Galena continues to hobble along with NeuVax, resisting defeat even though their peptide vaccine targeting HER2-positive breast cancer has failed in patients who have HER2-positive breast cancer as well as in patients who have breast cancer that is, ahem, HER2-lite (this is not a thing). With each failed study, Galena becomes less ambitious: the company announced the presentation of a study-update abstract at San Antonio where the study in question features neither real cancer nor real endpoints.
Neratinib is basically useless and has unmanageable side effects. Puma can publicly acknowledge only one of these problems, so here we are, with the company testing various diarrhea prophylaxis strategies to support an argument that a 2% increase in five-year disease-free survival among early-stage HER2+ breast cancer patients is somehow worth all this misery. Continue reading “New strategies for SEs, but same old neratinib”
This is unpleasant: a paper published in Clinical Cancer Research described a pattern of “hyperprogression” identified in patients treated with PD-1/PD-L1 inhibitors in clinical trials at Gustave Roussy. The investigators compared tumor growth rate (TGR) prior to treatment with PD-1/PD-L1 agents with the TGR after, defining hyperprogression as greater than or equal to a two-fold increase of the TGR between the reference and post-treatment periods (and here I thought the worst thing that could happen was toxic epidermal necrolysis; see Google Images for more on that one). In the evaluable population of 131 patients, 9% met the definition of hyper-progressive disease, which was associated with older age and shorter OS.
While time to progression generally decreases with lines of treatment, a 2x+ increase in rate of growth seems particularly dramatic, and it’s another blemish on what was considered for a while a unicorn of cancer therapy. Continue reading ““Hyperprogression” identified as a risk of checkpoint inhibitors”
I asked my friend @Buyersstrike yesterday if anyone took The Motley Fool seriously, and he replied that yeah, some people think it’s real. Whether anyone could take this particular example, entitled No Cure Yet for Breast Cancer, but 3 Big Advances in 2016, seriously is a separate and more concerning question (TL;DR: HOW?), but for entertainment’s sake, let’s pick it apart.
First, the title. No cure “yet”? Are we anticipating a cure? It’s just around the corner? There’s also a promise that said cure will save “millions of lives”, which, given that 40,000 people die annually from breast cancer, is a promise that will take a while to realize. But that’s just the kind of article this is, which you already knew from the happy pink-ribbon-adorned women in the accompanying photo. Continue reading ““No Cure Yet”, but lots of baseless hype”
We know the narrative: liquid biopsy promises a safe, painless, non-invasive, less-costly method of interrogating tumor DNA to identify targeted therapies for patients who are not amenable to biopsy. Patients will have a real-time view into the resistance patterns of their disease (companies are promoting the idea that patients should have a biopsy after every line of therapy, which was never feasible with tissue biopsy) and be equipped to select treatments that are more likely to work.
All this from a couple vials of blood? Well. Not so fast. Continue reading “My Experience with Liquid Biopsy”
Breast cancer advocacy has hinged for decades on the idea that early detection – via screening mammography – is the key to breast cancer survival. Mammograms save lives, and questioning the value of that bumper-sticker science is not just raising a hypothesis, but a waging a sexist, classist attack on womankind.
Just look at this screencap from Mammographysaveslives.org:
Who needs citations? It says right there that these are FACTS.
Some jerk at the Dartmouth Institute for Health Policy and Clinical Practice was not persuaded by FACTS and decided it was time to kill some women. H. Gilbert Welch, M.D., M.P.H. and colleagues reviewed SEER data from 1975-2012 to analyze the impact of screening mammography on the size of breast cancers at diagnosis as well as track mortality trends over the same period. If screening were effective, the villains suggest, we would see a decrease in detection of large cancers over time. Continue reading “Early Detection Doesn’t Save Lives”
In August, when BMS announced that nivolumab failed to meet its primary endpoint in Checkmate 026, I brushed it off. The flaw was obvious: Checkmate 026 randomized treatment-naive advanced non-small cell lung cancer (NSCLC) subjects with PD-L1 of 1+% to nivo monotherapy or chemo. The competing Merck pembrolizumab study targeted the same previously untreated advanced NSCLC patient population, with the significant difference that Merck’s patients were enrolled based on 50+% PD-L1 expression (note: the studies used different diagnostics/PD-L1 thresholds).
So BMS over-reached. They went head-to-head with Merck for the broader label (not requiring positive PD-L1 expression for treatment, which dramatically increases the patient population), and hubris makes fools of us all. Like a lot of people, I figured the results would improve on subgroup analyses.
As you’ve seen by now, the results did not improve, and Checkmate 026 appears unsalvageable.