Avid Bioservices Inc (CDMO)

[sulaco]

Vin, tamoxifen by itself is NOT SOC

True, in trials results matter but you should sure as hell have some idea of mechanism when you design trials, especially in combination trials.

Difficult to argue with you that "results matter."

I did notice you failed to acknowledge you were wrong when you said that 20% of HER positive tumors meant that only 20% of breast tumors express HER. As I pointed out, and the MAYO clinic site confirmed, HER positive tumors refers to tumors which HER2 is OVER-expressed based on histochemical assays, or FISH assays. Got it?

OK, 20% of breast cancer has OVER-expressed HER2. Researchers and physicians all refer to HER2+ BC and understand the significance of the term. It's still only 20% of BC, which was my original point. Case closed.

What are you talking about? These are the options. If the SOC is tamoxifen alone or Herceptin alone, then the trial arms could be tamoxifen alone or Herceptin alone vs IO + tamoxifen or IO + Herceptin. If the IO is the standard of care, your trial can also have two arms, one is the SOC, IO alone vs the combo of IO + your antigen specific antibody, hormone blocker, or antibody drug conjugate.

What are you talking about? Tamoxifen is adjuvant therapy, meaning additional therapy after an initial intervention (usually surgery or chemo). (Conversely, neoadjuvant therapy is defined as chemical intervention or radiation BEFORE surgery.)

Tamoxifen alone is not the standard of care for ANY breast cancer in the United States. Many studies have confirmed this. It can be used as solo therapy in elderly women (where PFS is not as pressing a concern given advanced age and the burden of surgery on an elderly lady) and in women who refuse breast surgery (mastectomy, partial mastectomy, lumpectomy, or minimal resection, all with or without lymph node dissection.) But that in no way makes it SOC.

For the vast majority of ER+ breast cancer patients, tamoxifen is used as adjuvant therapy after the quite variable surgical resection of their tumors. The duration is usually 5 years, but new studies show 10 years are better. (Guess your studies are going to go on for awhile.)


Another Study Shows 10 Years of Tamoxifen Better Than 5 for Early-Stage, Estrogen-Receptor-Positive Disease

10 years of tamoxifen better

Also, Herceptin alone is not the standard of care for ANY breast cancer in the United States. It, too, is used as adjuvant therapy.

So both your trial designs are just not feasible. You can't go off SOC.

Vin, I like your hopium with adjuvant hormonal therapy and downstream I/O 1.0 inhibitors, but they seem more far-fetched than your unfavored Bavi.