
Karyopharm kicks the Xpovio can to an uncertain 2024
The sellside appears remarkably unconcerned about Karyopharm’s plan to go back to the drawing board with a pivotal Xpovio endometrial cancer study that will not read out until mid-2024. Yesterday the group’s plan to use the dubious dataset generated by the Siendo trial fell apart when the FDA said Siendo was “unlikely” to support approval and called for a new study, sending Karyopharm down 40%. Xpovio is marketed for multiple myeloma, and Siendo represented its nearest-term opportunity to break into solid cancers, specifically as maintenance for patients responding to front-line chemo for endometrial cancer. But the sellside’s treatment of this as a mere delay ignores the fact that this market is changing fast; Glaxosmithkline’s Jemperli and Merck & Co/Eisai’s Keytruda plus Lenvima carry second-line labels, and the former faces the imminent readout of the Ruby trial, which includes a maintenance phase. Perhaps the most significant catalyst is the Due-E study of Astrazeneca’s Imfinzi plus chemo first line, followed by Imfinzi with or without Lynparza as maintenance, reading out next year. Xpovio might yet yield a positive result in 2024, but by then the endometrial cancer landscape might have changed markedly.
Selected studies in endometrial cancer | ||||
---|---|---|---|---|
Drug | Trial | Setting | Primary sponsor | Results |
Xpovio + chemo | Siendo | 1L maintenance | Karyopharm | Has data |
Jemperli + chemo +/- Zejula | Ruby | 1/2L chemo combo then monoRx or Zejula combo maintenance | Glaxosmithkline | Imminent (had been expected mid-2021) |
Keytruda +/- chemo | NCT03914612 | 1L chemo combo then monoRx maintenance | NCI | Mid-2023 |
Imfinzi + chemo +/- Lynparza | Duo-E | 1L chemo combo then monoRx or Lynparza combo maintenance | Astrazeneca | Sep 2023 |
Xpovio | New pivotal study | TBD, likely in p53 wild-type patients | Karyopharm | Mid-2024 |
Source: company statements & clinicaltrials.gov. |