Study met its primary endpoint demonstrating significant improvement
in progression-free survival (PFS) with POMALYST®/IMNOVID®
in combination with bortezomib and dexamethasone (PVd) compared with
bortezomib and low-dose dexamethasone
SUMMIT, N.J.--(BUSINESS WIRE)--
Celgene Corporation (NASDAQ:CELG) today announced that the Phase III,
randomized, open-label, international clinical study, OPTIMISMM,
achieved its primary endpoint, showing a statistically significant and
clinically meaningful improvement in progression-free survival (PFS) for
the pomalidomide arm versus the comparator arm.
OPTIMISMM evaluated the efficacy and safety of POMALYST/IMNOVID
(pomalidomide) plus bortezomib and low-dose dexamethasone (PVd) versus
bortezomib and low-dose dexamethasone in patients with
relapsed/refractory multiple myeloma. It is the only phase III trial to
investigate a triplet combination in patients who have all received
prior lenalidomide (REVLIMID®), a population for which there
is a growing unmet medical need.
"The OPTIMISMM results confirm the expanding role of pomalidomide in
previously treated multiple myeloma patients," said Paul Richardson,
M.D., Clinical Program Leader and Director of Clinical Research, Jerome
Lipper Multiple Myeloma Center at the Dana Farber Cancer Institute, RJ
Corman Professor of Medicine, Harvard Medical School and principal
investigator of the study. "We see the PVd combination as an important
step in improving care, and especially for patients previously treated
with lenalidomide in this setting."
In the study, the safety profile was consistent with previously reported
data. Detailed data from OPTIMISMM will be presented at future medical
The combination of POMALYST/IMNOVID, bortezomib and low-dose
dexamethasone is not currently approved for use.
POMALYST® (pomalidomide) is a thalidomide analogue indicated,
in combination with dexamethasone, for patients with multiple myeloma
who have received at least two prior therapies including lenalidomide
and a proteasome inhibitor and have demonstrated disease progression on
or within 60 days of completion of the last therapy.
Important Safety Information
WARNING: EMBRYO-FETAL TOXICITY and VENOUS AND ARTERIAL
POMALYST is contraindicated in pregnancy. POMALYST is a
thalidomide analogue. Thalidomide is a known human teratogen
that causes severe birth defects or embryo-fetal death. In
females of reproductive potential, obtain 2 negative pregnancy
tests before starting POMALYST treatment.
Females of reproductive potential must use 2 forms of
contraception or continuously abstain from heterosexual sex
during and for 4 weeks after stopping POMALYST treatment.
POMALYST is only available through a restricted distribution
program called POMALYST REMS®.
and Arterial Thromboembolism
Deep venous thrombosis (DVT), pulmonary embolism (PE),
myocardial infarction, and stroke occur in patients with
multiple myeloma treated with POMALYST. Prophylactic
antithrombotic measures were employed in clinical trials.
Thromboprophylaxis is recommended, and the choice of regimen
should be based on assessment of the patient's underlying risk
Pregnancy: POMALYST can
cause fetal harm and is contraindicated in females who are pregnant.
If POMALYST is used during pregnancy or if the patient becomes
pregnant while taking this drug, the patient should be apprised of the
potential risk to a fetus.
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity & Females of
Reproductive Potential: See Boxed WARNINGS
Males: Pomalidomide is present in the
semen of patients receiving the drug. Males must always use a
latex or synthetic condom during any sexual contact with females
of reproductive potential while taking POMALYST and for up to 4
weeks after discontinuing POMALYST, even if they have undergone a
successful vasectomy. Males must not donate sperm.
Blood Donation: Patients must not
donate blood during treatment with POMALYST and for 1 month
following discontinuation of POMALYST therapy because the blood
might be given to a pregnant female patient whose fetus must not
be exposed to POMALYST.
Program: See Boxed WARNINGS
Prescribers and pharmacies must be certified with the POMALYST
REMS program by enrolling and complying with the REMS
requirements; pharmacies must only dispense to patients who are
authorized to receive POMALYST. Patients must sign a
Patient-Physician Agreement Form and comply with REMS
requirements; female patients of reproductive potential who are
not pregnant must comply with the pregnancy testing and
contraception requirements and males must comply with
Further information about the POMALYST REMS program is
available at www.CelgeneRiskManagement.com
or by telephone at 1-888-423-5436.
Venous and Arterial Thromboembolism: See
Boxed WARNINGS. Patients with known risk factors, including
prior thrombosis, may be at greater risk, and actions should be taken
to try to minimize all modifiable factors (e.g., hyperlipidemia,
hypertension, smoking). Thromboprophylaxis is recommended, and the
choice of regimen should be based on assessment of the patient's
underlying risk factors.
