Company Update (NASDAQ:AMGN): Amgen, Inc. Highlights Key Clinical Data To Be Presented At European Cancer Congress 2015


Amgen, Inc. (NASDAQ:AMGN) announced it will present data from its oncology portfolio and pipeline at the European Cancer Congress 2015 (ECC 2015), Sept. 25 – 29, 2015, in Vienna.

“Amgen is excited to be sharing clinical data at ECC that demonstrates our commitment to advancing the scientific understanding of cancer care,” said Sean E. Harper, M.D., executive vice president of Research and Development atAmgen. “Amgen’s oncology research and development is focused on multiple pathways that may lead to deeper understanding of existing treatments and to the development of new treatment options for patients.”

Key data to be presented at the congress include findings from clinical trials in melanoma, metastatic colorectal cancer and bone metastases.

Talimogene laherparepvec

Talimogene laherparepvec is an investigational oncolytic immunotherapy administered as an intralesional injection that is designed to initiate an anti-tumor immune response. Talimogene laherparepvec is under review by the European Medicines Agency and the U.S. Food and Drug Administration (FDA) for the treatment of metastatic melanoma. Data to be presented on talimogene laherparepvec will include:

  • Safety data from the Phase 1b part of the MASTERKEY-265 study combining talimogene laherparepvec (T-VEC) and pembrolizumab for unresectable stage IIIB-IV melanoma
    Abstract 24LBA, Oral Session, Sunday, Sept. 27, 11:30 a.m. – 12:30 p.m. CEST (Hall A2)
  • Durable complete responses (CR) in patients (pts) with stage IIIB-IV melanoma treated with talimogene laherparepvec (T-VEC) in OPTiM
    Abstract 3334 / P211, Poster Session, Sunday, Sept. 27, 4:45 p.m. – 6:45 p.m. CEST (Hall C)
  • Clinical benefits associated with durable response (DR) in patients (pts) with unresected stage IIIB/C/IV melanoma treated with talimogene laherparepvec (T-VEC) or GM-CSF in the randomized Phase 3 OPTiM trial (NCT00769704)
    Abstract 3330 / P207, Poster Session, Sunday, Sept. 27, 4:45 p.m. – 6:45 p.m. CEST (Hall C)

Vectibix® (panitumumab)

Vectibix, approved by the FDA and the European Commission for the treatment of metastatic colorectal cancer, is a fully human monoclonal antibody that targets epidermal growth factor receptor (EGFR), a protein that plays an important role in cancer cell signalling in many tumor types. Long-term survival data from the PEAK trial final analysis adds to the understanding of how Vectibix works when added to standard first-line chemotherapy for the treatment of wild-type RAS metastatic colorectal cancer. Overall, the Vectibix clinical trial program continues to generate additional data regarding biomarkers and drug sequencing. Data to be presented on Vectibix will include:

  • Final analysis of the PEAK trial: Overall survival (OS) and tumour responses during first-line treatment with mFOLFOX6 + either panitumumab (pmab) or bevacizumab (bev) in patients (pts) with metastatic colorectal carcinoma (mCRC)
    Abstract 2014, Poster Discussion, Sunday, Sept. 27, 8 a.m. – 9 a.m. CEST (Hall A1)
  • Efficacy outcomes by severity of skin toxicity from ASPECCT: Randomized Phase 3 study of panitumumab (pmab) versus cetuximab (cmab) in chemorefractory wild-type (WT) KRAS exon 2 metastatic colorectal cancer (mCRC)
    Abstract 2110 / P100, Poster Session, Sunday, Sept. 27, 9:15 a.m. –11:15 a.m. CEST (Hall C)
  • Retrospective observational study to estimate the attrition of patients across lines of systemic treatment for metastatic colorectal cancer in Canada
    Abstract 2132 / P122, Poster Session, Sunday, Sept. 27, 9:15 a.m. –11:15 a.m. CEST (Hall C)
  • Tumour response outcomes during the first-line treatment of metastatic colorectal carcinoma (mCRC) with panitumumab + FOLFIRI
    Abstract 2130 / P120, Poster Session, Sunday, Sept. 27, 9:15 a.m. –11:15 a.m. CEST (Hall C)
  • Quality of life (QoL) during second-line treatment with FOLFIRI +/- panitumumab (pmab) in patients (pts) with RAS wild-type (WT) metastatic colorectal carcinoma (mCRC)
    Abstract 2118 / P108, Poster Session, Sunday, Sept. 27, 9:15 a.m. –11:15 a.m. CEST (Hall C)
  • Highly sensitive and multiplexed next-generation sequencing MiSeqDx Extended RAS Panel for FFPE colorectal samples
    Abstract 803 / P146, Poster Session, Monday, Sept. 28, 4:45 p.m. – 6:45 p.m. CEST (Hall C)

