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WO2016094341A1 - Thérapie à triple combinaison, comportant du ganetespib, un taxane et un anticorps, pour utilisation dans le traitement de cancer du sein her2 positif - Google Patents

Thérapie à triple combinaison, comportant du ganetespib, un taxane et un anticorps, pour utilisation dans le traitement de cancer du sein her2 positif Download PDF

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Publication number
WO2016094341A1
WO2016094341A1 PCT/US2015/064379 US2015064379W WO2016094341A1 WO 2016094341 A1 WO2016094341 A1 WO 2016094341A1 US 2015064379 W US2015064379 W US 2015064379W WO 2016094341 A1 WO2016094341 A1 WO 2016094341A1
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WO
WIPO (PCT)
Prior art keywords
subject
her2
paclitaxel
trastuzumab
breast cancer
Prior art date
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PCT/US2015/064379
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English (en)
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WO2016094341A8 (fr
Inventor
David Proia
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Synta Pharmaceuticals Corp.
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Publication date
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Publication of WO2016094341A1 publication Critical patent/WO2016094341A1/fr
Publication of WO2016094341A8 publication Critical patent/WO2016094341A8/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Definitions

  • This invention relates to a combination therapy comprising ganetespib, a taxane, and a monoclonal antibody that interferes with the HER2/neu receptor, pharmaceutical
  • BC HER2-positive breast cancer
  • the method comprises the steps of:
  • the subject is determined not to have HER2- positive breast cancer (BC)
  • said subject is treated with a drug or therapy other than ganetespib/paclitaxel/trastuzumab.
  • compositions comprising:
  • the pharmaceutical composition can be used for treating patients with HER2-positive breast cancer.
  • composition in the preparation of a medicament for the treatment of HER2-positive breast cancer in a subject, wherein said composition comprises:
  • ganetespib or a
  • ganetespib or a pharmaceutically acceptable salt thereof for use in combination with i) an effective amount of an taxane, or a pharmaceutically acceptable salt thereof; and ii) an effective amount of a monoclonal antibody that interferes with the HER2/neu receptor for the treatment of HER2-positive breast cancer in a subject.
  • Figure 2 is a bar graph showing the most common ganetespib-related grades 1/2 adverse events in > 20% of patients.
  • Figure 3 is a line graph showing mean paclitaxel concentration versus time profile (log-linear axis) for the disclosed combination therapy.
  • Preliminary paclitaxel PK data for the first four patients was not appreciably different from those reported in the literature (see Maier-Lenz H, et al. Semin Oncol, 1997; 24 (suppl 19): S 19- 16-19- 19; Mross K, et al.
  • Paclitaxel PK Parameters included: AUC: 5922 h*ng/mL, tl/2: 11.9 h, Cmax: 3308 ng/niL, CI: 13.1 L/h/ m2, MRT: 4.3 h.
  • ganetespib in combination with other chemotherapeutic agents is particularly effective in treating certain specific types of breast cancer, such as HER2- positive breast cancer.
  • the HER2-positive breast cancer is metastatic HER2-positive breast cancer (MBC).
  • MBC metastatic HER2-positive breast cancer
  • the particular dosing regimens disclosed herein demonstrate potency against HER2-positive breast cancer, while showing minimal side effects (see Figure 2).
  • the method comprises administering the combination of the invention to a subject that has been previously treated with an anti-HER2 agent.
  • the anti-HER2 agent is trastuzumab.
  • the HER2- positive breast cancer is trastuzumab refractory.
  • the terms “treat”, “treatment”, and “treating” also include the reduction of the risk of recurrence of cancer or the delay or inhibition of the recurrence of cancer.
  • the terms “treat”, “treatment”, and “treating” includes the inhibition of the progression of cancer either physically by the stabilization of a discernible symptom, physiologically by the stabilization of a physical parameter, or both.
  • the terms “treat”, “treatment”, and “treating” of cancer include the reduction or stabilization of tumor size or cancerous cell count.
  • HER2-positive breast tumor or breast cancer refers to a breast cancer or breast tumor comprising cells that have HER2 protein present at their cell surface.
  • HER2 protein may be overexpressed, e.g., by gene amplification.
  • an antibody that interferes with HER2/neu receptor is an antibody that interacts with the HER2/neu receptor and, in doing so, inhibits its function. These agents are sometimes referred to as “anti-HER2 agents”. Accordingly, the terms “an antibody that interferes with HER2/neu receptor” and “anti-HER2 agent” are interchangeably used herein.
  • sample includes any bodily fluid (e.g., urine, serum, blood fluids, lymph, gynecological fluids, cystic fluid, ascetic fluid, ocular fluids, and fluids collected by bronchial lavage and/or peritoneal rinsing), ascites, tissue samples (e.g., tumor samples) or a cell from a subject.
