Amgen Inc. is set to launch the first FDA-approved oncolytic cancer vaccine Imylgic (T-VEC) in melanoma within a week, at an average cost of $65,000.

Pricing will vary depending on the patient and the company will “work with the health care community to implement a program that helps limit the average cost” to $65,000 for “eligible participating institutions,” the company said in a statement on Oct. 27 after the approval. A copay assistance program with no income limitation will support the program, and there is also support for patients with no insurance coverage.

T-VEC (talimogene laherparepvec) is a herpes simplex-1 virus modified to prevent it from replicating in normal tissue and with an added gene for human granulocyte-macrophage colony-stimulating factor (GM-CSF) production. The product is injected straight into tumors, but the company said that it also has a systemic immune response.

Imlygic was approved based on performance in the pivotal OPTiM study of 436 patients with unresectable stage IIIb, IIIc and IV melanoma, in which it demonstrated better durable response, a primary endpoint, but not overall survival, a secondary measure in the trial, compared to GM-CSF ([A#14150602004]).

The company noted that the drug had not been shown to improve overall survival or to have an effect on visceral disease, meaning cancer that spread to the lungs or other organs. When FDA’s Oncologic Drugs Advisory Committee and Cellular Tissue, and Gene Therapy Advisory Committee met in April, panelists voted in favor of approving the vaccine, though concluding that the product worked in non-visceral disease but not visceral disease ([A#00150504013]).

FDA had questioned trial design on a number of counts ([A#14150427005]). In addition to the lack of effect on visceral disease, the lack of a survival benefit drew scrutiny and the control was viewed as weak. But those concerns were not strong enough to prevent the advisory committee from voting 22-1 in favor of clearance in the US.

Among other things going for the vaccine, durable response was better for patients with Stage IIIb, IIIc and Stage IVM1a metastatic melanoma compared to the overall trial population in the OPTiM study.

Amgen acquired the candidate from BioVex Inc. in 2011 at the cost of $425m upfront and another $575m in milestones Also see "Amgen Takes Out Cancer Vaccine Developer BioVex In Potential $1B Deal" - Pink Sheet, 24 January, 2011..

But the bar has been raised in melanoma in recent years, with the approval of three immuno-oncology drugs that demonstrated an overall survival benefit – Bristol-Myers Squibb Co. CTLA-4 inhibitor Yervoy (ipilimumab) and anti-PD-1 Opdivo (niviolumab), and Merck & Co. Inc.’s anti-PD-1 Keytruda (pembrolizumab) Also see "Yervoy Approval Has Shifted Development Landscape For Melanoma" - Pink Sheet, 4 April, 2011..

Targeted BRAF/MEK combination therapies are also part of the armamentarium, like Novartis AGTafinlar (dabrafenib) with Mekinist (trametinib) and Roche’s Zelboraf (vemurafenib) and pending cobimetinib.

Imlygic has been evaluated in combination with Yervoy and is being tested as a partner for Keytruda. It could play a complementary role down the line with checkpoint inhibitors.

Europe's Committee for Medicinal Products for Human Use a week earlier recommended Imlygic for the treatment of adults with unresectable melanoma that is regionally or distantly metastatic (stage IIIB, IIIC and IVM1A) without affecting the bones, brain, lung or other internal organs Also see "CHMP Nod Little Consolation As Amgen's Imlygic Becomes Melanoma Also-Ran" - Pink Sheet, 23 October, 2015..

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