The shiver of sharks circling Spectrum Pharmaceuticals is growing bigger and bigger. Another law firm joined the pack Tuesday, filing a class-action suit that accused the biotech of misrepresenting clinical trial data and failing to enroll patients in a confirmatory phase 3 study.
In recent weeks, law firms Robbins Geller Rudman & Dowd, Levi & Korsinsky and The Klein Law Firm have called for investors who bought Spectrum stock between December 2021 and September 2022 to serve as lead plaintiffs in a class action against the company. All the notices cover the same events in the development of Spectrum’s oral pan-HER kinase inhibitor poziotinib.
The story starts in July 2020, when Spectrum published a statement about “positive topline results” from a cohort of non-small cell lung cancer (NSCLC) patients who received poziotinib in a phase 2 clinical trial. In the statement, Spectrum disclosed a 27.8% response rate that it said exceeded the threshold for success and a median duration of response of 5.1 months.
While Spectrum framed the results as positive in 2020, the FDA took a different view when it prepared a briefing document for its advisory committee two years later. The agency called the response rate “low” and the duration of response “minimal.” In between the Spectrum and FDA comments on the results, Daiichi Sankyo and AstraZeneca’s Enhertu raised the bar for efficacy in HER2-mutant NSCLC.
The law firms are also targeting Spectrum over the status of the confirmatory clinical trial for poziotinib. In August, Francois Lebel, M.D., then Spectrum’s chief medical officer, said a randomized confirmatory trial was “underway,” adding that “some sites” were open and the company believed it would “be able to show unequivocally” that it was taking the need to run a study “very seriously” and moving as fast as possible.
One month later, the FDA told its advisory committee that “confirmation of benefit will be significantly delayed given that confirmatory trial has not begun enrolling patients.” The law firms have identified the status of the confirmatory trial, plus the FDA’s take on the data, as a way to go after Spectrum.
“Although defendants represented that the safety and efficacy data from the ZENITH20 trial were positive and that they had initiated a required confirmatory phase 3 study, on September 20, 2022, a briefing document from the [FDA] disclosed not only negative data on the safety and efficacy of poziotinib, but also a failure by the company to enroll any patients in a required phase 3 confirmatory trial,” Klein Law wrote.
Fierce Biotech has contacted a representative of Spectrum for comment.