WIN Consortium
“It is with great sadness, that we announce the passing of our Chairman Emeritus of WIN Consortium (WIN), Dr John Mendelsohn on January 7th, 2019 at the age of 82.” WIN Consortium

WINning together

WIN was formed on the premise that we can accomplish more together than each organization can achieve working alone. We aim to improve cancer patients’ survival and quality of life. View WIN's history and unique attributes:

WIN represents a global collaboration of cancer centers, life science and biotech organizations, pharmaceutical and technology companies, health plans, and not-for-profit organizations.
The Worldwide Innovative Networking (WIN) Consortium in personalized cancer medicine was initiated in 2010 with leadership from leading cancer centers worldwide. WIN is a non-profit, non-governmental organization headquartered in Paris.

WIN was created to accelerate the pace and reduce the cost of translating novel cancer treatments to the bedside by developing and applying, through worldwide clinical trials and research projects, the most promising advances in genomic-based cancer research. WIN aims to initiate research projects each year in a global consortium guided by an independent scientific advisory board.

WIN now includes 40 institutional members. These stakeholders have come together from all parts of the world to address the challenge of increasing the efficacy of cancer diagnostics and therapeutics by understanding the genetics and biology of each individual’s tumor and accounting for genetic differences across diverse populations—from North and South America, Europe, Asia, and the Middle East.

Our goal is to significantly improve outcomes for patients around the globe. We aim to increase the number of patients worldwide that have access to innovative, global clinical trials in the area of genomic-based cancer therapeutics. Global diversity and inclusion of all stakeholders is WIN’s most important and differentiating asset.
WIN is comprised of organizations representing all stakeholders in personalized cancer medicine.
WIN enables cross-sector collaborations designed to accelerate the speed and efficacy with which breakthroughs in personalized cancer medicine can be realized and brought to patients worldwide.

Our members include leading academic, pharmaceutical, life science, not-for-profit, health IT, and healthpayer organizations.
Our members include 30 leading academic centers representing 18 countries and four continents, enabling coordinated studies with a global patient population.
The response to a genetically-targeted therapy can vary due to differences in ethnicity and environment. WIN's global studies are designed to identify and account for this variability, enhancing the speed and efficacy with which novel discoveries can be made and brought to patients around the world.

WIN's first trial, WINTHER, is currently being carried out through a collaboration between six academic centers in five countries, with key support from Europe (EUFP7), Fondation ARC, Pfizer and other pharma companies.
WIN prioritizes cross-sector interaction designed to enhance learning across and between continents and healthcare sectors.
WIN Symposia, held annually in Paris, brings together hundreds of leaders representing all stakeholders from around the world in a forum designed to promote the exchange of ideas and information.

Clinical trials and projects

WIN members collaboratively design and carry out global studies designed to achieve breakthroughs for patients worldwide. Our distinguished Scientific Advisory Board oversees WIN studies. Current trials include:

SPRING 01 (Survival Prolongation by Rationale Innovative Genomics) proof of concept trial is the first trial exploring the tri-therapy strategy in first line of advanced/metastatic non-small cell lung cancer (NSCLC), following the historical success of this approach in AIDS and tuberculosis for which only tri-therapy demonstrated long term efficacy.
The WIN SPRING trial will be conducted in the USA, France, Spain, Luxembourg and Israel in the following cancer centers: University of California - San Diego's Moores Cancer Center, Avera Cancer Institute (Sioux Falls, Arizona), Institut Curie (Paris), Centre Léon Bérard (Lyon), Hôpital Paris Saint-Joseph (Paris), Vall d'Hebron Institute of Oncology (Barcelona), Centre Hospitalier de Luxembourg (Luxembourg), and Chaim Sheba Medical Center (Israel).

The trial is sponsored by the WIN Consortium and funded by ARC Fondation for cancer research (France). The drugs are donated by Pfizer Inc.
WINTHER, the WIN Consortium's first global personalized cancer medicine trial, is an ongoing global study carried out at multiple leading academic cancer centers around the world.
WINTHER aims to validate a breakthrough concept that would offer treatment guided by each patients biology for the vast majority of cancer patients.