XGEVA® (denosumab)

XGEVA, approved by the FDA and by the European Commission, targets the RANK ligand pathway to prevent the formation, function and survival of osteoclasts, which break down bone. XGEVA is indicated for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors and for treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. SREs, also known as bone complications, are defined as radiation to bone, pathologic fracture, surgery to bone and spinal cord compression. XGEVA is also indicated in the U.S. for the treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy.

Data to be presented at ECC may advance the understanding of XGEVA treatment for cancer patients who can be affected by the consequences of bone metastases. Data to be presented on XGEVA will include:

  • Incidence and proportion of bone metastases in women with breast cancer: A meta-analysis of the published literature
    Abstract 1029 / P148, Poster Session, Saturday, Sept. 26, 4:45 p.m. –6:45 p.m. CEST (Hall C)
  • Prevalence of hypercalcemia of malignancy and associated survival in electronic health records (EHR) in the United States
    Abstract 1030 / P149, Poster Session, Saturday, Sept. 26, 4:45 p.m. –6:45 p.m. CEST (Hall C)
  • Bone Targeting Agent (BTA) treatment patterns and the impact of bone metastases (BM) on prostate cancer patients in a real-world setting
    Abstract 1527 / P298, Poster Session, Sunday, Sept. 27, 4:45 p.m. – 6:45 p.m. CEST (Hall C)
  • Bone Targeting Agent (BTA) treatment patterns and the impact of bone metastases (BM) on advanced breast cancer patients in a real-world setting
    Abstract 1523 / P294, Poster Session, Sunday, Sept. 27, 4:45 p.m. – 6:45 p.m. CEST (Hall C)
  • An observational time and motion study of denosumab subcutaneous injection and zoledronic acid intravenous infusion in patients with metastatic bone disease: Results from Belgium andGermany
    Abstract 1617 / P388, Poster Session, Sunday, Sept. 27, 4:45 p.m. – 6:45 p.m. CEST (Hall C)
  • X-TREME: Interim analysis from a German open-label, observational study for treatment persistence with denosumab in routine use in adults with bone metastases secondary to solid tumours
    Abstract 1522 / P293, Poster Session, Sunday, Sept. 27, 4:45 p.m. – 6:45 p.m. CEST (Hall C)

Additional data from Neulasta® (pegfilgrastim), and AMG 337, an investigational, oral inhibitor of MET kinase activity, include:

  • Final results from PAVES, a Phase 3, randomized, double-blind, placebo-controlled trial of pegfilgrastim in patients receiving first-line FOLFOX or FOLFIRI and bevacizumab for locally advanced or metastatic colorectal cancer (LA/mCRC) (NCT00911170)
    Abstract 1609 / P380, Poster Session, Sunday, Sept. 27, 4:45 p.m. – 6:45 p.m. CEST (Hall C)
  • Evaluation of MET using FISH, IHC, or Mass Spectrometry as a prognostic biomarker in patients with gastroesophageal cancer
    Abstract 2397 / P359, Poster Session, Monday, Sept. 28, 9:15 a.m. –11:15 a.m. CEST (Hall C) (Original Source)

Shares of Amgen closed last Friday at $153.21. AMGN has a 1-year high of $181.81 and a 1-year low of $127.67. The stock’s 50-day moving average is $161.80 and its 200-day moving average is $159.55.

On the ratings front, Amgen has been the subject of a number of recent research reports. In a report issued on September 8, UBS analyst Matt Roden upgraded AMGN to Buy, with a price target of $168, which implies an upside of 9.7% from current levels. Separately, on September 2, Raymond James’ Christopher Raymond initiated coverage with a Hold rating on the stock .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Matt Roden and Christopher Raymond have a total average return of 32.2% and 46.9% respectively. Roden has a success rate of 81.4% and is ranked #59 out of 3755 analysts, while Raymond has a success rate of 83.3% and is ranked #16.

Overall, 3 research analysts have assigned a Hold rating and 5 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $189.20 which is 23.5% above where the stock closed last Friday.