G1 Therapeutics must wait longer for survival readout of Cosela in TNBC
13 Feb 2024
Phase 3Drug ApprovalClinical Trial Termination
Shares in G1 Therapeutics plunged as much as 46% in after-hours trading on Monday after the company said that a pivotal trial of Cosela (trilaciclib) in triple-negative breast cancer (TNBC) will continue to its final survival analysis. “While a positive interim analysis would have enabled us to bring this therapy to patients in need sooner, we look forward to completing the study,” remarked CEO Jack Bailey.
The Phase III PRESERVE 2 trial is assessing overall survival (OS) as a primary endpoint in 187 patients with locally advanced unresectable or metastatic TNBC receiving first-line Cosela or placebo prior to gemcitabine and carboplatin. G1 previously stated that the interim OS analysis would take place after 70% of events.
However, last year, the company pushed back the interim OS analysis from a previous target of the second half of 2023 to the first half of 2024, noting at the time that "the number of actual events appears to be occurring more slowly than predicted.” G1 said that it now expects to conduct the final OS analysis of PRESERVE 2 in the third quarter.
String of setbacks
Cosela was first approved by the FDA in 2021 to reduce the frequency of chemotherapy-induced myelosuppression in adults receiving certain types of chemotherapy for extensive-stage small-cell lung cancer. The transient CDK4/6 inhibitor also gained approval in China for the same indication, where it is partnered with Simcere Pharmaceuticals.
However, along with the PRESERVE 2 delay, G1 discontinued the late-stage PRESERVE 1 study in metastatic colorectal cancer last year, prompting the drugmaker to cut 30% of its workforce.
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