With multiple cancer centers representing four countries - as well as partner biotech and pharma companies - WINTHER exemplifies WIN's commitment to innovative, collaborative studies that make effective, personalized medicine a reality for patients worldwide.
WIN is currently planning innovative global clinical trials that represent the next generation of studies focused on lung cancer.
European funded trials WINTHER EU FP7 funded and CHEMORES EU FP6 funded established foundations for WIN future global strategy for lung cancer currently under development.

The concept underlying the new strategy is developed in the following publications:
WIN provides a legal and fundraising framework that enables collective fundraising while protecting its members' intellectual property.
The WIN platform enables multiple organizations from different sectors to productively collaborate while providing for the protection of intellectual property. Each project or clinical trial has its own specific contract or funding mechanism.

People leadership

WIN leaders are selected for their contributions and commitment to making effective, personalized cancer medicine a reality for patients around the world. They guide WIN's strategic, operational, and scientific direction.

Richard L. Schilsky Photo
Richard L. Schilsky

Senior Vice President and Chief Medical Officer, American Society of Clinical Oncology (ASCO)

Josep Tabernero Photo
Vice Chairman, WIN Consortium; Chair, WIN Scientific Advisory Board
Josep Tabernero

Director and Clinical Research Director, Vall d'Hebron Institute of Oncology, VHIO (Spain); ESMO President (2018 – 2019); Chair, WIN Scientific Advisory Board

Razelle Kurzrock Photo
Chair, Clinical Trials Committee
Razelle Kurzrock

Chief, Division of Hematology & Oncology, Sr. Deputy Center Director for Clinical Science, University of California San Diego Moores Cancer Center (USA)

Vladimir Lazar Photo
Chief Scientific and Operating Officer
Vladimir Lazar

Chief Scientific and Operating Officer, WIN Consortium

Our members

WIN members include 40 leading organizations representing all stakeholders in personalized cancer medicine covering 21 countries and 4 continents. Our shared vision is delivering the promise of effective, personalized cancer medicine to patients worldwide.

WIN Symposia

WIN Symposia, held annually in Paris, gathers leaders representing a breadth of stakeholders from around the world to learn, share, and collaborate. Visit for registration and additional information.

WIN 2019 Symposium logotype

WIN 2019 Symposium

June 23, 2019 - June 24, 2019

The 11th edition of the WIN Symposia will take place at the WIN Symposium 2019 in Paris, France on 23-24 June 2019.
The program is under preparation.
Updated information and registration will accessible on our dedicated symposium website, once it becomes available:

WIN 2018 Symposium logotype

WIN 2018 Symposium

June 25, 2018 - June 26, 2018

The 10th year Anniversary edition of the WIN Symposia took place at the WIN Symposium 2018 in Paris, France on 25-26 June 2018.
The WIN Symposium Organizing Committee had chosen “Global Implementation of Precision Oncology: WINning the War against Cancer” as the theme for this celebratory event.

To read about the highlights of the WIN 2018 Symposium, click on the link below to access the Meeting Report.

To revisit this year’s Symposium, please visit our dedicated symposium website:

WIN 2017 Symposium logotype

WIN 2017 Symposium

June 26, 2017 - June 27, 2017

The WIN 2017 Symposium with the theme ‘Expediting Global Innovation in Precision Cancer Medicine’ was held in Paris, France, June 26-27, 2017. The overarching goal of our symposium was to share information to promote and accelerate cutting edge investigations and use of personalized, targeted cancer therapy.

What people are saying

Remembering WIN Chairman Emeritus, Dr. John Mendelsohn (1936-2019)
Paris, January 8th, 2019

It is with great sadness, that we announce the passing of our Chairman Emeritus of WIN Consortium (WIN), Dr John Mendelsohn yesterday evening, January 7th, 2019 at the age of 82.

Dr Mendelsohn, M.D., President Emeritus of the University of Texas, MD Anderson Cancer Center was a founding father of the WIN Consortium, a brilliant scientist and visionary, optimist and a truly inspirational leader.

