Study Supports Activity of GEMZAR(R) (Gemcitabine HC1 for Injection) in the Treatment of Early-Stage Breast Cancer



    Five Phase III Early-Stage Breast Cancer Studies Underway With GEMZAR

    CHICAGO, June 2 /CNW/ -- GEMZAR(R) (gemcitabine HC1 for injection),
approved in combination with paclitaxel (Taxol(R)) in the first- line,
post-surgical treatment of metastatic breast cancer, was the subject of a
study presented today with encouraging results in the pre-surgical treatment
of breast cancer. The study was presented at the 43rd Annual Meeting of the
American Society of Clinical Oncology (ASCO).
    Results showed that adding GEMZAR to the current standard-of-care
treatment was a promising regimen for patients with stage II-III breast
cancer. Eli Lilly and Company, the manufacturer and marketer of GEMZAR, also
cited five completed or ongoing Phase III trials which will further study
GEMZAR as a chemotherapeutic foundation for the treatment of early-stage
breast cancer.
    Today's Phase II study (Abstract No. 595(i)) evaluated the addition of
GEMZAR to the current standard-of-care of epirubicin and cyclophosphamide
followed by paclitaxel in patients with stage II-III breast cancer. The
treatment schedule was a dose-dense sequential neoadjuvant (pre-surgical)
chemotherapy combination, meaning that the combination was administered at
shorter intervals between treatments. Results showed a promising regimen in
terms of pathologic complete response (pCR-the absence of invasive tumor in
the breast). In addition, patients who tested positive for the HER-2 gene also
were given trastuzumab (Herceptin(R)) and demonstrated additional response.
    "The data released today reflects our ongoing, aggressive research plan
involving GEMZAR as a key therapeutic foundation for the treatment of breast
cancer," said Allen Melemed, M.D., medical director, global oncology at Lilly.
"We are encouraged with the activity GEMZAR has shown in this breast cancer
study."
    Enrollment has been completed in one trial, and is ongoing in an
additional four, Phase III early-stage breast cancer studies evaluating the
addition of GEMZAR to commonly-used treatment regimens. Two adjuvant (post-
surgical) therapy trials, NSABP B-38 (4,400 patients) and TANGO (3,000
patients), will compare the addition of GEMZAR to the paclitaxel arm of each
study. A third adjuvant trial, SUCCESS (3,600 patients), will compare the
addition of GEMZAR to a docetaxel-based regimen. Two additional trials, which
are neoadjuvant specific, NSABP B-40 (1,200 patients) and Neo-TANGO (800
patients), will evaluate the addition of GEMZAR to the paclitaxel or docetaxel
arm of the treatment regimen. For more information on these studies, log on to
www.lillytrials.com or www.clinicaltrials.gov.

    More About ASCO Abstract No. 595

    The trial enrolled stage II-III breast cancer patients (with a median age
of 45), including inflammatory tumors, a type of breast cancer that causes the
breast to swell, redden and feel warm. Of the 73 patients enrolled in the
study, 42 (57.5%) were classified as T2; 12 (16.5%) as T3, and; 19 (26%) as
T4, which included 13 patients with inflammatory tumors. A T-classification
represents the stage of the tumor with T4 being the most advanced. A biopsy
was performed before treatment for the biomarker component of the study.
    Patients received a first sequence of epirubicin and cyclophosphamide
(90/600 mg/m squared) for three cycles followed by a second sequence of
paclitaxel and GEMZAR (150/2500 mg/m squared) for six cycles. Treatment was
administered on day one, every two weeks, with growth factor support. HER-2
positive patients (20 patients, 27.3%), were given trastuzumab (2 mg/kg with a
loading dose 4 mg/kg) concomitantly. Afterward, the patients underwent
surgery, radiotherapy and adjuvant hormonal therapy according to institutional
practice.
    All patients from the study showed response to the regimen. Of the entire
study group, 27 (36.9%) patients achieved a pCR (absence of invasive tumor in
the breast), with 50% representation from the HER-2 positive patients who also
were given trastuzumab. Forty-seven patients (64.4%) underwent conservative
surgery.
    The grade 3/4 hematological toxicities were: leukopenia in six patients
(9%); neutropenia (a decrease in white blood cells) in eight patients (12%),
and; anemia (a decrease in red blood cells) in one (2%). Nausea (13%) and
vomiting (15%) were the most frequent grade 3/4 non-hematological toxicities.
Asymptomatic decrease in cardiac ejection fraction was observed in one patient
treated with trastuzumab with subsequent normalization.

