Novartis Phase II LBH589 data show substantial disease control and tumor reduction in extensively pretreated Hodgkin lymphoma patients
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Novartis International AG /
Novartis Phase II LBH589 data show substantial disease control and tumor
reduction in extensively pretreated Hodgkin lymphoma patients
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* LBH589 (panobinostat) shows sustained anticancer activity in Hodgkin
lymphoma patients who relapse or are refractory after autologous stem cell
transplant
* High unmet treatment need exists for patients who relapse or become
refractory after initial treatment; patients are often in their mid-thirties
or younger
* Worldwide regulatory filings are planned based on study findings
Basel, December 6, 2010 - The Novartis oral investigational drug LBH589
(panobinostat) demonstrated substantial disease control and tumor reduction in
extensively pretreated Hodgkin lymphoma patients who had relapsed or had become
refractory after an autologous stem cell transplant, according to new data from
a Phase II clinical trial presented today[1].
In this pivotal single-arm study, one of the largest ever conducted in this
patient population, 82% (n=106) of patients, most in their fifth line of therapy
or beyond, achieved disease control (defined as stable disease or better) and
74% (n=96) achieved tumor reduction at a median follow-up of 9.6 months,
demonstrating the sustained anticancer activity of LBH589. Partial and complete
responses to treatment, the primary endpoint, were observed in 27% of patients
(n=35), with a median duration of response of 6.9 months and a median
progression-free survival measured at 10.5 months among those 35 patients[1].
These data were presented today at the 52(nd) Annual Meeting and Exposition of
the American Society of Hematology (ASH) in Orlando, Florida. Worldwide
regulatory filings are planned based on the study results.
Currently, up to 35% of patients with Hodgkin lymphoma relapse or become
refractory after initial treatment, which typically involves at least two
regimens of combination chemotherapy along with high-dose chemotherapy and stem
cell transplant[2]. Most patients enrolled in this study had received nearly all
of the chemotherapy drugs known to be active in this disease, and 79% had failed
an additional round of chemotherapy after a stem cell transplant. In addition,
10% of patients had also received prior allogeneic stem cell transplantations
(stem cells from another person) in addition to an autologous transplant (stem
cells from the patient). Palliative care is currently the only option remaining
for these patients[3],[4].
"It's impressive to see this response to LBH589 in patients, many of whom have
received multiple courses of chemotherapy," said Anna Sureda, MD, Clinical
Hematology Division, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain.
"The responses suggest LBH589, which has a very different mechanism of action
than chemotherapy, has the potential to become a valuable treatment option for
these patients."
LBH589 is an oral pan-deacetylase (DAC) inhibitor, which targets changes in gene
function (also known as epigenetic regulation) that regulate processes in the
development of cancer, including proliferation and survival of Hodgkin lymphoma
cells in laboratory studies[5]. A Phase III clinical trial (PATH: PAnobinostat
Trial in Hodgkin's lymphoma) has begun enrollment, investigating the drug as a
maintenance therapy following autologous stem cell transplant in patients with
Hodgkin lymphoma who have an increased risk for relapse[6]. The clinical
development program for LBH589 also includes an ongoing Phase III clinical trial
in multiple myeloma and early-stage trials in acute myeloid leukemia and
myelodysplastic syndromes.
"These positive findings for LBH589 are encouraging for many Hodgkin lymphoma
patients who currently lack effective treatments," said Alessandro Riva, Global
Head, Oncology Development & Medical Affairs, Novartis Oncology. "Patients who
are not cured by autologous stem cell transplant and have stopped responding to
chemotherapy have an urgent unmet medical need for novel therapeutic options. We
are committed to the rapid development of this promising compound for these
patients."
Hodgkin lymphoma is most commonly diagnosed in teenagers and adults between the
ages of 15 and 35 and in adults over 50[7]. It is the third most common cancer
in people under the age of 20[8]. Treatment options for Hodgkin lymphoma
typically involve an initial round of combination chemotherapy, but standard
frontline treatments do not lead to long-term disease-free survival in all
patients[3],[4]. When a patient relapses or becomes refractory, treatment
options include high-dose chemotherapy, usually followed by stem cell
transplantation[3],[4]. The use of transplantation has resulted in improved
outcomes in patients with relapsed disease, but still 40% to 50% of these
patients subsequently relapse[2]. There is currently no standard of care for
patients who relapse or are refractory following these treatments[3],[4].
Study details
This Phase II clinical trial evaluated the efficacy and safety of oral LBH589 in
patients with refractory/relapsed classical Hodgkin lymphoma who had received
prior treatment with high dose chemotherapy and autologous stem cell
transplant[9].
The primary outcome measure was objective response rate to therapy. Secondary
outcome measures included response rate based on central review of CT scan/MRI,
time to response, duration of response, progression-free survival rate and
safety and tolerability of treatment[9].
As of the data analysis, 129 patients had been enrolled and treated. Patients
had received a median number of four (range 2-7) prior systemic regimens,
including combination regimens involving drugs such as gemcitabine, vinca-
alkaloids or platinum-based chemotherapies. At a median follow-up of 9.6 months,
a reduction in measurable tumor size was observed in 96 (74%) patients;
responses were observed in 35 patients (5 complete responses, 30 partial
responses; overall response rate 27%). Median progression-free survival was 6.1
months (10.5 months among responders)[1].
