You are here

FDA Advisors Recommend Approval of Skin Cancer Immunotherapy

T-Vec gets big ‘thumbs up’ after initial concerns over survival data

The skin cancer immunotherapy talimogene laherparepvec (T-Vec, Amgen) showed enough efficacy in the treatment of melanoma to receive marketing approval, an independent advisory panel to the FDA has ruled.

The panel voted 22 to 1 supporting approval of the treatment, an engineered virus that kills cancer cells when injected into tumors and also primes the immune system to attack the disease.

The recommendation comes 2 days after FDA staff expressed concerns over the design and results of a key study of T-Vec and raised questions about the interpretation of data from a late-stage trial. At that time, the reviewers said it was unclear whether the treatment improved overall survival.

T-Vec is built out of a herpes simplex virus that has been engineered to produce granulocyte macrophage colony-stimulating factor (GM-CSF), a growth factor that stimulates stem cells to produce immune cells. As an immunotherapy, T-Vec is injected directly into tumors. There, it replicates inside the tumor cells, causing them to rupture and die. The cell rupture releases tumor-derived particles along with GM-CSF, which stimulates the immune system to attack the cancer cells.

Pivotal clinical data were provided by the phase III OPTiM trial, an open-label, randomized study that compared T-Vec with GM-CSF in 436 patients with advanced melanoma that was not surgically resectable. T-Vec significantly improved the durable response rate (DDR), with 16.3% of treated patients achieving a complete or partial response during the first 12 months of therapy.

Amgen announced on April 29 that T-Vec was more effective in melanoma patients whose cancer had not spread to internal organs.

Analysts believe that, if approved, T-Vec could be the first of a new class of virus-based cancer drugs. Amgen acquired the rights to T-Vec in 2011 from its inventor, Biovex.

The product would enter a market that already has a number of new and effective therapies for melanoma, including ipilimumab (Yervoy, Bristol-Myers Squibb), nivolumab (Opdivo, Bristol-Myers Squibb), and pembrolizumab (Keytruda, Merck).

Sources: Reuters; April 30, 2015; and BioSpace; April 30, 2015.

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation
Delayed surgery reduces benefits; premature surgery raises risks
Mortality nearly doubled when patients stopped using their drugs