development at Astellas. “Our decision to move forward with this registrational trial is based on the results of our ongoing Phase 1 study, and we look forward to future clinical development milestones for enfortumab vedotin.”

The companies also plan to initiate a combination trial of enfortumab vedotin with CPI therapy in late 2017.

For more information about the phase 2 pivotal trial, including enrolling centers, please visit www.clinicaltrials.gov.

About Urothelial Cancer
Urothelial cancer is most commonly found in the bladder (90 percent). According to the American Cancer Society, approximately 79,000 people in the U.S. will be diagnosed with bladder cancer during 2017 and almost 17,000 will die from the disease. Outcomes are poor for patients diagnosed with metastatic disease, with a five-year survival rate of five percent.

About Enfortumab Vedotin
Enfortumab vedotin is an investigational ADC composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics’ proprietary, industry-leading linker technology. Enfortumab vedotin targets Nectin-4, a cell adhesion molecule identified as an ADC target by Agensys (an affiliate of Astellas), which is expressed on many solid tumors.

Nectin-4 is highly expressed in urothelial cancers, particularly in bladder cancer. Preclinical data demonstrate that enfortumab vedotin binds to Nectin-4 on cancer cells and releases the cell-killing agent into these target cells upon internalization.

About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at https://www.astellas.com/en.

About Seattle Genetics
Seattle Genetics is an innovative biotechnology company dedicated to improving the lives of people with cancer through novel antibody-based therapies. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. Seattle Genetics commercializes ADCETRIS® (brentuximab vedotin) for the treatment of several types of CD30-expressing lymphomas. The company is also advancing a robust pipeline of novel therapies for solid tumors and blood-related cancers designed to address significant unmet medical needs and improve treatment outcomes for patients. More information can be found at www.seattlegenetics.com and follow @SeattleGenetics on Twitter.

About the Astellas and Seattle Genetics Collaboration
Astellas and Seattle Genetics entered into the ADC collaboration in January 2007 and expanded it in November 2009. Under the collaboration, the companies are co-developing and have options to globally co-commercialize enfortumab vedotin.

Seattle Genetics Forward Looking Statement
Certain of the statements made in this press release are forward looking, such as those, among others, relating to the possibility that EV-201 will generate data that would be sufficient to support potential registration of enfortumab vedotin under the U.S. Food and Drug Administration’s (FDA) accelerated approval regulations, therapeutic potential of enfortumab vedotin, its possible safety, efficacy, and therapeutic uses and anticipated development activities including future clinical trials and intended regulatory actions. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to show sufficient activity in the clinical trials and risk of adverse events as enfortumab vedotin advance in clinical trials even after promising results in earlier clinical trials. In addition, as our drug candidates or those of our collaborators advance in clinical trials, adverse events and/or regulatory actions may occur which affect the future development of those drug candidates and possibly other compounds using similar technology. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended August 1, 2017 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.


SOURCE Astellas Pharma Inc.

For further information: Contacts for inquiries or additional information: Astellas Pharma Inc., Corporate Communications, TEL: +81-3-3244-3201 FAX: +81-3-5201-7473 or Seattle Genetics, Corporate Communications, +1-425-527-4188

Male Survivor Prostate/Bladder Cancer… A Diary Entry

Real patient experiences shared privately at www.TreatmentDiaries.com.  Read more, share if you like or join in the conversation.  Making sure you feel less alone navigating a diagnosis is important.  Connecting you to those who can relate and provide support is what we do.

 

Today I am a male survivor of bladder and prostate cancer – annual Oncology visit…still here, still healthy, PSA still less than 1%. Possibility for bladder cancer’s return are extremely minimal. That’s now six years in remission. Now thinking about removing the alien (aka port). To those either starting to deal with this inconvenience or have dealt with it…STAY POSITIVE!

Where it began…. The port was installed yesterday. No big deal, only discomfort came from injection site for the IV (I have crappy veins) and learning how not to sleep on my right side…could be worst. Day 1 of chemo was this morning not bad. I have an incredible oncologist, he’s upfront, informative and has a sense of humor!! The entire Cancer center staff is incredible. With their support, my great friends and especially my wife, the road (although, interesting) will be made a lot easier. Day 2 (consisting of three significant meds) will be interesting.

Completed my first round of chemo yesterday, only two rounds (8 treatments) remain. What have I learned; trust your doctors, do your research to be as informed as possible, surround yourself with positivity, support your body’s recovery by; eating, staying hydrated, and stay positive.

Last week’s sessions marked the halfway point for me, as well as reminded me how tough back to back treatments can be. The good news, my oncologist feels chemo is working and that’s all I need to know. My Christmas present…no treatment this week, well deserved!!

Having a positive, ‘I will survive this’ approach is the only one to take if living is your objective. Due to the aggressiveness of my ureteral carcinoma, bladder removal is being proposed as the best (next step) option. It’s the consensus of four doctors. This includes my oncologist who is someone that consistently emphasized a focus on my life’s quality and quantity above all else. As a result, we continue to have very frank and realistic conversations. Essentially, I trust him. It will be a significant change, however a good friend endured a similar situation more than six years ago. Her insight benefited me greatly during chemo and I’m certain, will continue prior to and after surgery. Stay positive and continued success to you.

