First-Time Data from POLO Trial Evaluating LYNPARZA®
(olaparib) in Germline BRCA-Mutated Metastatic Pancreatic Cancer
in Plenary Session and ASCO Press Program
KEYTRUDA® (pembrolizumab) Five-Year Survival
Data in Advanced Non-Small Cell Lung Cancer (NSCLC) from KEYNOTE-001
Trial in ASCO Press Program
Overall Survival Data for KEYTRUDA in Metastatic Renal Cell Carcinoma
(RCC), Recurrent/Metastatic Head and Neck Cancer and Advanced Gastric or
Gastroesophageal Junction (GEJ) Cancer
KENILWORTH, N.J.–(BUSINESS WIRE)–lt;a href="https://twitter.com/search?q=%24MRK&src=ctag" target="_blank"gt;$MRKlt;/agt; lt;a href="https://twitter.com/hashtag/MRK?src=hash" target="_blank"gt;#MRKlt;/agt;–Merck (NYSE: MRK), known as MSD outside the United States and Canada,
today announced that new research from the company’s broad oncology
clinical development program will be presented at the 55th
Annual Meeting of the American Society of Clinical Oncology (ASCO) in
Chicago from May 31-June 4. More than 140 abstracts have been accepted
evaluating Merck’s medicines – including KEYTRUDA, Merck’s anti-PD-1
therapy, LYNPARZA (in collaboration with AstraZeneca) and LENVIMA (in
collaboration with Eisai) – in over 25 types of cancer. LYNPARZA data
include new findings in metastatic pancreatic cancer with the first
presentation of results from the POLO study to be featured in the ASCO
Plenary Session and press program. Additionally, new or updated overall
survival (OS) findings for KEYTRUDA in non-small cell lung cancer
(NSCLC), renal cell carcinoma (RCC), head and neck cancer, and gastric
or gastroesophageal junction (GEJ) cancer will be presented.
“Research from our broad oncology clinical development program –
anchored by KEYTRUDA and including LYNPARZA and LENVIMA – continues to
support our goal of improving outcomes and providing clinically
meaningful results for patients and physicians,” said Dr. Roy Baynes,
senior vice president and head of global clinical development, chief
medical officer, Merck Research Laboratories. “At ASCO this year, we
look forward to presenting additional overall survival data for KEYTRUDA
across different tumor types, as well as first-time LYNPARZA data in
pancreatic cancer that reinforce our commitment to helping patients with
the most aggressive forms of cancer.”
Key abstracts to be presented at ASCO include:
-
First presentation of data from the Phase 3 POLO trial evaluating the
PARP inhibitor LYNPARZA as first-line maintenance treatment in
patients with germline BRCA-mutated (gBRCAm) metastatic
pancreatic cancer who did not progress on platinum-based chemotherapy
(Abstract #LBA4). These results will be presented in the ASCO Plenary
Session and highlighted in the ASCO press program. As previously
announced in February 2019, the POLO trial met its primary endpoint of
progression-free survival (PFS) compared to placebo. -
Five-year long-term OS data from the Phase 1b KEYNOTE-001 study
evaluating KEYTRUDA in patients with advanced NSCLC (Abstract
#LBA9015). These results will be highlighted in the ASCO press program. -
Updated data, including OS and progression-free survival 2 (PFS2)
findings, from the Phase 3 KEYNOTE-189 trial evaluating KEYTRUDA in
combination with pemetrexed (ALIMTA®) and platinum
chemotherapy in patients with metastatic nonsquamous NSCLC (Abstract
#9013). The KEYNOTE-189 study was conducted in collaboration with Eli
Lilly and Company, the makers of pemetrexed (ALIMTA®). -
First presentation of data from the Phase 3 KEYNOTE-062 trial
evaluating KEYTRUDA as first-line treatment (as monotherapy and in
combination with chemotherapy) in patients with advanced gastric or
gastroesophageal junction (GEJ) adenocarcinoma (Abstract #LBA4007). In
April 2019, Merck announced KEYTRUDA met a primary endpoint as
monotherapy, but not in combination with chemotherapy. -
Data, including OS, PFS and objective response rate (ORR), from new
subgroup analyses of the combined International Metastatic RCC
