Pulling Back the Curtain: Ify Osunkwo, MD, MPH
You mentioned learning to find
balance between your work and
personal life – what makes that
difficult, and do you have any ad-
vice for finding that balance?
It’s a struggle, and I tip into imbalance
often, especially when I have an excit-
ing project that I’m working on, but my
husband is the most patient, amazing
partner I could dream of. We have two
daughters and one son, and my husband
is an attorney with his own practice
a mile from the house, so a lot of the
responsibilities of dropping off and
picking up the kids fall on him. I
think that we have been married for
21 years is actually one of my biggest
career accomplishments.
I made a real effort to set better
boundaries for my personal life after
I had a rough patch at work a few
years ago. I looked around and I saw
that the people who were there for
me was my family. So, I said, “OK,
I need to start over and make time
for the people who are always going
to be there. Work people come and
go, but nothing is so serious that it
should come before my family.”
with them, I know that I need to be there
for them.
How do you spend that time that
you’ve carved out for yourself?
I love dancing. If there’s a party, I’m there,
and there better be a good DJ. I’m sure
most people think I’m a big extrovert, but
I also need to spend time relaxing at home
in my own quiet space.
Kd
Who is your dream dinner party
guest?
I would love to have dinner with
Michelle Obama. I have so many ques-
tions for her: How do you get your buff
arms? How do you balance your work and
your family life? How do you stay so calm
and collected?
She never looks stressed, or upset, or
frazzled – and that’s something I aspire
to, because, I must admit, my inherent
personality is quite the opposite.
What is one thing that people
would be surprised to learn about
you?
I have dyslexia, so I invert letters and
numbers when reading, and I have adult
attention deficit hyperactivity disorder
(ADHD). It’s not something I shared
with many people because I was em-
barrassed by it. Once, during medical
Once-Weekly Dosing Is Now FDA Approved
The FDA granted Priority Review to KYPROLIS ® , which was the fi rst hematology product approved under the FDA Oncology
Center of Excellence Real-Time Oncology Review Pilot Program. 1
SUPERIOR OUTCOMES
SUPERIOR PFS KYPROLIS ® once-weekly 70 mg/m 2 with dexamethasone (Kd) vs
KYPROLIS ® twice-weekly 27 mg/m 2 with dexamethasone* (Kd):
• EXTENDED PFS by 47%: 11.2 months in once-weekly arm vs 7.6 months in twice-weekly arm; HR = 0.69
(95% CI: 0.54-0.88); P = 0.0014 2
*Kd27 is not an FDA-approved dose for KYPROLIS ® .
INCREASED DEPTH OF RESPONSE:
• 4x AS MANY PATIENTS ACHIEVED ≥ CR: 7.1% in once-weekly arm (n = 17) vs 1.7% in twice-weekly arm (n = 4) 2,†
“Living with
dyslexia and
ADHD also
taught me that
everybody
struggles with
something –
sometimes we
know what it is,
and sometimes
we don’t.”
I love my job, of course, but I’ve
learned to say no to certain com-
mitments. For example, before I had
that “a-ha” moment, I would finish
my work in the clinic around 5 p.m.,
then I would see patients at the hos-
pital until 9 p.m. I gave everyone my
cell phone number and made sure
that I was available 24/7. I would
bring work home to finish.
I don’t do those things anymore
– not because I don’t love my job, but
because I need to give my kids and
my husband some part of me. If one
of my kids asks me to spend time
A subgroup analysis of ORR.
†
COMPARABLE SAFETY: Overall safety was comparable between the once-weekly and twice-weekly groups 2
Select adverse events of interest:
• The incidence of cardiac failure was 3.8% in the once-weekly arm (n = 9) vs 5.1% in the twice-weekly arm (n = 12) 2,3
• The incidence of pulmonary hypertension was 1.7% in the once-weekly arm (n = 4) vs 1.3% in the twice-weekly arm (n = 3) 3
PATIENTS WERE ABLE TO STAY ON THERAPY LONGER: Patients stayed on treatment for 31% longer
in the once-weekly arm (median 38 weeks) vs the twice-weekly arm (median 29.1 weeks) 2
CI = confi dence interval; CR = complete response; HR = hazard ratio; Kd = KYPROLIS ® and dexamethasone; ORR = overall response rate;
PFS = progression-free survival.