With others, his vision was to create a not-for-profit clinical research organization that advocates global collaboration, sharing information in order to bring the latest innovations in precision cancer medicine in treating diverse patient populations.

WIN remains part of his international lifelong legacy and achievements to improve personalized cancer care to the patient and we honor his memory in helping to continue to build WIN to where it is today. WIN, presently, a consortium of 40 members from 21 countries across 4 continents with the participation and expertise from the major stakeholders in precision oncology, academia, industry, not-for-profits and payors.

WIN is indebted to his knowledge, expertise, mentoring, time and friendship and we have been blessed to have him as our founding Chairman; he will be deeply missed.
WIN Consortium to Launch New Precision Oncology Study, Bank Samples for Blood Biomarker Discovery
PARIS (Genomeweb) – The Worldwide Innovative Networking (WIN) Consortium at its annual symposium this week provided an update on its precision oncology clinical trial pipeline.
On the heels of reporting data from the WINTHER trial at the American Society of Clinical Oncology's annual meeting earlier this month, the consortium leadership this week discussed launching another study called MERCURY. Like WINTHER, this new trial will also use both DNA and RNA data to match patients with a variety of tumors types to targeted therapies and evaluate the impact of this approach on their outcomes.

The consortium has enrolled the first three patients into SPRING, a trial that is investigating the safety and efficacy of triplet therapies as a front-line option for advanced non-small cell lung cancer patients and will validate a biomarker algorithm for identifying which patients will benefit from these combinations. WIN is also close to launching a repository of blood and tissue samples, called BOOSTER, that will be used to discover and validate blood biomarkers for the early detection of NSCLC.

At ASCO, researchers presented data from WINTHER — WIN Consortium's first completed study —showing that the addition of transcriptomics to genomics allowed 35 percent of 303 consented advanced cancer patients to be matched to a treatment. Without the RNA-based algorithm, the match-rate would have been 23 percent.
Although the study did not meet its prespecified clinical benefit endpoint due to a number of factors, a blinded, post-hoc analysis showed that when patients received treatments they were most likely to benefit from as determined by high matching scores, they lived significantly longer compared to those who did not get the top-matched therapies. The study demonstrated the value of RNA data in precision oncology, the importance of gauging gene expression in tumor and normal samples, and that patients were willing to provide these samples.

WIN consortium is taking these lessons and incorporating them into MERCURY, a double-basket study that will enroll patients with a range of tumors, and match them to a variety of drug arms including single and combination agents based on genomic and transcriptomic profiling. Patients will be tested on a 270-gene next-generation sequencing panel and have their differential gene expression measured in normal and tumor tissues using HTG Molecular Diagnostics' nuclease assay.

The WINTHER algorithm will propose the best matches for each patient, and principal investigators will assign patients to a cohort guided by the match score and DNA data. For every drug/tumor arm, researchers will aim to enroll 10 patients in the first phase of MERCURY, and the arm will be expanded to the second phase only if two or more see their tumors shrink in the first four months of treatment. Cohorts that expand to the second phase will enroll another 18 patients. Seven or more patients will have to have a response in order for a particular therapy to be considered effective, and the drugs that yield the best responses will move on for evaluation in Phase III registration trials.
WIN is hoping to demonstrate that the basket study design will result in more efficient development of cancer drugs by advancing treatments with a higher chance of success in Phase III.

Highlighting MERCURY at the symposium, Richard Schilsky, chairman of WIN and chief medical officer of ASCO,noted that the attrition rate in oncology drug development is 82 percent and around 53 percent of kinase inhibitors fail. Moreover, in Phase III studies, 45 percent of drugs fail due to lack of efficacy and 24 percent don't succeed because they didn't extend survival compared to existing options.

