Dr.Weeks’ Comment: For the past decade I have predicted that the future of cancer care will not be toxic chemotherapy and toxic radiation therapy but simply anti-inflammatory agents (remember the 4 most important words in oncology are “Cancer Spreads by Inflammation”) and immunotherapy – teaching one’s own immune system to fight cancer. The future is upon us. Don’t settle for chemo or radiation.
“…data from a median follow-up of 14 months, which showed that median overall survival was significantly longer with pembrolizumab vs investigator’s choice of chemotherapy…”
‘Really Durable Benefit’ Emerging With Bladder Cancer ImmunoTx
Some of the ‘Most Mature Data in Modern Immunotherapy’
SAN FRANCISCO — Immunotherapy is showing “really durable benefit” in patients with bladder cancer, experts said here at the Genitourinary Cancers Symposium (GUCS) 2018. Some patients are living much longer through immunotherapy than through chemotherapy — which is demonstrated by the “tail” at the end of overall survival curves from clinical trials.
The latest data come from long-term results from the KEYNOTE 045 trial, which shows ongoing superiority for immunotherapy with pembrolizumab (Keytruda, Merck) in comparison with chemotherapy in the treatment of locally advanced and metastatic bladder cancer.
This trial was the basis for the approval last year of pembrolizumab for the second-line treatment of advanced bladder cancer, also known as urothelial cancer.
That 2017 approval was based on interim data from a median follow-up of 14 months, which showed that median overall survival was significantly longer with pembrolizumab vs investigator’s choice of chemotherapy (10.3 v 7.3 months; P = .002).
Those results were published in the New England Journal of Medicine (NEJM).
Here at the GUCS 2018, lead study author Joaquim Bellmunt, MD, of the Dana-Farber Cancer Institute in Boston, Massachusetts, reported data from a median of 27.7 months’ follow-up. The median overall survival difference continued, with pembrolizumab once again showing significantly more benefit than chemotherapy (10.3 vs 7.3 months; P = .00017).
Bellmunt also noted that at a median follow-up of 24 months (a standard timepoint), 27% of patients in pembrolizumab arm were still alive, vs 14.3% in the chemotherapy arm.
“The 2-year survival rate is similar to what has been seen with other immune-sensitive cancers, such as melanoma,” he said.
The discussant for this paper, Robert J. Jones, MD, PhD, of the University of Glasgow and Beatson West of Scotland Cancer Center, United Kingdom, put the results into a wider context.
“Why is this exciting?” asked Jones. Because “this is some of the most mature data we have in the modern era of immunotherapy,” he answered.
Overall survival curves in metastatic cancer treatment trials inevitably go down with time, explained Jones: “There’s a predictable decay.”
But, in KEYNOTE-045, as has been seen in clinical trials of immunotherapy in melanoma, the overall survival curves show “a settling down at about the 20% mark,” he explained, referring to the percentage of patients who live on thanks to treatment.
In these Kaplan-Meier curves, there is a steady drop in the percentage of patients who are still alive over time. The curve eventually flattens out and stabilizes as the durable benefit emerges (the term “tail” refers to straightening that is seen at the bottom of the curve).
“This is the paradigm shift…with immunotherapy. The holy grail here is that we might be able to achieve this really durable benefit — albeit with a subgroup of patients with urothelial cancer,” he said.