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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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Sean E. Harper, EVP, Research and Development, gave an update for data from the phase III program with Onco-Vex. He stated, "We expect to have the complete analysis of the primary endpoint, as well as overall survival from our phase III study of T-Vec in patients with metastatic melanoma in 2013. I'd like to clarify here that we will perform an internal pre-specified interim analysis of the primary endpoint of durable response by this year's end, however, we do not plan to share these data externally in the context of an ongoing phase III study, but rather at study completion in 2013."
Source: Q1 2012 earnings conference call, 4/23/12.

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Roger M. Perlmutter, M.D., Ph.D., EVP, R&D, commented on the OncoVex program. He stated, "We have completed enrollment of our phase III study in patients with advanced malignant melanoma. The therapy previously referred to as OncoVEX GM-CSF, will henceforth, for obvious reasons, be denoted as TVEC. As you will recall, TVEC is administered by injection into visible tumor masses, and acts both by directly lysing the tumor, as well as simulating a systemic immune response to malignant cells. The primary end point for this study remains the durable complete response, though enrollment was increased to provide more power for observing an overall survival signal."
Source: Q3 earnings conference call, 10/24/11.

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Roger M. Perlmutter, M.D., Ph.D., EVP, R&D, gave an update regarding enrollment for the Oncovex GM-CSF program. He stated, "Turning now to new programs and development. I'm pleased to report that the phase III clinical study of OncoVEX GM-CSF for the treatment of stage 3/4 malignant melanoma has completed enrollment. You will recall that this trial is being conducted under an FDA agreed Special Protocol Assessment with the primary endpoint of durable clinical response."
Source: Q2 earnings conference call, 7/29/11.

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Roger M. Perlmutter, M.D., Ph.D., EVP, R&D, commented on the progress being made with the Biovex asset OncoVEX GM-CSF phase III program. He stated, "These observations led to the initiation of two phase III studies, both under special protocol assessment with the FDA. One in patients with malignant melanoma and the second in patients with head and neck cancer. The melanoma study in particular is more than 90% enrolled."
Source: Q4 2010 earnings conference call, 1/24/11.

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A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEXGM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease
Enrollment: 439
Study Start Date: April 2009
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT00769704?term=Oncovex&rank=2

Compound/DeviceSpecialtyIndicationCompound ClassTarget
OncoVEX GM-CSF (talminogene laherparepvec) (2) MelanomaOncologyMelanoma (metastatic)Viral and immunostimulated antineoplasticCancer cells

Mechanism of action: OncoVEX GM-CSF (talminogene laherparepvec) is an oncolytic, recombinant herpes simplex type-1 virus (HSV) encoding human cytokine granulocyte-macrophage colony stimulating factor (GM-CSF) with potential immunostimulating and antineoplastic activities. Upon administration, talminogene laherparepvec selectively infects and replicates in tumor cells, thereby inducing tumor cell lysis. In addition, expressed GM-CSF may stimulate a cytotoxic T cell response against tumor cells, resulting in immune-mediated tumor cell death in addition to HSV-mediated oncolytic tumor cell death.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2013-06-01 - 2013-06-30

Results:

Jun. 1, 2013
Amgen Presents Positive Results From Talimogene Laherparepvec Phase 3 Study In Patients With Metastatic Melanoma

THOUSAND OAKS, Calif., June 1, 2013 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced detailed results from a pivotal Phase 3 trial evaluating talimogene laherparepvec in patients with unresected stage IIIB, IIIC or IV melanoma compared to granulocyte-macrophage colony-stimulating factor (GM-CSF). The results will be presented as an oral presentation at the 2013 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract No. LBA9008).

The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically significant difference was observed in DRR with 16 percent in the talimogene laherparepvec arm versus two percent in the GM-CSF arm (95 percent CI, 12-21 percent, versus 95 percent CI, 0-5 percent, p<0.0001). The overall response rate was 26 percent with talimogene laherparepvec as compared to six percent for GM-CSF. A trend toward overall survival (HR = 0.79, 95 percent CI, 0.61-1.02) was also observed at a predefined interim analysis.

