Amgen Highlights Key Clinical Data to Be Presented at American Society of Clinical Oncology Annual Meeting
First Presentation of Results from a Pivotal, Phase 3 Head-to-Head Denosumab Bone Metastases Advanced Prostate Cancer Trial
First Integrated Analysis from Two Phase 3 Head-to-Head Denosumab Trials in Advanced Cancer Patients (Breast Cancer and Solid Tumors including Multiple Myeloma)
First Presentations of Phase 2 Data from AMG 479 in Pancreatic Cancer and AMG 386 in Ovarian Cancer
THOUSAND OAKS, Calif., May 20, 2010 /PRNewswire via COMTEX/ --Amgen (Nasdaq: AMGN) today announced that results from studies involving nine molecules in the Company's oncology portfolio will be presented at the 2010 American Society of Clinical Oncology (ASCO) Annual Meeting, June 4- 8, 2010 in Chicago.
"Cancer is a complex disease that requires a comprehensive approach. Our goal is to help patients battle cancer by leveraging our understanding of cancer biology and pharmacogenomics to develop more targeted therapies, while building on our legacy of discovering and delivering supportive care products that help lessen the side effects of cancer treatment," said Sean Harper, M.D., chief medical officer of Amgen. "The data presented at this year's ASCO Annual Meeting demonstrate Amgen's commitment towards this goal."
Abstracts are available on the ASCO website at http://abstract.asco.org/ and updated data will be presented at the meeting.
SELECTED ABSTRACTS OF INTEREST
Denosumab versus zoledronic acid for treatment of bone metastases in patients with castration-resistant prostate cancer
(Late Breaking Abstract Number 4507; Oral Presentation; June 6, 10:30 a.m., E Hall D2)
The first presentation of results of this international Phase 3, randomized, double-blind study comparing denosumab to Zometa(R) (zoledronic acid) in the treatment of bone metastases in patients with advanced prostate cancer. This is the final of three pivotal trials in a total of more than 5,700 advanced cancer patients investigating the potential of denosumab to treat bone metastases. Bone metastases, cancer cells that separate from tumors and migrate to bone tissue where they settle and grow, occur in more than 1.5 million people worldwide. These data are under embargo and will be presented in an oral session at the meeting.
A meta-analysis of results from two randomized, double-blind studies of denosumab versus zoledronic acid (ZA) for treatment of bone metastases
(Abstract Number 9015; Oral Presentation; June 5, 5:15 p.m., E 354b)
An integrated analysis of two previously reported, identically designed head-to-head Phase 3 trials demonstrated denosumab treatment was superior to Zometa in delaying or preventing skeletal-related events (SREs) in a broad population of patients with advanced malignancies involving bone. These trials evaluated patients with breast cancer and other solid tumors (excluding breast or prostate cancer) or multiple myeloma, respectively. Overall rates of disease progression, survival, adverse events and serious adverse events were similar in both groups.
Effects of denosumab versus zoledronic acid (ZA) on pain in patients (pts) with metastatic breast cancer: Results from a phase III clinical trial
(Abstract Number 1024; Poster Board: June 5, 12:00 p.m. - 1:00 p.m., E Hall D1, 13)
A combination of pre-specified and post-hoc analyses of a Phase 3 head-to-head study showed denosumab significantly extended the time breast cancer patients had no or mild pain, when compared to Zometa, with fewer denosumab patients experiencing worsening of pain. Overall adverse events rates were similar in both groups.
Effects of denosumab versus zoledronic acid (ZA) on pain in patients (pts) with advanced cancer (excluding breast and prostate) or multiple myeloma (MM): Results from a randomized phase III clinical trial
(Abstract Number 9043; Poster Board: June 7, 1:00 p.m. - 5:00 p.m., S Hall A2, 39B)
A combination of pre-specified and post-hoc analyses of a Phase 3 head-to-head study showed denosumab prolonged time to worsening of pain compared with Zometa. In addition, among patients with no/mild pain at baseline, fewer denosumab-treated patients reported moderate/severe pain than Zometa-treated patients. Overall adverse event rates were similar in both groups.
