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Sunday, December 6, 2015
Takeda Presents Data from Phase 3 TOURMALINE-MM1 Study for NINLARO® (ixazomib), First and Only Once-Weekly Oral Proteasome Inhibitor Recently Approved for Multiple Myeloma
ORLANDO, Fla.--(BUSINESS WIRE)--Takeda Pharmaceutical Company Limited (TSE:4502)
today announced results from the TOURMALINE-MM1 trial presented at the 57th
Annual Meeting and Exposition of the American Society of Hematology
(ASH), showing that treatment with NINLARO® (ixazomib)
capsules is effective in extending progression free survival (PFS) with
a manageable tolerability profile in patients with relapsed and/or
refractory multiple myeloma. Buy Kamagra Soft (Sildenafil Citrate) without Rx The TOURMALINE-MM1 trial is an
international, randomized, double-blind, placebo-controlled Phase 3
clinical trial designed to evaluate once-weekly oral ixazomib plus
lenalidomide and dexamethasone compared to placebo plus lenalidomide and
dexamethasone.
NINLARO was recently approved by the U.S. Buy Namenda (Memantine) with no prescription Food and Drug Administration
(FDA) in combination with lenalidomide and dexamethasone for the
treatment of patients with multiple myeloma who have received at least
one prior therapy. Buy Lanoxin (Digoxin) without prescription The approval was based on the Phase 3 TOURMALINE-MM1
data, which were highlighted at today’s ASH press briefing. Buy Inspra with free Rx Ixazomib
data will be featured in 18 presentations at this year’s ASH meeting,
including an oral presentation on Phase 2 data from an investigational
study evaluating the all-oral combination of ixazomib plus
cyclophosphamide and low-dose dexamethasone (ICd) in newly diagnosed
multiple myeloma patients.
“The data presented at ASH this year are the first major output from the
comprehensive ixazomib clinical trial program, TOURMALINE, demonstrating
Takeda’s ongoing commitment to providing effective and convenient
treatment options for patients with multiple myeloma,” said Andy Plump,
M.D., Ph.D, Takeda Chief Medical and Scientific Officer. Buy Casodex (Bicalutamide) with free Rx “The breadth
and depth of the TOURMALINE program allows us to gather important data
across a broad range of patients that live with multiple myeloma and to
expand on the efficacy and safety profile of our oral proteasome
inhibitor, ixazomib. Buy HMB online We will continue this and other important clinical
trials and look forward to sharing results over the next few years.”
The comprehensive ixazomib clinical development program, TOURMALINE,
includes a total of five pivotal trials – four investigating every major
multiple myeloma patient population and one in light-chain amyloidosis.
Ixazomib, an Investigational Oral Proteasome Inhibitor (PI), in
Combination with Lenalidomide and Dexamethasone (IRd), Significantly
Extends Progression-Free Survival (PFS) for Patients (Pts) with Relapsed
and/or Refractory Multiple Myeloma (RRMM): The Phase 3 Tourmaline-MM1
Study (Abstract #727)
TOURMALINE-MM1 (n= 722) is the first double-blind, placebo-controlled
trial with a proteasome inhibitor and has met the primary endpoint at
the first interim analysis. http://medical-questions-answers.blogspot.com Trial results demonstrate a statistically
significant (35%) improvement in PFS, with patients treated in the
ixazomib arm living for a significantly longer time without their
disease worsening compared to patients in the control arm (20.6 months
vs. 14.7 months in control group; Hazard Ratio [HR] 0.742; p = 0.012).
Overall response rate (ORR) was 78.3% in the ixazomib arm and median
duration of response was 20.5 months, vs. 71.5% and 15 months in the
control group. Median PFS in high-risk patients (HR 0.543; HR 0.596 in
patients with del(17p)) was similar to that in the overall patient
population and in standard-risk patients. Adverse events observed with
IRd were consistent with reported safety profiles for the individual
agents. The most common gr >=3 adverse events included neutropenia,
anemia, thrombocytopenia, and pneumonia. Gastrointestinal events
included diarrhea, nausea, and vomiting. Peripheral neuropathy (PN)
rates were 28% in the IRd arm vs. 21% in the control arm, 35% vs. 21%
had rash events, 8% vs. 10% had acute renal failure, and 4% vs. 3% had
heart failure.
