PRESS RELEASE: Nivolumab improves overall survival in patients with advanced kidney cancer: results from the CheckMate 025 trial

ECC2015 Press Release:

Vienna, Austria: The targeted drug nivolumab significantly prolongs survival in patients with advanced kidney cancer, whose disease has progressed after their first treatment, according to results to be presented at the 2015 European Cancer Congress [1] today (Saturday) and published simultaneously in the New England Journal of Medicine [2]


The CheckMate 025 phase III clinical trial, which compared nivolumab with the standard treatment, everolimus, in patients with clear cell renal cell carcinoma (a common type of kidney cancer), is the first to show an improvement in overall survival in these patients for any immune checkpoint inhibitor drug – therapies that target molecules playing an important role in the immune system’s ability to recognise and attack tumours. Nivolumab blocks the interaction between the programmed cell death protein 1 (PD-1) and another molecule called programmed cell death protein ligand 1 (PD-L1). However, the survival benefit was seen in patients regardless of the extent of PD-L1 expression in their tumours.

In the first of two late-breaking presentations of research that is predicted to change the way kidney cancer patients are treated, Padmanee Sharma, who is Scientific Director of the Immunotherapy Platform and Professor in the Departments of Genitourinary Medical Oncology and Immunology at the MD Anderson Cancer Center, USA, will tell the presidential session at ECC2015: “CheckMate 025 is the first and only study in which immunotherapy with an immune checkpoint inhibitor, used after prior treatment has failed, has shown a benefit in overall survival among patients with advanced kidney cancer for whom treatment options are currently limited. This analysis shows that patients taking nivolumab had a median overall survival of 25 months as compared to 19.6 months for those taking everolimus.

“Importantly, data from this analysis show that a greater proportion of patients had tumours that shrank in response to nivolumab than to everolimus; the objective response rate was 25% for nivolumab versus 5.4% for everolimus, the partial response rate was 24.1% versus 4.9%, the complete response rate was 1% versus 0.5% respectively, and many other patients experienced stable disease when the tumours did not grow – 34.4% for nivolumab-treated patients versus 55.2% for everolimus-treated patients. [3]

“It is exciting to see the outcome of this study, as the results are significant and clinically meaningful to patients and healthcare professionals alike. They are likely to change the treatment of patients with advanced kidney cancer, whose disease has progressed on prior treatment. Although we cannot speculate at this time on when nivolumab might enter the clinic, we hope that this study will quickly lead to approval of nivolumab as a standard of care therapy for these patients.”

There were fewer serious (grade 3-4) side effects among patients treated with nivolumab: 19% compared to 37% among patients treated with everolimus. The most common side effects were; fatigue (33%), nausea (14%) and severe itching (14%) for nivolumab, and fatigue (34%), inflammation of the mucous membrane of the mouth (30%) and anaemia (24%) for everolimus. There were no treatment-related deaths for nivolumab and two among patients receiving everolimus.

The international CheckMate 025 phase III clinical trial recruited 821 patients with advanced clear cell kidney cancer, who had received prior treatment, between October 2012 and March 2014 [4]. They were randomised to receive 3 mg/kg of nivolumab intravenously every two weeks or a 10 mg tablet of everolimus taken orally once a day. They were followed up for a minimum of 15 months and the data cut-off point for the analysis presented at ECC2015 was June 2015, at which point 17% of patients receiving nivolumab and 7% of patients receiving everolimus remained on the treatment. Deaths had occurred among 45% of patients on nivolumab and 54% of patients on everolimus, and the risk of death from any cause was 27% lower among the nivolumab patients.

The trial was stopped early in July 2015 when it became clear that there was superior overall survival among patients being treated with nivolumab. Patients were offered the opportunity to continue with nivolumab treatment or, for those on everolimus, to switch to nivolumab.

Professor Sharma will tell the congress: “Renal cell carcinoma is the most common type of kidney cancer in adults, with 338,000 new cases and more than 100,000 deaths worldwide each year. Globally, the five-year survival rate for those diagnosed with advanced kidney cancer is 12.1%, and so more effective treatments are desperately needed for these patients.”

