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 TOP-1, 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. 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”

New strategies for SEs, but same old neratinib

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”

“Hyperprogression” identified as a risk of checkpoint inhibitors

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”