Time for Nektar to Pivot

The most surprising thing about the latest failure of Nektar and Bristol Myers Squibb’s bempegaldesleukin is that it surprised investors. The former group’s stock opened down 52% this morning on news that the Pivot IO-001 trial, which was testing bempegaldesleukin plus Opdivo versus Opdivo alone in first-line melanoma, was a bust. Damningly, there was no benefit with the combo over Opdivo monotherapy on the co-primary endpoints of PFS and ORR, dealing another blow to the hypothesis that bempeg can turn cold tumours hot. Nektar has several more shots with the IL-2 project, but hopes must now be even lower than before, given that Pivot IO-001 is the latest of several flops. The group might be wise to shift focus to its Lilly-partnered autoimmune disease candidate NKTR-358, also an IL-2 agent; low doses of this cytokine are thought to activate immune-suppressing T regulatory cells. Phase 2 studies are ongoing in lupus and ulcerative colitis. At least Nektar has plenty of cash – $800m at the last count – thanks to its $1.85bn 2018 deal with Bristol. If IL-2 is confirmed as a complete dud, the many others in this space might not be so lucky.