I moved, but the DS-8201 stays

That drug. This is the volatile adolescent relationship I never had. I’ve been dose reduced and dose delayed multiple times; I have no idea how much drug I’ve actually had. My new center started me over at Cycle 1, so now I’ve really lost track. But the thing still works! Even my brain is stable. The side effects are brutal, and I think not discussed openly because the drug works so well and is so new, but the nausea and fatigue are unbelievable. I’ve never thrown up from a drug before this. I’ve got a carefully curated four-drug combo designed to control the nausea, and it’s shocking to me that it really takes that much, and honestly I’m a little surprised that after a decade, I haven’t adapted to regular doses of poison.

Two milestones passed since I last wrote. June 6 was ten years from my original diagnosis. I was living in Switzerland. The doctor who diagnosed me was honestly the only Swiss I met who was kind to me, and more importantly, she got me diagnosed. I was lying on a table after a breast ultrasound while the radiologist fought with her in German on the phone, right in front of me, about whether to perform a biopsy. I was 25, right? It was impossible. He was pissed but hung up the phone and did the goddamn biopsy. A week later, sitting across from my doctor in her office, I remember what she said, so gently. “You will require more treatment.” Okay. She told me it was cancer. When I didn’t burst into tears, she said, with some surprise, “You were expecting this?” Yes. I’d known, I’d always known. She called my boyfriend for me to tell him, to bring him in and talk to him. I couldn’t do it. I’ve never been able to tell anyone; I have my husband do it, always. July 8 was the anniversary of my surgery. I remember that morning vividly. It was the first time I’d seen the thermometer that you just hold to your forehead. I thought it was so cool. My boyfriend, now husband, and aunt were with me. We watched Lady Gaga perform on the Today show on the TV in the corner of the room. She looked so amazing that I got a platinum blond wig like hers and wore it around NYC when my hair fell out. The last thing I said to my husband as they were wheeling me away was, “I wish this weren’t happening.” I woke up and didn’t feel that different.

I forgot the anniversaries of both of these days, though they’d been fading in and out of my memory for a few weeks. They were so long ago, and it’s all so different now.

We moved to Palo Alto in June, and despite working in finance and living in Berkeley over a decade ago, somehow I’d never been here before we pulled up to the front door of our rented house. I cannot believe such a paradise exists. I can see the sun every day. (A marvel after Boston, Indiana, Sweden and Switzerland.) I bought a bike, an adorable little mint green e-bike, that I love and am using to go back and forth between my house and the hospital. If you see me on the road, please don’t hit me. My brain’s been irradiated, and I don’t quite trust my balance. I’m hoping this won’t end with an OS event.

So here I am, in a standoff with my bone marrow and soaking up the sun, ten years out from a diagnosis of metastatic IBC and two weeks from my 36th birthday. I am SO OLD.

News from ASCO Abstract Day

We’ve been waiting for this all year, right, this bright spot in a sea of dread? Nothing perks me up like the latest in metastatic breast cancer research.

My abstract highlights – including new results on DS-8201, tucatinib, the accursed entinostat and a novel Pfizer ADC plus my predictions for late-breaking abstract results – after the break.

Continue reading “News from ASCO Abstract Day”

DS-8201 has a PDUFA Date

Yes! The date is F1Q:20, so I might be getting a prolonged OS for Christmas!

Daiichi announced today that they’ve been granted FDA Priority Review for their highly worthy DS-8201, which looked promising out of the gate and recently demonstrated a 59.5% response rate in HER2+ metastatic breast cancer patients who had previously been treated with T-DM1. Those results, from a 118-subject Phase 1, were published in June. The study also reported some total insanity, like a 20.7-month duration of response (DOR) and a 22.1-month PFS. It’s not comparable given the phases, designs and number of subjects enrolled in this phase 1 versus EMILIA, but T-DM1 had a phase III PFS of around 9-10 months, so DS-8201 is likely to displace that agent as the second-line treatment of choice in this setting (first-line being taxane + Herceptin + Perjeta).

The data above are old news, but the press release says the submission package also includes pivotal phase 2 DESTINY-Breast01 data, which “validated” the phase 1 results and which no one has seen yet, though they note that it will be presented at San Antonio. DESTINY 1 looks at a similar population (T-DM1 pre-treated MBC), but its 230 subjects were randomized to varying dose levels. Primary endpoint is ORR, so it would be shocking if this result isn’t pretty compelling, considering what we’ve seen so far.

Like T-DM1, DS-8201 is an ADC where Herceptin is conjugated to a chemo agent; in DS-8201’s case, it’s a TOP-I inhibitor, similar to irinotecan.