    About Breast Cancer

    Breast cancer is the most common form of cancer among women, affecting
nearly one out of every eight women.(ii)  The disease is diagnosed in more
than 1.1 million women worldwide each year.(iii)  Breast cancer progresses in
stages based on tumor size, how the cancer affects the lymph nodes and whether
it has metastasized to other parts of the body.(iv)  In general, individuals
with earlier stages of disease have better chances for long-term survival and
recovery.


    GEMZAR

    Indications

    GEMZAR in combination with paclitaxel is indicated for the first-line
treatment of patients with metastatic breast cancer after failure of prior
anthracycline-containing adjuvant chemotherapy, unless anthracyclines were
clinically contraindicated.
    GEMZAR is indicated in combination with cisplatin for the first-line
treatment of patients with inoperable, locally advanced (stage IIIA or IIIB),
or metastatic (stage IV) non-small cell lung cancer.
    GEMZAR is indicated as first-line treatment for patients with locally
advanced (nonresectable stage II or stage III) or metastatic (stage IV)
adenocarcinoma of the pancreas. GEMZAR is indicated for patients previously
treated with 5-FU.
    GEMZAR in combination with carboplatin is indicated for the treatment of
patients with advanced ovarian cancer that has relapsed at least 6 months
after completion of platinum-based therapy.

    Important Safety Information for GEMZAR

    Myelosuppression is usually the dose-limiting toxicity with GEMZAR
therapy.

    Contraindication

    Known hypersensitivity to GEMZAR. Anaphylactoid reaction has been
reported rarely.

    Warnings

    Infusion times of GEMZAR longer than 60 minutes and more frequent than
weekly dosing have been shown to increase toxicity.
    Pulmonary toxicity has been reported with the use of GEMZAR. In cases of
severe lung toxicity, GEMZAR therapy should be discontinued immediately and
appropriate supportive care measures instituted.
    Hemolytic Uremic Syndrome (HUS) and/or renal failure have been reported
following one or more doses of GEMZAR. Renal failure leading to death or
requiring dialysis, despite discontinuation of therapy, has been rarely
reported. The majority of the cases of renal failure leading to death were due
to HUS.
    Serious hepatotoxicity, including liver failure and death, has been
reported very rarely in patients receiving GEMZAR alone or in combination with
other potentially hepatotoxic drugs.
    GEMZAR is Pregnancy Category D. GEMZAR can cause fetal harm when
administered to a pregnant woman.

    Precautions

    Use caution in patients with pre-existing renal impairment or hepatic
insufficiency. Administration of GEMZAR may exacerbate underlying hepatic
insufficiency.
    The optimum regimen for safe administration of GEMZAR with therapeutic
doses of radiation has not yet been determined in all tumor types. GEMZAR has
radiosensitizing activity and radiation recall reactions have been reported.
    It is not known whether GEMZAR or its metabolites are excreted in human
milk.
    The effectiveness of GEMZAR in pediatric patients has not been
demonstrated.
    The toxicities of GEMZAR observed in pediatric patients were similar to
those reported in adults.
    GEMZAR clearance is affected by age as well as gender.
    Patients receiving therapy with GEMZAR should be monitored closely by a
physician experienced in the use of cancer chemotherapeutic agents.

    Monitoring and Dosage Modifications
    Dosage adjustments for hematologic toxicity may be required.

    Serum creatinine, potassium, calcium, and magnesium should be monitored
during combination therapy with cisplatin.
    Patients should be assessed with a CBC, including differential and
platelet count, prior to each dose of GEMZAR. Modify or suspend therapy
according to the Dosage Reduction Guidelines in the full Prescribing
Information.
    Hepatic and renal function (including transaminases and serum creatinine)
should be evaluated prior to therapy with GEMZAR and periodically thereafter.

