The Onco'Zine Brief

In this edition of The Onco'Zine Brief, recorded during the 59th annual meeting of the American Society of Hematology - held December 9 to 12, 2017 in Atlanta, Georgia (USA), we talk with Anna Sureda, MD, Ph.D, Head of the Hematology Department at the Catalan Institute of Oncology, Barcelona, Spain - to discuss some of the exciting developments in the treatment of patients with Hodgkin’s lymphoma, non-Hodgkin’s lymphoma and Multiple Myeloma.

During our conversation we asked Dr Sureda about what she thinks about the exciting treatment options presented at the 59th Annual Meeting of the American Society of Hematology as well as the differences in how patients are being treated in the United States vs. Spain.

And we asked Dr Sureda about a particular study, the ECHELON-1, about the reason for the study, the study outcomes and what the results of this study mean for patients with advanced frontline Hodgkin lymphoma.

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In this episode Peter Hofland and Sonia Portillo, the team behind The Onco'Zine Brief, talk with Angela M. DeMichele, MD MSCE, Professor of Medicine and Epidemiology at the Perelman School of Medicine at the University of Pennsylvania.

Over the last 25 years, there has been an explosion of new and vitally important, anticancer drugs.

The development of these promising new therapeutic agents is generally based on preclinical and clinical research. In many cases, this research has, become prohibitively expensive. And only a relatively few investigational drugs have reached the market and successfully improved clinical outcomes in the treatment of patients with cancer and hematological malignancies. In the development of new therapies, the traditional clinical trial process of determining which drugs will ultimately benefit patients is long and expensive.

Over the last few decades scientists have tried to change – and improve - the way clinical trials are conducted. Their purpose… Improving the process and improving the way novel pharmaceutical drugs are being developed. But it still takes many years and huge investments to successfully bring a new drug to market.

But despite the huge efforts there is still a huge unmet medical need.

While there are many novel drugs being developed to help improve the outcome and improve survival, resources are limited. Optimal use of resources requires better understanding of cancer biology, the identification of novel therapeutic targets, and the ability to address inefficiencies in the cancer clinical trials system. This may especially be so in how we treat women with metastatic, high risk, breast cancer.

Based on the current limitations in how we conduct clinical trials, scientists of The Biomarkers Consortium, at the Foundation for the National Institutes of Health, are changing the way new anticancer drugs are being developed.

The Foundation’s unique and groundbreaking, re-engineered approach to clinical trials is the I-SPY Clinical Trial. This trial represents an unprecedented and streamlined method in developing new anticancer drugs. Using breast cancer treatment as a model - the I-SPY TRIALs are designed to significantly reduce the overall cost, time, and number of patients required to bring innovative anticancer agents to the right patient at the right time – and do this faster.

The I-SPY Trial Program integrates and links Phase I, Phase II and eventually Phase III clinical oncology trials to build a pipeline of novel anticancer agents. As a result, the new trial program accelerates the process of identifying a subset of high risk breast cancer patients that will directly benefit from these novel agents.

Among the targeted drugs being investigated in the I-SPY 2 trail are antibody-drug conjugates or ADCs. Antibody-drug Conjugates are part of a new wave of targeted antibody-based products. They are novel, innovative agents at the cutting edge of oncology and hematology.

During the Annual Meeting of the American Association of Cancer Research, held - April 16 – 20, 2016, in New Orleans, we sat down with Doctor Angela DeMichele, Professor of Medicine and Epi-demi-ology at the Perelman School of Medicine at the University of Pennsylvania.

We asked Doctor DeMichele a number of questions about a specific part of the I-SPY-2 trial in which researchers investigated a particular antibody-drug conjugate and how a combination of drugs, including antibody-drug conjugates, can bring a substantially greater proportion of patients to the primary endpoint of pathological complete response or PCR, an outcome in which, following neoadjuvant therapy, residual invasive cancer is detected in the breast tissue and lymph nodes during surgery.

And we asked her about the benefit of targeted therapy and how novel drugs like antibody-drug conjugates play a role.

