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Lilly and Merck Expand Immuno-oncology Collaboration with Phase III Nonsquamous Non-Small Cell Lung Cancer Trial

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Eli Lilly
and Company (NYSE: LLY) and Merck (NYSE: MRK), known as MSD outside the
United States and Canada, today announced the extension of an existing
collaboration to evaluate the safety and efficacy of the combination of
Lilly's ALIMTA(R) (pemetrexed for injection) and Merck's KEYTRUDA(R)
(pembrolizumab) in a pivotal Phase III study in first-line nonsquamous
non-small cell lung cancer (NSCLC). The study will be sponsored by Merck and
will be open to patients with NSCLC in the first-line setting, regardless of
PD-L1 status. Financial details of the collaboration were not disclosed.
The expansion of this oncology clinical trial collaboration comes following
the release of encouraging data from a Phase I study, presented earlier this
year at the 16(th) World Congress on Lung Cancer, which evaluated
pemetrexed, carboplatin and pembrolizumab in first-line nonsquamous NSCLC.
Pemetrexed is a leading therapeutic option used in combination with
platinum-based therapies in this setting, making it an ideal candidate for
combination studies with immunotherapy treatments. Pembrolizumab is a
humanized monoclonal antibody that works by increasing the ability of the
body's immune system to help detect and fight tumor cells. Pembrolizumab
blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2,
thereby activating T lymphocytes, which may affect both tumor cells and
healthy cells -- and is currently approved as a single-agent therapy for
certain types of NSCLC.
"The extension of our immuno-oncology collaboration with Merck reinforces
our combination-focused strategy, which we believe has the potential to help
this patient population where there is a significant unmet need," said
Richard Gaynor, M.D., senior vice president, product development and medical
affairs for Lilly Oncology. "Building upon this scientific partnership
represents our shared, strong commitment to improve the lives of those
living with cancer."
"Based on the data for ALIMTA, we believe this collaboration with Lilly has
great potential to help even more patients," said Roger Dansey, M.D.,
therapeutic area head and senior vice president, oncology late stage
development, Merck Research Laboratories. "We look forward to continuing our
collaboration with Lilly across all of these trials -- including the
registrational Phase III all-comers trial for NSCLC."
In addition to the studies of pemetrexed and pembrolizumab in first-line
nonsquamous NSCLC, other ongoing trials from the original agreement between
Lilly and Merck, through a subsidiary, include:
-- A Phase I/II study examining the combination of ramucirumab with
pembrolizumab in multiple tumors.

