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Spectrum Pharmaceuticals Announces Late-Breaking Oral Presentation of Data for Poziotinib in First-Line NSCLC Patients with HER2 Exon 20 Mutations at the Upcoming ESMO Congress 2021
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Rhea-AI Summary
Spectrum Pharmaceuticals (NASDAQ: SPPI) has announced a late-breaking presentation of early efficacy and safety data for poziotinib in first-line patients with non-small cell lung cancer (NSCLC) harboring HER2 exon 20 mutations. This presentation will take place at the ESMO 2021 Congress from September 16-20. The study, part of the ZENITH20 clinical trial, aims to evaluate the efficacy and safety of poziotinib in treatment-naïve NSCLC patients. Further details include the session time, presenter, and abstract information.
Positive
Presentation of early efficacy and safety data for poziotinib at ESMO 2021.
Focus on first-line NSCLC patients with HER2 exon 20 mutations, addressing an unmet medical need.
Ongoing enrollment in Cohort 4 of the ZENITH20 trial, indicating continued interest and potential in this therapeutic area.
Negative
Risks associated with the efficacy and safety of poziotinib remain uncertain until full data is released.
Dependence on the success of ongoing clinical trials to demonstrate viability of drug candidates.
HENDERSON, Nev.--(BUSINESS WIRE)--
Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today announced a late-breaking presentation of early poziotinib efficacy and safety data in first-line patients with non-small cell lung cancer (NSCLC) with HER2 exon 20 mutations from cohort 4 of the ZENITH20 clinical trial at the upcoming European Society for Medical Oncology Congress (ESMO) 2021 that will take place virtually September 16-20, 2021.
Details of the ESMO presentation are as follows:
Title: Efficacy and safety of poziotinib in treatment-naïve NSCLC harboring HER2 exon 20 mutations: A multinational Phase 2 study (ZENITH20-4)
Speaker: Robin Cornelissen, MD, PhD, Erasmus MC Cancer Institute, Department of Pulmonology, Rotterdam, The Netherlands Session: Proffered Paper session – NSCLC, metastatic 1
Location:Channel 1 Date and Time: September 18, 2021 from 2:20-2:30 p.m. CEST Presentation Number: LBA46
Abstract Number: 2581
The presentation will be available for viewing by registered participants during the conference via the ESMO website on September 18, 2021.
About the ZENITH20 Clinical Trial
The ZENITH20 study consists of seven cohorts of NSCLC patients. Cohorts 1 (EGFR) and 2 (HER2) in previously treated NSCLS patients with exon 20 mutations and Cohort 3 (EGFR) in first-line patients have completed enrollment. Cohort 4 (HER2) in first-line NSCLC patients with exon 20 mutations is still enrolling patients. Cohorts 1- 4 are each independently powered for a pre-specified statistical hypothesis and the primary endpoint is objective response rate (ORR). Cohort 5 includes previously treated or treatment-naïve NSCLC patients with EGFR or HER2 exon 20 insertion mutations. Cohort 6 includes NSCLC patients with classical EGFR mutations who progressed while on treatment with first-line osimertinib and developed an additional EGFR mutation. Cohort 7 includes NSCLC patients with a variety of less common mutations in EGFR or HER2 exons 18-21 or the extracellular or transmembrane domains.
AboutSpectrum Pharmaceuticals, Inc.
Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies. Spectrum has a strong track record of successfully executing across the biopharmaceutical business model, from in-licensing and acquiring differentiated drugs, clinically developing novel assets, successfully gaining regulatory approvals and commercializing in a competitive healthcare marketplace. Spectrum has a late-stage pipeline with novel assets that serve areas of unmet need. This pipeline has the potential to transform the company in the near future. For additional information on Spectrum Pharmaceuticals please visit www.sppirx.com.
Forward-looking statement — This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management's current beliefs and expectations. These statements include, but are not limited to, statements that relate to Spectrum’s business and its future, including certain company milestones, Spectrum's ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, the timing and results of FDA decisions, and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that Spectrum’s existing and new drug candidates may not prove safe or effective, the possibility that our existing and new applications to the FDA and other regulatory agencies may not receive approval in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the company's reports filed with the Securities and Exchange Commission. The company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC.® is a registered trademark of Spectrum Pharmaceuticals, Inc and its affiliate. REDEFINING CANCER CARE™ and the Spectrum Pharmaceuticals logos are trademarks owned by Spectrum Pharmaceuticals, Inc. Any other trademarks are the property of their respective owners.
What is the significance of the poziotinib presentation for Spectrum Pharmaceuticals (SPPI)?
The presentation showcases early efficacy and safety data for poziotinib in NSCLC patients, highlighting the company's advancements in targeted oncology therapies.
When is the ESMO 2021 presentation for poziotinib scheduled?
The presentation is scheduled for September 18, 2021, at 2:20 p.m. CEST.
What is the ZENITH20 clinical trial about?
The ZENITH20 trial includes seven cohorts evaluating poziotinib in various NSCLC patient groups, specifically targeting HER2 exon 20 mutations.
What does the early data for poziotinib indicate?
Early data demonstrates the potential efficacy and safety of poziotinib in treatment-naïve NSCLC patients, though full results will be necessary for a comprehensive assessment.
What is the primary endpoint of the ZENITH20 clinical trial?
The primary endpoint of the ZENITH20 study is the objective response rate (ORR) in the evaluated patient cohorts.