    Adverse Events

    The most severe adverse events (grades 3/4) with GEMZAR plus paclitaxel
for the treatment of patients with MBC were neutropenia (48%); alopecia (18%);
leukopenia (11%); anemia (7%); fatigue (7%); thrombocytopenia (6%); ALT
elevation (6%); and neuropathy-sensory (6%). The most common adverse events
(all grades) were nausea (50%); fatigue (40%); myalgia (33%); and vomiting
(29%). The most severe adverse events (grades 3/4) with GEMZAR for the first-
line treatment of patients with pancreatic cancer were neutropenia (24%-26%);
alkaline phosphatase elevation (16%-20%); AST elevation (12%-17%);
nausea/vomiting (12%-13%); ALT elevation (10%-11%); anemia (10%); leukopenia
(9%-10%); thrombocytopenia (8%-10%); bilirubin elevation (4%-8%); and pain
(2%-7%). The most common adverse events (all grades) were AST (72%-78%);
alkaline phosphatase (71%-77%); anemia (65%-73%); ALT (72%); leukopenia (64%-
71%); nausea and vomiting (64%-71%); neutropenia (61%-62%); thrombocytopenia
(36%-47%); pain (10%-42%); fever (30%-38%); proteinuria (10%-32%);
constipation (10%-31%); diarrhea (24%-30%); rash (24%-28%); and bilirubin
(16%-26%).
    The most severe adverse events (grades 3/4) with GEMZAR plus cisplatin
for the first-line treatment of patients with NSCLC were neutropenia
(57%-64%); thrombocytopenia (50%-55%); leukopenia (29%-46%); anemia (22%-25%);
nausea (27%); vomiting (23%); nausea/vomiting (39%); neuromotor (12%);
hypomagnesemia (7%);  neurohearing (6%); creatinine elevation (5%); alopecia
(1%-13%); and dyspnea (1%-7%). The most common adverse events (all grades)
were paresthesias (38%); hyperglycemia (30%); infection (18%-28%); and
constipation (17%-28%).
    The most severe adverse events (grades 3/4) with GEMZAR plus carboplatin
for the treatment of patients with advanced ovarian cancer were neutropenia
(71%), thrombocytopenia (35%), leukopenia (53%), anemia (28%), nausea (6%),
vomiting (6%), and constipation (7%). The most common adverse events (all
grades) were RBC transfusion (38%), alopecia (49%), neuropathy/sensory (29%),
nausea (69%), fatigue (40%), vomiting (46%), diarrhea (25%), and constipation
(42%).
    See complete Warnings, Precautions, Adverse Reactions, and Dosage and
Administration sections in the accompanying full Prescribing Information for
safety and dosing guidelines.

    About Lilly Oncology, a Division of Eli Lilly and Company

    For more than four decades, Lilly Oncology has been collaborating with
cancer researchers to deliver innovative treatment choices and valuable
programs to patients and their physicians. Inspired by courageous patients
living with cancer, Lilly Oncology is providing treatments that are considered
global standards of care and developing a broad portfolio of novel targeted
therapies to accelerate the pace and progress of cancer care. To learn more
about Lilly's commitment to cancer, please visit www.LillyOncology.com.

    About Eli Lilly and Company

    Lilly, a leading innovation-driven corporation, is developing a growing
portfolio of first-in-class and best-in-class pharmaceutical products by
applying the latest research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered in
Indianapolis, Ind., Lilly provides answers - through medicines and information
- for some of the world's most urgent medical needs.

    
     P-LLY

     ALIMTA(R) (pemetrexed for injection), Lilly
     GEMZAR(R) (gemcitabine HCl for injection), Lilly
     Taxol(R) (paclitaxel), Bristol-Myers Squibb
     Herceptin(R) (trastuzumab), Genentech
    

    This press release contains forward-looking statements about the
potential of GEMZAR for the treatment of breast cancer and reflects Lilly's
current beliefs. However, as with any pharmaceutical product under
development, there are substantial risks and uncertainties in the process of
development, commercialization, and regulatory review. There is no guarantee
that the product will receive additional regulatory approvals. There is also
no guarantee that the product will continue to be commercially successful. For
further discussion of these and other risks and uncertainties, see Lilly's
filing with the United States Securities and Exchange Commission.  Lilly
undertakes no duty to update forward-looking statements.

    (i) Sanchez-Munoz A, Duenos-Garcia R, et al. Neoadjuvant chemotherapy
with a dose-dense sequential combination of epirubicin and cyclophosphamide
followed by paclitaxel and gemcitabine +/- trastuzumab in stage II and III
breast cancer. Correlation between pathologic complete response and biologic
markers. Abstract No.595, American Society of Clinical Oncology (ASCO) Annual
Meeting 2007.
    (ii) American Cancer Society, "What Are the Key Statistics for Breast
Cancer?," American Cancer Society, www.cancer.org, (May 2, 2007).
    (iii) Pan American Health Organization, "Guidelines for International
Breast Health and Cancer Control," www.paho.org, (March 21, 2006).
    (iv) American Cancer Society, "How is Breast Cancer Staged?," American
Cancer Society, www.cancer.org (February 28, 2007).

    (Logo: http://www.newscom.com/cgi-bin/prnh/20031219/LLYLOGO)





For further information:

For further information: Gregory L. Clarke, Lilly, +1-317-276-5222 
(office), +1-317-554-7119 (mobile), gregory.clarke@lilly.com; or Neil 
Hochman, CPR Worldwide, +1-212-453-2067 (office), +1-516-784-9089 (mobile), 
n.hochman@cprworldwideusa.com


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