– Oral Presentations of the Phase 2 OPTIC Interim Analysis at the
American Society of Clinical Oncology (ASCO) and the European Hematology
Association (EHA) Annual Meetings –
– Findings Support
Response-Based Dosing Regimens of ICLUSIG Can Optimize Benefit-Risk
Profile in Patients with Resistant / Intolerant Chronic-Phase CML –
–
Adjudicated Data from Independent Review of Phase 2 PACE Trial in CML
and Ph+ ALL Also Featured as Poster Presentations at ASCO and EHA –
CAMBRIDGE, Mass. & OSAKA, Japan-Thursday 4 June 2020 [ AETOS Wire ]
(BUSINESS
WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)
today announced that interim analysis data from the Phase 2 OPTIC
(Optimizing Ponatinib Treatment In CML) trial will be presented during
an oral session at the virtual 56th American Society of Clinical
Oncology (ASCO) Annual Meeting and the 25th European Hematology
Association (EHA) Annual Meeting. The OPTIC trial is an ongoing,
randomized, open-label study prospectively evaluating response-based
dosing regimens of ICLUSIG® (ponatinib) over a range of three starting
doses (45-, 30-, or 15-mg) with the aim of optimizing its efficacy and
safety in patients with chronic-phase chronic myeloid leukemia (CP-CML)
who are resistant or intolerant to prior tyrosine kinase inhibitor (TKI)
therapy.
With a median follow-up of approximately 21 months,
data from the interim analysis of OPTIC show that the optimal
benefit-risk profile for ICLUSIG in patients with CP-CML is achieved
with a daily starting dose of 45-mg and, upon achieving ≤1% BCR-ABL1,
dose reduction to 15-mg. This dosing regimen resulted in an adjudicated
arterial occlusive event (AOE) rate of 5.3%.
“These data help
revise our understanding of how to treat with ICLUSIG to optimize the
benefit-risk in chronic-phase CML patients who are resistant or
intolerant to prior TKIs – which was demonstrated in the 45-mg followed
by dose reduction to 15-mg regimen – while maintaining a manageable
safety profile,” said Jorge Cortes, MD, Georgia Cancer Center at Augusta
University, and an OPTIC trial principal investigator. “It is also
important to note that clinical benefit was observed in all three
starting doses in this population of patients who were resistant to
multiple prior TKIs, and the majority had not demonstrated responses
better than a complete hematological response to the immediate prior
TKI.”
Takeda will be discussing these data with the U.S. Food and
Drug Administration (FDA). The complete primary analysis of the OPTIC
trial will be conducted and presented at a later date.
“ICLUSIG
has been an effective treatment option for appropriate CML patients
since its FDA approval in 2012,” said Christopher Arendt, Head, Oncology
Therapeutic Area Unit, Takeda. “These data provide additional context
around the safety profile of ICLUSIG, a third-generation targeted
inhibitor of BCR-ABL1, and may provide further guidance on how to reduce
the risk of arterial occlusive events, a concern that we believe has
limited patient access to ICLUSIG in the past. We are excited about the
OPTIC findings, and we intend to submit these data to the U.S. FDA as
quickly as possible as part of a supplemental New Drug Application.”
Interim Analysis (IA) of OPTIC: A Dose Ranging Study of Three Starting Doses of Ponatinib (PON).
Key findings, to be presented by Dr. Jorge Cortes, include:
By the interim analysis (IA; cutoff date of July 2019) with median
follow-up time of approximately 21 months, 77% (n/N=216/282) of patients
in the OPTIC trial were evaluable for the primary endpoint.
The OPTIC IA shows benefit of ponatinib in all three starting doses in a
largely resistant population where the majority of patients (>60%)
demonstrated a complete hematological response (CHR) or lower response
to immediate prior therapy.
The maximum rates of ≤1%
BCR-ABL1IS at 12 months were achieved in the 45-mg/day starting dose
cohort (38.7%), and responses were maintained with the dose reduction to
15-mg/day.
