BEERSE, Belgium, May 30, 2015 /PRNewswire/ --
FOR TRADE AND
MEDICAL MEDIA ONLY
Results from the Phase 2 MMY2002
trial (Abstract LBA8512) featured in the official press programme
of the 51st Annual Meeting of the
American Society of Clinical Oncology (ASCO)
Data from the international, multi-centre, open-label two part,
single arm Phase 2 MMY2002 (SIRIUS) trial show treatment with
single-agent daratumumab - an investigational, human anti-CD38
monoclonal antibody - achieved an overall response rate (ORR) of
29.2 percent (95% CI, 20.8-38.9), as assessed by an independent
review committee, in heavily pre-treated patients with multiple
myeloma.[1] The ORR was consistent
among the pre-specified subgroups based on age, prior lines of
therapy, type of myeloma and baseline renal function.
(Logo:
http://photos.prnewswire.com/prnh/20140324/NY88746LOGO )
Median duration of response was 7.4 months (95% CI, 5.5-not
estimable).[1] Ninety-five percent
of patients in the study were double refractory to a proteasome
inhibitor (PI) and immunomodulatory drug (IMiD). Patients received
a median of five prior lines of therapy, including a PI and an
IMiD. No patients discontinued treatment due to infusion-related
reactions (IRRs) and 4.7 percent of patients discontinued treatment
due to adverse events (AEs), none of which were considered
drug-related.
Janssen-Cilag International NV (Janssen) announced the data,
which will be included during the official press programme at the
American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago. These data will be
presented in full during the myeloma oral abstract session on
Tuesday, 02 June at 11:21 CT
(18:21 CET) by lead investigator
Sagar Lonial, M.D., Chief Medical
Officer, Winship Cancer Institute of Emory
University and Professor and Executive Vice Chair,
Department of Hematology and Medical Oncology, Emory University School of Medicine. In addition,
the data will be presented as an encore at Europe's most prestigious haematology
specialist congress - the European Hematology Association Annual
Meeting - taking place 11-14 June,
2015 in Vienna,
Austria.
"It is particularly noteworthy to see this level of response
with a single-agent in a heavily pre-treated population.
Ninety-seven percent of patients in this study were refractory to
their last line of therapy, and 95 percent were double refractory
to both a PI and an IMiD" said Dr. Lonial. "These findings speak to
the potential of daratumumab for people with multiple myeloma who
have exhausted currently available treatment options."
In part one of this ongoing international, multi-centre,
open-label, two-part, single-arm study, 34 patients were randomised
to receive either 8 mg/kg of daratumumab once every four weeks
(Q4W) or 16 mg/kg once a week (QW) for eight weeks, then once every
two weeks (Q2W) for 16 weeks and once every four weeks (Q4W)
following, until disease progression or unacceptable toxicity. In
part two, 90 additional patients were enrolled to receive 16 mg/kg
of daratumumab on the same dosing schedule as in part one. Results
are reported for all patients in parts one and two treated with 16
mg/kg of daratumumab (n=106). Very good partial response (VGPR) or
better was achieved in 12 percent (95% CI, 7-20) of patients, with
three stringent complete responses (sCR) (95% CI, 0.6-8.0) and 10
very good partial responses (VGPR) (95% CI, 4.6-16.7)
reported.[1] Median overall
survival (OS) has not been reached, and the estimated one-year
overall survival rate is 65
percent.[1] The median
progression-free survival was 3.7 months. After a median follow up
of 9.4 months, 45.2 percent of responders remain on
therapy.[1]
"Janssen's commitment in oncology is stronger than ever, and the
promising results of the MMY2002 study are an exciting step towards
furthering our understanding of multiple myeloma and its
treatment," said Thomas Stark, Vice
President Medical Affairs, Janssen EMEA. "We are working tirelessly
to develop new, innovative treatment options for the treatment of
multiple myeloma, and are looking forward to the results from
future studies investigating this compound, to truly address the
significant unmet clinical needs in this disease area."
Serious adverse events (SAEs) occurred in 30 percent of
patients. The most common AEs were fatigue (39.6 percent), anaemia
(33 percent), nausea (29.2 percent), thrombocytopenia (25.5
percent), neutropenia (22.6 percent), back pain (22.6 percent) and
cough (20.8 percent). Five patients (4.7%) discontinued treatment
due to AEs, none of which were considered drug-related.
Infusion-related reactions (IRR) were reported in 42.5 percent of
patients and were predominantly grade 1 or 2 (4.7 percent grade 3;
no grade 4 reported). These occurred mainly during the first
infusion. The most common IRRs included nasal congestion (12
percent), throat irritation (7 percent), cough, dyspnoea, chills,
and vomiting (6 percent each) - all of which were treated with
standard of care and slower infusion rates.
Daratumumab was granted Orphan Drug Status by the European
Medicines Agency in July 2013 for the treatment of plasma cell
myeloma.[2] On 20 May 2015,
Janssen announced plans to submit a Biologics License Application
(BLA) to the European Medicines Agency (EMA) and US Food and Drug
Administration (FDA) for daratumumab this year, based on these
MMY2002 data.
In August 2012, Janssen Biotech, Inc. and Genmab entered an
agreement which granted Janssen an exclusive license to develop,
manufacture, and commercialise daratumumab. Janssen is currently
the sponsor of all but one study globally.
