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.
https://www.biospace.com/article/lilly-s-pancreatic-drug-flunks-phase-iii-trial/
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