“The finding that overall survival was higher among patients treated with nivolumab, irrespective of PD-L1 expression, suggests that PD-L1 expression should not be used to determine which patients might respond to the therapy and whether or not offer it to them,” says Prof Sharma. 

“PD-L1 is a dynamic biomarker that changes over time as a result of evolving immune responses. So it is not surprising that PD-L1 measured in tumour samples before treatment does not capture the true expression of PD-L1 and how it may correlate to responses to treatment. I would expect that tumour samples taken while patients were on-treatment, as opposed to pre-treatment, might indicate that PD-L1 expression, as well as other markers of immune response, has a correlation with response to treatment.” 

Professor Peter Naredi, the ECCO scientific co-chair of the Congress, who was not involved in the research, commented: “I am as excited as Professor Sharma over the news we are hearing at this European Cancer Congress in Vienna. At the same presidential session two practice-changing randomised phase III trials are presented. For patients with advanced kidney cancer who have progressed on earlier treatment, we now get two novel treatment options, both with different mechanisms of action. Prof Sharma and her global network of colleagues show here a clear survival benefit for kidney cancer patients who receive nivolumab.”

The other late-breaking presentation in the presidential session will be made by Professor Toni Choueiri, who will be reporting results from the METEOR randomised phase III trial of cabozantinib versus everolimus in advanced clear cell kidney cancer.


Abstract no: LBA 3. “CheckMate 025: a randomised, open-label, phase III study of nivolumab (NIVO) versus everolimus (EVE) in advanced renal cell carcinoma (RCC)”. Presidential session I, 14.30–16.40 hrs (CEST), Hall D1, (presenting at 16.10 hrs).

[1] The European Cancer Congress is the 18th congress of the European CanCer Organisation (ECCO) and the 40th congress of the European Society for Medical Oncology (ESMO).
[2] “Nivolumab versus everolimus in advanced renal cell carcinoma”, by Robert Motzer et al. doi: 10.1056/NEJMoa1510665. Published online:
[3] Objective response rate is the number of patients with a complete or partial response to treatment, divided by the number of randomised patients.
[4] The following countries recruited patients to the trial: Austria, Belgium, France, Germany, Italy, Poland, Spain, UK, Czech Republic, Denmark, Finland, Sweden, Greece, Romania, Norway, Russia, USA, Canada, Brazil, Argentina, Japan and Australia.
[5] The CheckMate 025 trial is funded by Bristol-Myers Squibb.


Large variations in survival from blood cancers between European countries. Analysis shows lower survival from all cancers in Denmark, the UK & Eastern Europe than in neighbouring countries

ECC2015 Press Release:

Vienna, Austria: Comparisons of cancer patients’ survival and care in Europe up to 2007 show that although more patients are surviving for at least five years after diagnosis, there are large variations between countries, which are particularly significant in cancers of the blood.


Dr Milena Sant, from the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan, Italy, will tell the 2015 European Cancer Congress [1] today (Saturday) that new analysis of data from the EUROCARE 5 study has provided information on patients diagnosed after 2000 in each European country and reveals that survival is generally low in Eastern Europe and high in Northern and Central Europe, confirming trends highlighted in previous EUROCARE studies.

“In general, five-year relative survival – survival that is adjusted for causes of death other than cancer – increased steadily over time in Europe, particularly in Eastern Europe, for most cancers. However, the most dramatic geographical variations were observed for cancers of the blood where there have been recent advances in treatment, such as chronic myeloid and lymphocytic leukaemias, non-Hodgkin lymphoma and two of its sub-types (follicular and diffuse large B-cell lymphoma), and multiple myeloma. Hodgkin lymphoma was the exception, with smaller regional variations and a fairly good prognosis in most countries,” said Dr Sant.

