Dear fellow patients, caregivers and supporters,
Lots of news in kidney cancer this week! As Vice Chair of the International Kidney Cancer Coalition (IKCC), I had the opportunity to attend a key conference held in Vienna this week at which several important (and long-awaited) studies were presented. What follows are some highlights on the major presentations pertaining to kidney cancer.
As always, please note that any questions about your own care should be directed to your physician. I am a patient advocate at this conference, not a medical professional. That said, I hope you find the updates useful as springboards for discussion!
Two Successful Trials in mRCC (metastatic Renal Cell Carcinoma)
(cabozantinib vs everolimus in 2nd line mrcc).
The METEOR trial results were published based upon results from 658 patients in 26 countries. (Thank you to all of those patients and their families for your participation.) Compared to everolimus (brand name Afinitor), cabozantinib (an oral cancer medication that targets VEGF and MET) displayed a high level of disease control in the 2nd line setting. Further research will report on control of bone metastasis, and analyze particular subgroups of patients so that experts can better determine which patients (e.g., with which mutations) will most likely derive the most benefit. Some 60% of patients taking cabozantinib required dose reduction (further supporting arguments — as with other agents — that one size/dose does not fit all patients.)
For those inclined to read the full paper, please see here:
(nivolumab vs everolimus in 2nd line mrcc).
The CHECKMATE-025 trial accrued 821 patients in total who were both 2nd and 3rd line. Results as reviewed by Dr. Cora Sternberg (Italy) highlighted that those patients with only one prior treatment did better. Patients treated with nivolumab (intravenous therapy every 2 weeks) had an Overall Survival (OS) benefit of over 5 months as compared to everolimus (oral, daily). The ORR (overall response rate) with nivolumab was 25%. In some patients where treatment was stopped, the response appears to have continued. One clear question remains: how will we know when it is safe to stop therapy?
What’s new here is that nivolumab is the first immune checkpoint inhibitor drug to prove effectiveness in the treatment of kidney cancer (with others surely to follow). Nivolumab (a PD-1 inhibitor) demonstrated survival benefit in patients regardless of the extent of PD-L1 expression in their tumours. (A clear biomarker to be used as selection criteria is not yet known – in other words, it is not clear how to determine which 25% of patients will benefit from the treatment.)
This week in anticipation of our first “immuno-oncology” (IO) treatment for kidney cancer, the IKCC launched a brand new website for patients that includes what you need to know about clinical trials, side effects, and how the new treatments will integrate with existing treatment plans. Please check it out: www.10forIO.info and follow us on Twitter (@IOkidney) and Facebook (IOkidney)
For those inclined to read the full paper for the CheckMate-025 study, please see here: http://www.nejm.org/doi/full/10.1056/NEJMoa1510665
Sadly, not all trials give us the results we were hoping for. Another study of 705 patients reported results of a novel vaccine therapy. The trial design included two arms: IMA901 (a multi-peptide cancer vaccine) in combination with sunitinib (Sutent) vs sunitinib alone as 1st line therapy. Results were disappointing in that the vaccine therapy did not improve upon the results of sunitinib alone. While IMA901 was shown to have a favourable safety profile, there was no improvement in overall survival by adding the vaccine.
So, what does all of this mean to patients in Canada today?
First the good news: two new and very positive-looking drugs are on their way to approval. Those of you who know this process know full well that this is the very beginning of the “long and winding road” with no certainties of reimbursement in Canada. Neither of these two new drugs is yet FDA approved, let alone Health Canada approved… so the wait until provincial reimbursement could be as much as two years from now. We will keep you updated!
In the meantime, Kidney Cancer Canada provides an important voice for patients across Canada and will work on early access programs, clinical trials, compassionate use, and anything we need to do to improve access for patients. If you or your family member have had access to either of these new drugs, please let us know. (We will need your input for future submissions to government agencies!) If you need help today in accessing specialist care or clinical trials, please get in contact with us and we will do our very best to help you: contact us at email@example.com
With kind regards to all – and with sincere thanks to every patient and family who has helped bring these important new advances forward!
Vice Chair, International Kidney Cancer Coalition (IKCC)