AbbVie (NYSE: ABBV) today announced new and updated data across clinical and real-world studies in chronic lymphocytic leukemia (CLL).
Presentations featured during the 64th
‘As the only Bruton’s Tyrosine Kinase inhibitor (BTKi) studied across many clinical trials, including up to eight years of follow-up data in CLL and small lymphocytic lymphoma (SLL), these latest data add to overall evidence for IMBRUVICA,’ said
Presentations will include the five-year median follow-up efficacy and safety data from the minimal residual disease (MRD) Cohort of the Phase 2 CAPTIVATE study (Abstract 92)1 and data on MRD kinetics from the randomized, open-label Phase 3 GLOW study (Abstract 93).2 Additionally, new data from three studies evaluating the impact of IMBRUVICA treatment in the real-world setting will be presented (Abstracts 797,1809, 3132).3,4,5
Five-Year Update from the CAPTIVATE Study Adds to Clinical Data Investigating the Potential of a Fixed-Duration Regimen
The MRD Cohort of the Phase 2 CAPTIVATE (NCT02910583) study evaluated 164 patients age 70 years or younger with previously untreated CLL; those who achieved confirmed undetectable minimal residual disease (uMRD) after completion of I+V fixed-duration treatment were randomly assigned to placebo (PBO) (n=43), or continued IMBRUVICA treatment (n=43).1 For patients with confirmed uMRD, median time on study was 56 months (PBO arm range, 4065 months; IMBRUVICA arm range, 2568 months); median post-randomization follow-up was 41 months in both arms.1 At four years of follow-up, estimated progression-free survival (PFS) was 88 percent (95 percent Confidence Interval [CI], 74-95, seven progressive disease events) with PBO compared to 95 percent (95 percent CI, 82-99, two progressive disease events) with continued IMBRUVICA treatment.1 Additionally, at year four, patients in the PBO arm of the study achieved an estimated overall survival (OS) rate of 100 percent compared to 98 percent (95 percent CI, 84-99.7) in the IMB
RUVICA treatment arm.1
No new atrial fibrillation (AF) or Grade three or higher hemorrhage events occurred in the PBO arm during the three year post-randomization period, and one patient in the IMBRUVICA arm had AF in the second year post-randomization.1 During the three-year post-randomization period, adverse events (AEs) of any grade for patients treated with IMBRUVICA were arthralgia (4/41), hypertension (2/41), neutropenia (1/41) and diarrhea (1/41). No new grade three or higher hemorrhage events occurred in either arm.1
The Data of IMBRUVICA in the Treatment of CLL Through Real-World Studies
An oral presentation (Abstract 797) will report findings comparing time to next treatment (TTNT) in patients with CLL who received first-line treatment with IMBRUVICA or acalabrutinib based on a real-world study utilizing electronic medical records.3
A poster presentation (Abstract 1809) will highlight results from a pooled analysis of the RESONATE-2 (NCT01722487), ECOG1912 (NCT02048813), and iLLUMINATE (NCT02264574) clinical studies investigating the comparison of OS in previously untreated CLL patients treated with IMBRUVICA to that of the available age-matched general population, as well as comparative results of OS in patients treated with IMBRUVICA versus chemotherapy and chemoimmunotherapy.4
Thirdly, the final analysis from the informCLL real-world (RW) registry, which assessed RW outcomes with first-line IMBRUVICA versus chemoimmunotherapy (CIT) in patients with CLL and SLL, will be presented as a poster (Abstract 3132).5 The informCLL registry enrolled 1,459 patients, of whom 59 percent were previously untreated.5 First-line treatment with IMBRUVICA was associated with longer TTNT than with CIT and sustained benefit, with up to four years of follow-up.5 In the IMBRUVICA cohort (n=383), serious adverse events (AEs) occurred in 144 patients (38 percent), most commonly (greater or equal to three percent of patients) pneumonia (six percent) and atrial fibrillation (five percent); AEs led to discontinuation of IMBRUVICA in 135 patients (35 percent), most commonly atrial fibrillation (five percent) and fatigue (three percent). In the CIT cohort (n=363), serious AEs occurred in 85 patients (23 percent), most commonly febrile neutropenia (four percent) and pneumonia (three percent). AEs led to discontinuation of CIT in 61 patients (17 percent), and no single AE term led to discontinuation in three percent or more of patients (most common was anemia, two percent).5 The spectrum and frequency of AEs observed with first-line treatment appeared consistent with data from clinical studies and other RWE studies.5
IMBRUVICA (ibrutinib) is a once-daily oral medication that is jointly developed and commercialized by
IMBRUVICA is approved in more than 100 countries and has been used to treat more than 270,000 patients worldwide. There are more than 50 company-sponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of IMBRUVICA.
IMBRUVICA was first approved by the
Accelerated approval was granted for MCL and MZL based on overall response rate. Continued approval for MCL and MZL may be contingent upon verification and description of clinical benefit in confirmatory trials.
IMPORTANT SIDE EFFECT INFORMATION
Before taking IMBRUVICA, tell your healthcare provider about all of your medical conditions, including if you:
have had recent surgery or plan to have surgery. Your healthcare provider may stop IMBRUVICA for any planned medical, surgical, or dental procedure.
have bleeding problems
have or had heart rhythm problems, smoke, or have a medical condition that increases your risk of heart disease, such as high blood pressure, high cholesterol, or diabetes have an infection have liver problems are pregnant or plan to become pregnant. IMBRUVICA can harm your unborn baby. If you are able to become pregnant, your healthcare provider will do a pregnancy test before starting treatment with IMBRUVICA. Tell your healthcare provider if you are pregnant or think you may be pregnant during treatment with IMBRUVICA.
