Will Trodelbi become a second-line standard tx

for triple-negative breast cancer?

Gilead holds a press conference to commemorate the domestic launch of Trodelbi

Trodelbi improves key evaluation indicators compared to chemotherapy

Triple-negative breast cancer, lack of treatment options, ↑ need for effective treatment

Gilead Sciences Korea held a press conference at the Plaza Hotel in Seoul on the 7th to commemorate the domestic launch of Trodelbi, a treatment for metastatic triple-negative breast cancer

Antibody Drug Conjugate (ADC) anticancer drugs first appeared in the domestic triple-negative breast cancer treatment market.

 

To date, there have been no treatment options targeting triple-negative breast cancer treatment other than immunotherapy drugs and PARP inhibitors.

 

Gilead is aiming to make Trodelbi the standard treatment option in this area.

 

Gilead Sciences Korea held a press conference at the Plaza Hotel in Seoul on the 7th to commemorate the domestic launch of Trodelbi, a treatment for metastatic triple-negative breast cancer.

 

Trodelbi is an ADC that targets Trop-2 protein, which is frequently observed on the surface of breast cancer cells and is used as a treatment for advanced or metastatic triple-negative breast cancer.

 

Last May, Trodelbi was approved in Korea for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer that has previously received two or more systemic treatments, at least one of which was for metastatic disease, and was launched in Korea last month.

 

The phase 3 ASCENT study served as the basis for approval.

 

The study was conducted to compare the effectiveness and safety of Trodelbi and chemotherapy in 529 patients with locally advanced or metastatic triple-negative breast cancer who had previously received chemotherapy twice or more.

 

12% of all patients had brain metastases.

 

The primary endpoint was PFS in patients without brain metastases compared to baseline.

 

Secondary endpoints included overall patient PFS, OS, and ORR.

 

As for clinical results, the median PFS in patients without brain metastases, which was set as the primary endpoint, was recorded by Trodelbi at 5.6 months.

 

This was a higher figure than the 1.7 months recorded for chemotherapy.

 

The OS, measured regardless of the secondary endpoint of brain metastasis, was 11.8 months for Trodelbi and 6.9 months for chemotherapy in the entire patient group.

 

There was a significant difference in ORR, with Trodelbi being 31% and chemotherapy being 4%.

 

In terms of safety, serious adverse reactions such as neutropenia (7%), diarrhea (4%), and pneumonia (3%) occurred during Trodelbi administration.

 

Treatment discontinuation due to adverse reactions was calculated to be 5% for Trodelbi and chemotherapy.

 

Professor Son Joo-hyuk of the Department of Oncology at Yonsei Cancer Hospital said, “Trodelbi is considered a docile anticancer drug.

 

The basic principle is that cytotoxic anticancer drugs kill cancer cells, and as they bind to antibodies, we confirmed a good safety profile without severe toxicity,” he said.

 

“Trodelbi is an anticancer drug that should be used as a standard treatment for metastatic triple-negative breast cancer.” “I think it should be included not only in ESMO or NCCN but also in our country’s treatment guidelines,” he said.

 

According to the NCCN guidelines, Trodelbi is classified as Category 1 for the second-line or higher treatment of adult patients with metastatic triple-negative breast cancer.

 

Rare cancer, triple-negative breast cancer, need for secondary treatment options after treatment failure.

 

Triple-negative breast cancer is classified as a rare cancer among breast cancers.

 

Triple-negative breast cancer, which is negative for human epidermal growth factor receptor type 2 (HER2), hormone receptor (HR), and estrogen, is experiencing difficulties in developing targeted treatments.

 

In particular, compared to HR- and HER2-positive breast cancer, there is a shortage of treatments and treatment outcomes are not as good.

 

In the case of early triple-negative breast cancer, immunotherapy drugs can be used without biomarker analysis.

 

However, in metastatic triple-negative breast cancer, it can only be used if there is PD-L1 expression.

 

If BRCA mutation is confirmed, PARP inhibitors can be used, but if there is no corresponding biomarker mutation, there is no treatment.

 

Professor Kim Ji-hyung of the Department of Oncology at Gangnam Severance Hospital said, “Triple-negative breast cancer has aggressive clinical manifestations and there are almost no targeted therapies available.

 

“The disease-free survival rate is usually only 2 to 3 months, and there is no standard treatment,” he said.

 

“Immunotherapy drugs also require confirmation of the PD-L1 expression rate, so treatment options are limited.

 

“An effective treatment is needed for patients with metastatic triple-negative breast cancer who have failed primary treatment,” he said.