-- A Phase I/II study examining the combination of necitumumab with
pembrolizumab in NSCLC.
NOTES TO EDITORS
About KEYTRUDA(R) (pembrolizumab) Injection 100 mg
KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered
as an intravenous infusion over 30 minutes every three weeks for the
treatment of patients with metastatic non-small cell lung cancer (NSCLC)
whose tumors express PD-L1 as determined by an FDA-approved test with
disease progression on or after platinum-containing chemotherapy. Patients
with EGFR or ALK genomic tumor aberrations should have disease progression
on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.
KEYTRUDA is also indicated at the same dosing for the treatment of patients
with unresectable or metastatic melanoma and disease progression following
ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. These
indications are approved under accelerated approval based on tumor response
rate and durability of response. An improvement in survival or
disease-related symptoms has not yet been established. Continued approval
for these indications may be contingent upon verification and description of
clinical benefit in the confirmatory trials.
Selected Important Safety Information for KEYTRUDA(R) (pembrolizumab)
Pneumonitis, including fatal cases, occurred in patients receiving KEYTRUDA.
Pneumonitis occurred in 12 (2.9%) of 411 melanoma patients, including Grade
2 or 3 cases in 8 (1.9%) and 1 (0.2%) patients, respectively, receiving
KEYTRUDA. Pneumonitis occurred in 19 (3.5%) of 550 patients with NSCLC,
including Grade 2 (1.1%), 3 (1.3%), 4 (0.4%), or 5 (0.2%) pneumonitis in
patients, receiving KEYTRUDA. Monitor patients for signs and symptoms of
pneumonitis. Evaluate suspected pneumonitis with radiographic imaging.
Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold
KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or
recurrent Grade 2 pneumonitis.
Colitis (including microscopic colitis) occurred in 4 (1%) of 411 patients
with melanoma, including Grade 2 or 3 cases in 1 (0.2%) and 2 (0.5%)
patients, respectively, receiving KEYTRUDA.
Colitis occurred in 4 (0.7 %) of 550 patients with NSCLC, including Grade 2
(0.2%) or 3 (0.4%) colitis in patients receiving KEYTRUDA. Monitor patients
for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or
greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue
KEYTRUDA for Grade 4 colitis.
Hepatitis occurred in patients receiving KEYTRUDA. Hepatitis (including
autoimmune hepatitis) occurred in 2 (0.5%) of 411 patients with melanoma,
including a Grade 4 case in 1 (0.2%) patient, receiving KEYTRUDA. Monitor
patients for changes in liver function. Administer corticosteroids for Grade
2 or greater hepatitis and, based on severity of liver enzyme elevations,
withhold or discontinue KEYTRUDA.
Hypophysitis occurred in 2 (0.5%) of 411 patients with melanoma, including a
Grade 2 case in 1 and a Grade 4 case in 1 (0.2% each) patient, receiving
KEYTRUDA. Hypophysitis occurred in 1 (0.2 %) of 550 patients with NSCLC,
which was Grade 3 in severity. Monitor patients for signs and symptoms of
hypophysitis (including hypopituitarism and adrenal insufficiency).
Administer corticosteroids and hormone replacement as indicated. Withhold
KEYTRUDA for Grade 2 and withhold or discontinue for Grade 3 or Grade 4
hypophysitis.
Hyperthyroidism occurred in 5 (1.2%) of 411 patients with melanoma,
including Grade 2 or 3 cases in 2 (0.5%) and 1 (0.2%) patients,
respectively, receiving KEYTRUDA. Hypothyroidism occurred in 34 (8.3%) of
411 patients with melanoma, including a Grade 3 case in 1 (0.2%) patient,
receiving KEYTRUDA. Hyperthyroidism occurred in 10 (1.8%) of 550 patients
with NSCLC, including Grade 2 (0.7%) or 3 (0.3%). Hypothyroidism occurred in
38 (6.9%) of 550 patients with NSCLC, including Grade 2 (5.5%) or 3 (0.2%).
Thyroid disorders can occur at any time during treatment. Monitor patients
for changes in thyroid function (at the start of treatment, periodically
during treatment, and as indicated based on clinical evaluation) and for
clinical signs and symptoms of thyroid disorders. Administer replacement
hormones for hypothyroidism and manage hyperthyroidism with thionamides and
beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3
or Grade 4 hyperthyroidism.
Type 1 diabetes mellitus, including diabetic ketoacidosis, has occurred in
patients receiving KEYTRUDA. Monitor patients for hyperglycemia or other
signs and symptoms of diabetes. Administer insulin for type 1 diabetes, and
withhold KEYTRUDA and administer anti-hyperglycemics in patients with severe
hyperglycemia.
Nephritis occurred in patients receiving KEYTRUDA. Nephritis occurred in 3
(0.7%) patients with melanoma, consisting of one case of Grade 2 autoimmune
nephritis (0.2%) and two cases of interstitial nephritis with renal failure
(0.5%), one Grade 3 and one Grade 4. Monitor patients for changes in renal
function. Administer corticosteroids for Grade 2 or greater nephritis.
Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3
or 4 nephritis.
Other clinically important immune-mediated adverse reactions can occur. For
suspected immune-mediated adverse reactions, ensure adequate evaluation to
confirm etiology or exclude other causes. Based on the severity of the
adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon
improvement of the adverse reaction to Grade 1 or less, initiate
corticosteroid taper and continue to taper over at least 1 month. Resume
KEYTRUDA when the adverse reaction remains at Grade 1 or less following
steroid taper. Permanently discontinue KEYTRUDA for any severe or Grade 3
immune-mediated adverse reaction that recurs and for any life-threatening
immune-mediated adverse reaction.
Across clinical studies with KEYTRUDA, the following clinically significant,
immune-mediated adverse reactions have occurred: bullous pemphigoid and
Guillain-Barré syndrome. The following clinically significant,
immune-mediated adverse reactions occurred in less than 1% of patients with
melanoma treated with KEYTRUDA: exfoliative dermatitis, uveitis, arthritis,
myositis, pancreatitis, hemolytic anemia, and partial seizures arising in a
patient with inflammatory foci in brain parenchyma. The following clinically
significant, immune-mediated adverse reactions occurred in less than 1% of
550 patients with NSCLC treated with KEYTRUDA: rash, vasculitis, hemolytic
anemia, serum sickness, and myasthenia gravis.
Infusion-related reactions, including severe and life-threatening reactions,
have occurred in patients receiving KEYTRUDA. Monitor patients for signs and
symptoms of infusion related reactions including rigors, chills, wheezing,
pruritus, flushing, rash, hypotension, hypoxemia, and fever. For severe or
life-threatening reactions, stop infusion and permanently discontinue
KEYTRUDA.

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