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In this episode of The OncoZine Brief Peter Hofland interviews Darrin Uecker and Richard Nuccitelli of Pulse Biosciences.

The team at Pulse Biosciences has developed a technology is called Nano-pulse Stimulation, or NPS. This novel technology delivers ultra-short nanosecond pulses to stimulate cellular responses in targeted tissue. These pulses induce cells to die in a natural way.

Preclinical studies indicate that NPS can stimulate the adaptive immune response, commonly known as immunogenic cell death. The new technology thus engages the immune system to clear away damaged, diseased, or aged cells and recruit cancer-attacking T cells to the tumor site.

Darrin Uecker and Richard Nuccitelli explain how this new technology works, its history and how this may benefit patients.

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In this episode of The Onco’Zine Brief Peter Hofland and Sonia Portillo talk with Michael A. Caligiuri, MD, the current (2017- 2018) president of the American Association for Cancer Research | AACR.

Caligiuri is director of The Ohio State University Comprehensive Cancer Center and CEO of the Arthur G. James Cancer Hospital and Richard J. Solove Research Institute, located in Columbus, Ohio. He is a renowned physician-scientist, known for his work in immunology that is focused on human natural killer cells and their modulation for the treatment of leukemia, myeloma, and glioblastoma. Well over 1,500 cancer patients have been treated on clinical protocols that have come out of Caligiuri’s laboratory.

Caligiuri has been actively involved with the AACR since 1990, serving as a member, and more recently, chairperson of the Publications Committee and a member of the Clinical and Translational Cancer Research Committee, among other things.

During the 2017 annual meeting of the American Association for Cancer Research | AACR, Hofland and Portillo sat down with Caligiuri to ask him about his passion, his drive and what he wants to accomplish during his tenure as president of the organization.

One of Caligiuri main concerns is the health disparities in cancer that represent a major public health problem in our country. By promoting the exchange of novel ideas and information between the AACR and a wide range of professionals from academia, industry, government, and the community, Caligiuri hopes to drive a movement to help eliminate the disparities and harness the potential and maximize the many opportunities for bringing research on health disparities from bench to bedside or community, and back again. As part of this effort, he will, during his tenure as president of the AACR, bring together scientists and other professionals working in a variety of disciplines to discuss the latest findings in the field and to stimulate the development of new research in cancer health disparities.

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Born and raised in Curaçao NA, an island in the southern Caribbean Sea, Bob Pinedo, MD, PhD, now professor emeritus and a consultant to the Board of the Free University Medical Center in Amsterdam, The Netherlands, remains a real powerhouse in the World of Oncology.

He has spent more than 40 years researching cancer biology, drug treatment and resistance, and it can be said that his accomplishments have helped to better understand cancer treatment.

Here in the United States he has worked with a number of pioneers in oncology – including Dr. Bruce A. Chabner, at the National Cancer Institute (NCI) - where he conducted pharmacology studies to understand the effect of certain drugs on bone marrow stem cells.

He introduced the medical community to a process of multidisciplinary treatment across hematology, surgical and radiation oncology…

...and helped develop new clinical strategies.

The work Dr. Pinedo did to accomplish his goal was recognized by his peers.

As a result, in 2014, during the 50th aniversary of the American Society of Clinical Oncology (ASCO), he received the David A. Karnofsky Memorial Award and Lecture.

First presented in 1970, the award recognizes oncologists who have made outstanding contributions to cancer research, diagnosis, or treatment.

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In this episode of The Onco'Zine Brief Peter Hofland and Sonia Portillo interview Nancy Brinker, founder of Susan G. Komen for the Cure.

This program was originally recorded during the Annual Meeting of the American Association of Cancer Research - (AACR), held April 16 – 20, 2016, in New Orleans, Louisiana.

It can be said that Nancy Brinker embodies the global movement to end breast cancer.

Over the last 4 decades we’ve seen major developments and advances in the in diagnosis and treatment of cancer.

