The Puma Panel

I didn’t think neratinib was getting through. As much as I want more flexibility in prescribing and a more moderate drug approval pathway, why does it have to be neratinib?

Despite very modest clinical benefit, a lot of toxicity and a broad label, this morning’s FDA panel voted 12-4 in favor of more options for cancer patients. The panelists did seem to take patient selection seriously, though it’s unclear how that will pan out when Puma is loose in the market. What I’m curious about is whether patients will demand it, whether the patient representatives Puma paid to speak – the what-if-Mommy-dies, I-want-to-do-everything-to-fight-this types – are representative of the overall population. Continue reading “The Puma Panel”

New Threat: “Patient-Dictated” Care

While we’ve been worrying about nuclear war and rising global fascism, a post on KevinMD last week reminded us of a persistent and no less real danger: patients who ask for shit. The blog’s author draws a line between “patient-centered care” and “patient-dictated care”, the latter of which entails the physician sighing mightily yet rolling over at any patient request. What choice does he have, really? He’s just trying to keep the lights on in this crazy world.

The example given is antibiotic abuse, that old workhorse – just as scary and describable as it was in that 60 Minutes episode back in 1998. Can You Believe this Asshole Wants Antibiotics for a Cold?! has been kicking around at least since I was in high school, and despite its wear, it won’t die as the catchall justification for why physicians must remain the keepers of the knowledge. They are the rare, anointed ones, elevated by the combination of intellectual superiority and moral purity; they alone understand the dangers of antibiotic resistance. Continue reading “New Threat: “Patient-Dictated” Care”

Liquid Biopsy Continues to Disappoint

Confession: I have been burned by Guardant twice. Both times were my fault, the first on account of my wide-eyed idealism and the other because I didn’t stick to my guns when it counted, but this has seeded a personal and possibly misdirected venom toward the company.

It helps that the product sucks. Continue reading “Liquid Biopsy Continues to Disappoint”

Puma Post-APHINITY

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”

APHINITY!

It worked!

Which is all we know right now, with actual numbers to come later in 2017 (ASCO?), but this morning Roche announced that APHINITY met its primary endpoint of significant improvement in disease-free survival in patients treated with Herceptin, Perjeta and docetaxel in the adjuvant setting.

I can’t wait to see the numbers, but it almost doesn’t matter: Herceptin going off-patent is no longer an issue, and Roche has secured its ownership of the HER2+ patient from date of diagnosis until, well, forever. I’ll be interested to see if Perjeta becomes a co-backbone of HER2+ treatment alongside Herceptin, in the sense that you never really stop Herceptin, regardless of how many times the patient progresses on it; we tend not to even do a lot of biopsies to confirm that HER2 status hasn’t reversed, despite the fact that a flip from HER+ to HER2- does happen in the recurrent and metastatic settings. It’s too soon to consider whether Perjeta will still be the first-line HER2 treatment of choice in recurrent or metastatic disease if the patient has been previously treated with Perjeta, but assessing durability of benefit through multiple courses of treatment is one of the many possible next steps for this agent.

Seattle Genetics Bags Irinotec- Er, IMMU-132

Two billion dollars seems spendy for a repackaged chemo agent that has been on the market since 1996. It’s no secret, either; irinotecan is standard of care in colon and lung, though, weirdly, it doesn’t get prescribed a lot in breast (despite the fact that irinotecan targets TROP-2, which is commonly overexpressed in breast).

What Seattle Genetics may be banking on is the branding; this is a “new drug” for triple negative breast cancer, which is great marketing when, in reality, there is no drug that is for TNBC. IMMU-132 is an opportunity to give patients who only have access to chemo, well, more chemo. This isn’t T-DM1, which was a game-changer because it enabled the targeted delivery of a chemo agent (emtansine) that was too toxic to give on its own. IMMU-132 is more of a Doxil/doxorubicin situation. Continue reading “Seattle Genetics Bags Irinotec- Er, IMMU-132”

Galena and the vaccine that won’t die

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.

Continue reading “Galena and the vaccine that won’t die”