| | | Okay okay, maybe I was being a douche with my response. DS8201 was a potential threat in Non-small cell lung cancer (NSCLC), not in Triple negative breast cancer (TNBC).
I had hoped that folks on this board were all up to speed on that point, that NSCLC & TNBC are two separate diseases, and while there was consternation about DS8201 as a potential competitive threat to SG in NSCLC, more recent data showing DS8201 has an elevated risk of death dwindled its hopes as a legitimate contender, in my humble opinion, in NSCLC.
The fact we are seeing this same elevated risk of death by DS8201 in other disease tells me SG is a better drug head-to-head compared with DS8201 given we haven't had any drug associated deaths for SG, so far as I understand.
However in end-state HER2+ breast cancer, where patients are totally out of options and the alternative is death, interstitial lung disease by taking DS8201 compared to 60% chance of success seems like a decent gamble. My question is, does SG work in HER2+ breast cancer as well? Hope Rugo's presentation at ESMO seemed to indicate as much.
That said, HER2+ disease is one specific patient population which amounts to ~15% of all breast cancers, TNBC is a different patient population of ~15%, and HR+/HER2- (hormone receptor) is the rest of the pie.
Sacituzumab Govitecan has been filed in metastatic TNBC in 3rd-line and beyond, which as others have astutely pointed out could technically be considered 2nd line therapy because patients get more than one drug in 1st line. SG is also showing pretty remarkable results in 3rd line HR+ breast cancer (that other 70% of the pie).
That means SG could potentially target 85% of the total breast cancer population in late stage disease, and as referenced earlier ~42k patients die each year of Breast cancer in the US alone. 85% of 42k is 33K patients who are potentially eligible for SG according to published trial data, yet are running out of options and face death.
Oncologists could assess the clinical efficacy of SG in TNBC & HR+/HER2- from recent trials and deem SG a valid option to help save a patient's life. This means that upon launch of SG after approval by the FDA, Oncologists can consider SG as a last resort option. Off-label in some scenarios, but that happens all the time in end-stage cancer.
Assume 80% of those patients have access to insurance, that's 28k patients' families in the US who have a chance to convince doctors and their insurance plans to help cover the cost of SG - upon FDA approval.
I will assume IMMU will charge 120k for SG, then offer a discount down to 100k to insurers, so the annual market potential of SG in the US is 2.8B for end-stage disease in the first year alone. Then add earlier lines of therapy, not only those without any options. Then add Europe. Then add Asia. Then add other regions, hopefully.
Latest estimates are that 500k patients die each year of breast cancer globally, and while it is a macabre exercise to quantify the revenue potential of SG in this patient population, it also serves as a important reminder that patients need access to drugs that help extend lives in the hopes of living long enough for science to advance cures.
What a powerful position the FDA is currently sitting on, having the ability to positively impact 28,000 patients and their families each and every year in the US, which would pave the way to positively impact nearly 500k patients globally.
Dr. Stephen Hahn, what prestige will be bestowed upon you when arguably the greatest revolution in cancer science since PDL1 could be the first cancer drug approved under your tenure. Git er done! |
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