Lilly preps a PhIII study as breast cancer drug race heats up

One of the big surprises at the annual meeting of the American Association for Cancer Research last weekend belonged to none other than Eli Lilly ($LLY), which will soon be able to add another therapy to its list of Phase III assets in the clinic.

Several analysts and reporters seized on early glimpses of activity for Lilly's CDK4/6 inhibitor LY2835219, in part because Pfizer's ($PFE) rival therapy palbociclib was in the center spotlight with mostly positive--though not the most spectacular--Phase II data for hormone-receptor-positive metastatic breast cancer. Novartis ($NVS), meanwhile, has quickly pushed its rival program for LEE011 into Phase III, setting up a potential showdown over a market that could deliver billions of dollars in revenue. Both therapies target a pair of cyclin-dependent kinases that play a role in cancer.

Lilly's drug showed some early-stage promise and attracted considerable comment as a distant third in the running. But the pharma giant, which desperately needs to generate some excitement for its pipeline as revenue flags in the face of an onslaught of generics, was already setting the stage for Phase III when investigators arrived in San Diego. The company posted plans for a Phase III study of LY2835219 for breast cancer on clinicaltrials.gov less than a week ago. The study has yet to begin recruiting patients, but once it does investigators will start testing a combination of the experimental drug with AstraZeneca's ($AZN) Faslodex against the solo approved drug in a comparison arm.

"We view LLY's CDK 4/6 favorably when compared with PFE's previous MBC-specific Study 1006 of palbociclib (palbo) monotherapy given a partial response rate (PR) of 19% vs. palbo's 7% in all patients and Grade 3/4 neutropenia of 21% vs. palbo's 46%," noted Leerink's Seamus Fernandez in a statement after he sized up the Phase I results. "We maintain our LY2835219 peak 2026 sales forecast of $650M, with meaningful upside potential based on continually strong results / the success of combination trials, and potential expansion into add'l Rb-mediated tumors."

Lilly can benefit from a Phase III in a number of ways. One, Lilly CEO John Lechleiter likes nothing better than boasting about the size of the company's late-stage pipeline, which is his only out for a 6-year drought in new product development. It also provides some evidence that Lilly--one of the slowest developers in the business with a string of failures to its credit--may be picking up some speed in R&D. And it gives them boasting rights in a field that many top analysts are watching with rapt attention.

Lilly also has a Phase II breast cancer study waiting to start enlisting breast cancer patients. And its schedule on Phase III is anything but quick. The company says it expects to start the study in July, with a primary completion date in 2017.

Palbociclib is still the drug to watch in this race, especially if Pfizer goes ahead and files for an early approval. But Lilly now has an interesting pony in this race, and it's starting to narrow the gap.

- here's the posting on clinicaltrials.gov