A year ago, my life changed significantly…I was diagnosed with stage 3 bladder cancer. Later it was determined prostate cancer had also joined the party (need to limit those medical malady invites).    The prior 12 months allowed me to experience (against my better judgement) life’s highs, lows and a great deal of uncertainty. But with support of friends, their prayers, a positive mindset, humor, access to an incredible medical staff, and an extremely supportive wife, I’ve continued to stay upright.  Manage to stay upright despite; 12 rounds of chemo (Cisplatin sucks), bladder removal/reconstruction, losing 30 pounds in 2.5 weeks’ post bladder surgery, an inability to taste food during the holidays (not to mention I couldn’t drink), a dreadful winter, multiple catheters and pills, lots of pills.   Not that I think about it…. I didn’t have a good time.

This week my last three-month consult was completed. All the news received was the best I could hope for….no indication of cancer at this time. Now I am no longer a patient, but a patient/survivor who should share his experience with others. To all of you who posted to my diary…. THANK YOU!!  I can only hope to do the same for others!

Male Bladder Cancer Survivor…A Diary Entry

Real patient experiences shared privately at www.TreatmentDiaries.com.  Read more, share if you like or join in the conversation.  Making sure you feel less alone navigating a diagnosis is important.  Connecting you to those who can relate and provide support is what we do.

I was diagnosed with terminal systemic metastatic bladder cancer in 1991. I was given 3 to 9 months to live and sent home to get my “things” in order. The doctor recommended that I take a cruise! This was after bladder cancer was found in 1990, treated surgically twice, and I was told all was fine.

Fast forward to 2011.

I am working in Lebanon as a police trainer after serving 3 1/2 years training police in Iraq.

Since it has been a “few” years since my initial treatments, I have lost much of the details I once knew so very well. Since my cancer bout, I have lost my father and brother to cancer, among many friends and other family members. Only God knows who dies and who lives but I know what the doctors did to me that the others didn’t have the good fortune of having done to them and I credit that to my good health, cancer free status and living life large. It was excellent doctors, with excellent medications guided by Gods hand and the experimental High Dose chemotherapy that saved my life. It took me six months to fight the disease, but after that it was all downhill. I went back to work as a deputy sheriff and completed another 10 years for a 27-year retirement. I worked a couple little jobs before going to Iraq as an International Police Instructor and I have never slowed down.

I know that the decisions facing ever cancer warrior are daunting. I know that had I been given the option of removing my bladder, I don’t know what decision I would have made at the time. However, being fortunate enough to have hindsight, it would have been the best course of action for me. I wasn’t given that option and was told after having undergone surgery twice and a session of mild chemo each time, I was cancer free and sent on my way. We of course must believe our doctors and want to believe we are cancer free, but thinking back…. my bladder was completely full of cancer although “they said” it did not permeate the bladder wall. Obviously, it had or did, and circulated throughout my body. I had bladder cancer on my lung, behind my heart, inside my left femur as well as other places. In fact, that was how I learned that the cancer was systemic. When the cancer was flowing systemically, I felt no pain but when it permeated my femur and ate away about 4″ just above the knee, I had pain. I didn’t relate it to cancer in the beginning and my doctor fed me pain pills until I could no longer tolerate the pain. That’s when I learned that I was terminal and the rest is now history.

I hear lots of people saying to listen to their doctors, do what their doctors say, but I am the first to caution about putting too much faith in your doctors. Consider what they know, but it’s your life, not there’s and if it doesn’t make sense, then it’s your duty to research and engage in frank open and meaningful dialogue with your doctors. Life goes on and it is a minor inconvenience to give up your bladder compared to the alternative.

My prayers are with all of you fighting cancer. It is a nasty terrible disease but NEVER SURRENDER and hit it HARD. This is not a time to handle this disease delicately. I underwent three sessions of High Dose chemotherapy. It was difficult, and experimental, but it sure beats living for 3 to 9 months even if I had taken the cruise….and by the way…in early 2006 I took a 3-week cruise to Hawaii anyway!

From the Diary of a Bladder and Prostate Cancer Patient

blue ribbonThis diary entry from our partner, Treatment Diaries, is from a man diagnosed with bladder and prostate cancer in 2000.

Diary Entry:

A year ago, my life changed significantly…I was diagnosed with stage 3 bladder cancer. Later it was Prostate Cancerdetermined prostate cancer had also joined the party (need to limit those medical malady invites).    The prior 12 months allowed me to  experience (against my better judgement) life’s highs, lows and a great deal of uncertainty. But with support of friends, their prayers, a positive mindset, humor, access to an incredible medical staff, and an extremely supportive wife, I’ve continued to stay upright.  Manage to stay upright despite; 12 rounds of chemo (Cisplatin sucks), bladder removal/reconstruction, losing 30 pounds in 2.5 weeks post bladder surgery, an inability to taste food during the holidays (not to mention I couldn’t drink), a dreadful winter, multiple catheters and pills, lots of pills.   Now that I think about it….I didn’t have a good time.

This week my last three month consult was completed. All the news received was the best I could hope for….no indication of cancer at this time. Now I am no longer a patient, but a patient/survivor who should share his experience with others. To all of you who posted to my diary…..THANK YOU!!  I can only hope to do the same for others!

Take a look at Treatment Diaries – where cancer patients can connect and share anonymously