Among the major changes seen is the rise of patient advocacy and how patient advocacy helps patients, their families, and their caregivers navigate the cancer landscape.

The organization Nancy Brinker founded, has been a leading force in the development of patient advocacy and has changed the way the world talks about -- and treats -- breast cancer.

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Recorded during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), Peter Hofland and Sonia Portillo, the team behind The Onco'Zine Brief, interview Dr. Robert Andtbacka, associate professor in the Division of Surgical Oncology, at the Department of Surgery at the University of Utah School of Medicine, and surgeon and investigator with the Intermountain Healthcare and Huntsman Cancer Institute.

Andtbacka is a member of the Experimental Therapeutics Program, and he specializes in surgery for melanoma, soft tissue sarcomas, and cancers of the gastrointestinal tract.

His research interests include novel techniques to identify how melanoma spreads through the lymph and vascular systems; resistance to targeted therapies in soft tissue sarcomas, including gastrointestinal stromal tumors; and novel therapeutics for solid tumors.

In this interview Peter Hofland, Sonia Portillo and Robert Andtbacka discusses some of the exciting research presented at this year’s annual meeting of the American Society of Clinical Oncology, or ASCO, which took place June 2nd to 6th in Chicago, Illinois.

Andtbacka addresses current standards of care in melanoma, and the challenges that come with treating this disease, especially once it has metastasized to the brain. He also discusses some of the approaches that are being tested and developed for melanoma, and explained why combination therapies are showing he most promise both early and late-stages of the disease.

Some data presented at ASCO supports the combination of new drugs that can enhance existing therapies by altering the microenvironment of the tumor and making it more susceptible to treatments.

Andtbacka talks about why therapy combinations have really transformed oncology in recent years by offering patients long term survival benefit that were previously unseen.

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Patients living with invasive breast cancer with high levels of HER3 may face a significantly worse prognosis and decreased survival. This represents a large unmet medical need.

Overexpression of epidermal growth factor receptors, also known as EGFR, such as HER2 and HER3, can play a role in cancer cell development, including breast cancer. Statistics show that one in five breast cancers overexpress HER2, which is associated with a more aggressive disease. And about 50 to 70% of breast cancer tumors have detectable levels of HER3.

Depending on several factors, including the biomarker classification, breast cancer is typically treated with various combinations of surgery, radiation, chemotherapy, hormone therapy or targeted therapy. But many HER2-positive tumors progress to the point where no currently approved HER2-targeting treatments can continue to control the disease. Furthermore, there is no HER2-targeting therapies approved for HER2-weak positive tumors and no approved HER3-targeting therapy options.

Historically, HER3 has represented a challenge for drug development due to this receptor's lack of tyrosine kinase activity. However, recent reports of HER-3 targeted drugs have shown promising results in a number of preclinical settings.

A better understanding of HER3 regulation has contributed to improve the potential strategies to therapeutically target HER3 for cancer treatment.

In this interview held during the 2017 annual meeting of the American Society of Clinical Oncology, or ASCO, which took place June 2nd to 5th in Chicago, Illinois, Peter Hofland and Sonia Portillo, the team behind The Onco'Zine Brief, sat down with Antoine Yver, MD., MSc, Executive Vice President and Global Head, Oncology Research and Development at Daiichi Sankyo to talk about Daiichi Sankyo novel antibody-drug conjugate, DS-8201, and how this investigational drug has demonstrated a favorable safety profile and promising antitumor activity.

The trial drug is currently being evaluated in an open-label two-part phase I dosing study in patients with advanced, unresectable or metastatic solid tumors that are refractory or intolerant to standard treatment, or for whom no standard treatment is available.

DS-8201 is being development for HER2-positive advanced or metastatic breast cancer and gastric cancer, HER2-low-expressing breast cancer and other HER2-expressing solid cancers. The primary objective of the so-called dose escalation phase of the study was to assess the safety and tolerability of DS-8201 and determine the maximum tolerated dose (MTD).

