Lilly's $1.6bn cancer drug draws blank in pancreatic cancer trial

Eli Lilly is looking at other uses for its new cancer immunotherapy pegilodecakin after it flopped in a phase 3 pancreatic cancer trial.

The big US pharma said top-line results from the phase 3 SEQUOIA trial had not shown an overall survival benefit in patients taking pegilodecakin and FOLFOX (folinic acid, 5-FU, oxaliplatin) chemotherapy, compared with FOLFOX alone.

Also known as AM0010, pegilodecakin is a long-acting form of recombinant interleukin 10 (IL-10), and acts as an immunotherapy by stimulating the immune system to attack cancer.

Lilly added pegilodecakin to its pipeline following its $1.6 billion buyout of Armo Biosciences last year.

The phase 3 trial was testing the drug in patients whose disease had spread during or after treatment with a gemcitabine-based regimen.

An international, multi-centre randomised phase 3 study enrolling 567 patients, Armo begun SEQUOIA in March 2017 following results of the phase 1/1b IVY study, testing pegilodecakin as a single agent in combination with chemotherapy and checkpoint inhibitor therapy.

The early trial involved several tumour types – as well as pancreatic cancer, the early study also looked at non-small cell lung cancer (NSCLC) and renal cell cancers.

Lilly’s attention will move to the phase 2 CYPRESS1 and CPYPRESS 2 trials in NSCLC, which began in March last year, with results expected early next year.

Results of these phase 2 trials will inform future studies of pegilodecakin in NSCLC, and Lilly is assessing biomarkers and looking at other tumour types such as renal cell carcinoma for further development opportunities.

Maura Dickler, vice president, late phase development, Lilly Oncology, said: "Pancreatic cancer has proven to be one of the most difficult tumour types to treat and there have been very few recent treatment advancements in the later-line metastatic setting. We are grateful to the patients, investigators and researchers who participated in the study.

"While we are disappointed by the outcome of the SEQUOIA study, we look forward to the upcoming results in lung cancer, learning from those results and increasing our understanding of pegilodecakin's novel mechanism of action in cancer immunotherapy."