The average five-year relative survival, standardised for age, for Hodgkin lymphoma was the highest of all the blood cancers at 81%, with variations ranging from 79.4% for Ireland and the UK, to 85% in Northern European countries and 74.3% in Eastern European countries. By contrast, average five-year survival for chronic myeloid leukaemia was 53% (but this varied enormously according to age), with the geographical variation the greatest of all the blood cancers: 33.4% in Eastern Europe versus 51-58% in the rest of Europe. Significant deviations from the regional average were found in Sweden (69.7%), Scotland (64.6%), France (71.7%), Austria (48.2%), Croatia (37.8%), Estonia (48.9%), Czech Republic (45.2%) and Latvia (22.1%).

EUROCARE 5 has records from 22 million cancer patients diagnosed between 1978 and 2007 in 30 European countries and has been reporting results since the late 1990s. These latest data are on over 10 million patients diagnosed from 1995 up to 2007 and followed up to 2008, with an unprecedented coverage of 50% of the European population. They are published in 11 papers in the European Journal of Cancer [2] simultaneously with presentation at the European Cancer Congress.

For cancers that have a fairly good prognosis, the European average five-year relative survival was 82% for breast (with a variation of 74% in Eastern Europe compared to 85% in Northern Europe), 57% for colon (49% in Eastern Europe, 61% in central Europe), 56% for rectum (45% in Eastern Europe, 60% in central Europe), 83% for melanoma (74% in Eastern Europe, 88% in Northern Europe) and 83% for prostate (72% for Eastern Europe, 88% for central Europe).

Smaller variations were seen in cancers with a poor prognosis; lung cancer had a European average five-year relative survival of 13% (9% in Ireland and the UK, 15% in central Europe), ovarian cancer (average 38%, 31% in Ireland and the UK, 41% in Northern Europe), stomach cancer (average 25%, 17% in Ireland and the UK, 30% in Southern Europe), pancreas (average 7%, 5% in Northern Europe, and Ireland and the UK, 8% in Southern Europe) oesophagus (average 12%, 8% Eastern Europe, 15% central Europe) and brain (average 20%, 18% in Ireland and the UK, 24% in northern Europe.

“Between 1999-2001 and 2005-2007, the largest increases in five-year relative survival were seen in cancers such as chronic myeloid leukaemia where survival increased from 32% to 54%, prostate cancer, which increased from 73% to 82%, and rectal cancer which increased from 52% to 58%,” said Dr Sant.

Another analysis of the data reported in the EJC papers looked at overall survival for all cancers in Europe, taking data from over 7.5 million cancer patients in 29 European countries. This shows that Denmark, the UK and Eastern European countries have lower survival than neighbouring countries. Five-year relative survival, standardised for age, was 59.6% in Northern Europe, 58% in Central Europe, 54.3% for Southern Europe, 50.1% for Ireland and the UK, and 45% for Eastern Europe. In Denmark it was 50.9%. Within Eastern European countries, survival for most cancers was significantly lower than the regional average in Bulgaria, Latvia and Poland: 39%, 42% and 41% respectively. In the Czech Republic survival was significantly higher than the regional average, at 51%.

“Survival correlated with gross domestic product (GDP) and total national expenditure on health (TNEH): countries with recent higher increases in GDP and TNEH had a higher increase in cancer survival. However, this was not the case for countries such as Denmark and the UK, which continue to perform worse than expected for their level of TNEH,” said Dr Sant.

She said that variations in survival were due to a number of factors: differences in the biology and behaviour of some cancers and in screening and diagnosis (e.g. for breast, prostate and colorectal cancers), which can result in cancers being detected earlier and, potentially, at a more treatable stage, as well as the availability of newer and better treatments. “Socioeconomic status, lifestyle and general health differences between populations may also play a role.”