With the protocol-mandated dose reduction for
response in the higher dose cohorts, 75% of patients in the 45-mg cohort
and 88% of patients in the 30-mg cohort were able to maintain ≤1%
BCR-ABL1IS response for up to two years.
Safety data include:
As of the OPTIC IA cutoff date (July 2019), among all patients (N=282),
the most common treatment emergent adverse events (TEAEs) of any grade
(occurring in ≥10% of all patients) were thrombocytopenia (39.4%),
neutropenia (25.2%), hypertension (24.1%), anemia (17.4%), headache
(17.0%), increased lipase (16.0%), arthralgia (14.2%), constipation
(12.4%), platelet count decrease (10.6%) and ALT increase (10.3%).
There was a dose-dependent trend in AOE rates:
Pre-adjudicated AOEs were reported in (45-, 30-, 15-mg/day starting
dose cohorts) 8.5% (n/N = 8/94), 4.3% (n/N = 4/94), and 2.1% (n/N =
2/94).
Prospective adjudication of AOEs by
independent experts resulted in (45-, 30-, 15-mg/day starting dose
cohorts) 5.3% (n/N = 5/94), 4.3% (n/N = 4/94), and 1.1% (n/N = 1/94).
At the IA, there were no AOE-related deaths reported.
OPTIC Trial Design
The Phase 2 OPTIC trial is designed to prospectively evaluate
response-based dosing regimens of ICLUSIG over a range of three starting
doses, in patients with CP-CML resistant or intolerant to prior TKI
therapy.
The primary endpoint is achieving ≤1% BCR-ABL1 at 12 months.
The trial enrolled 283 participants around the world, each assigned a
daily starting dose of 45-mg, 30-mg or 15-mg at random. Dose reduction
at response occurred per study protocol.
In addition to the OPTIC
data, a poster featuring data from an independent retrospective review
of AOEs in the Phase 2 PACE (Ponatinib Ph+ ALL and CML Evaluation) trial
will be shared during ASCO and EHA.
About the OPTIC Trial
OPTIC
(Optimizing Ponatinib Treatment In CML) is a randomized, dose-ranging
trial designed to evaluate three starting doses of ICLUSIG (15 mg, 30
mg, 45 mg) in patients with resistant chronic-phase chronic myeloid
leukemia (CP-CML) or who had documented history of presence of T315I
mutation after receiving any number of prior TKIs. Dose reduction at
response occurred per study protocol. The trial is expected to inform
the optimal use of ICLUSIG® (ponatinib) in these patients. Approximately
283 patients were enrolled at clinical sites around the world. The
primary endpoint of the trial is achieving ≤1% BCR-ABL1 at 12 months.
About the PACE Trial
The
PACE (Ponatinib Ph+ ALL and CML Evaluation) trial evaluated the
efficacy and safety of ICLUSIG in CML and Ph+ ALL patients resistant or
intolerant to dasatinib or nilotinib, or with the T315I mutation. A
total of 449 patients were treated with ponatinib at a starting dose of
45 mg/day. An estimated 93% of patients previously received two or more
approved TKIs and 56% of all patients had received three or more
approved TKIs. 55% of the overall chronic-phase CML patient population
in the PACE trial achieved major cytogenetic response (MCyR) by 12
months – the primary endpoint of the PACE trial for CP-CML patients –
and 70% of T315I+ CP-CML patients achieved MCyR. Enrollment in the PACE
trial was completed in October 2011.
About CML and Ph+ ALL
CML
– a rare malignancy – is one of four main types of leukemia; it is a
result of a genetic mutation that takes place in early, immature
versions of myeloid cells, which form red blood cells, platelets and
most types of white blood cells. Subsequently, an abnormal gene called
BCR-ABL1 forms, turning the damaged cell into a CML cell. CML typically
progresses slowly, but it can change into a fast-growing acute leukemia
that is hard to treat.
Ph+ ALL is a rare form of ALL that affects
approximately 25% of adult ALL patients in the U.S. and is
characterized by the presence of an abnormal gene, known as the
Philadelphia chromosome. In patients who are Philadelphia chromosome
positive (Ph+), an abnormal chromosome is formed when pieces of
chromosomes 9 and 22 switch with each other. This forms a longer
chromosome 9 and a shorter chromosome 22, which leads to the development
of BCR-ABL1 and is associated with Ph+ ALL.
