Puma presented at Cowen today, and I listened to the webcast hoping for a reaction to APHINITY, but alas, they kept Q&A to the breakout session. The tone of the presentation did seem a little grim, but between the crushing of adjuvant dreams and half the slides being devoted to unmanageable diarrhea, I guess it was always going to play grim. Continue reading “Puma Post-APHINITY”
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”
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”
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.
One of the the core accusations of this blog is that cancer patients are pushed toward clinical trials in spite of alternatives with demonstrated safety and efficacy, which takes advantage of two patient biases: new (if unproven) means better and your physician has your best interests at heart.
Physicians are paid to participate in clinical trials. Let’s get that out of the way. There is nothing objective about recommending trials to patients; you only need to notice how often a physician points a patient toward a trial outside his or her practice to deduce that trial suggestions are not without bias.