Some quick takeaways from Guggenheim/Spectrum Fireside chat.
Overall, I thought it was really good. You get so much more out of a Q&A format vs the dog and pony show of going over a PowerPoint presentation. Here are some takeaways/2 cents:
- The patients in the Zenith 20 trial are HEALTHIER than patients in the MDACC trial. For Z20, patients are allowed after one systemic treatment failure whereas for the MDA trial, 71% of the patients failed 2 or more therapies w most patients on hospice. Healthier patients should improve the data.
- JT confirmed my belief that DoR will increase by about a month in the Zenith20 trial (just from doing an earlier scan). Couple that w Dr Heymach saying at WL that if his study had 1m scans the ORR would be 55%, and an improved dose reduction protocol w healthier patients in Z20, bodes well for better results.
- There are over 40 trial sites for Zenith 20
- MDACC HER2 cohort will be capped at 20 patients
- MDACCs trial will have central review of the scans. I scratched my head a little on that one since just having scans read at MDA is kind of like a ‘central’ review where the same doctors read scans as opposed to various trial sites docs reading the scans at their site and each doing it a little differently. But thinking about it, sending scans to a different facility is to confirm the data is unbiased. It will make the data stronger (unbiased) and more comfort to the FDA in the integrity of the data.
- MDA will publish their data in a medical journal sometime this year.
- For MDACCs trial, the DCR was 90 and 83% for EGFR and HER2. JT went on how that’s really important when you think of the potential commercially because in a trial you get off the drug once you event but in the real world, DCR is a very important forecaster of how long a patient will be on a drug. Ps Every time I looked at the Presentation slide showing how many patients had stable disease made me want to mention that but I just not ever got around to it.
- The Z20 EGFR previously treated cohort is registrational and it’s etched in stone (meeting minutes) while there is no such guarantee (yet) for the other 3 cohorts.
- FL gave a good defense of the safety of pozi which is backed up by many patients whereas some of the latecomers in this space have many fewer patients. And some of the toxicity you’re seeing is ‘on target’ tox which goes hand in hand w efficacy.
- And an almost aha moment was FL talking about looking at databases around the world, in trying to get better historical control data for exon 20 insertion pts in NSCLC taking non-specific treatment which is 23% RR for unselected patients taking chemo and anti-VEGF. The study that showed this 23% RR had only 2% mutations and 69% of that was for exon 20 (or something like that). I could almost envision Spectrum in a meeting w the FDA on BTD and not knowing what the unselected combo trial data showed. Ok, an aha moment w people w vivid imaginations.
- Basket and combo trials still seem a ways away. Seems like they’re doing prelim discussions w the FDA at this time. It will take some back and forth to get finalized I would suspect.
- They are already stocking inventory of Rolontis. It makes me wonder what is the expiration and/or stability of drug; it does show some confidence for approval.
AI