Increased Mortality with Pembrolizumab:
In clinical trials in patients with multiple myeloma, the addition of
pembrolizumab to a thalidomide analogue plus dexamethasone resulted in
increased mortality. Treatment of patients with multiple myeloma with
a PD-1 or PD-L1 blocking antibody in combination with a thalidomide
analogue plus dexamethasone is not recommended outside of controlled
Neutropenia (46%) was the most frequently reported Grade 3/4 adverse
reaction in patients taking POMALYST in clinical trials, followed by
anemia and thrombocytopenia. Monitor complete blood counts weekly for
the first 8 weeks and monthly thereafter. Patients may require dose
interruption and/or modification.
failure, including fatal cases, has occurred in patients treated with
POMALYST. Elevated levels of alanine aminotransferase and bilirubin
have also been observed in patients treated with POMALYST. Monitor
liver function tests monthly. Stop POMALYST upon elevation of liver
enzymes. After return to baseline values, treatment at a lower dose
may be considered.
Hypersensitivity Reactions: Angioedema
and severe dermatologic reactions have been reported. Discontinue
POMALYST for angioedema, skin exfoliation, bullae, or any other severe
dermatologic reactions, and do not resume therapy.
Dizziness and Confusional State:
In patients taking POMALYST in clinical trials, 14% experienced
dizziness (1% Grade 3 or 4) and 7% a confusional state (3% Grade 3 or
4). Instruct patients to avoid situations where dizziness or
confusional state may be a problem and not to take other medications
that may cause dizziness or confusional state without adequate medical
Neuropathy: In patients
taking POMALYST in clinical trials, 18% experienced neuropathy (2%
Grade 3 in one trial) and 12% peripheral neuropathy.
Second Primary Malignancies: Cases
of acute myelogenous leukemia have been reported in patients receiving
POMALYST as an investigational therapy outside of multiple myeloma.
Tumor Lysis Syndrome (TLS): TLS
may occur in patients treated with POMALYST. Patients at risk are
those with high tumor burden prior to treatment. These patients should
be monitored closely and appropriate precautions taken.
Nearly all patients treated with POMALYST + low-dose dex experienced at
least one adverse reaction (99%). The most common adverse reactions
(≥15%) included neutropenia (51.3%), fatigue and asthenia (46.7%), upper
respiratory tract infection (31%), thrombocytopenia (29.7%), pyrexia
(26.7%), dyspnea (25.3%), diarrhea (22%), constipation (21.7%), back
pain (19.7%), cough (20%), pneumonia (19.3%), bone pain (18%), edema
peripheral (17.3%), peripheral neuropathy (17.3%), muscle spasms
(15.3%), and nausea (15%). Grade 3 or 4 adverse reactions (≥15%)
included neutropenia (48.3%), thrombocytopenia (22%), and pneumonia
Avoid concomitant use of POMALYST with strong inhibitors of CYP1A2.
Consider alternative treatments. If a strong CYP1A2 inhibitor must be
used, reduce POMALYST dose by 50%.
USE IN SPECIFIC POPULATIONS
Pregnancy: See Boxed WARNINGS. If
pregnancy does occur during treatment, immediately discontinue the
drug and refer patient to an obstetrician/gynecologist experienced in
reproductive toxicity for further evaluation and counseling. There is
a POMALYST pregnancy exposure registry that monitors pregnancy
outcomes in females exposed to POMALYST during pregnancy as well as
female partners of male patients who are exposed to POMALYST. This
registry is also used to understand the root cause for the pregnancy.
Report any suspected fetal exposure to POMALYST to the FDA via the
MedWatch program at 1-800-FDA-1088 and also to Celgene Corporation at
Lactation: There is no
information regarding the presence of pomalidomide in human milk, the
effects of POMALYST on the breastfed infant, or the effects of
POMALYST on milk production. Pomalidomide was excreted in the milk of
lactating rats. Because many drugs are excreted in human milk and
because of the potential for adverse reactions in breastfed infants
from POMALYST, advise a nursing woman to discontinue breastfeeding
during treatment with POMALYST.
Pediatric Use: Safety and
effectiveness have not been established in pediatric patients.
Geriatric Use: No dosage
adjustment is required for POMALYST based on age. Patients > 65 years
of age were more likely than patients ≤65 years of age to experience
Renal Impairment: Reduce
POMALYST dose by 25% in patients with severe renal impairment
requiring dialysis. Take dose of POMALYST following hemodialysis on
Hepatic Impairment: Reduce
POMALYST dose by 25% in patients with mild to moderate hepatic
impairment and 50% in patients with severe hepatic impairment.
Smoking Tobacco: Advise
patients that smoking may reduce the efficacy of POMALYST. Cigarette
smoking reduces the AUC of pomalidomide by 32% by CYP1A2 induction.
Please see full Prescribing
Information, including Boxed WARNINGS.
Celgene Corporation, headquartered in Summit, New Jersey, is an
integrated global biopharmaceutical company engaged primarily in the
discovery, development and commercialization of innovative therapies for
the treatment of cancer and inflammatory diseases through
next-generation solutions in protein homeostasis, immuno-oncology,
epigenetics, immunology and neuro-inflammation. For more information,
please visit www.celgene.com.
Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
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results or outcomes may differ materially from those implied by the
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