Apr. 7 at 2:10 AM
$IOVA Focusing on the sarcoma opportunity, there are over 3,000 patients in the US and 5,000 in Europe with the UPS and DDLPS subtypes (high-grade & aggressive). Unmet need here is unfortunately very high, with less than 5% ORR for 2nd-line treatment, median PFS of 2-3 months, and median overall survival of 9 to 10 months (contrast to 50% ORR for Amtagvi). I see this as a blockbuster opportunity, but let's peg peak sales at
$500M to be conservative. It should also be relatively feasible to expand out into additional sarcoma subtypes from there. It sounds like the FDA would be equally (or even more) amenable to single-arm studies supporting accelerated approval for both UPS and DDLPS as well as additional subtypes (I don't see why related indications wouldn't work based on initial data).