- Eli Lilly on Wednesday said an independent Data Monitoring Committee recommended the Phase 3 MONARCH 2 trial continue without modification.
- Lilly has three other ongoing MONARCH trials testing the selective cyclin-dependent kinase (CDK4/6) inhibitor abemaciclib in breast cancer patients.
- The big pharma previously indicated it expected to file for approval of abemaciclib with the U.S. Food and Drug Administration before the end of the year.
The continuation of a Phase 3 trial as planned is typically not something that would upset shareholders, but in the case of Lilly's abemaciclib, the news could create a significant delay for the program.
The late-stage trial testing abemaciclib plus fulvestrant in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer will now continue into the first half of 2017. The primary endpoint of the study is progression-free survival compared with placebo plus fulvestrant at 31 months.
Lilly said it will await further data and continue discussions with the FDA to build its new drug application for abemaciclib as a monotherapy based on the Phase II MONARCH 1 study.
Independent Data Monitoring Committees often review trial data at planned interim checkpoints to ensure the study is on track, as companies typically are blinded from the data until the trial is over. The committee has the option to recommend that the trial be stopped early if a therapy is harming patients, if the drug is showing no signs of working or if it has overwhelming efficacy.
Lilly and its shareholders had been hoping for the latter.
The Indianapolis pharma has been doing its best to gain some ground in the oncology space with abemaciclib being one of the cornerstones of its portfolio. The CDK 4/6 inhibitor is currently battling Novartis' ribociclib to be second-to-market in the class behind Pfizer's already approved Ibrance (palbociclib). Ibrance has been making waves since its approval last year and recent positive data gave the drug another boost, setting it on track to achieve blockbuster revenue status before the end of the year.
Both Lilly and Novartis claim their CDK 4/6 inhibitor is best-in-class, with hopes of gaining a significant portion of the $4 billion breast cancer market.
Unlike Lilly, Novartis' ribociclib did get an early stoppage to its trial for overwhelming efficacy. Novartis is now expected to file for approval with the FDA before the end of the year. A slower path to filing for Lilly's drug could mean it ends up being third to market.
Lilly is depending on a combination strategy to set abemaciclib apart from competitors. The pharma inked a deal with Boehringer Ingelheim in July to test the drug in combination with Boehringer's insulin-like growth factor (IGF)-1/IGF-2 ligand neutralizing antibody BI 836845 in a Phase 1b trial.