About ICLUSIG® (ponatinib) tablets
ICLUSIG
is a kinase inhibitor targeting BCR-ABL1, an abnormal tyrosine kinase
that is expressed in chronic myeloid leukemia (CML) and Philadelphia
chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). ICLUSIG is a
targeted cancer medicine developed using a computational and
structure-based drug-design platform, specifically designed to inhibit
the activity of BCR-ABL1 and its mutations. ICLUSIG inhibits native
BCR-ABL1, as well as all BCR-ABL1 treatment-resistant mutations,
including the most resistant T315I mutation. ICLUSIG is the only
approved TKI that demonstrates activity against the T315I gatekeeper
mutation of BCR-ABL1. This mutation has been associated with resistance
to all other approved TKIs. ICLUSIG received full approval from the FDA
in November 2016. ICLUSIG is indicated for the treatment of adult
patients with CP, accelerated phase, or blast phase CML or Ph+ ALL for
whom no other TKI therapy is indicated, and treatment of adult patients
with T315I-positive CML (chronic phase, accelerated phase, or blast
phase) or T315I-positive Ph+ ALL. ICLUSIG is not indicated and is not
recommended for the treatment of patients with newly diagnosed chronic
phase CML.
IMPORTANT SAFETY INFORMATION (U.S.)
WARNING: ARTERIAL OCCLUSION, VENOUS THROMBOEMBOLISM, HEART FAILURE, and HEPATOTOXICITY
See full prescribing information for complete boxed warning.
Arterial occlusion has occurred in at least 35% of ICLUSIG®
(ponatinib)-treated patients including fatal myocardial infarction,
stroke, stenosis of large arterial vessels of the brain, severe
peripheral vascular disease, and the need for urgent revascularization
procedures. Patients with and without cardiovascular risk factors,
including patients less than 50 years old, experienced these events.
Interrupt or stop ICLUSIG immediately for arterial occlusion. A
benefit-risk consideration should guide a decision to restart ICLUSIG.
Venous Thromboembolism has occurred in 6% of ICLUSIG-treated patients.
Monitor for evidence of thromboembolism. Consider dose modification or
discontinuation of ICLUSIG in patients who develop serious venous
thromboembolism.
Heart Failure, including fatalities occurred
in 9% of ICLUSIG-treated patients. Monitor cardiac function. Interrupt
or stop ICLUSIG for new or worsening heart failure.
Hepatotoxicity, liver failure and death have occurred in ICLUSIG-treated
patients. Monitor hepatic function. Interrupt ICLUSIG if hepatotoxicity
is suspected.
WARNINGS AND PRECAUTIONS
Arterial Occlusions:
The 35% of patients reported to have arterial occlusive events (AOEs) in
the boxed warning included patients from both phase 1 and phase 2
trials. In the phase 2 trial, 33% of ICLUSIG-treated patients
experienced a cardiac vascular (21%), peripheral vascular (12%), or
cerebrovascular (9%) arterial occlusive event. Some patients experienced
more than 1 type of event. Fatal and life-threatening events have
occurred within 2 weeks of starting treatment, with doses as low as 15
mg per day. ICLUSIG can also cause recurrent or multisite vascular
occlusion. Patients have required revascularization procedures. The
median time to onset of the first AOE ranged from 193-526 days. The most
common risk factors observed with these events were hypertension,
hyperlipidemia, and history of cardiac disease. AOEs were more frequent
with increasing age and in patients with a history of ischemia,
hypertension, diabetes, or hyperlipidemia. In patients suspected of
developing AOEs, interrupt or stop ICLUSIG.
Venous
Thromboembolism: Venous thromboembolic events, including deep venous
thrombosis, pulmonary embolism, superficial thrombophlebitis, and
retinal vein thrombosis with vision loss, occurred in 6% of patients
with an incidence rate of 5% (CP-CML), 4% (AP-CML), 10% (BP-CML), and 9%
(Ph+ ALL). Consider dose modification or discontinuation of ICLUSIG in
patients who develop serious venous thromboembolism.
