The failure of a myeloid leukemia drug in a phase 3 trial in China isn’t a shock to Apollomics, which had already given up on the E-selectin inhibitor.
California-based Apollomics had been testing uproleselan as an adjunct to chemotherapy in relapsed and refractory acute myeloid leukemia (AML). A total of 140 patients had been enrolled in the phase 3 bridging trial, who received either uproleselan with chemotherapy or chemotherapy alone.
Not only did the trail fail to show that overall survival (OS) improved among patients who received uproleselan—missing the study’s primary endpoint—but these patients seemed to perform significantly worse. Specifically, median OS in the uproleselan arm was 9.3 months compared to 14.3 months in the chemotherapy-only arm
The incidence of serious adverse events (SAEs) was 43% in the uproleselan cohort, compared to 39% in the chemotherapy-only arm. The most common SAES in the uproleselan arm were decreased platelet count, infectious pneumonia and sepsis, Apollomics said in the Dec. 20 release.
While not offering an explanation for the poor performance, the company was unsurprised by today’s failure, pointing to uproleselan’s failure in another phase 3 trial in May conducted by the drug's owner GlycoMimetics. Apollomics acquired the China rights to the therapy in 2020.
In the wake of GlycoMimetics' own failure, Apollomics had previously announced that it would close its China study early.
“While we are disappointed that uproleselan did not show a clinical benefit, the results were expected given that the global phase 3 trial of uproleselan in a similar patient population by our partner, Glycomimetics, did not meet its primary endpoint earlier this year,” Apollomics CEO Guo-Liang Yu, Ph.D., said in the release.
“Our regulatory and commercial strategy in China has always required a positive global phase 3 trial, and therefore we are currently wrapping up this program,” the CEO added.
The news appeared to be more of a surprise for investors, who sent the biotech’s stock down 25% in pre-market trading Friday morning to $7 per share from a Thursday closing price of $9.37.
Apollomics has already undergone layoffs this summer—including co-founder and president Sanjeev Redkar, Ph.D., and chief medical officer Peony Yu, M.D.—in order to conserve its cash into 2025. This restructuring also saw Apollomics narrow the focus of its lead asset vebreltinib, with a phase 2 trial testing the c-MET inhibitor in people with various types of MET-altered non-small cell lung cancer now only enrolling patients with MET amplification.