The lessons from the WINTHER trial are also important for SPRING, another WIN study the US Food and Drug Administration approved for launch last year. The proof-of-concept study will evaluate the safety and efficacy of triple therapies in advanced NSCLC patients, and retrospectively validate the ability of the SIMS algorithm, which integrates genomics and transcriptomics, to match patients to a combination therapeutic strategy.
In a 2015 Oncotarget paper, researchers led by Razelle Kurzrock, director of the Center for
Personalized Cancer Therapy & Clinical Trials Office at the University of California, San Diego's
Moores Cancer Center, described how they developed SIMS by analyzing lung tumor and normal tissue using targeted genomic sequencing and also looking at copy number variation,transcriptomics, and miRNA expression. Using these techniques, they identified 24 "interventional nodes" that were driving cancer but could also be targeted by drugs, and developed a scoring system to rank how disturbed these nodes were. Based on which nodes were co-activated, Kurzrock's group defined triplet therapies for overcoming resistance.

The transcriptomic algorithm used in the WINTHER study was a precursor to SIMS. "Today,personalized oncology is based mostly on DNA sequencing. We believe … genomics is the tip of the iceberg," Kurzrock said at the symposium this week. "The idea is to go a little deeper into that iceberg and incorporate transcriptomics using comparison of tumor and normal tissue". She estimated that SPRING will need to study around 10 to 12 combinations to ensure matches for most NSCLC patients. The first triplet being investigated in SPRING include two treatments developed by Pfizer, Ibrance (palbociclib) and Inlyta (axitinib); and a third, Bavencio (avelumab)
codeveloped by Pfizer and Merck KGaA. Ibrance is a CDK4 and CDK6 inhibitor. Inlyta is antiangiogenic drug that blocks c-KIT, VEGF receptors, and PDGFR, while Bavencio is an immunotherapy that targets PD-L1. The hypothesis behind SPRING is that "drugs with different modalities of action will be able to achieve what single agents can't achieve," said Kurzrock, adding that if patients don't respond to one triplet, they could rotate to another arm. Each arm will operate in two phases: patients will undergo dose escalation in Phase I and receive treatment at the recommended doses in Phase II. In the Ibrance/Inlyta/Bavencio arm, the plan is to enroll 100 patients in the Phase II portion. If in the initial crop of 50 patients retrospective analysis of SIMS shows that the algorithm can accurately predict responders, the researchers may ask FDA for permission to prospectively use SIMS to match the rest of the cohort, or an expansion cohort, to the triplet.
In order to be eligible for SPRING, however, advanced NSCLC patients can't already have targetable genomic alterations in EGFR, ALK, or ROS1 genes, for example. Moreover, they will receive the triplet combination in the first-line setting.
"This trial was developed with input from the FDA," Kurzrock said. "They actually encouraged us to include patients in the first line … because they felt that treatments for patients that don't have
[targetable] tumor drivers are still not good enough".
So far the Ibrance/inlyta/Bavencio arm has enrolled three patients. One patient has completed the dose escalation phase. Benjamin Solomon from Avera Cancer Institute and a SPRING investigator said that the other two patients enrolled at that institute are at the first dose level and are tolerating it well". That was expected based on what we know about overlapping toxicities in these three drugs", Solomon said.
He added that as seen in WINTHER, these patients also seem willing to undergo dual biopsies once they understand the value of it. "Our two patients who have been enrolled haven't had any complications from that," Solomon said.

Meanwhile, as the first SPRING arm continues to enroll patients, the consortium already has a second arm waiting in the wings, which will investigate Inlyta, Bavencio, and Merck KGaA's c-Met inhibitor tepotinib.

Another area WIN is hoping to make an impact is in the area of blood-based diagnostic markers for NSCLC. With BOOSTER, "we want to look for biomarkers for early detection [of NSCLC] and monitor the course of the disease," said Amir Onn, a lead investigator in the effort who also heads up the Institute of Pulmonary Oncology at Sheba Medical Center in Israel. Despite the positive impact of targeted drugs in certain molecularly defined subpopulations of cancer patients, the mortality rates in NSCLC have remained stubbornly low. Around 14 percent of NSCLC patients with stage IIIA disease are alive five years after diagnosis; with stage IIIB disease the five year survival rate is 5 percent. When the disease has spread to other parts of the body, the five-year survival rate drops to 1 percent.

