Avid Bioservices Inc (CDMO)

[sulaco]

Vin, you contradict yourself

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.

OK, so you're saying this to prove the possibility of running trials with your adjuvant hormonal therapy and I/O 1.0 downstream anti-XYZ agents....(which was your initial point all along).

but then you say that you really didn't mean it!

I never said Tamoxifen or Herceptin alone were the single agent SOC.

Oh yes you just did.

If the SOC is tamoxifen alone or Herceptin alone....

OK, so let me get this straight. Your point all along is to test your adjunctive hormonal therapy with I/O agents to see if there is synergy, and then you give examples of those trials, but then say that you didn't say it!

If 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.

I/O is NOT the standard of care for breast nor prostate cancer. Can't run that trial with your adjuvant hormonal therapy.

Note that I said IF the single agent was the SOC. Please show me where I stated that Tamoxifen alone or Herceptin alone are the SOC.

No, of course you didn't. You just used those exact drugs as an example of SOC.

If you're just talking hypothetically about these trials, you're even farther behind Bavi; at least we have REAL trials planned. Not gedanken "thought" experiments!

By the way, Herceptin is approved for treatment of HER2 positive cancer as a single agent. From the web link below.

You're reaching. Your own quotes of studies here are all examples of Herceptin adjuvant use!

{{Adjuvant Breast Cancer
Herceptin is approved for the treatment of early-stage breast cancer that is Human Epidermal growth factor Receptor 2-positive (HER2+) and has spread into the lymph nodes, or is HER2-positive and has not spread into the lymph nodes. If it has not spread into the lymph nodes, the cancer needs to be estrogen receptor/progesterone receptor (ER/PR)-negative or have one high risk feature.* Herceptin can be used in several different ways:

As part of a treatment course including the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. This treatment course is known as "AC?TH."

Meaning adjuvant treatment course.

With the chemotherapy drugs docetaxel and carboplatin. This treatment course is known as "TCH."

Meaning adjuvant treatment course.

Alone after treatment with multiple other therapies, including an anthracycline (doxorubicin)-based therapy (a type of chemotherapy).

Meaning adjuvant treatment course.


Metastatic Breast Cancer

Herceptin in combination with the chemotherapy drug paclitaxel is approved for the first line treatment of Human Epidermal growth factor Receptor 2-positive (HER2+) metastatic breast cancer.

Meaning adjuvant treatment course.

Herceptin alone is approved for the treatment of HER2-positive breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.

Meaning adjuvant treatment course.