Delaying skeletal-related events in a randomized phase III study of denosumab versus zoledronic acid in patients with advanced cancer
(Abstract Number 9133; Poster Board; June 7, 1:00 p.m. - 5:00 p.m., S Hall A2, 51B)
A post-hoc subset analysis comparing the treatment effect in only patients with solid tumors (other than breast cancer or prostate cancer) and bone metastases showed that denosumab delayed or prevented SREs more effectively than Zometa. Both treatment groups had similar rates of overall survival, disease progression and overall adverse events.
Denosumab in the treatment of bone metastases from advanced cancer or multiple myeloma (MM): Analyses from a phase III randomized trial
(Abstract Number 9042; Best of ASCO Poster Board: June 7, 1:00 p.m. - 5:00 p.m., S Hall A2, 39A)
In an exploratory analysis from a head-to-head study, patients receiving denosumab had longer time to first skeletal related event (SRE) or hypercalcemia of malignancy (HCM) and time to radiation to bone compared with Zometa. Also a lower proportion of patients experienced an on-study SRE in the denosumab group compared with Zometa.
Effects of denosumab versus zoledronic acid (ZA) on health-related quality of life (HRQL) in metastatic breast cancer: Results from a randomized phase III trial
(Abstract Number 1025; Poster Discussion; June 5, 8:00 a.m. - 12:00 p.m., E450b)
In bone metastases secondary to breast cancer, patients receiving denosumab or zoledronic acid showed improvement or maintenance in health-related quality of life (HRQL) relative to baseline, while a greater proportion of denosumab-treated patients reported a clinically meaningful improvement in HRQL. Potential benefits of subcutaneous delivery of denosumab on HRQL were not captured since both treatment arms received subcutaneous and IV administration.
An additional four abstracts evaluating the impact of bone metastases, including health economic outcomes, will be presented at the meeting.
In addition to the denosumab data, fifteen studies across five molecules in the Amgen therapeutic pipeline will be presented. Selected presentations include:
A placebo-controlled, randomized Phase 2 study of conatumumab or AMG 479, or placebo plus gemcitabine in patients with metastatic pancreatic cancer
(Abstract Number: 4035; Poster Discussion: June 4, 2:00 p.m. - 6:00 p.m., E450b; 23)
AMG 479 in relapsed or refractory Ewing's family tumors or desmoplastic small round cell tumors: Phase 2 results
(Abstract Number: 10001; Oral Presentation: June 7, 1:15 p.m., S406)
Primary analysis from a randomized, double-blind, placebo-controlled Phase 2 study of AMG 386 in combination with paclitaxel in patients with advanced ovarian cancer
(Abstract Number: 5000; Oral Presentation: June 7, 9:45 a.m., E Arie Crown Theater)
Biomarkers as predictors of response to treatment with motesanib or bevacizumab in combo with paclitaxel in patients with locally recurrent or metastatic breast cancer
(Abstract Number: 1048; Poster Board: June 5, 2:00 p.m. - 6:00 p.m., S Hall A2, 23A)
Placental growth factor as a marker of therapeutic response to treatment with motesanib in patients with progressive advanced thyroid cancer, advanced nonsquamous non-small cell lung cancer, and locally recurrent or advanced metastatic breast cancer
(Abstract Number: 3037; Poster Board: June 7, 8:00 a.m. - 12:00 p.m., S Hall A2, 10G)
Twelve abstracts will be presented on Vectibix(R) (panitumumab), including use in combination with chemotherapy for the treatment of metastatic colorectal cancer (mCRC). Selected presentations include:
Randomized, open label, phase III study of panitumumab (pmab) with
FOLFOX4 versus FOLFOX4 alone as first-line treatment (tx) for
metastatic colorectal cancer (mCRC): Efficacy by skin toxicity
(Abstract Number: 3538; Poster Discussion: June 8, 11:00 a.m. to 12:00
p.m., S Hall 406 (Vista Room), IE)
Randomized, open label, phase III study of panitumumab (pmab) with
FOLFIRI versus FOLFIRI alone as second-line treatment (tx) in
patients (pts) with metastatic colorectal cancer (mCRC): Efficacy
-- by skin toxicity (ST)
(Abstract Number 3529; Poster Discussion: June 8, 11:00 a.m. to 12:00
p.m., S Hall 406 (Vista Room), 20)
