Collective Wisdom: Kidney Cancer Updates from ASCO 2016

By: Deb Maskens, Vice Chair, International Kidney Cancer Coalition (ikcc.org)

This year’s ASCO (American Society of Clinical Oncology) meeting in Chicago, June 3-7, had the theme: “Collective Wisdom, the Future of Patient-Centered Care and Research”. This meeting hosted over 30,000 attendees, including cancer researchers and healthcare professionals from all over the world, and a small but very active group of some 400 patient advocates focused on various aspects of cancer care, survivorship, and health policy issues.

Attending on behalf of the International Kidney Cancer Coalition (IKCC), I had the opportunity to attend sessions focused on health system sustainability, compassionate access, survivorship care, and of course specific medical updates in kidney cancer. What follows is my personal summary of highlights and take-aways as an mrcc patient and patient advocate.

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Kidney Cancer Updates

Two major papers for kidney cancer were much anticipated and presented at a joint session on Sunday June 5th:

1. Cabozantinib

Dr. Tony Choueiri presented the Overall Survival (OS) data from the METEOR clinical trial. (At a previous conference it was noted that cabozantinib was superior to everolimus in this trial based upon PFS data (Progression Free Survival – or the period during which the cancer does not get worse.) At ASCO, Dr. Choueiri presented the difference in overall survival from those patients who had taken cabozantinib versus everolimus. The OS difference is statistically significant at approximately 5 months. Note: while this trial cannot be compared head-to-head with the CheckMate 025 trial, the overall survival benefit appears to be the same as nivolumab, another drug compared to everolimus in a different trial. For a more detailed review, click here.

OS

What does this mean to patients?
It looks like cabozantinib will become a viable option for patients whose disease has progressed on a first-line VEGF-TKI (e.g., following sunitinib or pazopanib). However, access to cabozantinib depends upon regulatory approval and reimbursement. Currently cabozantinib is FDA approved in the United States under the brand name Cabometyx.

In Canada, there is currently no early access program for cabozantinib. The company (Exelixis, based in San Francisco) has not yet filed for Health Canada approval. (In this case, any delay in bringing the drug to Canada is related to the manufacturer not filing for regulatory approval (yet) in Canada, not due to processes within Canada. Patients interested in cabozantinib should ask their physician and also consider clinical trials that might include cabozantinib. Please make sure you are registered with Kidney Cancer Canada so that we can inform you of any new access programs as they arise.

2. Nivolumab

Dr. David McDermott presented long-term survival data from earlier (Phase 1 (34 patients) and Phase 2 (167 patients) studies) of nivolumab in kidney cancer, noting that some 30% of patients were alive at the 4-year mark. Of those, a significant percentage of long-term survivors showed no response to nivolumab (had either SD (stable disease) or PD (progressive or worsening disease) as their best outcome. Toxicities were noted over a 50-month timeframe showing that the vast majority of toxicities happened in the first 6 months, and hardly any were noted beyond one year. For a more detailed review, click here.

nivolumab

What does this mean to patients
Lots of questions about how immuno-oncology (e.g., nivolumab) works and for which patients (noting there is no biomarker). Traditional measures of response (e.g., tumour shrinkage) seem to be inadequate to determine long-term patient benefit. Complete response (or “NED – No Evidence of Disease) may not be realistic because a long-term durable response may be seen without completely removing all evidence of disease. Certainly there were lots of questions about the data that will be more fully answered by observing the results of those patients who participated in the bigger Phase 3 clinical trial.

Nivolumab questions asked by researchers:

  1. Are we using the correct dose and schedule?
  2. Could treatment be stopped after xx months?
  3. How can we pre-select those patients who are most likely to benefit and advise those who are most likely not to benefit

In Canada, nivolumab is currently available through a Patient Access Program through Bristol Myers Squibb. For more information, please contact Kidney Cancer Canada.

Clinical Trials in Kidney Cancer

Now more than ever before, clinical trials present an excellent opportunity for kidney cancer patients to access new medications and to contribute to finding the best treatments. Clinical trials are available in numerous countries from the moment of diagnosis through to advanced disease. Many of these trials are recruiting kidney cancer patients specifically, and some will accept patients with various types of solid tumours (renal cell carcinoma being one). Patients are advised to ASK and keep asking about clinical trials as options.

Lots of information about clinical trials for kidney cancer patients is up on our website: www.10forIO.info We regularly post updates about new clinical trials on our Facebook and Twitter accounts as @IOkidney. Be sure to follow these accounts online and bookmark the website as one of your sources for kidney cancer information.

Clinical trials are available in many Canadian provinces. Please visit the Kidney Cancer Canada website and call our helpline for more information about specific trials that might be available to patients in your province – or in a neighbouring province where access might be possible.

Outside of Clinical Trials…

With new treatments becoming available, there are many unanswered questions about how clinical trial results will translate to real benefit in clinical practice. The number of potential sequences is growing exponentially and there is no agreement, even among the top experts in kidney cancer. (Of course from a patient perspective, the *best* sequence will be a sequence of ONE treatment that really works and is durable!) Researchers and advocates alike are calling for the collection of Real World Evidence (RWE) through patient registries that track patients over the long-term. Patients should ask about whether their information is being collected and shared for the benefit of all.

In Canada, many kidney cancer patients have given their consent for their (anonymized) information to go into the Canadian Kidney Cancer Information System (cKCis). Please ask your physician whether your cancer centre is participating in this national information system and whether you can contribute your information.

Lots More on ASCO.org Website

Lots more updates in kidney cancer were presented (see http://am.asco.org/abstracts) for updates on brain metastasis, stereotactic radiation, and many trials reporting on use of new agents including avelumab, atezolizumab, pembrolizumab, alone and in combination. For a great article on emerging combination therapies for kidney cancer see this Editorial by Drs. Rana McKay and Tony Choueiri.

Closing Thoughts

Sessions on “Compassionate Use” and “Financial Toxicity” served as an important reminder that none of this research will help patients unless the treatments are affordable and offer VALUE (a word spoken 1,000 times at ASCO this year). While existing “Value Frameworks” from ASCO (and ESMO and other organizations) attempt to quantify value to our healthcare systems, we all need to remember that patients, caregivers and families have social values that also need to be integrated.

When all is said and done, all of this research is for patients towards a cure. As U.S. Vice President Joe Biden said in his address to ASCO, we need to work together like never before, to collaborate in ways we have not seen before – across cancers, across borders, breaking down any barriers that get in the way of progress. Patients will need to be equal partners – as one motto says “not FOR us, but WITH us”.

We look forward to your comments on this summary.

 

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