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New VELCADE® Data Highlight Treatment’s Versatility and Its Continued Role as a Backbone of Multiple Myeloma Therapy


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© Business Wire 2013
2013-12-09 06:01:03 -

Note: This release corresponds to ASH abstracts 1968, 3177 and 3187

Janssen-Cilag International NV (Janssen) today announced that new data, presented at the 55 th Annual Meeting of the American Society for Hematology (ASH), continue to reinforce VELCADE ’ s ® (bortezomib) role as the backbone of multiple myeloma treatment. The data demonstrate the survival benefits of higher cumulative dose levels of VELCADE, show significantly improved response rates and disease progression when it is used in combination with dexamethasone and demonstrate its association with low rates of cardiotoxicity.

“Bortezomib is at the core of many multiple myeloma treatment regimens, yet our understanding of how best to use it, and its full potential, continues to grow.” said Professor Maria-Victoria Mateos, Consultant Physician of the Haematology Department at

the University Hospital of Salamanca, Spain and lead investigator on a study assessing higher dose levels of bortezomib (ASH abstract 1968), “The association between higher cumulative dose levels of bortezomib and increased overall survival in multiple myeloma patients receiving VELCADE-melphalan-prednisone is another important potential step towards wider use of optimal treatment regimes. As our understanding of the efficacy and safety of bortezomib develops so does our ability to extend and improve the lives of patients with multiple myeloma.”

Abstract 1968: Higher total dose levels of VELCADE associated with overall survival benefit in patients with previously-untreated multiple myeloma receiving VMP 1

In data reported on December 7, 2013, further analysis of the landmark Phase III VISTA trial has shown that a higher cumulative VELCADE dose (reflecting prolonged treatment duration and/or dose intensity) is associated with improved overall survival (OS) in patients with previously-untreated multiple myeloma receiving VMP. These data demonstrate the importance of maintaining patients on VELCADE therapy, using dose/schedule modifications, and AE management, to maximise cumulative dose and provide better OS. In this study.



- OS was seen to be significantly longer in patients in the higher (≥39mg/m 2 ) vs. lower (<39mg/m 2 ) cumulative VELCADE dose group (median 66.3 vs 46.2 months, HR adjusted for age 0.561; p=0.0002)
- The group who received lower cumulative VELCADE doses displayed a higher incidence of early treatment discontinuations
- In an analysis conducted at 180 days among patients alive at that time point (to overcome confounding effects of early deaths), OS remained significantly longer in patients from the higher cumulative VELCADE dose group (median OS 60.4 vs 50.3 months, HR 0.709, p=0.0356)


Five year follow-up data of the landmark VISTA trial was first presented in 2011. It reported superiority of treatment with VELCADE-melphalan-prednisone (VMP) vs melphalan-prednisone (VP) in transplant-ineligible patients with previously-untreated multiple myeloma. 2

Abstract 3177: Adding dexamethasone to VELCADE as a combination partner improves response rates and delays disease progression compared to VELCADE alone, while showing a comparable safety profile 3


Data reported on December 8, 2013, of a retrospective matched-pair analysis in patients with relapsed multiple myeloma, showed significant benefits when using a combination of VELCADE and dexamethasone compared to VELCADE alone. This strengthens the evidence for using a combination of VELCADE plus dexamethasone from first relapse in multiple myeloma.
Data from this analysis showed.

- Overall response rate (ORR) was significantly higher for VELCADE-dexamethasone vs VELCADE alone (75% vs 41%, p<0.001)
- Median progression-free survival (PFS) (11.9 vs 6.4 months p=0.051) and median time to progression (TTP) (13.6 vs 7.0 months, p=0.003) were longer for VELCADE-dexamethasone vs VELCADE alone
- Median OS was not reached in either group (p=0.884); 1-/2- year OS rates were 78.7% and 68.4% respectively (VELCADE-dexamethasone) vs 86.4% and 62.2% (VELCADE alone)
- Both groups had similar safety profiles, including rates of grade ≥3 thrombocytopenia, infections and peripheral neuropathy


On November 21, 2013, the CHMP granted a positive opinion recommending the use of VELCADE (bortezomib) in combination with dexamethasone for the treatment of adult patients with progressive multiple myeloma who have received at least one prior therapy and who have already undergone, or are unsuitable for haematopoietic stem cell transplantation. 4 This is now referred to the European Commission (EC) which will review the option to expand VELCADE’s label to include this setting.

Abstract 3187: Low levels of heart failure reported in Phase II and III studies of VELCADE in multiple myeloma 5


Multiple myeloma patients are living longer and it is therefore ever-more important that adverse events associated with therapy are carefully managed and/or minimised to ensure optimal quality of life.
Cardiotoxicity from treatment is recognised as a potentially significant risk factor that could be contributing to higher-levels of cardiac events in these patients. However, data presented on December 8 ,2013 from a retrospective analysis of heart failure reported in Phase II and III studies of VELCADE in multiple myeloma showed that this medicine was associated with a low rate of grade ≥3 heart failure, in both newly-diagnosed and relapsed/refractory settings. In addition, the data showed that the rate of grade ≥3 heart failure in VELCADE groups was not significantly higher vs non-VELCADE comparator groups. This study noted.