Database Consortium (IMDC) intermediate/poor risk and sarcomatoid
subgroups in the Phase 3 KEYNOTE-426 trial evaluating KEYTRUDA in
combination with axitinib compared to sunitinib as first-line therapy
in patients with metastatic RCC (Abstract #4500). -
Results from the final analysis, including new OS data, from the Phase
3 KEYNOTE-048 trial evaluating KEYTRUDA as first-line therapy (as
monotherapy and in combination with chemotherapy) in patients with
recurrent or metastatic head and neck squamous cell carcinoma
(Abstract #6000). -
First presentation of data from the Phase 3 SOLO3 trial evaluating
LYNPARZA in patients with relapsed BRCAm advanced ovarian
cancer (Abstract #5506). As previously announced in December 2018, the
SOLO3 trial met its primary endpoint of ORR with LYNPARZA compared to
chemotherapy. -
First presentation of data from KEYNOTE-240 evaluating KEYTRUDA in
previously treated patients with advanced hepatocellular carcinoma
(HCC) (Abstract #4004). As previously announced in February 2019,
KEYNOTE-240 did not meet its co-primary endpoints of OS and PFS
compared with placebo plus best supportive care; there was an
improvement in OS and results were directionally favorable for PFS in
patients treated with KEYTRUDA compared with placebo, however these
results did not meet statistical significance.
Details on Studies Listed Above, and Key Abstracts with Merck’s
Collaboration Partners
| Cancer Type | Abstract Title | Presentation Details | ||
| KEYTRUDA (pembrolizumab) | ||||
| Gastric or gastroesophageal junction |
Pembrolizumab with or without chemotherapy versus chemotherapy for advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: The phase III KEYNOTE-062 Study |
Abstract #LBA4007 (oral)
J. Tabernero Sunday, June 2 11:57 a.m.-12:09 p.m. CT, Arie Crown Theater |
||
| Head and neck |
Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) |
Abstract #6000 (oral)
D. Rischin Friday, May 31 2:45-2:57 p.m. CT, E450 |
||
| Liver |
Results of KEYNOTE-240: phase 3 study of pembrolizumab (Pembro) vs best supportive care (BSC) for second line therapy in advanced hepatocellular carcinoma (HCC) |
Abstract #4004 (oral)
R. Finn Sunday, June 2 10:57-11:09 a.m. CT, Arie Crown Theater |
||
| Lung |
Five-year long-term overall survival for patients with advanced NSCLC treated with pembrolizumab: Results from KEYNOTE-001 |
Abstract #LBA9015 (poster discussion)
E. Garon Sunday, June 2 8:00-11:00 a.m. CT, Hall A (poster) 4:30-6:00 p.m. CT, Hall D1 (discussion) |
||
|
KEYNOTE-189: Updated OS and progression after the next line of therapy (PFS2) with pembrolizumab (pembro) plus chemo with pemetrexed and platinum vs placebo plus chemo for metastatic nonsquamous NSCLC |
Abstract #9013 (poster discussion)
S. Gadgeel Sunday, June 2 8:00-11:00 a.m. CT, Hall A (poster) 4:30-6:00 p.m. CT, Hall D1 (discussion) |
|||
| Renal cell |
Pembrolizumab (pembro) plus axitinib (axi) versus sunitinib as first-line therapy for metastatic renal cell carcinoma (mRCC): Outcomes in the combined IMDC intermediate/poor risk and sarcomatoid subgroups of the phase 3 KEYNOTE-426 study |
Abstract #4500 (oral)
B. Rini Monday, June 3 8:00-8:12 a.m. CT, Arie Crown Theater |
||
| LYNPARZA (olaparib) (in collaboration with AstraZeneca) | ||||
| Ovarian |
Olaparib monotherapy versus (vs) chemotherapy for germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed ovarian cancer (PSR OC) patients (pts): Phase III SOLO3 trial |
Abstract #5506 (oral)
R. Penson Monday, June 3 3:15-3:27 p.m. CT, S406 |
||
|
Olaparib maintenance therapy in patients (pts) with a BRCA1 and/or BRCA2 mutation (BRCAm) and newly diagnosed advanced ovarian cancer (OC): SOLO1 China cohort |
Abstract #5554 (poster)
L. Wu Saturday, June 1 1:15-4:15 p.m. CT, Hall A |
|||
| Pancreatic |
Olaparib as maintenance treatment following first-line platinum-based chemotherapy (PBC) in patients (pts) with a germline BRCA mutation and metastatic pancreatic cancer (mPC): Phase III POLO trial |
