Lilly puts two-thirds of midphase cancer pipeline up for sale in major shake-up of R&D priorities

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Eli Lilly's headquarters

Eli Lilly is seeking partners for two-thirds of its midphase oncology compounds. The Big Pharma wants to offload six phase 2 candidates to focus its R&D dollars on a clutch of early to midstage assets it thinks can become the new standard of care.

Lilly is prioritizing the development of seven candidates, although one—breast cancer drug abemaciclib—is already in front of the FDA. Two of the remaining six are in phase 2, while the rest are yet to get out of phase 1. The list includes a PD-L1 antibody and PI3K/mTOR dual inhibitor Lilly is developing for use in combinations. And the small-molecule Chk-1 inhibitor it picked up from Array BioPharma.

The candidates made the cut after being assessed against a framework Lilly is now using to make decisions. 

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“Lilly will pursue new standard-of-care changing therapies that target tumor dependencies in molecularly enriched populations, build rational combinations that overcome resistance and develop next-generation immunotherapies,” the company said in a statement.

The prioritization of drugs that hit targets key to multiple tumor subtypes, can anchor a regimen that becomes the new standard of care and are backed by data that meet Lilly’s screening criteria has pushed some candidates out into the cold. Lilly has made phase 2 MET inhibitor merestinib and phase 1 angiopoietin2 and CSFR1 antibodies second-tier priorities pending the delivery of further data. But it has already seen enough of a clutch of other assets to put them on the block.

Lilly lists 10 assets in its partnered pipeline, the same number as are in its top and second-tier priority pipelines. Three of the phase 1 partnered assets are already owned by third parties. But the remaining seven—including six in phase 2—are yet to be the subject of outlicensing deals.

The seven drugs seeking new homes are:

  • Galunisertib, a small molecule inhibitor of TGF beta R1 kinase  
  • Ralimetinib, a p38 MAP kinase inhibitor
  • Emibetuzumab, a MET antibody
  • A notch Inhibitor 
  • A FGFR inhibitor 
  • A CXCR4 peptide antagonist
  • A FGFR-3 antibody-drug conjugate

The decision to cull half of the cancer pipeline coincided with a setback for Lilly’s baricitinib. The Incyte-partnered rheumatoid arthritis drug was due to come to market this year. But a demand by FDA for another study to allay its concerns about the incidence of blood clots looks set to push back the timeline by 18 months or more. 

That bodes badly for Lilly. 

“Management's announcement today that the new studies required will take a minimum of 18 months to conduct is more in line with our refiling timeline of 2019, though even that may be too optimistic. In addition, the association with the potential risk of increased thromboembolic events may impair the future commercial value of the product, whilst favoring new entrants, such as AbbVie’s upadacitinib,” Jefferies analyst Jeffrey Holford, Ph.D. wrote in a note to investors.

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