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Spectrum Pharmaceuticals Presents Twice Daily Dosing Data for Poziotinib at the ESMO TAT Virtual Congress 2021

Nachrichtenquelle: Business Wire (engl.)
02.03.2021, 17:45  |  141   |   |   

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented results from Cohort 3 and initial twice daily (BID) dosing safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial. These preliminary data demonstrate improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also suggest improved anti-tumor activity with 8mg BID dosing. The presentation is part of the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 being held March 1-2, 2021.

“As predicted by the pharmacokinetic modeling, the 8mg BID arm is showing an improved therapeutic effect and a lowered adverse event rate in this early data,” said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. “The data build on the positive results we have reported for Cohort 2 which will be the basis for our NDA submission later this year. We look forward to reporting additional data at AACR in April.”

A copy of the ESMO presentation titled “Safety, tolerability and preliminary efficacy of poziotinib with twice daily strategy in EGFR/HER2 Exon 20 mutant non-small cell lung cancer” is available on Spectrum’s website at https://investor.sppirx.com/events-and-presentations.

ZENITH20 Trial Design and Preliminary Safety and Efficacy Data for Cohort 5

Cohort 5 of the ZENITH20 trial includes previously treated NSCLC patients with EGFR or HER2 exon 20 insertion mutations. This cohort is investigating the efficacy of poziotinib with a BID dosing strategy. For the first 20 patients randomized to poziotinib 16 mg QD or 8 mg BID in Cohort 5, a trend towards improved responses was reported in the BID arm with 30% of patients reaching a partial response and two patients still too early to evaluate.

Preliminary Data on Best Overall Response

 

 

Cohort 1

Cohort 5a

Cohort 5d

 

16mg QD

16mg QD

8mg BID

 

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Spectrum Pharmaceuticals Presents Twice Daily Dosing Data for Poziotinib at the ESMO TAT Virtual Congress 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented results from Cohort 3 and initial twice daily (BID) dosing safety and efficacy data for poziotinib from Cohort 5 …

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