Heart
Failure: Fatal or serious heart failure or left ventricular dysfunction
occurred in 6% of patients in the phase 2 trial. The most common heart
failure events (each 3%) were congestive cardiac failure and decreased
ejection fraction. Monitor patients for signs or symptoms consistent
with heart failure and treat as clinically indicated, including
interruption of ICLUSIG. Consider discontinuation if serious heart
failure develops.
Hepatotoxicity: Hepatotoxic events were
observed in 29% of patients (11% were grade 3 or 4). Severe
hepatotoxicity occurred in all disease cohorts. Three patients with
BP-CML or Ph+ ALL died: one with fulminant hepatic failure within one
week of starting ICLUSIG and two with acute liver failure. The most
common forms were elevations of AST or ALT (54% all grades, 8% grade 3
or 4, 5% not reversed at last follow-up), bilirubin, and alkaline
phosphatase. The median time to onset of event was 3 months. Monitor
liver function tests at baseline, then at least monthly or as clinically
indicated. Interrupt, reduce or discontinue ICLUSIG as clinically
indicated.
Hypertension: Treatment-emergent elevation of systolic
or diastolic blood pressure (BP) occurred in 68% of patients, of which
12% were serious and included hypertensive crisis. Patients may require
urgent clinical intervention for hypertension associated with confusion,
headache, chest pain, or shortness of breath. In patients with baseline
BP <140/90 mm Hg, 80% developed treatment-emergent hypertension (44%
Stage 1 and 37% Stage 2). In 132 patients with Stage 1 hypertension at
baseline, 67% developed Stage 2. Monitor and manage BP elevations during
ICLUSIG use and treat hypertension to normalize BP. Interrupt, dose
reduce, or stop ICLUSIG if hypertension is not medically controlled. In
the event of significant worsening, labile or treatment-resistant
hypertension, interrupt treatment and consider evaluating for renal
artery stenosis.
Pancreatitis: Pancreatitis was reported in 7% of
patients (6% were serious or grade 3/4). Many of these cases resolved
within 2 weeks with dose interruption or reduction of ICLUSIG. The
incidence of treatment-emergent lipase elevation was 42% (16% grade 3 or
greater). Check serum lipase every 2 weeks for the first 2 months and
monthly thereafter or as clinically indicated. Consider additional serum
lipase monitoring in patients with a history of pancreatitis or alcohol
abuse. Dose interruption or reduction may be required. In cases where
lipase elevations are accompanied by abdominal symptoms, interrupt
treatment with ICLUSIG and evaluate patients for pancreatitis. Do not
consider restarting ICLUSIG until patients have complete resolution of
symptoms and lipase levels are <1.5 x ULN.
Increased Toxicity
in Newly Diagnosed CP-CML: In a prospective, randomized clinical trial
in the first-line treatment of newly diagnosed patients with CP-CML,
ICLUSIG 45 mg once daily increased the risk of serious adverse reactions
2-fold compared to imatinib 400 mg once daily. The median exposure to
treatment was less than 6 months. The trial was halted for safety in
October 2013. Arterial and venous thrombosis and occlusions occurred at
least twice as frequently in the ICLUSIG arm compared to the imatinib
arm. Compared to imatinib, ICLUSIG exhibited a greater incidence of
myelosuppression, pancreatitis, hepatotoxicity, cardiac failure,
hypertension, and skin and subcutaneous tissue disorders. ICLUSIG is not
indicated and is not recommended for the treatment of patients with
newly diagnosed CP-CML.
Neuropathy: Overall, 20% of patients
experienced a peripheral neuropathy event of any grade (2% were grade
3/4). The most common were paresthesia (5%), neuropathy peripheral (4%),
hypoesthesia (3%), dysgeusia (2%), muscular weakness (2%), and
hyperesthesia (1%). Cranial neuropathy developed in 2% of patients
(<1% grade 3/4). Of the patients who developed neuropathy, 26%
developed neuropathy during the first month of treatment. Monitor
patients for symptoms of neuropathy, such as hypoesthesia,
hyperesthesia, paresthesia, discomfort, a burning sensation, neuropathic
pain or weakness. Consider interrupting ICLUSIG and evaluate if
neuropathy is suspected.
