After Cancer Drug Fails Pancreatic Cancer Trial, Lilly Plans to Continue Studies in Lung and Renal Cancer

Eli Lilly and Company announced that its Phase III SEQUOIA trial of pegilodecakin plus FOLOFX (folinic acid, 5-FU, oxaliplatin) in metastastic pancreatic cancer that had progressed during or after first-line gemcitabine-containing regimen did not meet its primary endpoint.

The SEQUOIA trial compared pegilodecakin and FOLFOX to FOLFOX alone. The primary endpoint was overall survival. The trial is a global, multi-center, randomized Phase III study. Key secondary endpoints are progression-free survival and objective response rate.

Lilly picked up pegilodecakin, an immunotherapy that stimulates the body’s immune system and expands tumor-attacking T-cells, when it acquired ARMO BioSciences in June 2018 for $1.6 billion. Pegilodecakin, a PEGylated IL-10, had shown clinical benefit as a monotherapy and in combination with chemotherapy and checkpoint inhibitors in several tumor types.

“Pancreatic cancer has proven to be one of the most difficult tumor types to treat and there have been very few recent treatment advancements in the later-line metastatic setting,” said Maura Dickler, vice president, late phase development, Lilly Oncology. “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.”

The company is also conducting two Phase II trials, CYPRESS 1 and CYPRESS 2, of the drug in combination with checkpoint inhibitors in non-small cell lung cancer (NSCLC). The CYPRESS studies were launched by ARMO in March 2018, with results expected in early 2020. Lilly also indicates it is evaluating biomarkers and running studies in NSCLC and other cancers, including renal cell carcinoma, where pegilodecakin has shown promising activity.

Pancreatic cancer is a very difficult cancer to treat. Only about 3% of patients in the U.S. who are diagnosed live five years. It is the third leading cause of cancer death in the U.S. and barring more successful drug development, is expected to grow to the second leading cause of cancer-related death in the next decade. Worldwide, it is the seventh leading cause of cancer-related death.

Not many details about the trial were released, but Lilly did say the most common Grade 3/4 adverse events that occurred more than 5% were neutropenia, thrombocytopenia, fatigue and anemia. The company expects to present data at a future medical conference.

To be fair to Lilly, this was a particularly difficult clinical trial goal, with the patient population already not responding to gemcitabine-containing chemotherapy and looking for improvements in overall survival. The company is not giving up on the drug, with some analysts thinking that lung cancer in particular could be the biggest opportunity.

Earlier this week, Lilly announced it was closing its Erl Wood research center in Surrey, UK, which focuses on neuroscience research. The facility will close by the end of 2020, affecting 270 staffers with about 80 redundancies. About a third of the staff will move to a nearby location, but the company’s neuroscience research will move to the U.S.

At the beginning of the year, on January 8, Lilly announced it was cutting 250 jobs at its factory near Strasbourg in Eastern France. About 1,400 people worked at the site.