Eli Lilly nixes Verzenio’s phase 3 HER2-positive early breast cancer trial – FiercePharma

Eli Lilly has made the difficult decision to cull a phase 3 study of Verzenio in HER2-positive early breast cancer, Dan Skovronsky, M.D., Ph.D., chief scientific and medical officer at Lilly, said on a call with investors Thursday.

Details were slim, but Skovronsky blamed the decision on changes in the treatment landscape plus global enrollment challenges.

Importantly, this decision does not change our commitment to an investment in breast cancer, Lillys chief scientist said.

News of the Verzenio trial halt comes a week after Lilly announced it was pulling the plug on Olumiants development in lupus. Separately, Olumiants application in moderate-to-severe atopic dermatitis could be in jeopardy, thanks to a stalemate with the FDA about the exact patient population, the company said last week. Lilly expects regulatory action on Olumiants eczema bid very soon, Skovronsky said Thursday.

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During the call,Lilly shed more light on Olumiants regulatory impasse in eczema. Lilly believes Olumiant benefits eczema patients most when used in early treatment, Patrik Jonsson, SVP and president of Lilly immunology and president of Lilly USA, said on the call. The FDA, conversely, currently has the position of saving Olumiant for the refractory patients, where we see the incremental value of Olumiant to be quite limited.

If that doesnt change, a complete response letter is likely, Jonsson said.

Lilly has also submitted Olumiant for approval in alopecia, though ananalyst on Wednesdays call questioned whether safety concerns around the JAK-inhibitor class at large could blunt the drugs ambitions there. Lilly simply said it was encouraged by the data its seen so far, and it highlighted the immense opportunity in the disease.

There are currently no treatments approved for alopecia areata, Jonsson said. We have the opportunity here to be first in disease with Olumiant.

There are about 360,000 patients diagnosed with alopecia in the U.S., some 100,000 of whom would be eligible for treatment with a JAK inhibitor, Jonsson added.

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For the fourth quarter, Eli Lillys revenue jumped 8% to $7.9 billion. Excluding COVID-19 antibodies, sales for the last three months of the year climbed 6%. Full-year sales increased 15% to $28.3 billion or 10% after subtracting Lillys pandemic antibodies from the equation.

Last month, The FDAtweakedits emergency nod for Lilly and Regenerons monoclonal antibodies, citing recent data showing the drugs arent effective against omicron. The antibodies are now limited to patients whove been infected with or exposed to a variant susceptible to the therapies.

Lilly snared $1.1 billion in COVID-19 antibody revenue for the fourth quarter. Lilly says it delivered roughly 435,000 doses out of 614,000 in the last three months of the year, with most of the remaining doses already shipped out last month.

Lilly credited its fourth-quarter momentum to growth drugs like Trulicity, Taltz, Verzenio, Olumiant, Emgality and more.

"Lillys margin profile represents one of the strongest expansion stories in Pharma, in our opinion, with the potential for mid-teens EPS growth, Cantor Fitzgerald analyst Louise Chen wrote in a note to clients Thursday. Her team thinks Lilly is poised to enter a growth period through 2030, helped by multiple readouts for products like donanemab in Alzheimers disease and tirzepatide in Type 2 diabetes.

Lilly has forecasted full-year 2022 sales between $27.8 billion and $28.3 billion.

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Eli Lilly nixes Verzenio's phase 3 HER2-positive early breast cancer trial - FiercePharma