Ocular Toxicity: Serious ocular
toxicities leading to blindness or blurred vision have occurred in
patients. Retinal toxicities including macular edema, retinal vein
occlusion, and retinal hemorrhage occurred in 2%. Conjunctival
irritation, corneal erosion or abrasion, dry eye, conjunctivitis,
conjunctival hemorrhage, hyperaemia and edema or eye pain occurred in
14%. Visual blurring occurred in 6%. Other ocular toxicities include
cataracts, periorbital edema, blepharitis, glaucoma, eyelid edema,
ocular hyperaemia, iritis, iridocyclitis, and ulcerative keratitis.
Conduct comprehensive eye exams at baseline and periodically during
treatment.
Hemorrhage: Hemorrhage occurred in 28% of patients (6%
serious, including fatalities). The incidence of serious bleeding
events was higher in patients with AP- or BP-CML, and Ph+ ALL.
Gastrointestinal hemorrhage and subdural hematoma were the most commonly
reported serious bleeding events occurring in 1% each. Most hemorrhagic
events occurred in patients with grade 4 thrombocytopenia. Interrupt
ICLUSIG for serious or severe hemorrhage and evaluate.
Fluid
Retention: Fluid retention occurred in 31% of patients. The most common
events were peripheral edema (17%), pleural effusion (8%), pericardial
effusion (4%) and peripheral swelling (3%). Serious events occurred in
4%. One instance of brain edema was fatal. Serious treatment-emergent
events included: pleural effusion (2%), pericardial effusion (1%), and
edema peripheral (<1%). Monitor patients for fluid retention and
manage as clinically indicated. Interrupt, reduce, or discontinue
ICLUSIG as clinically indicated.
Cardiac Arrhythmias: Arrhythmias
occurred in 19% of patients (7% were grade ≥3). Arrhythmia of
ventricular origin was reported in 3% of all arrhythmias, with one case
being grade ≥3. Symptomatic bradyarrhythmias that led to pacemaker
implantation occurred in 1% of patients. Atrial fibrillation was the
most common arrhythmia (7%), approximately half of which were grade 3 or
4. Other grade 3 or 4 arrhythmia events included syncope (2%),
tachycardia and bradycardia (each 0.4%), and electrocardiogram QT
prolonged, atrial flutter, supraventricular tachycardia, ventricular
tachycardia, atrial tachycardia, atrioventricular block complete,
cardio-respiratory arrest, loss of consciousness, and sinus node
dysfunction (each 0.2%). For 27 patients, the event led to
hospitalization. In patients with signs and symptoms suggestive of slow
heart rate (fainting, dizziness) or rapid heart rate (chest pain,
palpitations or dizziness), interrupt ICLUSIG and evaluate.
Myelosuppression:
Myelosuppression was reported in 59% of patients (50% were grade 3/4).
The incidence of these events was greater in patients with AP- or
BP-CML, and Ph+ ALL than in patients with CP-CML. Severe
myelosuppression (grade 3 or 4) was observed early in treatment, with a
median onset time of 1 month (range <1-40 months). Obtain complete
blood counts every 2 weeks for the first 3 months and then monthly or as
clinically indicated and adjust the dose as recommended
Tumor
Lysis Syndrome: Two patients (<1%, one with AP-CML and one with
BP-CML) treated with ICLUSIG developed serious tumor lysis syndrome.
Hyperuricemia occurred in 7% of patients. Due to the potential for tumor
lysis syndrome in patients with advanced disease, ensure adequate
hydration and treat high uric acid levels prior to initiating therapy
with ICLUSIG.