  • Other subject samples include tear drops, serum, cerebrospinal fluid, feces, sputum, and cell extracts.
  • the sample is removed from the subject.
  • the sample is urine or serum.
  • the sample comprises cells.
  • the sample does not comprise cells.
  • the sample can be the portion of the subject that is imaged. Samples are typically removed from the subject prior to analysis; however, tumor samples can be analyzed in the subject, for example, using imaging or other detection methods.
  • relapse is understood as the return of a cancer or the signs and symptoms of a cancer after a period of improvement.
  • the term "subject” refers to human and non-human animals, including veterinary subjects.
  • the term "non-human animal” includes all vertebrates, e.g., mammals and non-mammals, such as non-human primates, mice, rabbits, sheep, dog, cat, horse, cow, chickens, amphibians, and reptiles.
  • the subject is a human and may be referred to as a patient.
  • the compound of Formula (I) is in a tautomeric form of the compound of Formula (I).
  • the language "tautomer of a compound of Formula (I)” includes all tautomeric forms of the compound of Formula (I).
  • the tautomer of the compound of Formula (I) is the compound of Formula (la):
  • the taxanes are anti-cancer agents that include paclitaxel (Taxol ) and docetaxel
  • taxane is defined herein to mean a compound with a taxane core:
  • taxanes include, but are not limited to, carbazitaxel, tesetaxel, opaxio, larotaxel, taxoprexin, BMS-184476, hongdoushan A, hongdoushan B, and hongdoushan C, and others.
  • the combination therapy comprises a taxane selected from paclitaxel, docetaxel, carbazitaxel, tesetaxel, opaxio, larotaxel, taxoprexin, BMS- 184476, hongdoushan A, hongdoushan B, and hongdoushan C.
  • the taxane is paclitaxel or docetaxel.
  • taxanes bound to or pendent from a pharmaceutically acceptable polymer, such as a polyacrylamide are well known in the art.
  • taxane as used herein includes such polymer linked taxanes.
  • the combination therapy comprises administering:
  • the combination therapy comprises administering:
  • the combination therapy comprises administering:
  • an effective amount includes an amount of any drug that is sufficient to treat the cancer, to reduce or ameliorate the severity, duration, or progression of cancer, to retard or halt the advancement of cancer, to cause the regression of cancer, to delay the recurrence, or progression of a symptom associated with cancer, or to enhance or improve the therapeutic effect(s) of another therapy.
  • an effective amount can induce, for example, a complete response, a partial response, or a stable disease state; as determined, for example, using RESIST criteria.
  • an "effective amount” to the subject will depend on the mode of administration, the type, and severity of the cancer, and on the characteristics of the subject, such as general health, age, sex, body weight, and tolerance to drugs. The skilled artisan will be able to determine appropriate dosages depending on these and other factors.
  • an "effective amount" of any additional therapeutic agent(s) will depend on the type of drug used.
  • Suitable dosages are known for approved therapeutic agents and can be adjusted by the skilled artisan according to the condition of the subject, the type of condition(s) being treated and the amount of a compound of the invention being used by following, for example, dosages reported in the literature and recommended in the Physician 's Desk Reference (57th ed., 2003).
  • the dosage of an individual agent used in combination therapy may be equal to or lower than the dose of an individual therapeutic agent when given independently to treat, manage, or ameliorate a disease or disorder, or one or more symptoms thereof.
  • the amount of the compound of Formula (I) administered is from about 2 mg/m 2 to about 500 mg/m 2 , for example, from about 50 mg/m 2 to about 500 mg/m 2 , from about 100 mg/m 2 to about 500 mg/m 2 , from about 125 mg/m 2 to about 500 mg/m 2 , from about 150 mg/m 2 to about 500 mg/m 2 or from about 175 mg/m 2 to about 500 mg/m 2.
  • the amount of the compound of Formula (I) administered is about 50 mg/m to 2 2 2 2 about 200 mg/m , about 100 mg/m to about 200 mg/m , from about 125 mg/m to about 200
  • the amount of the compound of Formula (I) administered is
  • the amount of the taxane administered is about from about 50
  • the amount of the taxane administered is about 200 mg/m . In a certain embodiment, the amount of the taxane administered
  • 2 2 2 2 2 is about 70 mg/m to about 90 mg/m or about 50 mg/m to about 100 mg/m .
  • the amount of the monoclonal antibody that interferes with the HER2/neu receptor (e.g. , trastuzumab) administered is from about 0.1 mg/m to
  • the styrene foam to about 10 mg/m , or from about 2 mg/m to about 10 mg/m .
  • the styrene foam to about 10 mg/m , or from about 2 mg/m to about 10 mg/m .
  • the HER2/neu receptor administered is about 1.5 mg/m to about 2.5 mg/m .
  • ganetespib is administered at a dose of 2 - 500 mg/m ; the taxane
  • the HER2/neu receptor is administered at a dose of 0.1 - 10 mg/m .
  • ganetespib is administered at a dose of 50 - 200 mg/m ;
  • taxane is administered at a dose of 50 - 100 mg/m ; and the monoclonal antibody that
