CHICAGO--Amgen's ($AMGN) big Phase III effort on the viral cancer vaccine talimogene laherparepvec may have fallen just shy of hitting the mark for a key metric on overall survival, but after hitting the primary goal on durable response rates for patients with melanoma, the big biotech says it plans to move ahead and seek an approval to start selling the treatment. And investigators here at ASCO have also begun to add some new data to back up its potential as a combination cancer therapy.
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| Amgen R&D chief Sean Harper |
In a statement put out Monday morning, Amgen R&D chief Sean Harper said that "talimogene laherparepvec has demonstrated the ability to produce durable and complete responses in patients with metastatic melanoma which provides a strong basis for a filing later this year and potential approval of talimogene laherparepvec as a novel treatment for this devastating disease."
While cancer vaccines have had a poor track record in the clinic in recent years, Amgen has tapped T-Vec as one of the big biotech's top prospects. The engineered virus is designed to specifically replicate in cancer cells, expressing the white blood cell growth factor GM-CSF to spur an immune system response. Amgen's then R&D chief Roger Perlmutter--now at Merck ($MRK)--acquired the program about three years ago, buying out BioVex in a $1 billion deal.
The OS setback never stopped Amgen from confidently asserting T-Vec's market potential as a standalone treatment.
"We're enthusiastic about the monotherapy data," says David Reese, Amgen's vice president of translational sciences. And the company plans to follow up with new work on a range of tumor types.
Some of the analysts following this program said they might lower potential sales forecasts after hearing that it failed to achieve an all-important statistical significance for survival. But the drug still has major potential as a combo. Amgen underscored that point on Monday morning, noting that T-Vec in combination with Yervoy either shrank or eliminated the tumors in 56% of the small group of patients enrolled in a Phase Ib study.
- here's the release