On May 26, 2022 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported additional exploratory data for poziotinib in non-small cell lung cancer (NSCLC) patients harboring HER2 exon 20 insertion mutations at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held in Chicago from June 3-7 (Press release, Spectrum Pharmaceuticals, MAY 26, 2022, View Source [SID1234615103]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In poziotinib treated patients with advanced NSCLC harboring HER2 exon 20 insertion mutations, baseline ctDNA presence was associated with the tumor tissue genotyping with a concordance of 95%. In patients who responded to treatment, reduced ctDNA levels were associated with tumor mass reduction by central imaging. Increases in ctDNA were observed prior to confirmation of tumor escape, or disease progression.
"This early data suggests that a reduction in ctDNA may be a predictor of response to treatment with poziotinib," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "We are encouraged by these findings and look forward to further investigate ctDNA as a potential predictive biomarker of poziotinib treatment response."
Poziotinib is currently under review by the U.S. Food and Drug Administration (FDA) with a PDUFA date of November 24, 2022 and has received Fast Track designation from the agency.
Session title and information for the poster is listed below and is available on the ASCO (Free ASCO Whitepaper) online itinerary planner.
Circulating tumor DNA (ctDNA) in HER2 exon 20 insertion mutations and responses in NSCLC HER2 exon 20 insertion treated with poziotinib
Session Title: Developmental Therapeutics—Molecularly Targeted Agents and Tumor Biology
Session Date and Time: Sunday, June 5, 2022, 8-11 a.m. CDT, 6-9 a.m. PT
Location: McCormick Place, Chicago IL
Abstract: 3051 / Poster: 43
Copies of the presentation will be available on Spectrum’s website at View Source following presentation at the meeting.
About the ZENITH20 Clinical Trial
The ZENITH20 study is a multicenter, open-label Phase 2 trial, evaluating poziotinib in patients with advanced or metastatic NSCLC patients with EGFR or HER2 exon 20 insertion mutations. The trial is comprised of 7 independent cohorts. Cohorts 1 – 4 were each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR, or objective response rate evaluated by independent review committee (RECIST v1.1). Cohorts 5 – 7 are exploratory. Secondary outcome measures are disease control rate, duration of response, progression-free survival, and safety and tolerability. The patients’ quality of life is also measured and assessed throughout. Cohort 4 includes first-line NSCLC patients with HER2 exon 20 mutations and cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations.
About Poziotinib
Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. HER2 exon 20 insertion mutations are a rare subset accounting for approximately 2-4% in NSCLC. There is no approved therapy for either treatment-naïve or previously treated NSCLC with HER2 exon 20 insertion mutations. The company holds an exclusive license from Hanmi Pharmaceutical to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.