Lilly's Pancreatic Cancer Candidate Fails In Phase III Study

Eli Lilly and Company (NYSE:LLY) announced that its immunotherapy candidate, pegilodecakin, in combination with chemotherapies, failed to show survival benefit in a phase III SEQUOIA study, evaluating the regimen in metastatic pancreatic cancer.

Shares of the company fell 1.6% on Oct 16 following announcement of the study failure. The company’s shares decreased 6.7% against the industry’s increase of 0.2%.

The SEQUOIA study evaluated pegilodecakin in combination with FOLFOX, which is a combination of chemotherapies (folinic acid, 5-FU, oxaliplatin), in patients with metastatic pancreatic cancer whose disease had progressed during or following a first-line gemcitabine-containing regimen versus FOLFOX alone for improvement in overall survival. The study failed to meet the primary endpoint of overall survival.

Please note that Lilly added pegilodecakin to its pipeline with the acquisition of ARMO Biosciences in 2018.

Apart from pancreatic cancer, Lilly is also evaluating pegilodecakin in combination with checkpoint inhibitors in two phase II studies as a treatment for non-small cell lung cancer. Top-line data from these studies are expected in early 2020. The company also has plans to develop the candidate for treating other tumor types including renal cell carcinoma.

Currently, pancreatic cancer is the third most common type of cancer leading to death in U.S. patients per the American Cancer Society. Per the press release, more than 56,700 patients will be diagnosed with pancreatic cancer in 2019.

Although Lilly markets Gemzar for pancreatic cancer, the drug, once a blockbuster, does not generate significant sales due to generic competition. Other drugs available for pancreatic cancer include Celgene’s (NASDAQ:CELG) Abraxane and Roche’s Tarceva.

Several other pharma/biotech companies are developing their treatment regimens to cater to this significantly growing market. NuCana plc (NASDAQ:NCNA) is evaluating Acelarin in phase III study, Clovis Oncology’s Rubraca is in mid-stage development and Tyme Technologies, Inc. (NASDAQ:TYME) initiated a pivotal study on its pipeline candidate racemetyrosine last month.

We note that Lilly’s oncology segment remained the second largest revenue generator for the company in the first half of 2019 with $2.2 billion in sales. Key oncology drugs of the company are Alimta, Cyramza and Erbitux, which are approved for multiple cancer indications. Successful development of pegilodecakin for treating pancreatic cancer would have offset lower sales of Gemzar as well as boosted oncology sales.

Zacks Rank

Lilly currently carries a Zacks Rank #3 (Hold).

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