Abstract #LBA4 (plenary)
H. Kindler Sunday, June 2 3:15-3:30 p.m. CT, Hall B1 |
||
| KEYTRUDA + LENVIMA (lenvatinib) (in collaboration with Eisai) | ||||
| Endometrial |
A phase 3 trial evaluating efficacy and safety of lenvatinib in combination with pembrolizumab in patients with advanced endometrial cancer |
Abstract #TPS5607 (poster)
V. Makker Saturday, June 1 1:15-4:15 p.m. CT, Hall A |
||
| Liver |
Lenvatinib (len) plus pembrolizumab (pembro) for the first-line treatment of patients (pts) with advanced hepatocellular carcinoma (HCC): Phase 3 LEAP-002 study |
Abstract #TPS4152 (poster)
J. Llovet Monday, June 3 8:00-11:00 a.m. CT, Hall A |
||
| Lung |
Randomized, double-blind, phase 3 trial of first-line pembrolizumab + platinum doublet chemotherapy (chemo) ± lenvatinib in patients (pts) with metastatic nonsquamous non-small-cell lung cancer (NSCLC): LEAP-006. |
Abstract #TPS9118 (poster)
R. Hui Sunday, June 2 8:00-11:00 a.m. CT, Hall A |
||
| Melanoma |
Lenvatinib (len) plus pembrolizumab (pembro) in patients (pts) with advanced melanoma previously exposed to anti–PD-1/PD-L1 agents: Phase 2 LEAP-004 study |
Abstract #TPS9594 (poster)
A. Arance Fernandez Monday, June 3 1:15-4:15 p.m. CT, Hall A |
||
For more information, including a complete list of abstract titles and
presentation dates and times for data from Merck’s oncology portfolio,
please visit the ASCO website at https://iplanner.asco.org/am2019/#/.
About KEYTRUDA® (pembrolizumab) Injection,
100mg
KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of
the body’s immune system to help detect and fight tumor cells. KEYTRUDA
is a humanized monoclonal antibody that 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.
Merck has the industry’s largest immuno-oncology clinical research
program. There are currently more than 1,000 trials studying KEYTRUDA
across a wide variety of cancers and treatment settings. The KEYTRUDA
clinical program seeks to understand the role of KEYTRUDA across cancers
and the factors that may predict a patient’s likelihood of benefitting
from treatment with KEYTRUDA, including exploring several different
biomarkers.
KEYTRUDA® (pembrolizumab) Indications and
Dosing
Melanoma
KEYTRUDA is indicated for the treatment of patients with unresectable or
metastatic melanoma. The recommended dose of KEYTRUDA in patients with
unresectable or metastatic melanoma is 200 mg administered as an
intravenous infusion over 30 minutes every three weeks until disease
progression or unacceptable toxicity.
KEYTRUDA is indicated for the adjuvant treatment of patients with
melanoma with involvement of lymph node(s) following complete resection.
The recommended dose of KEYTRUDA for the adjuvant treatment of adult
patients with melanoma is 200 mg administered as an intravenous infusion
over 30 minutes every three weeks until disease recurrence, unacceptable
toxicity, or for up to 12 months in patients without disease recurrence.
Lung Cancer
KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is
indicated for the first-line treatment of patients with metastatic
nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK
genomic tumor aberrations.
KEYTRUDA, in combination with carboplatin and either paclitaxel or
paclitaxel protein-bound, is indicated for the first-line treatment of
patients with metastatic squamous NSCLC.
KEYTRUDA, as a single agent, is indicated for the first-line treatment
of patients with stage III NSCLC who are not candidates for surgical
resection or definitive chemoradiation, or metastatic NSCLC, and whose
tumors express PD-L1 [tumor proportion score (TPS) ≥1%] as determined by
an FDA-approved test, with no EGFR or ALK genomic tumor aberrations.
KEYTRUDA, as a single agent, is indicated for the treatment of patients
with metastatic NSCLC whose tumors express PD-L1 (TPS ≥1%) 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.
