Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Finally! We get to see pozi Breast Cancer data at the upcoming San Antonio Breast Cancer Conference (SABCS) to be held December 8 – 11, 2020 as noted in today's PR. Here's a couple of posts on it from the past. Back then I thought, the US trial could do better than the Korean trial PFS of 4.04m and had a chance of reaching the PFS target designed in the trail of 4.5m since the US trial had a larger dose. Obviously, it didn't reach 4.5m probably due to toxicity of the increased dose.

antihama
Thursday, 01/24/19 11:55:22 AM
Re: antihama post# 2415
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Post # of 2536


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MASCC Jun 21–23 or SABCS Dec 10-14; pozi previously treated HER2 breast cancer results w abstract and/or topline beforehand. (Note - the trial reached full enrollment as of Dec 6, 2018 so the results should be mature for 2019).
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This is not mentioned in the new Presentation but if they wanted they could present A PR/abstract. I would think it’s a strong possibility. While the trial went to 'Active, not recruiting' on Dec 6th, they also revised the estimated primary completion date to Oct 2020 meaning the final patient recruited was in the Sep – Oct timeframe and not Dec. The primary endpoint is ORR at 24m. We know the 'Proffered paper' at ESMO 2017, w non-continuous dosing results
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PFS 4.04 months, DCR 75.49%, ORR 18.8% - those are the results of the Korean BC study. Ville post 1748
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(Historical Note - remember Dr Raj, not specifically talking about this study, saying the Korean data looks "Impressive"). They came close (but no cigar); at the initiation of the trial they were looking to see 4.5m PFS as opposed to Standard of Care of 3.3 months (see post 1743). I expect to see better results for the US study under the assumption of a higher dose will result in improved outcomes. Of course, let’s not forget the pozi - T-DMI P1 combo trial. While not PR material, in all likelihood this year, they can see what’s happening there. We’ll know if they are synergistic if we see a bigger combo trial later this year.
antihama
Sunday, 01/27/19 11:32:27 AM
Re: Tartiaboy post# 2487
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Post # of 2536


I'd give MASCC about a 10% shot, SABCS about a 80% probability, 'other' about a 5% shot, and no data/PR about 10%. Regarding MASCC, I'm thinking of the 1st cohort of 32 pts that had the discontinued dosing schedule and SABCS for the continuously dosed pts and/or both cohorts. Regarding 4.5m PFS, that was the goal in the Korean study (vs 3.3m SOC), it would have been enough for Korean AA (we didn’t believe Dr Raj when he said it but it was true…for Korea). I'm guessing that's what the US trial is shooting for, 4.5m, even though the trial is not built for US AA. So if they get 4.5m PFS that would be very promising. The US trial pts are getting 100% more dose so under the assumption that this greater dose will more than compensate for the heavier weights of US patients, I'm going w a 60% probability that it can reach a 4.5m PFS but that’s all speculation, albeit reasonable, on my part.

Side Note/calculations – Being away from my files for the most part and/or working on household projects, it took me awhile to confirm the 100% bigger dose (and hence the delay in getting back to you). I wanted to make sure that it was continuous dosing and not 16mg P.O. for 3wks q28days. I wasn’t 100% convinced of 16 mg continuous dosing since originally the dosing for the 1st 32 pts was
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During each cycle, eligible patients receive 24 mg of poziotinib orally (as three 8-mg tablets) once daily for 14 days, followed by a 7 day treatment-free period. – SABCS 2016 abstract
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But they mentioned continuous dosing during the Q4 17 Qtr CC Q&A
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I know the first cohort of 32 patients were treated with 24 milligrams once daily two weeks and one week off. And then the second cohort that you mentioned hasn't started yet - has enrolled the first patient that's a 16 milligram continuous dosing
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The Korean mBC trial pts were taking pozi 12mg once daily on a 14-day on/7-day off schedule so

12mg * 14d = 168 and if you extend that to 112 days or 4 cycles of 21d = 672 mg/112 days (ie 112 is a common denominator w the US trial)

For the US trial
16mg * 28 days = 448 mg per cycle * 3 cycles = 1344mg/112 days
1344/672 = 2 x more dose

So that's where I'm coming regarding possible news regarding the US trial. If there is no news this year regarding the mBC trial one can assume it didn't meet expectations.