These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of the company and are subject to significant risks and uncertainties that could cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. Spectrum Pharmaceuticals (NASDAQ:SPPI) has announced additional results from its Phase 2 (ZENITH20) trial, evaluating poziotinib in previously treated non-small cell … In December 2019, the company reported that the primary endpoint for Cohort 1 (EGFR) was not met but clinical activity was seen. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to Spectrum’s business and its future, including the Company’s ability to advance development of its late-stage pipeline assets, the ability of poziotinib to meet currently unaddressed medical needs and the size of the potential markets, the timing of the results of cohort 1 and cohort 2 in Spectrum’s ZENITH20 clinical trial, the future potential of Spectrum’s existing drug pipeline, the progression of the poziotinib development program and other statements that are not purely statements of historical fact.

Dose interruptions were reported in 78 patients (87%), and dose reductions in 70 patients (78%), which was similar to the rates in Cohort 1. Minimum 15 minutes delayed. “Thus far, we are pleased with the rapid recruitment and are eagerly awaiting our first topline readout in patients with previously treated EGFR exon 20 insertion mutations in the fourth quarter of this year.”.

Cohorts 1 - 4 are each independently powered for a pre-specified statistical hypothesis with a primary endpoint of ORR. Recent pre-clinical data supports development of poziotinib for osimertinib resistance, as well as atypical mutations. These forward-looking statements relate to a variety of matters, including, without limitation, statements that relate to the company’s business and its future, including the significance of Cohort 2’s reported results; the timing and outcome of a potential meeting with the FDA regarding poziotinib and the FDA’s determination of a path forward for poziotinib; poziotinib’s potential to significantly advance the treatment of NSCLC patients with HER2 exon 20 insertion mutations; the timing and result of future FDA approvals; the timing of the results of Cohort 3; the overall progression of the poziotinib development program; the company’s ability to advance development of its late-stage pipeline assets and such assets’ ability to serve areas of unmet need; the future potential of the company’s existing drug pipeline; and other statements that are not purely statements of historical fact. Cohorts 5 - 7 are exploratory. Based on these results, Spectrum has requested a meeting with the U.S. Food and Drug Administration (FDA) to discuss the data and its plans for a New Drug Application (NDA) submission. The observed lower bound of 18.9% exceeded the pre-specified lower bound of 17%. HENDERSON, Nev.--(BUSINESS WIRE)--Jul. “With increased use of osimertinib as the treatment of first-line NSCLC patients with classical EGFR mutations, the emergence of osimertinib resistance is a growing occurrence in this setting,” said Jeffrey Clarke, MD, Assistant Professor of Medicine at Duke University Hospital/Duke Cancer Institute.
Risks that could cause actual results to differ include, but are not limited to, the uncertainties inherent in new product development, including clinical trial results and additional analysis of existing pre-clinical and clinical data, the possibility that Spectrum's new and existing drug candidates, including poziotinib, may not ultimately prove to be safe or effective, the possibility that Spectrum's new and existing drug candidates, if approved, may not be more effective, safer, or more cost efficient than competing drugs, and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission.
Median duration of response was 5.1 months, with a median follow-up of 8.3 months and the median progression-free survival was 5.5 months. 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. 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. The intent-to-treat analysis demonstrated a confirmed objective response rate (ORR) of 27.8% (95% CI, 18.9%-38.2%). “The emergence of osimertinib resistance and the lack of effective treatments for atypical mutations are growing treatment voids that poziotinib may be uniquely suited to fill.”.

Top line results from Cohort 3 are expected by the end of the year.

“There is no approved treatment for NSCLC patients with HER2 exon 20 insertion mutations, and we look forward to sharing this data with the FDA and discussing the path forward for poziotinib registration.”. Spectrum Pharmaceuticals is a biopharmaceutical company focused on acquiring, developing, and commercializing novel and targeted oncology therapies.

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