About Multiple Myeloma
Multiple myeloma (MM) is an incurable blood cancer that starts
in the bone marrow and is characterised by an excessive
proliferation of plasma cells.[3]
MM is the second most common form of blood cancer, with around
39,000 new cases in Europe in
2012.[4] MM most commonly affects
people over the age of 65 and is more common in men than in
women.[5] Across Europe, five-year survival rates are 23
percent to 47 percent of people
diagnosed.[6] 25 percent of
patients with MM will die within one year of
diagnosis.[7],[8]
Although treatment may result in remission, unfortunately patients
will most likely relapse as there is currently no cure. While some
patients with MM have no symptoms at all, most patients are
diagnosed due to symptoms which can include bone problems, low
blood counts, calcium elevation, kidney problems or
infections.[5]
About Daratumumab
Daratumumab is an investigational human IgG1K
monoclonal antibody (mAb) that binds with high affinity to CD38 on
the surface of multiple myeloma cells, inducing rapid tumour cell
death through diverse mechanisms of
action.[9] Daratumumab is in Phase
3 clinical development for multiple myeloma.
About Janssen
The Janssen Pharmaceutical Companies of Johnson & Johnson
are dedicated to addressing and solving the most important unmet
medical needs of our time, including oncology (e.g. multiple
myeloma and prostate cancer), immunology (e.g. psoriasis),
neuroscience (e.g. schizophrenia, dementia and pain), infectious
disease (e.g. HIV/AIDS, hepatitis C and tuberculosis), and
cardiovascular and metabolic diseases (e.g. diabetes). Driven by
our commitment to patients, we develop sustainable, integrated
healthcare solutions by working side-by-side with healthcare
stakeholders, based on partnerships of trust and transparency. More
information can be found on http://www.janssen-emea.com. Follow us
on http://www.twitter.com/janssenEMEA for our latest
news.
Janssen Pharmaceutical NV, Janssen Research & Development,
LLC, Janssen Biotech, Inc., and Janssen-Cilag International NV are
part of the Janssen Pharmaceutical Companies of Johnson &
Johnson.
Janssen in Oncology
In oncology, our goal is to fundamentally alter the way cancer
is understood, diagnosed and managed, reinforcing our commitment to
the patients who inspire us. In looking to find innovative ways to
address the cancer challenge, our primary efforts focus on several
treatment and prevention solutions. These include a focus on
hematologic malignancies, prostate cancer and lung cancer; cancer
interception with the goal of developing products that interrupt
the carcinogenic process; biomarkers that may help guide targeted,
individualised use of our therapies; as well as safe and effective
identification and treatment of early changes in the tumour
microenvironment.
This press release contains "forward-looking statements" as
defined in the Private Securities Litigation Reform Act of 1995
regarding product development. The reader is cautioned not to rely
on these forward-looking statements. These statements are based on
current expectations of future events. If underlying assumptions
prove inaccurate or known or unknown risks or uncertainties
materialise, actual results could vary materially from the
expectations and projections of any of the Janssen Pharmaceutical
Companies and/or Johnson & Johnson. Risks and uncertainties
include, but are not limited to: challenges and uncertainties
inherent in new product development, including the uncertainty of
clinical success and of obtaining regulatory approvals;
competition, including technological advances, new products and
patents attained by competitors; challenges to patents; changes to
applicable laws and regulations, including global health care
reforms; and trends toward health care cost containment. A further
list and description of these risks, uncertainties and other
factors can be found in Johnson & Johnson's Annual Report on
Form 10-K for the fiscal year ended December
28, 2014, including in Exhibit 99 thereto, and the
company's subsequent filings with the Securities and
Exchange Commission. Copies of these filings are available online
at http://www.sec.gov, http://www.jnj.com or
on request from Johnson & Johnson. None of the Janssen
Pharmaceutical Companies or Johnson & Johnson undertake to
update any forward-looking statement as a result of new information
or future events or developments.
References
- Lonial S, et al. Phase 2 Study of daratumumab
Monotherapy in Patients with ≥3 Lines of Prior Therapy or Double
Refractory Multiple Myeloma (MM). (Abstract LBA8512). Oral abstract
presented at ASCO Congress, 2 June
2015.
- European Medicines Agency. Public Summary of Orphan Drug
Designations - EU/3/13/1153. Available at:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/orphans/2013/08/human_orphan_001232.jsp&mid=WC0b01ac058001d12b
Last accessed 12 May 2015.
- American Society of Clinical Oncology. Multiple myeloma:
overview. Available at:
http://www.cancer.net/cancer-types/multiple-myeloma/overview. Last
accessed 18 May 2015.
- GLOBOCAN 2012 Cancer Incidence, Mortality and Prevalence
Worldwide. Available at:
http://globocan.iarc.fr/old/burden.asp?selection_pop=62968&Textp=Europe&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=13&type=0&window=1&submit=%C2%A0Execute.
Last accessed May 13, 2014.
- American Cancer Society. Multiple myeloma: detailed guide.
Available at:
http://www.cancer.org/acs/groups/cid/documents/webcontent/003121-pdf.pdf
Last accessed 18 May 2015.
- Cancer Research UK. Myeloma Survival Statistics. Available at:
http://www.cancerresearchuk.org/cancer-info/cancerstats/types/myeloma/survival/multiple-myeloma-survival-statistics
Last accessed 18 May 2015.
- The Myeloma Beacon. Risk of Infection Among Multiple Myeloma
Patients Is High And Rising (ASH 2012). Available at:
http://www.myelomabeacon.com/news/2013/01/11/infection-risk-multiple-myeloma-high-and-rising-ash-2012/
Last accessed: 18 May 2015.
- NetDoctor. What is myeloma? Available at:
http://www.netdoctor.co.uk/diseases/facts/multiplemyeloma.htm Last
accessed 18 May 2015.
- de Weers M, Tai YT, van der Veer MS, et al. Daratumumab,
a novel therapeutic human CD38 monoclonal antibody, induces killing
of multiple myeloma and other hematological tumors. J
Immunol. 2011;186:1840-8.
PHEM/DAT/0515/0003
May 2015
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