Is HER2 Antibody-Drug Conjugate DS-8201 Effective for Breast Cancer?

Is HER2 Antibody-Drug Conjugate DS-8201 Effective for Breast Cancer?

Formerly certified by Japan's Ministry of Foreign Affairs Medical Visa Guarantee Agency B-66 Travel Services Arrangement Business License No. 35, Fukuoka Prefecture, Japan Japanese Medical Equipment Sales and Rental Business Management

Formerly certified by Japan's Ministry of Foreign Affairs Medical Visa Guarantee Agency B-66 Travel Services Arrangement Business License No. 35, Fukuoka Prefecture, Japan Japanese Medical Equipment Sales and Rental Business Management

Is HER2 Antibody-Drug Conjugate DS-8201 Effective for Breast Cancer?

On December 11, 2019, Shanu Modi published "The efficacy and safety of HER2 antibody-drug conjugate DS-8201 monotherapy in HER2-positive advanced breast cancer patients with prior T-DM1 treatment experience in the DESTINY-Breast01 Phase II clinical trial" in the medical journal The New England Journal of Medicine.

This Phase II clinical trial was conducted internationally across multiple institutions in patients with HER2-positive advanced breast cancer who had prior T-DM1 treatment experience, using the HER2 antibody-drug conjugate DS-8201 5.4mg/kg monotherapy, continuing until disease progression or unexpected adverse events occurred. Primary endpoint: objective response rate. Secondary endpoints: duration of response and overall survival.

The trial was conducted because previous Phase I trial results in HER2-positive advanced breast cancer patients with prior T-DM1 treatment using DS-8201 showed a 59.5% objective response rate with a median duration of response of 20.7 months, generating significant interest. Therefore, this Phase II trial was designed to confirm the efficacy and safety of DS-8201.

ECOG 0 = 55.4%, ECOG 1 = 44%, ECOG 2 = 0.5%

The trial results were as follows. The primary endpoint objective response rate was 60.9%, including 6.0% complete response and 54.9% partial response.

Secondary endpoints showed a median duration of response of 14.8 months, median progression-free survival of 16.4 months, and median overall survival not reached, with 6-month overall survival rate of 93.9% and 12-month overall survival rate of 86.2%.

Regarding safety, at least one adverse event occurred in 99.5% of patients, with Grade 3 or higher adverse events in 57.1% of patients. Grade 3 or higher adverse events occurring in 5% or more of patients included: neutropenia 20.7%, anemia 8.7%, nausea 7.6%, leukopenia 6.5%, lymphopenia 6.5%, fatigue 6.0%. Treatment dose reduction due to adverse events occurred in 23.4%, and treatment discontinuation in 15.2%.

Based on the DESTINY-Breast01 clinical trial results, Shanu Modi concluded: HER2-positive advanced breast cancer patients with prior T-DM1 treatment experience receiving HER2 antibody-drug conjugate DS-8201 monotherapy demonstrated sustained anti-tumor efficacy.

[Important Notice] The clinical trial data and medical information translated by "Medical Supporter" from studies conducted overseas are not intended to encourage participation in clinical trials or the use of new drugs. Additionally, the translated information is for reference only and is not a treatment guideline. Please consult with healthcare professionals, and refer to the original article below for accurate content.

Source: Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer (N Engl J Med. 2019 Dec 11. doi: 10.1056/NEJMoa1914510.)

Trastuzumab Deruxtecan in Previously Treated HER2-Positive Breast Cancer (N Engl J Med. 2019 Dec 11. doi: 10.1056/NEJMoa1914510.)

#BreastCancer #HER2AntibodyDrugConjugate #DS8201

Medical Supporter was formerly certified as a medical visa guarantor by Japan's Ministry of Foreign Affairs and the Ministry of Economy, Trade and Industry (B-066).

Figure 1

Figure 2

Figure 3

Figure 4