ASH Clinical News ACN_5.1_Digital | Page 14

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.