“The TOURMALINE-MM1 trial evaluated ixazomib plus lenalidomide and
dexamethasone in some of the most common patient types in the
relapsed/refractory multiple myeloma setting who are in urgent need of
new treatment options due to the complex nature of this disease. This
trial enabled us to gather efficacy and safety data across a large
variety of patients such as older patients, patients with moderate renal
impairment, light chain disease, and high risk cytogenetics,” said lead
investigator and presenter Philippe Moreau, M.D., University of Nantes,
France.”
The TOURMALINE-MM1 trial is currently ongoing. Patients continue to be
treated to progression in this trial and will be evaluated for long-term
outcomes.
Takeda has submitted additional review applications for ixazomib to
regulatory authorities around the world, including the European
Medicines Agency (EMA), based on the TOURMALINE-MM1 data.
Randomized Phase 2 Study of the All-Oral Combination of
Investigational Proteasome Inhibitor (PI) Ixazomib Plus Cyclophosphamide
and Low-Dose Dexamethasone (ICd) in Patients (Pts) with Newly Diagnosed
Multiple Myeloma (NDMM) Who Are Transplant-Ineligible (Abstract #26)
Takeda also presented preliminary data from an open-label, multicenter,
Phase 2 study that investigates the all-oral triplet combination of
ixazomib plus cyclophosphamide and low-dose dexamethasone (ICd) as a
first line therapy for patients not eligible for transplant. Preliminary
data demonstrated comparable activity across treatment arms with a
manageable toxicity profile in line with previous ixazomib studies and
with manageable myelosuppression. This is the first study to assess ICd
for the frontline treatment of multiple myeloma.
The Phase 2 study (n = 70) randomized patients receiving ixazomib,
low-dose dexamethasone and two different doses of cyclophosphamide 300
mg/m2 (ICd-300, n = 36) or 400 mg/m2 (ICd-400, n = 34), with a mean
duration follow-up of 7.0 months in both arms. Preliminary results
across treatment arms demonstrated best unconfirmed complete response
plus very good partial response (CR+VGPR) of 27% (ICd-300) and 23%
(ICd-400), as well as early overall response rates (ORR) of 80%
(ICd-300) and 73% (ICd-400). Toxicity was manageable in both the ICd-300
and ICd-400 arms, but toxicity rates appeared higher with ICd-400.
Thrombocytopenia events occurred in 5 patients (no gr >=3) in the ICd-300
arm and 4 patients (3 gr >=3) in the ICd-400 arm. Most common adverse
events (>15% all patients) included anemia, neutropenia, nausea, PN,
diarrhea, vomiting, constipation, and fatigue. Most common gr >=3 adverse
events were neutropenia, anemia and pneumonia; no Grade 3 PN was
observed.
“Research has shown that the combination of a proteasome inhibitor with
cyclophosphamide and dexamethasone is active in patients with multiple
myeloma. As treatment practices for multiple myeloma can vary across
regions, it is important that we gain an understanding of the utility of
ixazomib in a number of combination settings,” said lead investigator
and presenter Meletios A. Dimopoulos, M.D., National and Kapodistrian
University of Athens, School of Medicine. “Preliminary data suggest that
this may be a viable all-oral triplet regimen. We are committed to
gathering additional data of ixazomib in this investigational setting.”
About NINLARO (ixazomib) capsules
NINLARO (ixazomib) is the first and only oral proteasome inhibitor
approved by the U.S. Food and Drug Administration (FDA) in combination
with lenalidomide and dexamethasone for the treatment of patients with
multiple myeloma who have received at least one prior therapy. NINLARO
is administered orally, once-weekly on days 1, 8, and 15 of a 28-day
treatment cycle. NINLARO is currently under review by the European
Medicines Agency (EMA) and was granted an accelerated assessment by the
Committee for Medicinal Products for Human Use (CHMP). NINLARO also
received Breakthrough Therapy status by the U.S. FDA for relapsed or
refractory systemic light-chain (AL) amyloidosis, a related ultra orphan
disease, in 2014.