Common adverse events (mostly grade 1 or 2) included diarrhea, nausea, fatigue,
vomiting, anorexia, dysguesia, asthenia, constipation, leucopenia and muscle
spasms. Common related grade 3/4 adverse events included thrombocytopenia,
anemia and neutropenia. Thrombocytopenia was reversible with dose hold or
modification and was manageable long term, with only 5% treatment
discontinuation for this reason. The overall rate of discontinuation due to
adverse events was 16%[1].
About LBH589
Because it is an investigational compound, the safety and efficacy profile of
LBH589 has not yet been established. Access to this investigational compound is
available only through carefully controlled and monitored clinical trials. These
trials are designed to better understand the potential benefits and risks of the
compound. Because of uncertainty of clinical trials, there is no guarantee that
LBH589 will ever be commercially available anywhere in the world.
Disclaimer
The foregoing release contains forward-looking statements that can be identified
by terminology such as "planned," "investigational," "potential,"
"investigating," "ongoing," "encouraging," "committed," "promising," or similar
expressions, or by express or implied discussions regarding potential future
approvals to market LBH589, or regarding potential future revenues from LBH589.
You should not place undue reliance on these statements. Such forward-looking
statements reflect the current views of management regarding future events, and
involve known and unknown risks, uncertainties and other factors that may cause
actual results to be materially different from any future results, performance
or achievements expressed or implied by such statements. There can be no
guarantee that LBH589 will be submitted or approved for sale in any market, or
that LBH589 will achieve any particular revenue levels. In particular,
management's expectations could be affected by, among other things, unexpected
clinical trial results, including unexpected new clinical data and unexpected
additional analysis of existing clinical data; unexpected regulatory actions or
delays or government regulation generally; competition in general; government,
industry and general public pricing pressures; the company's ability to obtain
or maintain patent or other proprietary intellectual property protection; the
impact that the foregoing factors could have on the values attributed to the
Novartis Group's assets and liabilities as recorded in the Group's consolidated
balance sheet, and other risks and factors referred to in Novartis AG's current
Form 20-F on file with the US Securities and Exchange Commission. Should one or
more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those
anticipated, believed, estimated or expected. Novartis is providing the
information in this press release as of this date and does not undertake any
obligation to update any forward-looking statements contained in this press
release as a result of new information, future events or otherwise.
About Novartis
Novartis provides healthcare solutions that address the evolving needs of
patients and societies. Focused solely on healthcare, Novartis offers a
diversified portfolio to best meet these needs: innovative medicines, cost-
saving generic pharmaceuticals, preventive vaccines, diagnostic tools and
consumer health products. Novartis is the only company with leading positions in
these areas. In 2009, the Group's continuing operations achieved net sales of
USD 44.3 billion, while approximately USD 7.5 billion was invested in R&D
activities throughout the Group. Headquartered in Basel, Switzerland, Novartis
Group companies employ approximately 100,000 full-time-equivalent associates and
operate in more than 140 countries around the world. For more information,
please visithttp://www.novartis.com.
References
[1] Sureda A, Younes A, Ben-Yehuda D, et al. Final analysis: Phase II study of
oral panobinostat in relapsed/refractory Hodgkin lymphoma patients following
autologous hematopoietic stem cell transplant. 52nd ASH Annual Meeting and
Exposition. 2010. Abstract #169. Available at
http://ash.confex.com/ash/2010/webprogram/Paper34050.html. Accessed November
2010.
[2] McBride NC, Cavenagh JD, Ward MC, et al. Liposomal daunorubicin (DaunoXome)
in combination with cyclophosphamide, vincristine and prednisolone (COP-X)
as salvage therapy in poor-prognosis non-Hodgkins lymphoma. Leuk Lymphoma.
2001Jun;42(1-2):89-98.
[3] NCCN Clinical Practice Guidelines in Oncology(TM) Hodgkin Lymphoma.
V.2.2010. Available at
http://www.nccn.org/professionals/physician_gls/PDF/hodgkins.pdf. Accessed
November 2010.
[4] Engert A, Eichenauer DA, Dreyling M; on behalf of the ESMO Guidelines
Working Group. Hodgkin's lymphoma: ESMO Clinical Recommendations for
diagnosis, treatment and follow-up. Ann Oncol. 2009;20 suppl 4: iv108-iv109.
[5] Younes A, Ong, T-C, Ribrag V, et al. Efficacy of panobinostat in Phase II
study in patients with relapsed/refractory Hodgkin lymphoma (HL) after high-
dose chemotherapy with autologous stem cell transplant. Blood (ASH Annual
Meeting Abstracts), 2009;114:923.
[6] A Phase III randomized, double blind, placebo controlled multi-center study
of panobinostat for maintenance of response in patients with Hodgkin's
lymphoma. Available at
http://www.clinicaltrials.gov/ct2/show/NCT01034163 Accessed November 2010.
[7] Straus D. Relapsed and refractory Hodgkin lymphoma. Lymphoma Research
Foundation. Available at http://www.lymphoma.org/atf/cf/%7B0363cdd6-
51b5-427b-be48-e6af871acec9%7D/HL09RELREF.PDF. Accessed November 2010.
[8] The Leukemia & Lymphoma Society. Hodgkin lymphoma facts & statistics.
Available at http://www.leukemia-
lymphoma.org/all_page.adp?item_id=8312 Accessed November 2010.
[9] Phase II study of oral panobinostat in adult patients with
relapsed/refractory classical Hodgkin's lymphoma. Available at
http://www.clinicaltrials.gov/ct2/show/NCT00742027. Accessed November 2010.
# # #
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Datum: 06.12.2010 - 17:31 Uhr
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News-ID 49443
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