  • HER2/neu receptor interferes with the HER2/neu receptor is administered at a dose of 0.5 - 5 mg/m .
  • ganetespib is administered at a dose of 100 - 150 mg/m ;
  • taxane is administered at a dose of 70 - 90 mg/m ; and the monoclonal antibody thai interferes with the HER2/neu receptor is administered at a dose of 1.5 - 2.5 mg/m .
  • ganetespib is administered at a dose of 100- 150 mg/m ;
  • the disclosed combination therapy is cyclically administered for 28 days.
  • the disclosed combination therapy is administered for a first period of time, followed by a "dose-free" period, then administered for a second period of time.
  • the second administration can be followed by a second "dose-free" period, then administered for a third period of time, followed by a "dose-free” period, then administered for a fourth period of time, followed by a "dose-free” period, then administered for a fifth period of time.
  • dose-free includes the period of time in between, for example, the first dosing period and the second dosing period in which the disclosed combination therapy is not administered to the subject.
  • a preferred cycle is administering the disclosed combination therapy for 28-days at a dose described above, wherein ganetespib, paclitaxel, and trastuzumab are administered on days 1, 8, and 15, and administering paclitaxel and trastuzumab are administered on day 22.
  • administration on days 1, 8, and 15 of the cycle comprises the steps of:
  • trastuzumab administered at a dose of 0.5 - 5 mg/m .
  • administration on day 22 of the cycle comprises the steps of:
  • trastuzumab (2) administering trastuzumab at a dose of 0.5 - 5 mg/m .
  • This cycle can then repeated, as described below.
  • the language "one cycle” includes the first period of time during which the disclosed combination therapy is administered, followed by a dose-free period of time.
  • the dosing cycle can be repeated and one of skill in the art will be able to determine the appropriate length of time for such a cyclical dosing regimen.
  • the cycle is repeated at least once.
  • the cycle is repeated two or more times.
  • the cycle is repeated 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 or more times, or as many times as medically necessary as determined by one of skill in the art, e.g. , as long as the subject exhibits a response with no dose limiting toxicities.
  • the cycle is repeated until the patient has been determined to be in partial remission (e.g., 50% or greater reduction in the measurable parameters of tumor growth) or complete remission (e.g., absence of cancer).
  • partial remission e.g. 50% or greater reduction in the measurable parameters of tumor growth
  • complete remission e.g., absence of cancer
  • a first therapeutic agent such as a compound described herein, can be administered prior to (e.g., 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 1 week or 2 week before), concomitantly with, or subsequent to (e.g., 5 minutes, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 12 hours, 24 hours, 48 hours, 72 hours, 96 hours, 1 week or 2 weeks after) the administration of a second therapeutic agent or treatment, such as an anti-cancer agent, to a subject with cancer.
  • a second therapeutic agent or treatment such as an anti-cancer agent
  • one agent may be administered more frequently than the other agent such that multiple doses of one agent are administered for each dose of the other agent(s).
  • the disclosed combination therapy can be administered to a subject by routes known to one of skill in the art.
  • routes of administration include, but are not limited to, parenteral, e.g., intravenous, intradermal, subcutaneous, oral, intranasal (e.g., inhalation), transdermal, topical, transmucosal, and rectal administration.
  • parenteral e.g., intravenous, intradermal, subcutaneous, oral, intranasal (e.g., inhalation), transdermal, topical, transmucosal, and rectal administration.
  • Each of the agents can be administered by the same or by different routes of administration.
  • each of the agents is administered by intravenous infusion.
  • compositions that include the disclosed combination therapy, and typically at least one additional substance, such as an excipient, a known therapeutic other than those of the present disclosure, and combinations thereof.
  • the pharmaceutical composition of the invention is formulated to be compatible with its intended route of administration.
  • the composition is formulated in accordance with routine procedures as a pharmaceutical composition adapted for intravenous, subcutaneous, intramuscular, oral, intranasal, or topical administration to human beings.
  • the pharmaceutical composition is formulated for intravenous administration.
  • the compound of Formula (I) is formulated at a concentration of 8 mg/niL in 90%v/v PEG 300 and 10% v/v Polysorbate 80 for intravenous administration.
  • Pharmaceutically acceptable formulations of the compound of Formula (I), and the preparations thereof, can be found in U.S. Patent Publication No. US 2013/0172333, incorporated herein by reference.
  • the subject is identified as having HER2-positive metastatic breast cancer that is trastuzumab refractory.