The TOURMALINE clinical development program further reinforces Takeda’s
ongoing commitment to developing innovative therapies for people living
with multiple myeloma worldwide and the healthcare professionals who
treat them. Five global Phase 3 trials are ongoing:
TOURMALINE-MM1, investigating ixazomib vs. placebo, in combination
with lenalidomide and dexamethasone in relapsed and/or refractory
multiple myeloma
TOURMALINE-MM2, investigating ixazomib vs. placebo, in combination
with lenalidomide and dexamethasone in patients with newly diagnosed
multiple myeloma
TOURMALINE-MM3, investigating ixazomib vs. placebo as maintenance
therapy in patients with newly diagnosed multiple myeloma following
induction therapy and autologous stem cell transplant (ASCT)
TOURMALINE-MM4, investigating ixazomib vs. placebo as maintenance
therapy in patients with newly diagnosed multiple myeloma who have not
undergone ASCT
TOURMALINE-AL1, investigating ixazomib plus dexamethasone vs.
physician choice of selected regimens in patients with relapsed or
refractory AL amyloidosis
In addition to the TOURMALINE program, a large number of investigator
initiated studies are evaluating ixazomib for patients globally.
For additional information on the ongoing Phase 3 studies please visit .clinicaltrials.gov.
To learn more about NINLARO, please visit .NINLARO.com
or call 1-844-N1POINT (1-844-617-6468).
Important Safety Information
WARNINGS AND PRECAUTIONS
Thrombocytopenia has been reported with NINLARO. During
treatment, monitor platelet counts at least monthly, and consider more
frequent monitoring during the first three cycles. Adjust dosing as
needed. Platelet nadirs occurred between Days 14-21 of each 28-day
cycle and recovered to baseline by the start of the next cycle.
Gastrointestinal Toxicities, including diarrhea,
constipation, nausea and vomiting, were reported with NINLARO and may
occasionally require the use of antidiarrheal and antiemetic
medications, and supportive care. Adjust dosing for severe symptoms.
Peripheral Neuropathy (predominantly sensory) was reported with
NINLARO. Monitor patients for symptoms of peripheral neuropathy and
adjust dosing as needed.
Peripheral Edema was reported with NINLARO. Monitor for fluid
retention. Investigate for underlying causes when appropriate and
provide supportive care as necessary. Adjust dosing as needed.
Cutaneous Reactions: Rash, most commonly maculo-papular and
macular rash, was reported with NINLARO. Manage rash with supportive
care or with dose modification.
Hepatotoxicity has been reported with NINLARO. Monitor hepatic
enzymes regularly during treatment and adjust dosing as needed
Embryo-fetal Toxicity: NINLARO can cause fetal harm. Women
should be advised of the potential risk to a fetus, to avoid becoming
pregnant, and to use contraception during treatment and for an
additional 90 days after the final dose of NINLARO.
ADVERSE REACTIONS
The most common adverse reactions occurring in greater than or equal to
20% of patients treated with NINLARO were diarrhea, constipation,
thrombocytopenia, peripheral neuropathy, nausea, peripheral edema,
vomiting and back pain.
SPECIAL POPULATIONS
Hepatic Impairment: Reduce the NINLARO starting dose to 3mg in
patients with moderate or severe hepatic impairment
Renal Impairment: Reduce the NINLARO starting dose to 3
mg in patients with severe renal impairment or end-stage renal disease
requiring dialysis. NINLARO is not dialyzable.
Lactation: Advise women to discontinue nursing while on NINLARO.
DRUG INTERACTIONS: Avoid concomitant administration of NINLARO
with strong CYP3A inducers.
INDICATION
NINLARO (ixazomib) is indicated in combination with lenalidomide and
dexamethasone for the treatment of patients with multiple myeloma who
have received at least one prior therapy.
Please see the accompanying full Prescribing
Information for NINLARO.
About Multiple Myeloma
Multiple myeloma is a cancer of the plasma cells, which are found in the
bone marrow. In multiple myeloma, a group of plasma cells, or myeloma
cells, becomes cancerous and multiplies, increasing the number of plasma
cells to a higher than normal level. Because plasma cells circulate
widely in the body, they have the potential to affect many bones in the
body, possibly resulting in compression fractures, lytic bone lesions
and related pain. Multiple myeloma can cause a number of serious health
problems affecting the bones, immune system, kidneys and red blood cell
count, with some of the more common symptoms including bone pain and
fatigue, a symptom of anemia. Multiple myeloma is a rare form of cancer,
with more than 26,000 new cases in the U.S. and 114,000 new cases
globally per year.
About Takeda
Located in Osaka, Japan, Takeda (TSE:4502)
is a research-based global company with its main focus on
pharmaceuticals. As the largest pharmaceutical company in Japan and one
of the global leaders of the industry, Takeda is committed to strive
towards better health for people worldwide through leading innovation in
medicine.
Additional information about Takeda is available through its corporate
website, .takeda.com.
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