In NSCLC, the recommended dose of KEYTRUDA is 200 mg administered as an
intravenous infusion over 30 minutes every three weeks until disease
progression, unacceptable toxicity, or up to 24 months in patients
without disease progression.
When administering KEYTRUDA in combination with chemotherapy, KEYTRUDA
should be administered prior to chemotherapy when given on the same day.
See also the Prescribing Information for the chemotherapy agents
administered in combination with KEYTRUDA, as appropriate.
Head and Neck Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or
metastatic head and neck squamous cell carcinoma (HNSCC) with disease
progression on or after platinum-containing chemotherapy. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. In HNSCC, KEYTRUDA 200 mg
is administered as an intravenous infusion over 30 minutes every three
weeks until disease progression, unacceptable toxicity, or up to 24
months in patients without disease progression.
Classical Hodgkin Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients
with refractory classical Hodgkin lymphoma (cHL), or who have relapsed
after 3 or more prior lines of therapy. This indication is approved
under accelerated approval based on tumor response rate and durability
of response. Continued approval for this indication may be contingent
upon verification and description of clinical benefit in the
confirmatory trials. In adults with cHL, KEYTRUDA 200 mg is administered
as an intravenous infusion over 30 minutes every three weeks until
disease progression or unacceptable toxicity, or up to 24 months in
patients without disease progression. In pediatric patients with cHL,
KEYTRUDA is administered as an intravenous infusion over 30 minutes at a
dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until
disease progression or unacceptable toxicity, or up to 24 months in
patients without disease progression.
Primary Mediastinal Large B-Cell Lymphoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients
with refractory primary mediastinal large B-cell lymphoma (PMBCL), or
who have relapsed after 2 or more prior lines of therapy. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in confirmatory trials. KEYTRUDA is not recommended for
the treatment of patients with PMBCL who require urgent cytoreductive
therapy. In adults with PMBCL, KEYTRUDA 200 mg is administered as an
intravenous infusion over 30 minutes every three weeks until disease
progression, unacceptable toxicity, or up to 24 months in patients
without disease progression. In pediatric patients with PMBCL, KEYTRUDA
is administered as an intravenous infusion over 30 minutes at a dose of
2 mg/kg (up to a maximum of 200 mg) every three weeks until disease
progression or unacceptable toxicity, or up to 24 months in patients
without disease progression.
Urothelial Carcinoma
KEYTRUDA is indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma (mUC) who are not eligible
for cisplatin-containing chemotherapy and whose tumors express PD-L1
[combined positive score (CPS) ≥10] as determined by an FDA-approved
test, or in patients who are not eligible for any platinum-containing
chemotherapy regardless of PD-L1 status. This indication is approved
under accelerated approval based on tumor response rate and duration of
response. Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory
trials.
KEYTRUDA is indicated for the treatment of patients with locally
advanced or metastatic urothelial carcinoma (mUC) who have disease
progression during or following platinum-containing chemotherapy or
within 12 months of neoadjuvant or adjuvant treatment with
platinum-containing chemotherapy.
In locally advanced or metastatic urothelial carcinoma, KEYTRUDA 200 mg
is administered as an intravenous infusion over 30 minutes every three
weeks until disease progression or unacceptable toxicity, or up to 24
months in patients without disease progression.
Microsatellite Instability-High (MSI-H) Cancer
KEYTRUDA is indicated for the treatment of adult and pediatric patients
with unresectable or metastatic microsatellite instability-high (MSI-H)
or mismatch repair deficient (dMMR)
-
solid tumors that have progressed following prior treatment and who
have no satisfactory alternative treatment options, or -
colorectal cancer that has progressed following treatment with
fluoropyrimidine, oxaliplatin, and irinotecan.
This indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. The safety and
effectiveness of KEYTRUDA in pediatric patients with MSI-H central
nervous system cancers have not been established.
In adult patients with MSI-H cancer, KEYTRUDA 200 mg is administered as
an intravenous infusion over 30 minutes every three weeks until disease
progression, unacceptable toxicity, or up to 24 months in patients
without disease progression. In pediatric patients with MSI-H cancer,
KEYTRUDA is administered as an intravenous infusion over 30 minutes at a
dose of 2 mg/kg (up to a maximum of 200 mg) every three weeks until
disease progression or unacceptable toxicity, or up to 24 months in
patients without disease progression.