  • the term "refractory” cancer or tumor is understood as a malignancy that is either initially unresponsive to chemo- or radiation therapy, or which becomes unresponsive over time.
  • "trastuzumab refractory” refers to a cancer or tumor that is initially unresponsive to trastuzumab, or which becomes unresponsive trastuzumab over any given period of time.
  • a cancer refractory to a given intervention may not be refractory to all interventions.
  • a refractory cancer is typically not amenable to treatment with surgical interventions.
  • detecting As used herein, "detecting”, “detection” and the like are understood that an assay performed for identification of a specific analyte in a sample, e.g., a gene or gene product with a mutation, or the expression level of a gene or gene product in a sample, typically as compared to an appropriate control cell or tissue.
  • the specific method of detection used is not a limitation of the invention. The detection method will typically include comparison to an appropriate control sample.
  • identify or “select” refer to a choice in preference to another.
  • identify a subject or select a subject is to perform the active step of picking out that particular subject from a group and confirming the identity of the subject by name or other distinguishing feature.
  • identifying a subject or selecting a subject as having one or more mutations in one or more genes of interest, having a wild-type gene, or having a change in the expression level of a protein can include any of a number of acts including, but not limited to, performing a test and observing a result that is indicative of a subject having a specific mutation; reviewing a test result of a subject and identifying the subject as having a specific mutation; reviewing documentation on a subject stating that the subject has a specific mutation and identifying the subject as the one discussed in the documentation by confirming the identity of the subject e.g., by an identification card, hospital bracelet, asking the subject for his/her name and/or other personal information to confirm the subjects identity.
  • control samples can be diluted, for example, in a dilution series to allow for quantitative measurement of analytes in test samples.
  • a control sample may include a sample derived from one or more subjects.
  • a control sample may also be a sample made at an earlier time point from the subject to be assessed.
  • the control sample could be a sample taken from the subject to be assessed before the onset of the cancer, at an earlier stage of disease, or before the administration of treatment or of a portion of treatment.
  • the control sample may also be a sample from an animal model, or from a tissue or cell lines derived from the animal model, of the cancer.
  • the level of signal detected or protein expression in a control sample that consists of a group of measurements may be determined, e.g., based on any appropriate statistical measure, such as, for example, measures of central tendency including average, median, or modal values.
  • Adequate renal function as defined by a serum creatinine ⁇ 1.5 x ULN.
  • contraception e.g. , hormonal or barrier method of birth control; abstinence
  • Female subjects of childbearing age must have a negative serum pregnancy test at study entry.
  • HrV/AIDS Patients with HrV/AIDS are allowed on study if they have an undetectable viral load, CD4 > 300 and are on a stable Highly Active Antiretroviral Therapy (HAART) regimen for 1 month prior to study enrollment.
  • HAART Highly Active Antiretroviral Therapy
  • Patients are required to have HER2+ breast cancer defined as a FISH- ratio of > 2.0 or IHC 3+.
  • Metastatic patients who have not received ado-trastuzumabemtansine are eligible if: Heavily pretreated prior to FDA approval of ado-trastuzumab emtansine (22-Feb-2013) for the treatment of patients with HER2+ MBC who previously received trastuzumab and a taxane, separately or in combination. No prior history of intolerance or hypersensitivity to trastuzumab and/or adverse events related to trastuzumab, murine proteins, or any of the excipients that resulted in trastuzumab being permanently discontinued. Exclusion Criteria
  • SSRls include escitalopram oxalate, citalopram, fluvoxamine, paroxetine, sertraline and fluoxetine).
  • Uncontrolled systemic disease e.g. , clinically significant cardiac, pulmonary or metabolic disease.
  • AV atrioventricular
  • LBBB o Complete left bundle branch block
  • Brain metastases that are:
  • o Have required any type of therapy (including radiation, surgery or steroids) to control symptoms from brain metastases within 60 days prior to the first study treatment.
  • CR Complete Response
  • Not Evaluable (NE) is when no imaging/measurement is done at all at a particular time point. The patient is not evaluable (NE) at that time point.
  • ganetespib with paclitaxel and trastuzumab in pre-treated HER2+ MBC patients was well-tolerated with expected and manageable main toxicities of grades 1/2 diarrhea and fatigue (see Figure 2 and Table 2).
  • the MTD of weekly ganetespib in this triplet combination is 150 mg/m .
  • Preliminary paclitaxel PK data are consistent with those reported in literature (see Figure 3). Despite prior taxanes, pertuzumab, and T-DM1, the CBR in this heavily pre-treated cohort of patients was 50%.