She concluded: “Results from EUROCARE can help to identify regions of low survival where action is needed to improve patients’ outcomes. Population-based survival information is essential for physicians, policy-makers, administrators, researchers and patient organisations who deal with the needs of cancer patients, as well as with the issue of the growing expenditure on health care. It is vital to close the gap between the world of research and that of patient advocacy groups in order to improve cancer care. In connection with the publication of the EUROCARE 5 results, the European Cancer Patient Coalition calls for a reduction in the fragmentation of care services and the promotion of comprehensive multidisciplinary cancer care centres in order to help reduce survival inequalities across Europe, and it stresses that survival is also affected by the organisation and funding of health care systems.”

EUROCARE is possible thanks to a consolidated partnership between two Italian research institutes (the Fondazione IRCCS Istituto Nazionale dei Tumori in Milan and the Istituto Superiore di Sanità in Rome) and the network of over hundred European cancer registries.

Professor Peter Naredi, the ECCO scientific co-chair of the Congress, who was not involved in the research, commented: “EUROCARE 5 once again shows how important it is that we follow the outcome of cancer care in Europe. When we improve diagnostics and treatments of a cancer type it does not take long to improve survival for that patient population as well. But what Dr Sant and co-workers also indicate is that improved survival does not come without a financial incentive from the governments. I hope this will continue to encourage the European community to spend money on cancer care and research.”


Abstract no: LBA 1. “Is Europe doing better in cancer care since the 90s? The latest findings from the EUROCARE-5 study”. Presidential session I, 14.30–16.40 hrs (CEST), Saturday 26 September , Hall D1 (presenting at 15.30 hrs).


[1] The European Cancer Congress is the 18th congress of the European CanCer Organisation (ECCO) and the 40th congress of the European Society for Medical Oncology (ESMO).
[2] Survival of Cancer Patients in Europe, 1999 - 2007: The EUROCARE-5 Study. Eds: P. Minicozzi, R. Otter, M. Primic-Žakelj, S. Francisci, European Journal of Cancer, vol.51, issue 15, October 2015, pp 2099-2266.
[3] Italian Ministry of Health and European Partnership for Action Against Cancer (EPAAC) funded EUROCARE 5.


Childhood cancers in Europe: progress has been made, but much remains to be done, says major report

ECC2015 Press Release:

Vienna, Austria: Each year in Europe, 6,000 young people die from cancer, and two-thirds of those who survive suffer from treatment-related side effects. Although there has been considerable progress in the treatment of childhood cancers over the past few decades, and cancer in childhood is rare, these are major problems that need to be overcome, says a report from SIOPE, the European Society for Paediatric Oncology, launched at the 2015 European Cancer Conference[1]today.

“The SIOPE Strategic Plan: A European Cancer Plan for Children and Adolescents”[2] sets out the plans of the European Community of Paediatric Haematology Oncology to improve both the cure rate and the quality of life for survivors of childhood cancers over the forthcoming ten years, with the ultimate aim of increasing disease-free and late-effect free survival. Cancer is still the first cause of death by disease in children aged one year and over in Europe, and more than 300,000 European citizens are paediatric cancer survivors. In addition to the side effects of treatment, five years after diagnosis these survivors still have a risk of death that is higher than that of the general population.

“This is a serious problem, for patients, their families, and for health services, with major inequalities existing across Europe,” says Professor Gilles Vassal, from the Institut Gustave Roussy, Villejuif, France, and President of SIOPE. “Add to this the fact that 35% of such cancers normally occur before the child is five years old, and that many paediatric cancers are difficult to treat, and you will understand why we thought it essential to try to tackle this problem in a practical way.”

The report, drawn up after widespread consultation, including discussions with parents, patients and survivors, sets out existing problems and proposes solutions to tackle them. It formed part of the EU 7th Framework Programme project ‘European Network for Cancer Research in Children and Adolescents’ (ENCCA)[3]. Among these problems are poor access to new drugs for child patients; lack of funding; disparities across Europe in access to treatment and hence survival; and the fact that paediatric oncology was relatively isolated from the adult oncology community.

But all is not gloomy, says Prof Vassal. “Major progress, both current and expected, in understanding paediatric tumour biology through high throughput technologies becoming more widely available will help us to develop effective targeted therapies. And the support to paediatric oncology shown by the European Commission and Parliament provides not just resources, but also encouragement to those working in the field.”