"There is a need to do better in diagnosing and managing this disease," Onn said.
Moreover, current tools are not good at diagnosing lung cancer. In the US, it takes 350 CT scans to detect one case of lung cancer, Onn noted. He also cited a study in which US Veterans Affairs hospitals implemented lung cancer screening guidelines, and screened some 2,000 patients who consented to partake in the study. CT scans detected nodules in 60 percent of patients, the vast majority of which were benign.

"So, obviously, CT is not good enough to detect lung cancer," Onn said. "We need additional technologies. Why don't we use blood or tissue markers?"
However, he cited another study that demonstrated the ability of a multi-analyte blood test to detect a range of cancers. It didn't work as well in lung cancer compared to its performance in other tumor types. The WIN Consortium is hoping to make a difference in this regard through BOOSTER.

This effort is planning to enroll 4,000 NSCLC patients globally who undergo curative surgery for early-stage lung cancer, and collect blood before and after three months following surgery. These samples will be compared for identification of a variety of biomarkers. "Hopefully, we'll be able to identify markers that are associated with disease," Onn said. The researchers then plan to validate these biomarkers by following patients longitudinally to see whether or not they develop the disease.

Turna Ray
Senior Editor, Genomeweb
WIN Consortium Applies Transcriptomics to Bolster Patient Matching in Precision Oncology Study
CHICAGO (GenomeWeb) – The combination of DNA and RNA analysis allowed more cancer patients to be matched to precision medicine options than would have been possible based on DNA analysis only, a study presented at the American Society of Clinical Oncology’s annual meeting showed.

Although the WINTHER study, conducted by the WIN Consortium, did not meet a prespecified clinical benefit endpoint, a blinded, post-hoc analysis showed that when patients received treatments they were most likely to benefit from, as determined by high matching scores, they lived significantly longer compared to those who did not get the top-matched therapies. The WINTHER investigators said the data demonstrate the importance of integrating transcriptomics into precision oncology trials alongside DNA analysis.

In the WINTHER study, conducted by the WIN Consortium, 35 percent of 303 consented advanced cancer patients matched to a treatment. First, patients were tested for targetable alterations in cancer genes using Foundation Medicine's FoundationOne test. Those who weren’t matched to targetable drugs based on detected genetic alterations had another shot at getting matched to a treatment based on the differences in gene expression in the tumor and normal samples (assessed by microarrays). Without the RNA-based algorithm, the match-rate would have been 23 percent.

"One of the issues with precision medicine trials has been the low matching rate," Razelle Kurzrock, co-leader of the WINTHER trial and director of the Center for Personalized Cancer Therapy & Clinical Trials Office at the University of California, San Diego's Moores Cancer Center, told GenomeWeb. However, the match-rate seen in WINTHER is high for a precision medicine trial, she said, given that most other studies have placed between five percent and 25 percent of patients on to treatment arms after DNA profiling.

"As there are more drugs available and people gain more experience, and in particular, by adding transcriptomics, we are increasing the percentage of patients matched," Kurzrock said.

The aim of the WINTHER study was to use transcriptomics to try to bolster the number of patients receiving personalized therapies. Out of 303 consented patients, ultimately 107 patients were treated, 69 based on DNA profiling and 38 based on RNA profiling.

Although a high match rate is often touted as demonstrating the success of the precision oncology paradigm, it ultimately has little value unless patients benefit from the treatment to which they were matched. And in WINTHER, there were a number of difficulties that kept researchers from recruiting the number of patients originally planned and from meeting the study's primary endpoint.

Researchers had aimed to enroll 200 patients — 60 in arm A where patients were tested by FoundationOne and 140 in arm B where patients were matched based on transcriptomics — from America, Europe, and Israel. "Back when we designed this trial, we thought that we would find actionable results in a minority of patients [in arm A,] and that most patients would be treated in arm B," said Jordi Rodon from MD Anderson Cancer Center while presenting the data.

However, the trial was unable to recruit the requisite number of patients in the US due to regulatory delays and funding limitations.

Moreover, researchers set a high bar for themselves in terms of the benefit they wanted patients to experience in the study. They decided to compare the progression-free survival patients had to matched therapies in WINTHER (PFS2) against the progression-free survival they had to the therapy prior to joining the trial (PFS1).

