June 4, 2013

$PVCT: T-Vec & $AMGN's Bottom Line

Amgen trumpets T-Vec oncolytic virus results from PhIII melanoma study by FierceBiotech's John Carroll.

What's good for Amgen & T-Vec is good for Provectus & PV-10, and what's bad for Amgen & T-Vec is good for Provectus & PV-10. The bottom line for T-VEC may be the drug is not ready for "prime time," but perhaps may be suitable for combination with ipilimumab/Yervoy or PD-1 antibodies heralded at ASCO 2013.
"With today's reported interim results, we believe the probability of success for T-Vec demonstrating an OS benefit at final data later this year should increase although more modestly given previous reports of favorable OS trend," ISI's Mark Schoenebaum wrote over the weekend. "Admittedly, T-Vec's role in a subset of advanced melanoma patients as an injectable (injected directly into the tumor) is becoming less clear with increasing competition in the melanoma space, such as the development of PD-1 antibodies."
Regarding the second part of Schoenebaum's quote above from the FierceBiotech article, T-Vec ultimately is not that good of an agent. PV-10 is much more robust in response and systemic potential, both in treated lesions and those untreated, respectively. For example, the response rate percentage for all treated lesions in PV-10's MM Phase 2 trial was (is) astounding, given the trial's treatment protocol, and likely will (should) go up given further flexibility designed into the Phase 3 trial (i.e., no limit to treatment).

The competition in melanoma highlights that available agents are so marginal for end stage disease that there needs to and will be significantly more attention placed on agents like PV-10, and to a lesser extent T-Vec, in combination with appropriate other agents.

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