Kd once-weekly vs twice-weekly study design: Phase 3, randomized, multicenter, open-label study (N = 478) in patients with relapsed and refractory
multiple myeloma who had received 2 to 3 lines of therapy, KYPROLIS ® and dexamethasone 70 mg/m 2 once weekly (n = 240) versus KYPROLIS ® and
dexamethasone 27 mg/m 2 twice weekly (n = 238). The primary endpoint was PFS. Secondary endpoints included ORR and safety. 2
INDICATION AND IMPORTANT SAFETY INFORMATION FOR KYPROLIS
INDICATION
Tumor Lysis Syndrome
KYPROLIS ® (carfi lzomib) is indicated in combination with dexamethasone or
• Cases of Tumor Lysis Syndrome (TLS), including fatal outcomes, have
with lenalidomide plus dexamethasone for the treatment of patients with
occurred. Patients with a high tumor burden should be considered at
relapsed or refractory multiple myeloma who have received one to three
greater risk for TLS. Adequate hydration is required prior to each dose in
Cycle 1, and in subsequent cycles as needed. Consider uric acid lowering
lines of therapy.
drugs in patients at risk for TLS. Monitor for evidence of TLS during
IMPORTANT SAFETY INFORMATION FOR KYPROLIS
treatment and manage promptly, and withhold until resolved.
Cardiac Toxicities
• New onset or worsening of pre-existing cardiac failure (e.g., congestive
heart failure, pulmonary edema, decreased ejection fraction), restrictive
cardiomyopathy, myocardial ischemia, and myocardial infarction including
fatalities have occurred following administration of KYPROLIS. Some
events occurred in patients with normal baseline ventricular function.
Death due to cardiac arrest has occurred within one day of administration.
• Monitor patients for signs or symptoms of cardiac failure or ischemia.
Evaluate promptly if cardiac toxicity is suspected. Withhold KYPROLIS for
Grade 3 or 4 cardiac adverse events until recovery, and consider whether
to restart at 1 dose level reduction based on a benefi t/risk assessment.
• While adequate hydration is required prior to each dose in Cycle 1, monitor
all patients for evidence of volume overload, especially patients at risk for
cardiac failure. Adjust total fl uid intake as clinically appropriate.
• For patients ≥ 75 years, the risk of cardiac failure is increased. Patients
with New York Heart Association Class III and IV heart failure, recent
myocardial infarction, conduction abnormalities, angina, or arrhythmias
may be at greater risk for cardiac complications and should have a
comprehensive medical assessment prior to starting treatment with
KYPROLIS and remain under close follow-up with fl uid management.
Acute Renal Failure
• Cases of acute renal failure, including some fatal renal failure events, and
renal insuffi ciency adverse events (including renal failure) have occurred.
Acute renal failure was reported more frequently in patients with advanced
relapsed and refractory multiple myeloma who received KYPROLIS
monotherapy. Monitor renal function with regular measurement of the
serum creatinine and/or estimated creatinine clearance. Reduce or
withhold dose as appropriate.
Learn more at KYPROLIS-HCP.com
12
ASH Clinical News
Pulmonary Toxicity
• Acute Respiratory Distress Syndrome (ARDS), acute respiratory failure,
and acute diffuse infi ltrative pulmonary disease such as pneumonitis and
interstitial lung disease have occurred. Some events have been fatal. In
the event of drug-induced pulmonary toxicity, discontinue KYPROLIS.
Pulmonary Hypertension
• Pulmonary arterial hypertension (PAH) was reported. Evaluate with cardiac
imaging and/or other tests as indicated. Withhold KYPROLIS for PAH until
resolved or returned to baseline and consider whether to restart based on
a benefi t/risk assessment.
Dyspnea
• Dyspnea was reported in patients treated with KYPROLIS. Evaluate
dyspnea to exclude cardiopulmonary conditions including cardiac failure
and pulmonary syndromes. Stop KYPROLIS for Grade 3 or 4 dyspnea until
resolved or returned to baseline. Consider whether to restart based on a
benefi t/risk assessment.
Hypertension
• Hypertension, including hypertensive crisis and hypertensive emergency,
has been observed, some fatal. Control hypertension prior to starting
KYPROLIS. Monitor blood pressure regularly in all patients. If hypertension
cannot be adequately controlled, withhold KYPROLIS and evaluate.
Consider whether to restart based on a benefi t/risk assessment.
Venous Thrombosis
• Venous thromboembolic events (including deep venous thrombosis
and pulmonary embolism) have been observed. Thromboprophylaxis
is recommended for patients being treated with the combination of
KYPROLIS with dexamethasone or with lenalidomide plus dexamethasone.
The thromboprophylaxis regimen should be based on an assessment of
the patient’s underlying risks.