
Dave Scially
1.7K posts

Dave Scially
@scially
Retired HF manager. Oenophile. Professional Basketball Team Investor. Quaker-in-training. CJR Overseer. Novice Golfer.













$IOVA Why upcoming 24/31May ASCO data/presentation is so important? -> So I reviewed the previously disclosed upfront Lifileucel+Keytruda 1L metastatic melanoma data from IOV-COM-202 to Jan2022 n=12 data cut and compared it 2L Lifileucel use response rates and also to existing/published Keytruda data in 1L unresectable/metastatic melanoma -> here's my thoughts on upcoming ASCO data (not sure data cutoff date? but significantly longer): updated data cut should show: 1) more patients (higher n) but ORR should remain around 60% (54%-66%?) at 6mo vs Keynote-006 (67% treatment-naive unresectable/metastatic) Keytruda mono 34%ORR/27%PR/6%CR at 6mo (Keytruda 43%ORR/29%PR/14%CR at 5y but repeat dosing unlike Lifileucel 1x w Keytruda so longer term ORR should also increase/TBD w combo); 2) Lifileucel CR rate should increase from 25% at prior Jan2022 data cut based on 2L increasing CR rates with time (1L should work even better and improve CR with time), which may be the most IMPORTANT advantage (CR rate) over Keytruda alone; 3) wildcard to this is the Lifileucel+Keytruda patients who progressed (based on limited data on corp pres) seem to have stopped Keytruda so why did they stop Keytruda and more importantly what would have happened if they had not?!? (scary good) -> upcoming ASCO data should provide strong supporting evidence for reproducibility in TILVANCE-301 Ph3 confirmatory trial for upfront combo Lifileucel+Keytruda in frontline metastatic melanoma -> if I had advanced/metastatic melanoma and had a significantly improved (3-4x?TBD %) shot at CR/cure by adding 1x Lifileucel dose, this treatment paradigm be aggressively sought after by patients and pushed by Med Oncs -> the TAM and UPTAKE for Amtagvi will more than double, could even see a triple -> proof of concept for applicability to other immunogenic cancers (i.e. lung/renal/bladder/endomet/brain/CR/H&N) -> increases BP bidders and likelihood of a high enough offer for WR and accelerates BO to this Q3/Q4 timeframe IMO (ATC onboarding/insurance/process initial delays will resolve by Q3/Q4 as well for full ramp) $XBI


On closer inspection, the #ASCO24 ASPEN-07 data are extremely disappointing and $ALXO's comparison of ORR with the efficacy data for Padcev monotherapy is misleading (comparison of ORR with cORR). A look at the confirmed ORR shows that Padcev mono with 40.6% (ITT evaluation!) /1