The expectation generally is that with each cancer progression patients will derive less and less benefit from later lines of treatment. "The idea is if PFS2 can be equal to PFS1 then disease is stable," said Vladimir Lazar, chief scientific and operating officer of the WIN Consortium and an investigator on WINTHER. "But if PFS2 is longer than PFS1, then you’ve reversed the tendency of incrementally worse outcomes on subsequent lines of treatment and that shows a clinical benefit."

The patients recruited to WINTHER were heavily pretreated, with 25 percent having had more than five prior lines of therapy. But the investigators had hoped to demonstrate that even such heavily pretreated, advanced cancer patients would benefit more from matched treatment compared to the prior line of therapy. In this regard they hoped to show a PFS2 to PFS1 ratio of greater than 1.5 in 50 percent of patients in arm A and in 40 percent of patients in arm B.

The PFS2/PFS1 ratio "is a powerful way [of showing treatment benefit] because every patient serves as his or her own control," said Lazar, but he noted that the goal in WINTHER to show a ratio greater than 1.5 was far too ambitious when a ratio of greater than 1.3 is well accepted and has been used in prior precision oncology studies, such as MOSCATO.

In WINTHER, this prespecified endpoint was ultimately reached in only 20 percent of patients in arm A and in 22 percent of patients in arm B.

Eddy Yang from the University of Alabama at Birmingham reviewed the WINTHER data at the meeting and commended the investigators for setting a higher bar in terms of the PFS ratio. He noted though that while the PFS ratio "eliminates that variability between patients" when evaluating the benefit of treatment, there are also downsides to using this endpoint. "There are a lot of other factors that can influence this ratio," he said, such as the prior and current treatment given to the patient, whether the previous PFS was measured accurately, and the differences in prognosis between tumor types.

Yang recognized that the increase in the match rate from 23 percent to 35 percent using transcriptomics is significant in that it represents perhaps the highest match rate in a precision oncology trial. The match rate reported in WINTHER, however, was exceeded by another precision oncology study called i-PREDICT, which also released data at the meeting.

In that study, also led by Kurzrock, researchers from the University of California, San Diego, MD Anderson Cancer Center, and elsewhere enrolled approximately 150 advanced cancer patients using the FoundationOne test to gauge 315 genes, and if possible, based on tumor mutational burden, circulating tumor DNA, and PD-L1 status by immunohistochemistry. They reported being able to match 73 patients, or nearly 50 percent, to a targeted drug or immunotherapy combination.

"I think what’s happening, is that precision oncology trials are getting better," Kurzrock said, though she maintained that to the best of her knowledge WINTHER has the highest match rate based on the published data from precision oncology trials. While there was an abstract on i-PREDICT at ASCO, it has not been published on.

Despite the high match rate, the biggest challenge within WINTHER was garnering sufficient tumor content in samples to enable RNA analysis. Although 253 out of 303 consented patients agreed to provide tumor and normal samples, only 158 patients received treatment recommendations based on their FoundationOne results and transcriptomic analysis, largely due to difficulties with procuring sufficient tumor samples for RNA analysis.

Rodon noted that for transcriptomic analysis the sample quality requirements were much more stringent and required 50 percent tumor content. "The consensus is building that RNA is actually very important," Kurzrock said. But because RNA has been more difficult as far as getting adequate samples and processing, she said that not many in the research community have included RNA analysis in precision oncology studies.

In WINTHER, each site had to learn how to process the samples for transcriptomics, but the sites got better at doing this as they gained experience, recalled Kurzrock. In subsequent WIN Symposium trials, researchers hope to avoid the attrition rates seen in WINTHER by using paraffin-embedded samples, which can be microdissected to increase the tumor content.

Another difficulty in WINTHER was with access to drugs. Based on the literature and the Comparative Toxicogenomics Database (a repository of chemical–gene/protein interactions), WIN has amassed a database of genes that are deregulated in cancer and which influence drugs response and resistance. Using this database, researchers are able to identify the targetable genes that are deregulated in each patient's tumor and apply an algorithm to rank the drugs that they might benefit from most.