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Abstract

La présente invention concerne une thérapie de combinaison comprenant du ganetespib, un taxane, et un anticorps monoclonal qui interfère avec le récepteur HER2/neu, des compositions pharmaceutiques en comportant, et des procédés d'utilisation, par exemple, pour traiter des êtres humains atteints d'un cancer du sein HER2-positif.
PCT/US2015/064379 2014-12-08 2015-12-08 Thérapie à triple combinaison, comportant du ganetespib, un taxane et un anticorps, pour utilisation dans le traitement de cancer du sein her2 positif WO2016094341A1 (fr)

Applications Claiming Priority (2)

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US201462088853P 2014-12-08 2014-12-08
US62/088,853 2014-12-08

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WO2016094341A1 true WO2016094341A1 (fr) 2016-06-16
WO2016094341A8 WO2016094341A8 (fr) 2016-09-15

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012155063A1 (fr) * 2011-05-11 2012-11-15 Synta Pharmaceuticals Corp. Traitement du cancer avec un composé inhibiteur de hsp90
WO2013055874A2 (fr) * 2011-10-14 2013-04-18 Genentech, Inc. Utilisations d'un article de manufacture comprenant du pertuzumab inhibiteur de dimérisation de her2 et article manufacture comprenant du pertuzumab inhibiteur de dimérisation de her2
WO2013170182A1 (fr) * 2012-05-11 2013-11-14 Synta Pharmaceuticals Corp. Traitement d'un cancer au moyen d'un composé inhibiteur de hsp90

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012155063A1 (fr) * 2011-05-11 2012-11-15 Synta Pharmaceuticals Corp. Traitement du cancer avec un composé inhibiteur de hsp90
WO2013055874A2 (fr) * 2011-10-14 2013-04-18 Genentech, Inc. Utilisations d'un article de manufacture comprenant du pertuzumab inhibiteur de dimérisation de her2 et article manufacture comprenant du pertuzumab inhibiteur de dimérisation de her2
WO2013170182A1 (fr) * 2012-05-11 2013-11-14 Synta Pharmaceuticals Corp. Traitement d'un cancer au moyen d'un composé inhibiteur de hsp90

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ANONYMOUS: "NCT02060253 on 2014_12_07: ClinicalTrials.gov Archive", 7 December 2014 (2014-12-07), XP055251796, Retrieved from the Internet <URL:https://clinicaltrials.gov/archive/NCT02060253/2014_12_07> [retrieved on 20160219] *
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KOMAL JHAVARI ET AL: "A Phase I Clinical Trial of Ganetespib (Heat shock protein 90 inhibitor) in Combination with Paclitaxel and Trastuzumab in Human Epidermal Growth Factor Receptor-2 Positive (HER2+) Metastatic Breast Cancer", SAN ANTONIO BREAST CANCER SYMPOSIUM, 8 December 2014 (2014-12-08), XP055251851, Retrieved from the Internet <URL:http://www.syntapharma.com/documents/2014SABCS_Ganetespib.pdf> [retrieved on 20160219] *
KOMAL JHAVERI ET AL: "Abstract P5-19-23: A phase I clinical trial of ganetespib (heat shock protein 90 inhibitor) in combination with paclitaxel and trastuzumab in human epidermal growth factor receptor-2 positive (HER2+) metastatic breast cancer", CANCER RESEARCH, vol. 75, no. 9 Supplement, 1 May 2015 (2015-05-01), US, pages P5-19-23 - P5-19-23, XP055251721, ISSN: 0008-5472, DOI: 10.1158/1538-7445.SABCS14-P5-19-23 *
MAIER-LENZ H ET AL., SEMIN ONCOL, vol. 24, no. 19, 1997, pages 19.16 - 19.19
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