Spectrum Pharmaceutecals Inc (SPPI)

[antihama]

ESMO posi data is better than I thought. I was looking at the Intro slide from the ESMO presentation and it provides current SoC for treating 1st line HER2 Ex20mu patients

Background
• EGFR and HER2 exon 20 insertion mutations are rare subsets of accounting for approximately
10% each of all mutations and 2-4% each in NSCLC
• There is no approved therapy for either treatment-naïve or previously treated NSCLC with
HER2 exon 20 mutations
• Currently utilized treatments include chemotherapy agents with or without checkpoint inhibitors
and TKIs. None are specific to exon 20 mutations. Efficacy reported in literature is mostly from
small uncontrolled studies and varies widely 1- 5
• Response rates range 6.9 – 35%
• Median PFS range 3 to 7 months
• Poziotinib is an oral pan-HER TKI with activity in patients with EGFR or HER2 exon 20 mutated
NSCLC

And here's the data from Cohort 4

This data is from 48 first-line patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 insertion mutations who received 16mg of oral poziotinib once daily. These results showed a confirmed objective response rate (ORR) of 44%, as evaluated centrally by an independent image review committee using RECIST 1.1 criteria....

...The primary endpoint of ORR was 44% (95% CI:29.5-58.8%) in the 48 treated patients including one complete response. 88% of patients (42/48) showed tumor reduction with a DCR of 75%. Median DoR was 5.4 months (range 2.8-19.1+). Median PFS was 5.6 months (range 0-20.2+). 88% of patients had dose interruptions and 77% had reductions from the 16mg QD starting dose, while 13% had adverse event (AE) related discontinuations.

Again BID dosing should improve on those #s. Also, the slide on patient characteristics is interesting too. It gives some data on BID dosing.

Here's the link on the Spectrum site to the Late Breaking Presentation
https://investor.sppirx.com/index.php/static-files/03852749-4c8d-4ca4-adaa-92d4820d96f7