"These are the first data from a controlled trial of oncolytic immunotherapy to demonstrate activity in melanoma," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We are pleased with the results of this pivotal Phase 3 trial for talimogene laherparepvec and we look forward to the mature overall survival data later this year."

In regionally and distantly metastatic melanoma (stages III and IV), cancer has spread to skin, lymph nodes, or to other organs distant from the site of origin. The DRR was highest among patients with stage III and stage IVM1a disease. The observed DRR for talimogene laherparepvec were: 33 percent in stage IIIB/IIlC, 16 percent in stage IVM1a, and three and eight percent respectively for stages IVM1b and IVM1c. The DRR with GM-CSF was not higher than four percent in any of the stage subsets.

"Over the last 30 years, the incidence of metastatic melanoma has increased by over 200 percent, so there is a need for new treatment options," said study author Robert Andtbacka, M.D., assistant professor, University of Utah Huntsman Cancer Institute. "The results of this study are encouraging in a disease as devastating as metastatic melanoma."

The most frequently observed adverse events were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia. Serious adverse events occurred in 26 percent of talimogene laherparepvec patients and 13 percent of GM-CSF patients.

Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to work in two important and complementary ways – causing local lytic destruction of tumors while also stimulating a systemic anti-tumor immune response.

Full results will be presented today at the 2013 ASCO Annual Meeting at the Melanoma/Skin Cancers session on Saturday, June 1, 3:45 p.m. CDT, S406 (Abstract No. LBA9008).
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Source: press release, 6/01/13. http://wwwext.amgen.com//media/media_pr_detail.jsp?year=2013&releaseID=1...

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Mar. 19, 2013

Amgen Announces Top-Line Results Of Phase 3 Talimogene Laherparepvec Trial In Melanoma

THOUSAND OAKS, Calif., March 19, 2013 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced top-line results from the Phase 3 trial in melanoma, which evaluated the efficacy and safety of talimogene laherparepvec for the treatment of unresected stage IIIB, IIIC or IV melanoma compared to treatment with subcutaneous granulocyte-macrophage colony-stimulating factor (GM-CSF).

The study met its primary endpoint of durable response rate (DRR), defined as the rate of complete or partial response lasting continuously for at least six months. A statistically significant difference was observed in DRR: 16 percent in the talimogene laherparepvec arm versus two percent in the GM-CSF arm. The analysis of overall survival (OS), a key secondary endpoint of the study, is event driven. A pre-planned interim analysis conducted with the analysis of DRR has shown an OS trend in favor of talimogene laherparepvec as compared to GM-CSF. The OS data is expected to mature in late 2013 in line with previous guidance.

"These are the first Phase 3 results of this novel approach to cancer therapy," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "A high unmet need exists in melanoma and we believe the innovative mechanism of action of talimogene laherparepvec may offer a promising approach for these patients."

The most frequent adverse events observed in this trial were fatigue, chills and pyrexia. The most common serious adverse events include disease progression, cellulitis and pyrexia.

Among the various types of skin cancer, melanoma is the most aggressive and also the most serious. Although melanoma accounts for less than five percent of skin cancer cases, or 132,000 cases globally each year, melanoma accounts for 75 percent of all skin cancer deaths.[i]

Talimogene laherparepvec is an investigational oncolytic immunotherapy designed to work in two important and complementary ways - to cause local lytic destruction of tumors while also stimulating a systemic anti-tumor immune response.

Additional safety and efficacy data will be submitted to the American Society of Clinical Oncology (ASCO) for the 2013 Annual Meeting.
More
Source: press release, 3/20/13. http://wwwext.amgen.com//media/media_pr_detail.jsp?year=2013&releaseID=1...