However, says the report, there is a worrying tendency for politicians to think that the 80% cure rate seen in paediatric cancer means that it is not a major issue and that therefore efforts should only be concentrated on cancer prevention in adults and on transforming cancer into a chronic disease in an ageing population. In order to try to move this situation forward, the report sets out a number of goals, and lists the key factors that will be necessary in order to achieve them. These include a commitment of all funding bodies to finance projects and structures of relevance to paediatric oncology; a strong partnership with patients, parents, and survivors, including better communication and dissemination of information; better collaboration with adult oncology; and intelligent and transparent partnerships with industry.

“One of the most important objectives focuses on increasing our knowledge of the biology of paediatric tumours,” says Professor Martin Schrappe, from the University of Kiel, Germany, and SIOPE President-Elect. “Cancers in adults result from a multi-step process, usually after exposure to external carcinogens such as tobacco, alcohol, and diet, and often progress over many years. Paediatric malignancies develop early in life and over a much shorter time period; this suggests that fewer and stronger events are required for them to progress. Compared with adult cancers, most of them show fewer genetic defects and have a lower genetic complexity.

“Major progress has been made in understanding paediatric tumour biology, and this has led to the discovery of some unique cancer hallmarks. Now we need to use modern, innovative technologies to further decipher the mechanisms of paediatric tumour development, progression and relapse, and speed up its translation to the clinic.”

In order to do this effectively and fairly, says the report, interactions need to be strengthened at several levels – between networks of basic research teams, between basic scientists and clinical researchers, and by increasing the involvement of patients and parents in the search for personalised medicines. SIOPE will monitor progress through research into outcomes.

Another important issue for SIOPE is improving the quality of life for survivors. “We believe that in 2020, there will be nearly half a million European paediatric cancer survivors, and many of them will have side effects that are severe enough to affect their daily lives. While the fact that so many survive is a cause for rejoicing, we have a duty to provide them with optimal long-term care so that the rest of their lives may be as normal as possible. One way of doing this would be the creation of a ‘survivorship passport’ for each child and adolescent cured of a cancer. This would contain a history of their disease and treatment together with relevant follow-up measures aimed at improving their quality of life, and a database for storing the clinical data and hence facilitate monitoring and research,” says Prof Schrappe.

“Why does my child have cancer,” is a frequently asked but equally frequently unanswered question. Because so little is known about the causes of childhood cancers, this is hardly surprising, says the report. What is needed is to increase the understanding of a predisposition to cancer in children by using whole genome sequencing, and addressing questions on the possible environmental causes of such cancers through evidence-based studies.

“We are proud to have achieved consensus on the important steps that need to be taken to tackle the issue of childhood cancer in Europe,” says Prof Vassal. “Through setting specific and obtainable objectives, strengthening collaborations, and establishing funding partnerships, we believe that we will be able to make a real difference to the lives of paediatric cancer survivors. We would like to see our report form the basis of a European Cancer Plan for children and adolescents, and we urge all those involved to work together with us in order to see this come about.”


[1] The European Cancer Congress is the 18th congress of the European CanCer Organisation (ECCO) and the 40th congress of the European Society for Medical Oncology (ESMO).
[2] The full report will be posted on the SIOPE website,, after the embargo lifts. Embargoed PDFs may be obtained from
[3] The mission of ENCCA, which runs from 2011–2015, is to structure and enhance efficient collaboration within the field of paediatric oncology in Europe. With 39 leading European institutions working together as partners, ENCCA has limited the fragmentation of knowledge and improved communication channels by bringing together all stakeholders in the field.

The European Society for Paediatric Oncology (SIOP Europe or SIOPE) is the only pan-European organisation representing all professionals in the field of childhood cancers. With currently more than 1,500 members across 31 European countries, today SIOPE is leading the way to ensure the best possible care and outcomes for all children and adolescents with cancer in Europe. More information on SIOPE can be found on its website