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 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 |
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Cohort 1 |
Cohort 5a |
Cohort 5d |
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16mg QD |
16mg QD |
8mg BID |
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