Reversible Posterior Leukoencephalopathy Syndrome
(RPLS): Post-marketing cases of RPLS have been reported in
ICLUSIG-treated patients. RPLS is a neurological disorder that can
present with signs and symptoms such as seizure, headache, decreased
alertness, altered mental functioning, vision loss, and other visual and
neurological disturbances. Hypertension is often present, and diagnosis
is made with supportive findings on magnetic resonance imaging of the
brain. If RPLS is diagnosed, interrupt ICLUSIG treatment and resume
treatment only once the event is resolved and if the benefit of
continued treatment outweighs the risk of RPLS.
Impaired Wound
Healing and Gastrointestinal Perforation: Impaired wound healing
occurred in patients receiving ICLUSIG. Withhold ICLUSIG for at least 1
week prior to elective surgery. Do not administer for at least 2 weeks
following major surgery and until adequate wound healing. The safety of
resumption of ICLUSIG after resolution of wound healing complications
has not been established. Gastrointestinal perforation or fistula
occurred in patients receiving ICLUSIG. Permanently discontinue in
patients with gastrointestinal perforation.
Embryo-Fetal
Toxicity: Based on its mechanism of action and findings from animal
studies, ICLUSIG can cause fetal harm when administered to a pregnant
woman. In animal reproduction studies, oral administration of ponatinib
to pregnant rats during organogenesis caused adverse developmental
effects at exposures lower than human exposures at the recommended human
dose. Advise pregnant women of the potential risk to the fetus. Advise
females of reproductive potential to use effective contraception during
treatment with ICLUSIG and for 3 weeks after the last dose.
ADVERSE REACTIONS
Most
Common Adverse Reactions: The most common non-hematologic adverse
reactions (≥20%) were abdominal pain, rash, constipation, headache, dry
skin, arterial occlusion, fatigue, hypertension, pyrexia, arthralgia,
nausea, diarrhea, lipase increased, vomiting, myalgia and pain in
extremity. Hematologic adverse reactions included thrombocytopenia,
anemia, neutropenia, lymphopenia, and leukopenia.
To report SUSPECTED ADVERSE REACTIONS, contact Takeda at 1-844-817-6468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid concurrent use or reduce ICLUSIG dose if co-administration cannot be avoided.
Strong CYP3A Inducers: Avoid concurrent use.
USE IN SPECIFIC POPULATIONS
Females
and Males of Reproductive Potential: Ponatinib may impair fertility in
females and it is not known if these effects are reversible. Verify
pregnancy status of females of reproductive potential prior to
initiating ICLUSIG.
Lactation: Advise women not to breastfeed during treatment with ICLUSIG and for 6 days after last dose.
For
more information about ICLUSIG, visit www.ICLUSIG.com. For the
Prescribing Information including the Boxed Warning for arterial
occlusion, venous thromboembolism, heart failure, and hepatoxicity,
please visit
https://www.iclusig.com/pdf/ICLUSIG-Prescribing-Information.pdf. For
more information about ongoing research, please visit
www.clinicaltrials.gov.
Takeda’s Commitment to Oncology
Our
core R&D mission is to deliver novel medicines to patients with
cancer worldwide through our commitment to science, breakthrough
innovation and passion for improving the lives of patients. Whether it’s
with our hematology therapies, our robust pipeline, or solid tumor
medicines, we aim to stay both innovative and competitive to bring
patients the treatments they need. For more information, visit
www.takedaoncology.com.
About Takeda Pharmaceutical Company Limited
Takeda
Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global,
values-based, R&D-driven biopharmaceutical leader headquartered in
Japan, committed to bringing Better Health and a Brighter Future to
patients by translating science into highly-innovative medicines. Takeda
focuses its R&D efforts on four therapeutic areas: Oncology, Rare
Diseases, Neuroscience, and Gastroenterology (GI). We also make targeted
R&D investments in Plasma-Derived Therapies and Vaccines. We are
focusing on developing highly innovative medicines that contribute to
making a difference in people's lives by advancing the frontier of new
treatment options and leveraging our enhanced collaborative R&D
engine and capabilities to create a robust, modality-diverse pipeline.
Our employees are committed to improving quality of life for patients
and to working with our partners in health care in approximately 80
countries.
For more information, visit https://www.takeda.com
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Contacts
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Kazumi Kobayashi
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