Patients who matched to an approved or investigational drug based on this algorithm were enrolled in arm B. But Kurzrock estimated that only around 50 percent of patients received the top ranked drug according to DNA and RNA matching.

A clinical management committee reviewed DNA and RNA test results from study participants, but ultimately made recommendations based on patient's comorbidities and whether a particular drug or trial was available at a specific institute or country. "We ranked more than one option for patients, and we discussed with the physician the range of options," Kurzrock said. "And we tried to give the best option considering the reality that existed for that patient."

The reality for many patients in WINTHER, though, was that they didn't get the top treatment option according to molecular testing. So, researchers conducted a post-hoc analysis to evaluate how patients fared when they did receive drugs based on a high matching algorithm for both arms A and B.

"We thought this was very important to do because if patients were not well matched, we wanted to know if that made a difference when they were highly matched versus poorly matched," Kurzrock said, emphasizing that this was a blinded analysis to avoid bias.

For arm A, researcher devised an algorithm — dividing the number of genomic alterations matched by the total number of characterized DNA alterations — to determine which patients got a high matching score. For arm B, they used the RNA algorithm. When investigators compared all treated patients with good performance status and a high matching score against everyone else, the median overall survival was 25.8 months versus 4.5 months, respectively. "This contains an important lesson in that if you give a better matched drug, patients do better," Kurzrock said.

Following Rodon's presentation at the meeting, some oncologists in the audience commended the investigators for using transcriptomics to guide therapy choice, and in particular analyzing gene expression in tumor versus normal samples. Others at the meeting were more reserved in their judgement.

"Doing a transcriptional analysis, looking at that set of drugs, we're not ready yet," said another oncologist from the audience. "Sequencing every patient, it's negligent as an oncologist to do that in advanced cancer patients, not because we can match all patients but because we can match very few as you said. That's evolving at a rapid rate, but to try to push that too hard and talk about effective personalized medicine actually doesn't help the field."

Rodon responded that WINTHER was a learning opportunity and the WIN collaborators are proceeding carefully. The study, for example, only matched patients based on RNA data when they failed to match to a therapy using FoundationOne. Additionally, despite the challenges the study faced in procuring samples with high tumor content, it was apparent that patients are willing to give tumor and normal samples from molecular analysis.

"I’m not saying that on the basis of this one trial transcriptomics can become the standard of care, but the trial definitely suggests that transcriptomics should be an important part of additional clinical trials," Kurzrock said, noting the need for further studies.

The follow-on study to WINTHER will be SPRING, which will investigate the safety and efficacy of giving advanced lung cancer patients a triplet therapeutic strategy based on a biomarker algorithm that matches patients to the combinations. This algorithm incorporates targeted genomic sequencing, copy number variation, transcriptomics, and miRNA expression, and patients will have their normal and tumor tissue analyzed.

Kurzrock reflected that genomic and transcriptomic testing are very rapidly evolving technologies. While some may feel that these tools aren't ready to used broadly in cancer care, "there is more and more evidence, and to me it's pretty compelling evidence, that genomics and now transcriptomics is important for precision medicine trials,” she said.

Turna Ray
Senior Editor, Genomeweb
Avera To Enroll First Patients in Landmark Lung Cancer Tri-Therapy Clinical Trial
Sioux Falls,Jan. 19, 2018(GLOBE NEWSWIRE)

SIOUX FALLS, S.D. — The first patients in the world will be able to enroll in a new cancer study at Avera as part of an international collaboration that looks to transform care for lung cancer patients.

This clinical trial that received the approval of the FDA is Avera’s latest collaboration as part its membership in the Worldwide Innovative Networking (WIN) Consortium.

“We’re taking a bold step in a new direction so lung cancer patients have hope for more treatment options after diagnosis. This latest step in our collaboration with WIN represents one clinical trial but is part of our larger goal to revolutionize cancer care through personalized medicine,” said Benjamin Solomon, MD, the lead investigator for the study at Avera and medical oncologist with Avera Cancer Institute. “If successful, this study could lead to a complete paradigm shift in our approach to lung cancer treatment with a goal of realizing big improvements in outcomes for patients.”

