Spectrum Pharmaceuticals Presents Poziotinib Data in Patients with Brain Metastases from the ZENITH20 Clinical Trial at 2021 ASCO Annual Meeting

Rhea-AI Summary

Spectrum Pharmaceuticals (SPPI) presented data from the ZENITH20 clinical trial on the CNS activity of poziotinib in NSCLC patients with EGFR or HER2 exon 20 mutations. Among 36 patients with brain metastases, 8% achieved complete responses. The trial enrolled 284 patients, with brain metastasis affecting up to 25% of NSCLC patients, indicating a significant unmet need. These findings were showcased at the 2021 ASCO Annual Meeting.

Francois Lebel, CMO, emphasized the promising CNS activity for poziotinib in this patient group.

Positive

• 8% of patients with brain metastases achieved complete responses with poziotinib.
• CNS activity data indicates potential for significant clinical benefits in NSCLC patients with EGFR or HER2 mutations.

Negative

• The trial only reported outcomes for 36 patients with brain metastases, which may limit broader applicability.
• No guarantee that the positive results will lead to FDA approval or commercial success.

Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, today presented an e-poster on poziotinib CNS activity in patients with NSCLC with EGFR or HER2 exon 20 mutations. These data from Cohorts 1, 2 and 3 of the ongoing ZENITH20 clinical trial assessed the results from 36 patients with brain metastases at baseline with three patients (8%) achieving intracranial complete responses. The presentation titled “CNS activity of poziotinib in NSCLC with exon 20 insertion mutations” is available on the website for the 2021 ASCO Annual Meeting being held June 4-8, 2021.

“CNS metastases are a common and life-threatening complication of metastatic disease in NSCLC patients,” said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. “These data show clinically meaningful CNS activity for poziotinib treated NSCLC patients with CNS metastases with EGFR or HER2 exon 20 insertion mutations.”

CNS Activity from the ZENITH20 Clinical Trial

The ZENITH20 trial has enrolled NSCLC patients with EGFR and HER2 exon 20 insertion mutations. This analysis looked at the results for 284 patients from Cohorts 1, 2 and 3. 36 patients had brain metastases as reviewed by an independent central imaging laboratory from baseline. Brain metastasis occurs frequently in NSCLC, up to 25% of patients, and is associated with short survival. Patients received poziotinib at a dose of 16mg once daily.

The poster presentations will be available for viewing by registered participants during the conference via the ASCO website beginning on June 4, 2021.

About Spectrum 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.

Notice Regarding Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. 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 significance of CNS activity in patients with NSCLC with EGFR or HER2 mutations; the ability to achieve a clinically meaningful effect for patients with brain metastases and the magnitude of that effect; the company’s ability to advance and fund the development and commercialization of its late-stage pipeline assets and such assets’ ability to serve areas of unmet need; and other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations, and assumptions of the management of Spectrum 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. Risks that could cause actual results to differ include, but are not limited to, the possibility that the different methodologies, assumptions and applications the company utilizes to assess particular safety or efficacy parameters may yield different statistical results, and even if the company believes the data collected from the clinical trials of its product candidates, including poziotinib, are positive, these data may not be sufficient to support approval by the FDA; the possibility that success in early clinical trials, especially if based on a small patient sample, might not result in success in later clinical trials, and other unforeseen events during clinical trials which could cause delays or other adverse consequences; other uncertainties inherent in new product development; 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 (the “SEC”). 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. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Spectrum in general, see the risk disclosures in the Annual Report on Form 10-K of Spectrum for the year ended December 31, 2020, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Spectrum.

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FAQ

What are the results of the ZENITH20 trial for SPPI?

The ZENITH20 trial showed that 8% of NSCLC patients with brain metastases achieved complete responses with poziotinib.

What is the significance of the CNS data for Spectrum Pharmaceuticals?

The CNS activity data suggests that poziotinib may provide clinically meaningful benefits for NSCLC patients suffering from brain metastases.

When was the data from the ZENITH20 trial presented?

The data was presented during the 2021 ASCO Annual Meeting held from June 4-8, 2021.

What does the future hold for poziotinib after these results?

While the results are promising, there is no assurance of FDA approval, and further trials are needed to confirm efficacy.