Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

Pozi competition prognosis? Pozi is in good shape and ahead of the potential competition.

1) DS-8201 (DS-8201a)
– Looks to be effective in HER mutations with a 73% ORR+ PFS of 14.1m in 11 patients w 8 being HERex20in mutated. For all HER2 mutated it has a 59% ORR + PFS of 14.1m in 18 patients.

– no data on EGFRex20in

– NCT03529110 w 500 randomized 2nd line patients started recruiting on July 20, 2018 for HER2 mutations. So that’s all HER2 mutations. Right now, it’s showing 8 trial sites w 7 of them in Japan.

So it looks like DS 8201 will present competition for pozi in HER2ex20in but not for EGFRex20in. However, it looks like data will come out a year or so later than pozi, that’s if Spectrum executes on its plan i.e. BTD before year end, patient recruiting etc. Also, I’m not so sure the DS 8201 trial is registrational since it will have only have about 50 patients per cohort and I expect that if they want to make this trial registrational they would need to add more patients per cohort. Even ignoring this, and the trial remains 50 patients per cohort, pozi will have a head start for HER2ex20in NSCLC and DS 8201 won’t be competing w pozi for EGFR2ex20in patients AND won’t be competing w posi in 1st line NSCLC with 1st-line trials ongoing.

2) TAK-788
- Preliminary data shows an ORR of 20% in HER2 mutations (i.e. all mutations) and a 38% ORR in EGFRex20in, Of the HERex20in, 4/5 patients did not take a prior TKI and for EGFRex20in patients 12/18 did not take a prior TKI. So more patients weren’t on 2nd/ 3rd line therapy as was the case w pozi. I think these ORR #s would go down somewhat in a mostly 2nd/3rd line setting.

- NCT02716116 w 250 non-randomized 2nd line patients, started recruiting in April 2016 w 6 cohorts in various NSCLC EGFR and HER2 ex20in and another for EGFR/HER2 solid tumors. Not sure how long the trial is going to take but say around the same time you’d expect it takes for the pozi 2nd line cohorts to finish recruiting. Anyhows, it looks like pozi ORR #s are much better. And ditto as above for 1st-line patients; pozi is way ahead on that.

Thanks dcaf for providing the link and I really did delete you accidently, no kidding.

Here’s the link and relevant info can be gotten on pp 72-75.


https://www.accc-cancer.org/docs/ossn-network/hi/presentations/2018/wakelee-heather.pdf?sfvrsn=1efe18c9_4