SPIRITT: A multicenter, open-label, randomized, phase II clinical
trial evaluating safety and efficacy of FOLFIRI with either
panitumumab or bevacizumab as second-line treatment in patients
with metastatic colorectal cancer (mCRC) with wild-type KRAS
(Abstract Number: TPS195; Poster Board: June 7, 8:00 a.m. to 12:00
p.m., S Hall A1)
PEAK: A randomized phase II study to compare the efficacy of
panitumumab plus mFOLFOX6 to bevacizumab plus mFOLFOX6 in
patients (pts) with previously untreated, unresectable,
-- metastatic colorectal cancer (mCRC) expressing wild-type KRAS
(Abstract Number: TPS189; Poster Board: June 7, 8:00 a.m. to 12:00
p.m., S Hall A2)
Five abstracts will be presented on Neulasta(R)(pegfilgrastim), including:
A phase III randomized, double-blind, placebo-controlled study
of pegfilgrastim in first-line colorectal cancer patients
-- receiving bevacizumab and either FOLFOX or FOLFIRI
(Abstract Number: TPS326; Poster Board: June 7, 8:00 a.m. to 12:00
p.m., S Hall A2)
Estimation of the U.S. rate of neutropenic complications for
-- cancer hospital discharges.
(Abstract Number: 6027; Poster Discussion: June 5, 12:00 p.m. to 1:00
p.m., S Hall 504, 19)
Seven abstracts will be presented on Aranesp(R) (darbepoetin alpha),including:
Design of an ongoing randomized study on the long-term safety and
efficacy of darbepoetin alfa (DA) administered 500 mcg every
three weeks (Q3W) to non-small cell lung cancer (NSCLC) patients
-- (pts) with anemia concomitant with chemotherapy (ACC)
(Abstract Number: TPS325; Poster Board: June 7, 8:00 a.m. to 12:00
p.m., S Hall A2, 44B)
An exploratory analysis of transfusion risk when initiating
darbepoetin alfa (DA) therapy at baseline hemoglobin (Hb) < 9 g/
dl vs 9 to < 10 g/dl vs > = 10 g/dl in patients (pts) with
-- chemotherapy-induced anemia (CIA)
(Abstract Number: 9077; Poster Board: June 7, 1:00 p.m. to 5:00 p.m.,
S Hall A2, 448)
Amgen will launch its newly designed AmgenOncology.com website at ASCO this year. The site features innovative user design, award-winning science video, as well as the Chemotherapy Guide PDA download, and all the latest highlights on Amgen Oncology Science. For the latest updates on Amgen's presence at ASCO and other Amgen news follow us on Twitter, @Amgen.
About Denosumab and Amgen's Research in Bone Biology
Denosumab is the first fully human monoclonal antibody in late stage clinical development that specifically targets RANK Ligand, the essential regulator of osteoclasts (the cells that break down bone). The denosumab development program is the largest ever initiated by Amgen. This broad and deep development program demonstrates Amgen's commitment to researching and delivering pioneering medicines to patients with unmet medical needs. Amgen is studying denosumab in numerous tumor types across the spectrum of cancer-related bone diseases. Over 11,000 patients have been enrolled in the denosumab oncology clinical trials, testing the drug for the reduction of SREs in patients with breast and prostate cancer, as well as other solid tumors and multiple myeloma, for the amelioration of treatment-induced bone loss in patients with non-metastatic breast or prostate cancers, and for its potential to delay bone metastases in prostate cancer.
Vectibix is the first fully human anti-EGFR antibody approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of mCRC. Vectibix was approved in the U.S. in September 2006 as monotherapy for the treatment of patients with EGFR-expressing metastatic colorectal carcinoma after disease progression on or following fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
The effectiveness of Vectibix as a single agent for the treatment of EGFR-expressing, metastatic colorectal carcinoma is based on progression-free survival. Currently no data are available that demonstrate an improvement in disease-related symptoms or increased survival with Vectibix. Retrospective subset analyses of metastatic colorectal cancer trials have not shown a treatment benefit for Vectibix in patients whose tumors had KRAS mutations in codon 12 or 13. Use of Vectibix is not recommended for the treatment of colorectal cancer with these mutations.
