Amgen and Onyx Data at ASCO 2014 highlight oncology pipeline and portfolio

Amgen (NASDAQ:AMGN) and its subsidiary Onyx Pharmaceuticals, Inc., today announced data from several studies of both pipeline and marketed products will be presented at the 50^th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 30-June 3 in Chicago. The research that will be presented demonstrates Amgen’s and Onyx’s continued progress in developing treatments for patients with difficult-to-treat cancers, as well as investigating new uses and areas of interest for their current cancer care treatments.

“The data presented at ASCO this year is a testament to our focus on addressing unmet needs and the strategic acquisitions that we have made, such as Onyx, to further our leadership in oncology,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Amgen and Onyx continue to be on the cutting edge of research and are constantly looking for innovative approaches to tackle some of the toughest cancers.”

During the meeting, Amgen and Onyx will present results from more than 45 studies in 17 different cancers, including six oral presentations and 25 posters across 11 oncology molecules. Abstracts are currently available on the ASCO website at http://abstract.asco.org/.

Amgen Data Includes

Blinatumomab (AMG 103)
Amgen will present results from the following pivotal Phase 2 study assessing blinatumomab, a bispecific T cell engager (BiTE^®) antibody, in patients with acute lymphoblastic leukemia (ALL).

• Confirmatory open-label, single-arm, multicenter Phase 2 study of the BiTE^® antibody blinatumomab in patients with relapsed/refractory B-precursor acute lymphoblastic leukemia
  Abstract No. 7005, Oral Abstract Session, Tuesday, June 3, 9:45 a.m. to 12:45 p.m. CT, E354a

Talimogene Laherparepvec
New data will be presented in patients with metastatic melanoma. Talimogene laherparepvec data to be presented at ASCO includes monotherapy data from the Phase 3 OPTiM trial as well as data on the combination of talimogene laherparepvec with another immunotherapy.

• Primary analysis of a Phase 1b multicenter trial to evaluate safety and efficacy of talimogene laherparepvec (T-VEC) and ipilimumab (ipi) in previously untreated, unresected, stage IIIB-IV melanoma 
  Abstract No. 9029, Poster Highlights Session, Monday, June 2, 8 a.m. to 11 a.m. CT, E354b  and 11:30 a.m. to 12:45 p.m. CT, E Arie Crown Theater
• Patterns of durable response with intralesional talimogene laherparepvec (T-VEC): Results from a Phase 3 trial in patients with stage IIIB-IV melanoma
  Abstract No. 9026, Poster Highlights Session, Monday, June 2, 8 a.m. to 11 a.m. CT, E354b and 11:30 a.m. to 12:45 p.m. CT, E Arie Crown Theater
• Primary overall survival (OS) from OPTiM, a randomized Phase 3 trial of talimogene laherparepvec (T-VEC) versus subcutaneous (SC) granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment (tx) of unresected stage IIIB/C and IV melanoma
  Abstract No. 9008a, Oral Abstract Session, Monday, June 2, 3 p.m. to 6 p.m. CT, E Arie Crown Theater

Vectibix^® (panitumumab)
Two studies to be presented at ASCO will provide more detailed information about predictive biomarkers in patients with metastatic colorectal cancer (mCRC). On May 23, 2014, the U.S. Food and Drug Administration (FDA) approved Vectibix plus FOLFOX chemotherapy as a first-line treatment for patients with wild-type KRAS mCRC. With this approval, Vectibix became the first and only biologic therapy indicated for use with FOLFOX, one of the most commonly used chemotherapy regimens in the first-line treatment of wild-type KRAS mCRC patients.

• Survival outcomes in the PRIME study for patients with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC), by baseline Eastern Cooperative Oncology Group (ECOG) performance status
  Abstract No. 3557, General Poster Session, Saturday, May 31, 8 a.m. to 11:45 a.m. CT, S Hall A2
• Extended RAS analysis and subsequent anti-EGFR and anti-VEGF treatment (tx) in PEAK: a 1st-line Phase 2 study of FOLFOX6 + panitumumab (pmab) or bevacizumab (bev) in metastatic colorectal cancer 
  Abstract No. 3629, General Poster Session, Saturday, May 31, 8 a.m. to 11:45 a.m. CT, S Hall A2

XGEVA^® (denosumab)
Amgen will present data from imaging studies that reveal early, sustained and progressive activity in giant cell tumor of bone (GCTB) and additional data regarding the prevention of skeletal related events (SREs) in patients with bone metastases.

• Response to treatment with denosumab in patients with giant cell tumor of bone (GCTB): FDG PET results from two Phase 2 trials
  Abstract No. 10505, Oral Abstract Session, Sunday, June 1, 8 a.m. to 11 a.m. CT, S406
• Effect of denosumab versus zoledronic acid (ZA) at preventing skeletal-related events (SREs) in patients with metastatic bone disease: subgroup analyses by baseline characteristics
  Abstract No. 9501, Oral Abstract Session,  Monday, June 2, 3 p.m. to 6 p.m. CT, E253
• Symptomatic skeletal events (SSE) in patients with advanced prostate cancer: results from a Phase 3 trial of denosumab for the prevention of skeletal-related events
  Abstract No. 5075, General Poster Session, Monday, June 2, 1:15 p.m. to 5 p.m. CT, S Hall A2

Onyx Data Includes

Kyprolis^® (carfilzomib)
New data will be presented from the CHAMPION-1 study evaluating the safety and efficacy of once-weekly carfilzomib with dexamethasone for patients with relapsed or refractory multiple myeloma.

• Results of the dose-escalation portion of a Phase 1/2 study (CHAMPION-1) investigating weekly carfilzomib in combination with dexamethasone for patients with relapsed or refractory multiple myeloma
  Abstract No. 8594, General Poster Session, Monday, June 2, 1:15 p.m. to 5 p.m. CT, S Hall A2

Amgen Post-ASCO Summary Webcast 
Amgen will hold a post-ASCO summary webcast on Tuesday, June 3, 2014, at 1 p.m. PT. Sean E. Harper, M.D., executive vice president of Research and Development at Amgen, along with members of Amgen’s clinical development team will participate to discuss data presented at ASCO and Amgen’s broader oncology portfolio of products. 

Live audio of the conference call will be simultaneously broadcast over the Internet and will be available to members of the news media, investors and the general public. 

The webcast, as with other selected presentations regarding developments in Amgen’s business given by management at certain investor and medical conferences, can be found on Amgen’s website, www.amgen.com, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.