Females who are able to become pregnant should use effective birth control (contraception) during treatment with IMBRUVICA and for 1 month after the last dose.
Males with female partners who are able to become pregnant should use effective birth control, such as condoms, during treatment with IMBRUVICA and for 1 month after the last dose.
are breastfeeding or plan to breastfeed. Do not breastfeed during treatment with IMBRUVICA and for 1 week after the last dose.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking IMBRUVICA with certain other medicines may affect how IMBRUVICA works and can cause side effects.
How should I take IMBRUVICA
Take IMBRUVICA exactly as your healthcare provider tells you to take it.
Take IMBRUVICA 1 time a day at about the same time each day.
IMBRUVICA comes as capsules, tablets, and oral suspension.
If your healthcare provider prescribes IMBRUVICA capsules or tablets: o Swallow IMBRUVICA capsules or tablets whole with a glass of water. o Do not open, break, or chew IMBRUVICA capsules. o Do not cut, crush, or chew IMBRUVICA tablets.
Do not use if the carton seal is broken or missing.
If you miss a dose of IMBRUVICA take it as soon as you remember on the same day. Take your next dose of IMBRUVICA at your regular time on the next day. Do not take extra doses of IMBRUVICA to make up for a missed dose.
If you take too much IMBRUVICA call your healthcare provider or go to the nearest hospital emergency room right away.
What should I avoid while taking IMBRUVICA
You should not drink grapefruit juice, eat grapefruit, or eat
What are the possible side effects of IMBRUVICA
IMBRUVICA may cause serious side effects, including: Bleeding problems (hemorrhage) are common during treatment with IMBRUVICA, and can also be serious and may lead to death. Your risk of bleeding may increase if you are also taking a blood thinner medicine. Tell your healthcare provider if you have any signs of bleeding, including: blood in your stools or black stools (looks like tar), pink or brown urine, unexpected bleeding, or bleeding that is severe or that you cannot control, vomit blood or vomit looks like coffee grounds, cough up blood or blood clots, increased bruising, dizziness, weakness, confusion, change in your speech, or a headache that lasts a long time or severe headache.
Infections can happen during treatment with IMBRUVICA. These infections can be serious and may lead to death. Tell your healthcare provider right away if you have fever, chills, weakness, confusion, or other signs or symptoms of an infection during treatment with IMBRUVICA.
Heart problems. Serious heart rhythm problems (ventricular arrhythmias, atrial fibrillation and atrial flutter), heart failure and death have happened in people treated with IMBRUVICA, especially in people who have an infection, an increased risk for heart disease, or have had heart rhythm problems in the past. Your heart function will be checked before and during treatment with IMBRUVICA. Tell your healthcare provider if you get any symptoms of heart problems, such as feeling as if your heart is beating fast and irregular, lightheadedness, dizziness, shortness of breath, swelling of the feet, ankles or legs, chest discomfort, or you faint. If you develop any of these symptoms, your healthcare provider may do tests to check your heart and may change your IMBRUVICA dose.
High blood pressure (hypertension). New or worsening high blood pressure has happened in people treated with IMBRUVICA. Your healthcare provider may start you on blood pressure medicine or change current medicines to treat your blood pressure.
Decrease in blood cell counts. Decreased blood counts (white blood cells, platelets, and red blood cells) are common with IMBRUVICA, but can also be severe. Your healthcare provider should do monthly blood tests to check your blood counts.
Second primary cancers. New cancers have happened during treatment with IMBRUVICA, including cancers of the skin or other organs.
Tumor lysis syndrome (TLS). TLS is caused by the fast breakdown of cancer cells. TLS can cause kidney failure and the need for dialysis treatment, abnormal heart rhythm, seizure, and sometimes death. Your healthcare provider may do blood tests to check you for TLS.
Diarrhea is a common side effect in people who take IMBRUVICA. Drink plenty of fluids during treatment with IMBRUVICA to help reduce your risk of losing too much fluid (dehydration) due to diarrhea. Tell your healthcare provider if you have diarrhea that does not go away.
These are not all the possible side effects of IMBRUVICA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of IMBRUVICA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use IMBRUVICA for a condition for which it was not prescribed. Do not give IMBRUVICA to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about IMBRUVICA that is written for health professionals.
About VENCLYXTA (venetoclax)
VENCLYXTA (venetoclax) is a first-in-class medicine that selectively binds and inhibits the B-cell lymphoma-2 (BCL-2) protein. In some blood cancers, BCL-2 prevents cancer cells from undergoing their natural death or self-destruction process, called apoptosis. VENCLYXTA targets the BCL-2 protein and works to help restore the process of apoptosis.
VENCLYXTA is being developed by AbbVie and
About AbbVie in Oncology
At AbbVie, we are committed to transforming standards of care for multiple blood cancers while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 20 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines.
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words ‘believe,’ ‘expect,’ ‘anticipate,’ ‘project’ and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, failure to realize the expected benefits from AbbVie’s acquisition of
Email: [email protected]