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Spectrum’s shares slide after key pipeline drug fails in first cohort of study

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The first part of a lung cancer drug trial run by a company that earlier this year announced a major restructuring of its business has failed, sending the company’s shares tumbling.

Henderson, Nevada-based Spectrum Pharmaceuticals said Thursday that Cohort 1 of its 554-patient Phase II ZENITH20 trial of the drug poziotinib, in previously treated non-small cell lung cancer patients with EGFR exon 20 insertion mutations, failed to meet its primary endpoint of improved overall response rate (ORR).

Shares of Spectrum fell more than 56% on the Nasdaq when markets opened following the news and remained down Thursday afternoon.

The cohort had enrolled 115 patients who received 16mg of poziotinib per day. The intent-to-treat analysis showed an ORR of 14.8%, with 17 patients responding, while 62 patients had stable disease. The median duration of response was 7.4 months. The trial has six other cohorts, including those with HER2 exon 20 insertion mutations and those who have not yet received treatment. The company said that Cohorts 2 and 3, which respectively test the drug among previously treated HER2 patients and previously untreated EGFR patients, have undergone futility analysis and met the necessary ORR thresholds to continue, with results expected next year. The remaining cohorts are continuing as well.

In a statement, Spectrum CEO Joe Turgeon said that despite not succeeding on the primary endpoint in Cohort 1, poziotinib showed biological activity, with the company “encouraged” by the disease control rate, duration of response and a safety profile consistent with other second-generation tyrosine kinase inhibitors that target EGFR.

“While the response rate of Cohort 1 in this trial was lower than we expected, the positive signals observed for this cohort provide support for the continued clinical evaluation of poziotinib in this patient population with significant unmet medical need,” Turgeon said in a statement.

Nevertheless, the news is a disappointment, considering that poziotinib was one of the crown jewels in Spectrum’s decision at the beginning of this year to shift its focus from niche cancer indications to potentially more lucrative areas of oncology. In January, it announced it would sell all seven of the drugs it was marketing at the time to a division of Indian generic drugmaker Aurobindo, in a deal worth up to $300 million. These included drugs for treating B-cell and T-cell non-Hodgkin’s lymphoma, chemotherapy drugs and others.

Photo: flytosky11, Getty Images

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