Drug Development

Frustrated Eli Lilly may have to settle for a lonely last-place finish in the blockbuster CDK 4/6 race

A frustrated Eli Lilly will have to wait patiently for its closely-watched Phase III study of the CDK 4/6 breast cancer drug abemaciclib to wrap up next year before it gets the final read out on its effect on survival rates. The pharma giant reported that the pivotal trial will have to continue “as the interim efficacy criteria were not met.”

Final results are now expected sometime in the first half of 2017, which could delay a launch into 2018.

The executive crew at Lilly had raised hopes that abemaciclib, a designated “breakthrough” drug at the FDA, could be prepped for a market launch on the interim data. And that had followed some discussion on whether the mid-stage results would be sufficient. Disappointed investors drove Lilly’s shares down 1.5% in pre-market trading Wednesday morning.

The delay puts Lilly well behind Novartis in the competition to hustle a competitor to Pfizer’s Ibrance to the marketplace for breast cancer patients. Just days ago Novartis gained a breakthrough drug designation for LEE011 (ribociclib) in combination with letrozole for the treatment of hormone receptor positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer. The BTD came through after the pharma giant ended the MONALEESA-2 study among previously untreated breast cancer patients early, concluding that it had clear evidence of efficacy that could be used for a near-term application.

According to the trial design on clinicaltrials.gov, Lilly’s drug was restricted to patients who have not previously been treated with a CDK 4/6 drug. If that makes its way to the label, Lilly’s treatment would not be allowed for any patient who had been treated with either Pfizer’s Ibrance or Novartis’s LEE011. And with both of those drugs on the market ahead of Lilly, that could significantly shrink its market reach.

“It’s important to understand that ribo will compete with palbo upfront in 1L mBC in ER+/HER2- and abema will be 4th or 5th line with around 20% RR, approx comparable to other drugs in that same situation,” notes Sally Church, who covers the oncology field in her Biotech Strategy Blog, in an email message.  “Will the FDA want more efficacy or equivalent?  I think Lilly are in a risky position.  Look up the past noise on ixabepilone and eribulin in that setting – they did not get an easy ride from FDA at all.”

Lilly experienced one of the most painful droughts in pipeline productivity over the past decade, but recently has made a comeback with a slate of late-stage programs like this with blockbuster potential. Any fresh evidence that the company continues to have trouble accelerating pipeline efforts, though, won’t help its rep in the drug development field.

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Sr. Manager, Regulatory Affairs, CMC
CytomX Therapeutics San Francisco, CA
Marketing Associate - Demand Generation
Catalytic Data Science Charleston, SC
Associate Principal, Life Sciences Partnerships
Flatiron Health New York City or San Francisco

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