Active Biotech's project ANYARA improved overall survival in a subgroup of renal cell cancer patients
(Thomson Reuters ONE) -
Phase II/III Overall Survival and PFS data presented at the 2013 ASCO Annual
Meeting
Lund (Sweden), June 3, 2013. Active Biotech (NASDAQ OMX NORDIC: ACTI) today
presented overall survival (OS) and Progression Free Survival (PFS) data from
the ANYARA Phase II/III study in renal cell cancer at the scientific conference
"2013 ASCO Annual Meeting" held in Chicago (USA).
The coordinating investigator Professor Robert Hawkins presented "A randomized
phase II/III study of naptumomab estafenatox plus IFN-alpha versus IFN-alpha in
advanced renal cell carcinoma*".
The study encompassed 513 patients and was designed to evaluate the effect of
ANYARA (naptumomab estafenatox) in combination with interferon-alpha, compared
with interferon-alpha alone, in patients with advanced renal cell cancer. The
primary endpoint was overall survival (OS).
The results showed that although the ANYARA Phase II/III study did not achieve
its primary endpoint to show a prolonged OS in the overall ITT population, the
addition of ANYARA to interferon-alpha improves OS and PFS in a biomarker
defined subgroup. In this subgroup, patients with high levels of pre-formed
antibodies against superantigens or the cytokine IL-6 were excluded. High
baseline levels of these antibodies were shown to decrease ANYARA levels while
the biomarker IL-6 has previously been suggested to be a predictive marker for
immune therapies.
In this subgroup of 130 patients, the median OS for the ANYARA vs. placebo
treatment arm were 63.3 vs. 31.1 months (HR: 0.59; p=0.020), respectively. The
median PFS were 13.7 (ANYARA) vs. 5.8 (placebo) months (HR: 0.62; p=0.016).
To test the robustness of these data, an alternative subgroup of 131 patients,
based on previously published cut-off levels of these biomarkers, was
investigated. In this subgroup, the median OS for ANYARA in combination with
interferon-alpha versus interferon-alpha alone were 30.4 and 21.7 months
(HR=0.65, (p=0.036), respectively. The median PFS of ANYARA in combination with
interferon-alpha versus interferon-alpha alone were 8.5 and 5.8 months (HR=0.75,
p=0.162), respectively.
Professor Robert Hawkins, the Christie Hospital, Manchester, UK said: "As shown
with other immune therapies, patients may be pre-selected using biomarkers to
increase their chances to obtain treatment benefits. The results from this study
with ANYARA were striking and should be confirmed".
Tomas Leanderson, President & CEO Active Biotech, added: "Based on these
encouraging results, we are seeking a partner for the continued development of
this unique, targeted cancer therapy".
For more detailed information, please see www.asco.org. The presentation is
available on Active Biotech's web site www.activebiotech.com.
* R. Hawkins, M. Gore, Y. Shparyk, V. Bondar, O. Gladkov, T. Ganev, M. Harza, S.
Polenkov, I. Bondarenko, P. Karlov, O. Karyakin, R. Khasanov, G. Hedlund, G.
Forsberg, Ö. Nordle, T. Eisen.
ABOUT THE ANYARA PHASE II/III STUDY
The Phase II/III study was designed to evaluate the effect of ANYARA in
combination with interferon-alpha, compared with interferon-alpha alone, in
patients with advanced renal cell cancer. The primary endpoint was overall
survival (OS). In May 2008, a positive interim analysis of safety and efficacy
was performed and the study continued into the Phase III part. Enrollment of
513 patients was completed in June 2009 and recruited patients from
approximately 50 sites in Europe (UK, Ru, Uk, Bu, Ro). Secondary endpoints in
the study were Progression Free Survival (PFS) and safety.
ABOUT ANYARA
ANYARA is a TTS (Tumor Targeting Superantigen) compound that makes the treatment
of cancer tumor-specific. The development of ANYARA is mainly focused on renal
cell cancer. Positive data was reported from clinical Phase I trials in lung
cancer, renal cell cancer and pancreatic cancer. In July 2009, the results from
two Phase I studies of ANYARA were published in the Journal of Clinical
Oncology, where ANYARA was studied both as a single agent (monotherapy) and in
combination with an established tumor therapy - docetaxel (Taxotere®) - in
patients with advanced cancer. The results showed that ANYARA was well tolerated
both as monotherapy and in combination with docetaxel. ANYARA has been granted
orphan-drug status by the EMA for the indication renal cell carcinoma.
ABOUT RENAL CELL CARCINOMA
Renal Cell Carcinoma (RCC) affects approximately 180,000 people worldwide each
year. Approximately 50 % of the patients are affected by metastases. If the
disease has metastasized, average survival is around 2 years. The survival rate
of patients diagnosed with renal cancer is only 5-15% after five years. The
market for treatment of RCC is estimated at approximately USD 2.7 billion per
year (EvaluatePharma March 2012). Approved first line treatments are Sutent,
Avastin in combination with IFN, Torisel and Votrient. Approved for second line
treatment are Nexavar and Everolimus.
ABOUT ACTIVE BIOTECH
Active Biotech AB (NASDAQ OMX NORDIC: ACTI) is a biotechnology company with
focus on autoimmune/inflammatory diseases and cancer. Projects in pivotal phase
are laquinimod, an orally administered small molecule with unique
immunomodulatory properties for the treatment of multiple sclerosis, tasquinimod
for prostate cancer and ANYARA primarily for the treatment of renal cell cancer.
In addition, laquinimod is also in Phase II development for Crohn's and Lupus.
The company also has one additional project in clinical development, the orally
administered compound paquinimod (57-57) for systemic sclerosis. Please visit
www.activebiotech.com for more information.
For further information:
Active Biotech
Tomas Leanderson, President & CEO
Tel: +46 46 19 20 95
tomas.leanderson(at)activebiotech.com
Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, SE-220 07 Lund
Tel: +46 46 19 20 00
Fax: +46 46 19 11 00
Active Biotech's Safe Harbor Statement in Accordance with the Swedish Securities
Market Act
This press release contains certain forward-looking statements. Such forward-
looking statements involve known and unknown risks, uncertainties and other
important factors that could cause the actual results, performance or
achievements of the company, or industry results, to differ materially from any
future results, performance or achievement implied by the forward-looking
statements. The company does not undertake any obligation to update or publicly
release any revisions to forward-looking statements to reflect events,
circumstances or changes in expectations after the date of this press release.
Active Biotech is obligated to publish the information contained in this press
release in accordance with the Swedish Securities Market Act. This information
was provided to the media for publication 3:00 pm CET on June 3, 2013.
Active Biotech?s project ANYARA improved overall survival in a subgrou:
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[HUG#1706561]
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Datum: 03.06.2013 - 15:01 Uhr
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