Indy’s Eli Lilly making noise with cancer push; Brickyard neighbor revving its drug-discovery engine

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I’ve been to the headquarters of Eli Lilly & Co.–about 15 minutes (or about 5 miles) from the “Brickyard” where the Indianapolis 500 is run each year. The racing is loud; very loud. But the noise stands in contradistinction to the quiet resolve Lilly has employed the past 141 years to reach the pinnacle of pharmaceutical achievement.

Still, despite a quiet shift occurring at Lilly as the company moves from the field of diabetes care to high-stakes cancer treatment, it’s making some noise that could eventually rival an Indy race. Well, figuratively, of course.

Yes, good things are happening despite the customary missteps and side swipes all drug development entails.

For example, earlier this month Novartis AG beat Lilly to the punch, becoming the second drugmaker, after front-runner Pfizer Inc., to snag FDA approval for its CDK4/6 cancer drug, Kisqali (ribociclib). Recently, Lilly announced that its long-awaited Phase 3 readout for its rival drug abemaciclib looks quite good.

Although we won’t get the specific data for a while yet, the Pharma giant says its Monarch-2 trial comes with positive progression-free data on advanced hormone-receptor-positive, HER2 negative breast cancer.

Top-line data from the near 700 patients showed that the combo therapy created a statistically significant improvement in progression-free survival (PFS) when compared with AstraZeneca PLC’s Faslodex with placebo. Exact numbers will be “presented at an upcoming medical meeting, close” Lilly said in a statement.

According to Endpoints, investigators compared abemaciclib combined with AstraZeneca’s Faslodex (fulvestrant) to Faslodex alone. And the data now set up an FDA filing sometime the next three months.

This good turn of events comes after a snag last year when the study was not stopped early. It was briefly paused for an independent Data Monitoring Committee (DMC) to assess its survival numbers, but at the time, the DMC said the study could go on “without modification as the interim efficacy criteria were not met.”

Lilly would have liked to have seen the trial stop early, but this week’s results very likely prove sufficient. The drug, which has an FDA “breakthrough” designation, is slated to submit an NDA to the agency in the second quarter, based on the Monarch 1 Phase 2 data out last summer, as well as an additional application for its Monarch 2 data in the third quarter.

The NDA on Monarch 1 will be for the treatment of refractory metastatic breast cancer patients whose disease had progressed following multiple prior treatments, including endocrine therapy and one to two chemotherapy regimens in the metastatic setting, says FiercePharma.

Lilly is some distance behind rival Pfizer, which has already seen its competing Ibrance (palbociclib) approved by the FDA, and now with Novartis gaining an FDA nod for its entry, Lilly is likely to be third to market in this potential blockbuster arena.

Along with Monarch 1 and 2, Lilly currently has three additional trials testing abemaciclib in breast cancer, including a late-stage trial in combination with a nonsteroidal aromatase inhibitor in patients with HR+, HER2- loco-regionally recurrent or metastatic breast cancer.

Steve’s Take:

Although running third at the moment in this race (think the Indy races), analysts at Barclays said in a note to clients:

“Lilly did not disclose specific details on Monarch 2, but we believe that the data could make the upcoming ASCO meeting in June. From an efficacy perspective, we anticipate that the focus will be on both the absolute and relative PFS benefit, with market leader Ibrance in the PALOMA-3 trial showing a median PFS of 9.2 months vs. 3.8 months for [Astra’s] fulvestrant.”

Barclays added:

“From a safety perspective, the top question will inevitably be targeted on diarrhea rates in the abemaciclib arm, which has been the top investor concern on abemaciclib, followed by neutropenia rates, which are a systemic issue for the CDK4/6 class. Lilly characterized the adverse events as consistent with prior abemaciclib studies, which could require co-use of loperamide and monitoring though this is widely known already.”

Over at Leerink Partners, Seamus Fernandez gauged Lilly’s time­line, in­clud­ing a likely ASCO pre­sen­ta­tion, after talk­ing to company reps. His take was that Lilly has the “data pack­age ready to go” and will sub­mit an NDA for sin­gle-agent abe­maci­clib in 2Q17 based on the MONARCH-1 study; the pack­age will in­clude data on re­sponse rate (RR), PFS and OS (over­all sur­vival).

An ad­di­tional ap­pli­ca­tion sub­mis­sion for MONARCH-2 is ex­pected in 3Q17. Mgmt also con­firmed that the MONARCH-3 study, which is in com­bi­na­tion with letro­zole, is ex­pected to have an in­terim analy­sis in 2Q and the final read­out is ex­pected be­fore the end of 2017.”

Looking at the only benchmark for past sales of a CDK4/6 inhibitor to reach the market, Pfizer’s Ibrance reached $643 million in 2016. Out of the starting gate, that’s an indicator of the docs’ willingness to take out their prescription pads (well, iPads) and use it to help their patients.

But what about sales prospects for Lilly’s abemaciclib? Anyone willing to step up to the plate?

Actually, just one brave soul over at Bernstein by the name of Timothy Anderson. He predicts abemaciclib sales could top $1.3 billion in 2021, says Reuters. This assumes it would enter the market third with no substantive differentiation, he said, noting if detailed data showed the drug is more competitive, estimates would rise substantially.

Finally, let’s look at how analysts rate Eli Lilly, as taking a stand on a stock is where the rubber meets the road on Wall Street.

  • Wall Street Journal: among the 23 analysts covering Lilly,

17 currently rate it a Buy,

1 rates it Overweight,

5 rate it Hold;

For a consensus Buy

  • Motley Fool: among the 19 analysts covering Lilly,

12 rate it a Strong Buy.

2 rate it a Moderate Buy,

4 rate it a Hold,

1 rates it a Strong Sell;

For a mean recommendation of 1.71, or a solid Buy

(Mean Recommendation Conversions: 1 = Strong Buy; 2 = Moderate Buy; 3 = Hold; 4 = Moderate Sell; 5 = Strong Sell)

Bottom Line:

For years Lilly has focused on the crowded diabetes market where fairly consistent price hikes have had their profitability undercut considerably by rising discounts negotiated by insurers and pharmacy benefit managers. These ever-growing discounts and politically popular pricing scrutiny are issues for the entire healthcare industry, but especially Pharma.

Lilly’s pivot toward migraine, arthritis and more recently cancer doesn’t mean it’s abandoning the diabetes arena, however. Not by a long shot. One version of its best-selling insulin Humalog has almost doubled in price since 2011.

Lilly has the science talent and management acumen to successfully steer its drug-discovery and development program where the big dollars are likely to be in the near-term, and cancer is key where growth is concerned. Everyone knows it.

After skin cancer, breast cancer is the most common cancer in women in the United States, according to the US Centers for Disease Control and Prevention. About 40,610 women will die from breast cancer in 2017, the American Cancer Society estimates.

Steve's Take: A buy for the risk-adverse portfolio lacking a solid, yet rising Pharma @Lillypad Click To Tweet

I’m a fan of this mid-west pharma giant that’s been able to stay out of the crosshairs of the most ardent industry critics while quietly expanding into more lucrative clinical arenas. The company is making noise with its breast-cancer prospect and analysts have taken notice. I’d recommend a buy for the risk-adverse portfolio lacking a solid Pharma issue that’s on the rise.

Steve Walker has no position in any stocks mentioned. MedContent Inc. has no position in any stocks mentioned. MondayMorning.com has a disclosure policy.