- VELCADE is associated with a low rate of grade ≥3 heart failure in both newly diagnosed (2.0%) and relapsed/refractory (1.9%) settings
- Across comparator studies (APEX/VISTA) and pooled pre-ASCT induction analysis, the overall rates of grade ≥3 heart failure across VELCADE vs non VELCADE arms were equal (2.0% in VELCADE groups, 1.6% in the non-VELCADE groups)

ASH data comes on top of significant milestones for VELCADE in multiple myeloma

The data presented at ASH 2013 add to other recent positive milestones for VELCADE in Europe.

- In 2012, VELCADE was licensed by the European Commission (EC) for subcutaneous (under the skin) administration, offering greater safety and convenience for patients 6
- In June 2013, an alteration to VELCADE’s label was approved by the EC allowing it to be used as retreatment in adult patients who have previously responded to treatment with the same medicine 6
- In August 2013, the EC approved the use of VELCADE as induction therapy (a first therapeutic option) in combination with dexamethasone (VD) or thalidomide and dexamethasone (VTD) for adult patients with previously-untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation 6
- On November 21, 2013, the CHMP granted a positive opinion recommending the use of VELCADE in combination with CAELYX ® (pegylated liposomal-doxorubicin) or dexamethasone for the treatment of adult patients with progressive multiple myeloma who have received at least one prior therapy and who have already undergone or are unsuitable for haematopoietic stem cell transplantation 4 This is now referred to the EC which will review the option to expand VELCADE’s label to include this setting


# ENDS #

NOTES TO EDITORS


About VELCADE (bortezomib) 6


VELCADE (bortezomib) is a medicine used to treat the blood-based cancer known as multiple myeloma. It contains an active substance called bortezomib and is the first in a specific class of medicines known as proteasome inhibitors. Proteasomes are present in all cells and play an important role in controlling cell function, growth and also how cells interact with the other cells around them. Bortezomib reversibly interrupts the normal working of cell proteasomes causing myeloma cancer cells to stop growing and die.

VELCADE has a predictable safety profile and a favourable benefit–risk ratio. The most common side effects reported with VELCADE (bortezomib) include fatigue, gastrointestinal adverse events, transient thrombocytopenia and neuropathy.

VELCADE is the market leader in the treatment of frontline non-transplant eligible multiple myeloma. It is co-developed by Millennium/Takeda and Janssen Pharmaceutical Companies. Millennium is responsible for commercialisation of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialisation in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 450,000 patients worldwide.


About multiple myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterised by an excess proliferation of abnormal plasma cells. It is the second most frequent form of malignant bone marrow diseases and is a relatively rare form of cancer that accounts for roughly one percent of all cancers and roughly two percent of all deaths from cancer. 7 In Europe, around 60,000 people are living with the disease and there are 21,420 new cases and 15,000 deaths every year. 8


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, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, Janssen develops innovative products, services and healthcare solutions to help people throughout the world. More information can be found at www.janssen-emea.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. .

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 disease area strongholds that focus on hematologic malignancies and prostate cancer; cancer interception with the goal of developing products that interrupt the carcinogenic process; biomarkers that may help guide targeted, individualized 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. 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 unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Cilag International NV, any of the Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to, general industry conditions and competition; economic factors, such as interest rate and currency exchange rate fluctuations; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Exhibit 99 of Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 30, 2012. Copies of this Form 10-K, as well as subsequent filings, are available online at www.sec.gov : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. , www.jnj.com : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies or Johnson & Johnson undertake to update any forward-looking statements as a result of new information or future events or developments.

###


The original language of this press release is English. Translations into French, German, Italian and Spanish are provided as a courtesy.



REFERENCES

1 Mateos M et al. Higher cumulative bortezomib dose results in better overall survival in patients with previously-untreated multiple myeloma receiving bortezomib-melphalan-prednisone (VMP) in the Phase 3 VISTA study [ASH abstract 1968].

2 San Miguel JF et al. Persistent significant overall survival benefit, after 5 years follow up and no increased risk of secondary primary malignancies with bortezomib-melphalan-prednisone versus melphalan-prednisone in patients with previously untreated multiple myeloma. J Clin Oncol. 2013; 1;31(4): 448-55.

3 Dimopoulos M et al. Retrospective matched-pair analysis of the efficacy and safety of bortezomib plus dexamethasone versus bortezomib monotherapy in patients with relapsed multiple myeloma. [ASH abstract 3177].

4 CHMP opinion on VELCADE combination, 22 November 2013. www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/ .. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww ..

5 Laubach J el al. Quantifying the risk of heart failure associated with proteosome inhibition: a retrospective analysis of heart failure reported in phase 2 and phase 3 studies of bortezomib in multiple myeloma. [ASH abstract 3187]


6 VELCADE European Public Assessment Report (EPAR). Available from: www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medic .. : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. [last accessed November 2013].

7 Myeloma Patients Europe: What is multiple myeloma? Available at: www.myeloma-euronet.org/en/multiple-myeloma/what-is.php : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. [last accessed November 2013].

8 Myeloma Patients Europe: FAQs - multiple myeloma. Available at: www.myeloma-euronet.org/en/multiple-myeloma/faq.php : cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww .. [last accessed November 2013].

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