Nirja Patel, Senior International Product Manager at Roche Shares her Views on the US FDA Approval of the PATHWAY anti-HER2 Test

Shots:

Nirja gave the details of the PATHWAY anti-HER2 (4B5) to identify metastatic breast cancer patients with low HER2 expression through its scoring algorithm that helps pathologists to identify “low expressors” of HER2
She told PharmaShots about how this test is able to identify patients who may benefit from Enhertu as a treatment option. She also elaborated on the key findings from the DESTINY-Breast04 trial under which the PATHWAY anti-HER2 (4B5) test was being evaluated.
The approval of this test shows Roche’s vision to bring integrated, high-medical-value solutions, raising the standard of care

Smriti: Please highlight the properties of the PATHWAY anti-HER2 (4B5) test along with the ability of this test to diagnose breast cancer in patients.

Nirja Patel: The PATHWAY anti-HER2 (4B5) test detects the HER2 protein in patients with breast cancer. HER2 is a receptor protein that helps cancer cells grow quickly. To determine a patient’s HER2 status, pathologists evaluate, or score, the level of HER2 receptor protein expressed in breast cancer tissue samples. If a patient's tumor expresses high levels of HER2, the patient is identified as HER2-positive and may be considered for HER2-targeted treatment. However, half of all patients with metastatic breast cancer express low levels of HER2, which historically classified them as HER2-negative.

The PATHWAY anti-HER2 (4B5) test now includes a scoring algorithm that helps pathologists to identify “low expressors” of HER2, assigning a HER2 low status to this group of patients. With this lower cutoff, the test is able to identify patients who may benefit from the targeted therapy ENHERTU® (fam-trastuzumab deruxtecan-nxki) as a treatment option.

The PATHWAY anti-HER2/neu (4B5) test is the only FDA approved companion diagnostic indicated as an aid in the assessment of HER2 low status in metastatic breast cancer patients.

Smriti: Shed some light on the study design of the (DESTINY-Breast04) trial evaluating the PATHWAY anti-HER2 (4B5) test.

Nirja Patel: DESTINY was a multi-center, international, phase 3 clinical trial of 557 patients. The study compared ENHERTU vs. chemotherapy (randomized 2:1), evaluating the progression-free survival for patients with metastatic breast cancer and trastuzumab deruxtecan (ENHERTU) vs conventional chemotherapy.

Smriti: What were the key findings obtained from the (DESTINY-Breast04) trial evaluating the PATHWAY anti-HER2 (4B5) test?

Nirja Patel: The PATHWAY anti-HER2 (4B5) test was used as part of the DESTINY-Breast04 trial sponsored by AstraZeneca and Daiichi Sankyo to identify patients whose tumors expressed low levels of HER2 protein. The trial reported a 50% reduction in the risk of disease recurrence or death and an overall gain of six months over standard of care in patients treated with ENHERTU whose tumors had low levels of HER2 expression.

Smriti: Give our readers some insights into Roche’s partnership with AstraZeneca & Daiichi Sankyo as well as the benefits that each company has personally reaped from it.

Nirja Patel: At Roche, this collaboration led the way in HER2 low diagnostics through critical innovations that support the identification of patients who may benefit from ENHERTU as a treatment option.

Smriti: As you have mentioned, the PATHWAY anti-HER2 (4B5) test is only FDA-approved diagnostic for breast cancer used as an aide to identify patients with HER2-low expression, how does your company plan to spread awareness regarding this diagnostic test among patients?

Nirja Patel: Our launch team has developed a multi-staged awareness and education program for the pathology community. Our primary focus is to educate and make pathologists aware of the use of this test as an aide to identify metastatic breast cancer patients with HER2-low expression who may benefit from treatment with ENHERTU.

Smriti: Are there any other HER2 diagnostics that Roche expects to develop or evaluate in the future for the treatment of breast cancer or other cancer indications?

Nirja Patel: The HER2 low approval also opens the door for multiple new tumor indications, beyond breast, being targeted by this next generation of new ADC therapies. Together, new indications combined with new ways of scoring will enable increased therapeutic options for a larger number of oncology patients.

Source: Canva

About the Author:

Nirja Patel is the Senior International Product Manager in Personalized Healthcare Solutions for Oncology at Roche Diagnostics. She has worked in the life sciences industry for over 12 years, both as a scientist and as a product manager. Nirja earned a BSc in Biochemistry from the University of Guelph. She also graduated from John’s Hopkins University with a MS in Biotechnology and holds an MBA from Boston University’s Questrom School of Business.  