To date a total of 134 patients have been treated in both the dose escalation part of the study, which included 24 patients, and dose expansion part of the study, which included 110 patients.

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For this edition of The OncoZine Brief, Peter Hofland and Sonia Portillo sat down with Jonathan E. Lim, M.D. co-founder of IGNYTA, and its President and Chief Executive Officer since July 2012.

Lim is the Founder and Managing Partner at City Hill Ventures, a company he founded in 2010. He is also a Co-Founder of Bonti, Eclipse Therapeutics and served as the Chief Executive Officer and President of Halozyme Therapeutics from 2003 to 3, 2010 and its Executive Director from 2003 to 2010.

Lim was a recipient of a National Institutes of Health Postdoctoral Fellowship, during which time he conducted clinical outcomes research at Harvard Medical School. His prior experience also includes two years of clinical training/ residency in general surgery at the New York Hospital-Cornell Medical Center and Memorial Sloan-Kettering Cancer Center; Founding Editor-in-Chief of the McGill Journal of Medicine; and basic science and clinical research at the Salk Institute for Biological Studies and Massachusetts Eye and Ear Infirmary. Lim has published articles in leading peer-reviewed medical journals such as the Annals of Surgery and the Journal of Refractive Surgery. He earned a B.S., with honors and M.S. in Molecular Biology from Stanford University, his M.D. degree from McGill University and his M.P.H. degree in Health Care Management from Harvard University.

As the co-founder of Ignyta, Lim focuses on the mission of developing precision medicines that can eventually eradicate residual disease in certain, well-defined, cancer populations.

This interview with Lim took place at during the 2017 Annual Meeting of the American Society of Clinical Oncology (ASCO) which took place June 2nd to the 5th in Chicago, Illinois. During our interview, Lim talked about some of the exciting data presented at ASCO, including the development of novel treatments that target gene fusions that drive tumor growth. These new approaches are focused on molecular targets rather than tumor histology, and they are changing the way we look at cancer treatment for a range of patients with unmet medical needs.

Among the drugs being developed by researchers at Ignyta is entrectinib, a drug that is designed to target precise causes of certain cancer types that are caused by multiple gene rearrangements or “fusions”, all with one single therapy.

During our interview, Lim explained that the company is running their clinical trials quite differently - in a form of a so-called “basket trial.” This means that they focus on a specific cancer cause regardless of the location or type of cancer.

And finally, Lim explained why for certain well-defined patient populations, attacking the genomic cause of disease may not only have the potential to shrink tumors, but to eradicate relapse and recurrence altogether.

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Recorded during the 53rd Annual Meeting of the American Society of Clinical Oncology (ASCO), held June 2 - 6, 2017 in Chicago, Ill, Sonia Portillo and Peter Hofland, the team behind The Onco'Zine Brief, interview Dr. Steve Benner – Senior Vice President and Therapeutics Area Head of Oncology at Astellas Pharmaceuticals, and Mark Reisenauer, Senior Vice President, Oncology business unit at Astellas Pharmaceuticals.

Astellas currently has several highly targeted drugs in (early) development and clinical trials. One of these investigational agents is enfortumab vedotin, which is demonstrating promising results for metastatic urothelial cancer patients that fail checkpoint inhibitor therapies or CPIs.

Enfortumab vedotin is an antibody-drug conjugate or ADC designed to deliver the cell-killing, microtubule-disrupting, agent called monomethyl auristatin E or MMAE to the target Nectin-4, a cell adhesion molecule identified as an ADC target by Astellas, which is expressed on many solid tumors.

Antibody-drug conjugates or ADCs are a new class of highly potent biopharmaceutical drug composed of an antibody linked, via a chemical linker, to a biologically active drug or cytotoxic compound.

These novel, targeted agents combine the unique and very sensitive targeting capabilities of antibodies allowing sensitive discrimination between healthy and cancer tissues with the cell-killing ability of cytotoxic drugs.

Astellas' investigational ADC enfortumab vedotin uses Seattle Genetics’ proprietary linker technology.

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