Gastric Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent
locally advanced or metastatic gastric or gastroesophageal junction
(GEJ) adenocarcinoma whose tumors express PD-L1 (CPS ≥1) as determined
by an FDA-approved test, with disease progression on or after two or
more prior lines of therapy including fluoropyrimidine- and
platinum-containing chemotherapy and if appropriate, HER2/neu-targeted
therapy. This indication is approved under accelerated approval based on
tumor response rate and durability of response. Continued approval for
this indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. The recommended dose of
KEYTRUDA is 200 mg as an intravenous infusion over 30 minutes every
three weeks until disease progression, unacceptable toxicity, or up to
24 months in patients without disease progression.
Cervical Cancer
KEYTRUDA is indicated for the treatment of patients with recurrent or
metastatic cervical cancer with disease progression on or after
chemotherapy whose tumors express PD-L1 (CPS ≥1) as determined by an
FDA-approved test. This indication is approved under accelerated
approval based on tumor response rate and durability of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in the confirmatory
trials. The recommended dose of KEYTRUDA is 200 mg as an intravenous
infusion over 30 minutes every three weeks until disease progression,
unacceptable toxicity or up to 24 months in patients without disease
progression.
Hepatocellular Carcinoma
KEYTRUDA is indicated for the treatment of patients with hepatocellular
carcinoma (HCC) who have been previously treated with sorafenib. This
indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. The recommended dose of
KEYTRUDA is 200 mg as an intravenous infusion over 30 minutes every
three weeks until disease progression, unacceptable toxicity, or up to
24 months in patients without disease progression.
Merkel Cell Carcinoma
KEYTRUDA is indicated for the treatment of adult and pediatric patients
with recurrent locally advanced or metastatic Merkel cell carcinoma.
This indication is approved under accelerated approval based on tumor
response rate and durability of response. Continued approval for this
indication may be contingent upon verification and description of
clinical benefit in the confirmatory trials. The recommended dose of
KEYTRUDA in adults is 200 mg administered as an intravenous infusion
over 30 minutes every three weeks until disease progression,
unacceptable toxicity, or up to 24 months in patients without disease
progression. The recommended dose of KEYTRUDA in pediatric patients is 2
mg/kg (up to a maximum of 200 mg), administered as an intravenous
infusion over 30 minutes every three weeks until disease progression or
unacceptable toxicity, or up to 24 months in patients without disease
progression.
Renal Cell Carcinoma
KEYTRUDA, in combination with axitinib, is indicated for the first-line
treatment of patients with advanced renal cell carcinoma. In renal cell
carcinoma, KEYTRUDA 200 mg is administered as an intravenous infusion
over 30 minutes every 3 weeks in combination with 5 mg axitinib orally
twice daily until disease progression, unacceptable toxicity, or for
KEYTRUDA, up to 24 months in patients without disease progression. When
axitinib is used in combination with KEYTRUDA, dose escalation of
axitinib above the initial 5 mg dose may be considered at intervals of
six weeks or longer. See also the Prescribing Information for
recommended axitinib dosing information.
Selected Important Safety Information for KEYTRUDA (pembrolizumab)
Injection, 100mg
Immune-Mediated Pneumonitis
KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases.
Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers
receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4
(0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC
patients receiving KEYTRUDA as a single agent, including Grades 3-4 in
3.2% of patients, and occurred more frequently in patients with a
history of prior thoracic radiation (17%) compared to those without
(7.7%).
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.
Immune-Mediated Colitis
KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7%
(48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3
(1.1%), and 4 (<0.1%). 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.
Immune-Mediated Hepatitis, or Hepatoxicity (in Combination With
Axitinib)
Immune-Mediated Hepatitis
KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7%
(19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3
(0.4%), and 4 (<0.1%). Monitor patients for changes in liver function.
Contacts
Media Contacts:
Pamela Eisele
(267) 305-3558
Kristen
Drake
(908) 740-1679
Investor Contacts:
Teri Loxam
(908)
740-1986
Michael DeCarbo
(908) 740-1807