In December 2007, the European Medicines Agency (EMA) granted a conditional marketing authorization for Vectibix as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens. Vectibix has been launched in over 20 EU countries, Russia, Israel, Switzerland, Australia and Canada. Applications in the rest of the world are pending.
Important Vectibix Safety Information
Warning Dermatologic Toxicity and Infusion Reactions
Dermatologic Toxicity: Dermatologic toxicities occurred in 89 percent of patients and were severe (NCI-CTC grade 3 or higher) in 12 percent of patients receiving Vectibix monotherapy.
Infusion Reactions: Severe infusion reactions occurred in approximately 1 percent of patients. Although not reported with Vectibix, fatal infusion reactions have occurred with other monoclonal antibody products.
The most common adverse events of Vectibix are skin rash with variable presentations, hypomagnesemia, paronychia, fatigue, abdominal pain, nausea, and diarrhea, including diarrhea resulting in dehydration.
The most serious adverse events of Vectibix are pulmonary fibrosis, pulmonary embolism, severe dermatologic toxicity complicated by infectious sequelae and septic death, infusion reactions, abdominal pain, hypomagnesemia, nausea, vomiting, and constipation.
Neulasta was approved by the U.S. FDA in 2002 for decreasing the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anticancer drugs associated with clinically significant incidence of febrile neutropenia. Similar indications for Neulasta were approved in Europe and Australia the same year.
Important Neulasta Safety Information
Do not administer Neulasta to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim.
Splenic rupture (including fatal cases), acute respiratory distress syndrome, and sickle cell crises have been reported. Allergic reactions, including anaphylaxis, have also been reported. The majority of allergic reactions occurred upon initial exposure. However, in rare cases, allergic reactions, including anaphylaxis, recurred within days after discontinuing antiallergic treatment.
Bone pain and pain in extremity occurred at a higher incidence in Neulasta-treated patients as compared with placebo-treated patients.
Important Aranesp Safety Information
Aranesp is indicated for the treatment of anemia due to the effect of concomitantly administered chemotherapy based on studies that have shown a reduction in the need for RBC transfusions in patients with metastatic, non-myeloid malignancies. Studies to determine whether Aranesp increases mortality or decreases progression-free/recurrence-free survival are ongoing.
- Aranesp is not indicated for use in patients receiving hormonal agents, therapeutic biologic products, or radiotherapy unless receiving concomitant myelosuppressive chemotherapy.
- Aranesp is not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure due to the absence of studies that adequately characterize the impact of Aranesp on progression-free and overall survival.
- Aranesp use has not been demonstrated in controlled clinical trials to improve symptoms of anemia, quality of life, fatigue, or patient well-being.
WARNINGS: INCREASED MORTALITY, SERIOUS CARDIOVASCULAR EVENTS, THROMBOEMBOLIC EVENTS, STROKE and INCREASED RISK OF TUMOR PROGRESSION OR RECURRENCE
- ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in some clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
- To decrease these risks, as well as the risk of serious cardio- and thrombovascular events, use the lowest dose needed to avoid red blood cell transfusion.
- Because of these risks, prescribers and hospitals must enroll in and comply with the ESA APPRISE Oncology Program to prescribe and/or dispense Aranesp, EPOGEN or PROCRIT to patients with cancer. To enroll in the ESA APPRISE Oncology Program, visit http://www.esa-apprise.com/ or call 1-866-284-8089 for further assistance.
- Use ESAs only for treatment of anemia due to concomitant myelosuppressive chemotherapy.
- ESAs are not indicated for patients receiving myelosuppressive therapy when the anticipated outcome is cure.
- Discontinue following the completion of a chemotherapy course.
- ESAs are contraindicated in patients with uncontrolled hypertension.
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit http://www.amgen.com/.
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