More than 60 percent of non-small cell lung cancer cases are detected in an advanced stage, and less than 5 percent of these patients are alive five years after diagnosis.

In the Survival Prolongation by Rationale Innovative Genomics (SPRING) trial, patients will be given a three-drug protocol that incorporates immunotherapy (avelumab) and two other targeted therapies (palbociclib and axitinib). All patients will be given the same drug combination and their response rates will be tracked to see which patients respond best.

Through the WIN Consortium, an Avera research team under Solomon’s leadership has helped design and implement the clinical trial from the ground up.

“This breakthrough research is happening in Sioux Falls, S.D., because of the high level of expertise and commitment available here,” said Vladimir Lazar, MD, PhD, founder and Chief Scientific and Operating Officer of the WIN Consortium. “With these clinical trials we want to go beyond what is now possible so patients around the world can have more hope when they get a lung cancer diagnosis.”

Because cancer evolves as it grows, it can acquire more genomic complexity over time. DNA sequencing and RNA expression levels in tumor and normal tissues will help guide care by analyzing the patient’s cancer genomic abnormalities to determine the specific changes that have occurred. A multi-drug combination has the potential to treat lung cancer by blocking multiple cancer pathways that develop as a result of these genomic changes.

For the most effective results, researchers work to pair the drug combinations that may work best to combat each lung cancer genomic abnormality. To accomplish this, WIN developed an algorithm, SIMS (Simplified Interventional Mapping System), which is hypothesized to better predict personalized treatment for cancer patients.

The end goal is to pair every lung cancer genomic abnormality with an effective drug combination. This may lead to dozens of clinical trials aimed at accomplishing this goal. In the future, this treatment algorithm could potentially be expanded to other tumor types such as colon or breast cancer.

The SPRING trial will be led by Razelle Kurzrock, MD, (University of California San Diego, Moores Cancer Center) and co-led by Enriqueta Felip, MD, (Vall d'Hebron Institute of Oncology). It will be launched in five countries and eight WIN member sites. Avera, one of two sites in the U.S., is the first to begin enrolling patients.

The SPRING trial will be conducted in two phases. Phase I will explore the safety of the drug combination and determine the optimal doses for Phase II, which will explore the efficacy of this tri-therapy regimen in first-line treatment of metastatic non-small cell lung cancer. The trial will have strict eligibility criteria and limited enrollment.

About Avera Health

Avera Health is an integrated health system comprised of more than 330 locations in 100 communities in a five-state region. A full continuum of care is offered through 32 hospitals, 200+ clinics, retirement communities, home care, sports and fitness centers, with award-winning care in 60+ medical specialties. With more than 17,000 employees and physicians, Avera is the largest private employer in South Dakota. Avera is distinguished through technology and innovation. We are home to the world’s most extensive telemedicine network, and a world-class genomics program that translates the latest cancer research directly to patient care. As a health care ministry, we carry on the legacy of the Benedictine and Presentation Sisters, delivering care in an environment guided by our values of compassion, hospitality and stewardship. For more information about Avera, see our website at

About the WIN Consortium

Founded in 2010, WIN is unique structurally in that it brings together organizations from academia, business and not-for-profits to focus on translating the latest advances in personalized cancer medicine into the standard of care. WIN is built on the recognition that all stakeholders in personalized cancer therapy must collaborate and share information, in order to effectively bring the latest innovations in personalized cancer care to the patient. WIN is a non-profit organization formed by 40 renowned members: Academic cancer centers (32 centers in 17 countries), companies (Pfizer, Merck KgaA, Covance, Illumina, HTG Molecular, Blue Cross Blue Shield Association, etc.), non-profit organizations such as Fondation ARC, European Cancer Patient Coalition, SurviveIt. The SPRING trial will be presented during the WIN Symposium “WINning the War against Cancer” in Paris (France) on June 25-26, 2018. For further information, please visit and