Gilead announced results from a breast cancer stud
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Posted On: 09/12/2022 11:53:22 AM
Gilead announced results from a breast cancer study using Trodelvy. I have included excerpts and a link below. The reason I am posting this is that Dr. Hope Rugo is the lead investigator and she is on CYDY’s Scientific Advisory Board. Her bio on the company’s website is impressive and includes the following:
Dr. Hope Rugo is the Director of the Breast Oncology Clinical Trials Program at UCSF. She is the principal investigator for multiple clinical trials studying novel targeted therapeutics combined with standard treatments to improve clinical results in early and late-stage breast cancer. She is also researching cognitive function in patients receiving chemotherapy for breast cancer as well as ways to reduce toxicity from therapy.
She has the opportunity to encourage combo treatments with Leronlimab. Have there been any announcements (or even rumors) that she is currently involved with any Leronlimab trials? Could she be working behind the scenes under one of the NDAs? It would be encouraging to see some activity from our advisory board.
Gilead is quite excited about a median survival improvement of 3.2 months. Is that a low bar?
It’s been weeks since Gilead touted “clinically meaningful” overall survival results from a second interim analysis of Trodelvy in a subset of metastatic breast cancer patients. Now we finally have a look at the hard data.
Patients with HR+/HER2- metastatic breast cancer who received Trodelvy after prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemo survived a median of 14.4 months, as opposed to just 11.2 months for those who received physician’s choice chemotherapy, Gilead announced on Wednesday.
Trodelvy, an antibody drug conjugate directed at Trop-2, posted less than ideal OS data upon an interim readout at ASCO back in June, showing no significant difference between the two arms on the key secondary endpoint. However, CMO Merdad Parsey and lead investigator Hope Rugo both emphasized that the OS data were still “very immature.”
HR+/HER2- breast cancer is the most common type of breast cancer, accounting for about 70% of new cases worldwide per year. Trodelvy is often pitted against AstraZeneca and Daiichi Sankyo’s ADC therapy Enhertu, which last month became the first therapy approved for a newly defined subset of breast cancer patients called HER2-low.
About 60% of HER2-negative patients fall into the HER2-low bucket, according to regulators, meaning they have some HER2 proteins, but not enough to be classified as HER2-positive.
Following AstraZeneca and Daiichi’s lead, Gilead also posted HER2-low and IHC0 data from the TROPiCS-02 trial on Wednesday, with progression-free survival coming in at 6.4 months in the treatment arm for HER2-low patients, and five months for IHC0 patients. In the intent to treat population, PFS was 5.5 months in the Trodelvy arm, compared to four months in the placebo arm (p=0.0003).
https://endpts.com/esmo22-trodelvys-long-awai...-expected/
Dr. Hope Rugo is the Director of the Breast Oncology Clinical Trials Program at UCSF. She is the principal investigator for multiple clinical trials studying novel targeted therapeutics combined with standard treatments to improve clinical results in early and late-stage breast cancer. She is also researching cognitive function in patients receiving chemotherapy for breast cancer as well as ways to reduce toxicity from therapy.
She has the opportunity to encourage combo treatments with Leronlimab. Have there been any announcements (or even rumors) that she is currently involved with any Leronlimab trials? Could she be working behind the scenes under one of the NDAs? It would be encouraging to see some activity from our advisory board.
Gilead is quite excited about a median survival improvement of 3.2 months. Is that a low bar?
It’s been weeks since Gilead touted “clinically meaningful” overall survival results from a second interim analysis of Trodelvy in a subset of metastatic breast cancer patients. Now we finally have a look at the hard data.
Patients with HR+/HER2- metastatic breast cancer who received Trodelvy after prior endocrine therapy, CDK4/6 inhibitors and two to four lines of chemo survived a median of 14.4 months, as opposed to just 11.2 months for those who received physician’s choice chemotherapy, Gilead announced on Wednesday.
Trodelvy, an antibody drug conjugate directed at Trop-2, posted less than ideal OS data upon an interim readout at ASCO back in June, showing no significant difference between the two arms on the key secondary endpoint. However, CMO Merdad Parsey and lead investigator Hope Rugo both emphasized that the OS data were still “very immature.”
HR+/HER2- breast cancer is the most common type of breast cancer, accounting for about 70% of new cases worldwide per year. Trodelvy is often pitted against AstraZeneca and Daiichi Sankyo’s ADC therapy Enhertu, which last month became the first therapy approved for a newly defined subset of breast cancer patients called HER2-low.
About 60% of HER2-negative patients fall into the HER2-low bucket, according to regulators, meaning they have some HER2 proteins, but not enough to be classified as HER2-positive.
Following AstraZeneca and Daiichi’s lead, Gilead also posted HER2-low and IHC0 data from the TROPiCS-02 trial on Wednesday, with progression-free survival coming in at 6.4 months in the treatment arm for HER2-low patients, and five months for IHC0 patients. In the intent to treat population, PFS was 5.5 months in the Trodelvy arm, compared to four months in the placebo arm (p=0.0003).
https://endpts.com/esmo22-trodelvys-long-awai...-expected/
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