$PVCT & $AMGN: T-VEC vs. PV-10

This week, Amgen released partial study results of T-Vec's melanoma Phase 3 trial that compared talimogene laherparepvec (formerly OncoVex) against control therapy GM-CSF.

Some articles on this can be found below:

• Novel Amgen virus-vaccine shrinks melanoma tumors (Linda A. Johnson, Huff Post Business),
• Amgen Trains Herpes Virus to Shrink Skin Cancer (Adam Feuerstein, TheStreet), and
• Amgen scores PhIII success with BioVex virus against melanoma (Ryan McBride, FierceBiotech)

"[16%] of the T-Vec patients reported meaningful tumor shrinkage for at least six months, compared to 2% for patients treated with GM-CSF. The difference in durable tumor response was statistically significant in favor T-Vec, achieving the primary endpoint of the study." (Adam Feuerstein)

Reaction is mixed.

"Until Amgen produces some solid OS rates, though, a number of analysts will remain on the sidelines as to whether the biotech giant has a shot at market success. Amgen likely will have to wait until the arrival of OS data later this year before it can file for an approval, said ISI's Mark Schoenebaum in a note to investors. "In our view, OS is the single most important data point to track for this trial (both from regulatory and commercial perspective)."" (Ryan McBride)

"RBC Capital Markets analyst Michael Yee wrote to investors that he's "cautious" on the likelihood the full survival results later this year will show T-VEC is better than a couple of existing treatments – and they [Yervoy and Zelboraf] don't have to be injected into a tumor every two weeks."" (Linda Johnson)

"UBS Securities analyst Matthew Roden noted T-VEC's 16 percent durable response rate in this study, as well as its 58 percent one-year survival rate in an earlier, mid-stage study, both exceed study results for Yervoy, Bristol-Myers Squibb Co.'s melanoma drug. Roden added that T-VEC doesn't have that drug's severe gastrointestinal side effects."" (Linda Johnson)

"However, Mara Goldstein of Cantor Fitzgerald called the findings "a win for immunotherapy." "We can't help but feel encouraged for other agents in development," she wrote to investors, "particularly in light of the failure" of a study of experimental cancer vaccine Stimuvax, being tested by Merck KGaA of Germany." (Linda Johnson)

Coverage and commentary by biotechnology journalists of Amgen and T-Vex can only help facilitate a more open assessment of PV-10 when the time comes, helping them to better understand treatments that prime or "...activate a patient's immune system enough to target and eliminate tumors that are not directed injected...[the] so-called off-target or systemic response..." (Adam Feuerstein)

""While the regulatory strategy is current unclear, today's news is an incremental positive and T-Vec is not currently in our/Street models, due to overall low expectations for the drug and the practical/commercial limitations of immunotherapies. We await presentation at ASCO and OS data to better assess the clinical and commercial profile of T-Vec," said J.P. Morgan biotech analyst Geoff Meacham in a note to clients Tuesday night." (Adam Feuerstein)

My key takeaway from the Amgen news is Goldstein's comments about the results being a win for immunotherapy. T-Vex, Allovectin-7 and PV-10 have been considered the 3 cancer immunotherapy treatments to watch.

Put into context, and presented again at the HemOnc Today conference in New York, PV-10 possesses a superior response rate advantage over T-Vec (and Allovectin) for injected lesions, non-injected lesions and non-injected systemic lesions.

And on April 8th Moffitt raises the curtain on PV-10's systemic benefit.

"Two recently approved skin cancer drugs -- Roche's Zelboraf and Bristol Myers' Yervoy -- both prolong survival significantly. In order to compete and perhaps even to be approved at all, Amgen will have to demonstrate that T-Vec can help skin cancer patients live longer and not just shrink tumors."  (Adam Feuerstein)

Zelboraf was approved with PFS as primary endpoint. Yervoy was approved with OS as primary endpoint. PFS and OS of course are both considered survival endpoints, and both are described as “time to event” endpoints versus “proportional endpoints” (e.g., ORR, DR, BORR, etc.).

PV-10 already demonstrated shown tremendously robust PFS in Provectus' MM Phase 2 trial. Patients, by definition, are living longer “progression free.” Management, however, believes the Moffitt forthcoming data is all they need prove PV-10 works systemically.

Amgen acquired BioVex in March 2011 for $425 million upfront and up to $575 million milestones. BioVex's purchase should put a firm floor of about $1B under the value of Provectus (or about $5-7 per share fully diluted).