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Lilly cancer drug pipeline hit by trial setback

An experimental cancer drug being tested by Eli Lilly did not extend survival versus a common chemotherapy regimen in patients with metastatic pancreatic cancer, the latest in a series of clinical setbacks for drugmaker efforts to develop new therapies for the hard-to-treat tumor type. Lilly offered few details beyond disclosing the drug, called pegilodecakin, did not meet the study’s primary endpoint of improving overall survival versus a trio of chemotherapies. In-depth data will be presented at an upcoming medical meeting, the pharma said in a Wednesday statement. Pegilodecakin is an important drug for Lilly and the chief asset acquired via a $1.6 billion deal for Armo BioSciences a year and a half ago.

When Lilly acquired Armo last spring, it highlighted opportunities for pegilodecakin in pancreatic, lung and renal cell cancers.

The drug’s failure to show a survival benefit in pancreatic cancer narrows those prospects, and puts greater importance on two Phase 2 lung cancer studies expected to read out results in early 2020.

Those trials, along with the Phase 3 SEQUOIA study that Lilly read out negative Tuesday, were all started by Armo based on early-stage, open-label data that tested pegilodecakin across a number of tumor types.

Lilly, perhaps signaling some caution, said the forthcoming Phase 2 data will “inform future studies” in lung cancer and added that it’s focused on assessing biomarkers for the next stage of clinical development.

A pegylated version of a cytokine called IL-10, pegilodecakin aims to recruit the body’s immune system in attacking tumors.

One concern with cytokine-based therapies is immune-related side effects. Lilly noted in its release that Grade 3 or 4 cases of neutropenia, thrombocytopenia, fatigue and anemia occurred more frequently in patients treated with pegilodecakin plus chemo then in those given chemo alone.

The SEQUOIA study was one of only three Phase 3 programs in Lilly’s cancer drug pipeline, a relatively sparse line-up compared to some of the company’s pharma peers.

It’s also worth noting that two key executives who led Lilly’s business development and oncology teams at the time of the Armo deal have since left the company.

Darren Carroll, a Lilly veteran who headed up business development and was the company’s principal representative in talks to buy Armo, retired in August. And Levi Garraway, who became Lilly Oncology’s global development head in 2016, also left in August to become chief medical officer at Roche.

Lilly’s decision to buy Loxo Oncology for $8 billion earlier this year, however, may soon deliver a boost to its business. Recent data for a key drug in that deal impressed, and could support U.S. approval as soon as next year.

Elsewhere, positive results for on-market drugs Cyramza (ramucirumab) and Verzenio (abemaciclib) could help Lilly expand market share for each.