Eli Lilly tries to offload midphase cancer compounds
In order to put its R&D budget into seven drug candidates that could become the new standard of care, Eli Lilly is looking for partners for six Phase 2 oncology candidates. “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,” according to a company statement.
One of the candidates Lilly is prioritizing – the breast cancer drug abemaciclib – is already under FDA review. Of the others, two are in Phase 2, while the rest are still in Phase 1. Included are a PD-L1 antibody and PI3K/mTOR dual inhibitor Lilly is working on to use in combination therapies. Also included is the small-molecule Chk-1 inhibitor Lilly acquired from Array BioPharma.
Lilly has decided it should prioritize 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. While Lilly has determined that Phase 2 MET inhibitor merestinib and Phase 1 angiopoietin2 and CSFR1 antibodies are second-level priorities until there is further data, they can be sacrificed.
The company’s strategy builds on key treatments such as Cyramza, Lartruvo and abemaciclib as foundational agents while developing new standard-of-care changing therapies. Lilly intends to focus on seven candidates for priority internal development, three additional candidates (Ang2 MAb, CSF1R MAb and merestinib) with study data pending and other molecules in the pipeline partnered.
About 10 molecules will have external or partnered development. Lilly is seeking partners for a FGFR-3 ADC inhibitor, ralimetinib kinase inhibtor, a FGFR inhibitor, a notch inhibitor, galunisertib TGF beta R1 kinaseinhibitor, a CXCR4 peptide antagonist and emibetuzumab MET antibody. Lilly’s decision came at the same time as a setback for the company’s baricitinib. The rheumatoid arthritis drug, developed in partnership with Incyte, was supposed to come to market this year. Now the resubmission will not take place this year. When the FDA requested another study because of issues regarding blood clots, Lilly realized that the new study could push back the timeline by 18 months or longer.
According to Jefferies analyst Jeffrey Holford, Ph.D., “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.”
“Lilly and Incyte have plans to explore baricitinib for other indications with a late-stage study in psoriatic arthritis slated to commence next year while studies in atopic dermatitis and lupus continue. Phase II atopic dermatitis data will be presented at a scientific forum by year end,” reported Arpita Dutt in Zacks.
While Lilly’s second-quarter revenue increased 8 percent from the second quarter a year ago to $5.8 billion, operating expenses remained flat. New products, including Trulicity, Taltz, Basaglar, Jardiance, Lartruvo and Cyramza, performed well to lead volume growth. Late life cycle products, including Cialis and Forteo, were leaders in price growth. Second-quarter earnings per share were $0.95 (reported), or $1.11.