During the 2021 San Antonio Breast Cancer Symposium, findings from a real-world analysis evaluating racial disparities in 

 testing for patients with TNBC were presented in a virtual poster. The results showed that the rate of 

 testing was high overall in evaluated patients with TNBC, although a larger proportion of White patients received testing compared with Black or African American patients. 

Among untested patients, Black or African American patients were offered testing more frequently compared with White patients; however, fewer Black or African American patients were able to undergo testing or declined testing for reasons including lack of transportation to the appointment, lack of availability for childcare during the appointment, inability to take time off work, desire to focus on initiation of cancer treatment, among others. 

 testing is offered through a robust mechanism, Ali explains. However, the results showed that a main reason for patients not receiving testing was because they declined testing. As such, these results indicate that underlying mechanisms beyond not being offered 

 testing to patients exist to cause patients to elect against testing. These mechanisms need to be explored to improve the rates of 

 testing in patients with TNBC, Ali concludes. 

Videos

Haythem Y. Ali, MD, member, Henry Ford Cancer Institute, Henry Ford Health System, discusses the need to understand real-world disparities with BRCA testing referrals and uptake in patients with triple-negative breast cancer.   



Dr. Ali on the Need to Understand Real-World Disparities in BRCA Testing in TNBC 

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses adjuvant studies with biosimilars in oncology.

The problem with adjuvant studies, says Ali, is that they take a long time to evaluate. If adjuvant studies are mandated before biosimilars are able to be used in oncology, physicians will never get access to them. Ali explains that by the time researchers have answered the question of their efficacy, they will have moved on to other adjuvant therapies.

It makes sense to ensure that the efficacy is reasonable in the metastatic setting, says Ali. Once physicians are comfortable with that, they should be comfortable prescribing the biosimilar in the other settings that the reference drug is approved for, adds Ali. It is a personal comfort, and it should not take physicians long to determine whether these drugs are working or not, he says.

Additionally, Ali notes that physicians have to work to correct the notion that biosimilars and generics are one in the same. Ultimately, more education is needed in general if biosimilars are to flourish in the field of oncology.

Dr. Ali on Adjuvant Studies With Biosimilars in Oncology

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses whether biosimilars can replace biologics in oncology.

Innovation is an integral part of oncology, explains Ali. Currently, physicians are not reliant on branded drugs. Therefore, it is likely that the old biologics will be replaced in the development process. Though there are incentives to using biosimilars, it is unlikely that they will be the only available therapies in oncology, says Ali.

In September 2017, ABP-215 (bevacizumab-awwb; Mvasi), a biosimilar for bevacizumab (Avastin), was approved by the FDA for the treatment of adult patients with colorectal, lung, brain, kidney, and cervical cancers. ABP-215 was the first biosimilar to be approved in the United States for the treatment of patients with cancer. In December 2017, MYL-1401O (Ogivri; trastuzumab-dkst), a biosimilar for trastuzumab (Herceptin), was approved for the treatment of HER2-positive patients with breast cancer or metastatic gastric or gastroesophageal junction adenocarcinoma.

Dr. Ali on Whether Biosimilars Can Replace Biologics in Oncology

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses neratinib (Nerlynx) in the treatment of patients with HER2-positive breast cancer.

The ExteNET trial of neratinib in patients with early stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin) showed that the invasive disease-free survival rate at 2 years was 94.2% with neratinib versus 91.9% with placebo. This data, along with the findings of the phase II CONTROL trial, led to the FDA approval of the agent.

Ali says that the nice thing about this trial is that it was done in patients who had not received pertuzumab (Perjeta), and it showed a benefit in the estrogen receptor (ER)-positive group. If there is a patient who is ER-positive with high-risk disease, Ali says that neratinib escalation may be a good option. Until more information on the adjuvant setting is reported, Ali says this is his thought process when choosing treatment.

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses neratinib (Nerlynx) in the treatment of patients with HER2-positive breast cancer.
 

Dr. Ali on Choosing Neratinib in HER2+ Breast Cancer

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses the future of adjuvant treatment for patients with HER2-positive breast cancer.

Ali says that a strong adjuvant strategy that is currently being used is de-escalating to single chemotherapy with trastuzumab (Herceptin). Prior attempts to lengthen the time of trastuzumab has not been shown to be beneficial in the adjuvant setting.

Another new adjuvant strategy is T-DM1 (ado-trastuzumab emtansine; Kadcyla). Ali says that T-DM1 will likely be useful in patients who do not achieve a complete response in the neoadjuvant setting. Trials are currently ongoing with the agent.

In the metastatic setting, there are tyrosine kinase inhibitors that are more selective than neratinib (Nerlynx), with a more favorable toxicity profile, Ali says. If these agents are successful, they may be used in the adjuvant setting.

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses the future of adjuvant treatment for patients with HER2-positive breast cancer.
 

Dr. Ali on the Future of Adjuvant Care for HER2+ Breast Cancer

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses misconceptions about biosimilars in oncology.

A biosimilar is defined by the FDA as a biological product that is highly similar to an existing FDA-approved reference product, and has no meaningful differences. Since biosimilars are relatively new to the cancer sphere in the United States, Ali says that some providers are unsure of the differences between biosimilars and generic drugs.

Ali says that the only way for providers to understand biosimilars, and therefore become comfortable with their use, is through education. There are a different set of rules to follow to get a biosimilar approved by the FDA, and providers should understand those rules and their importance, Ali explains.

Although there have been multiple approvals of biosimilars as cancer treatment in the United States, they are not yet available. But there are supportive care biosimilars in oncology for the myeloid growth factors GCSF, or filgrastim (Neupogen).

Dr. Ali Explains Misconceptions About Biosimilars

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses the adjuvant treatment of patients with HER2-positive breast cancer.

In July 2017, the FDA approved neratinib (Nerlynx) for the extended adjuvant treatment of patients with early stage, HER2-positive breast cancer following postoperative trastuzumab (Herceptin). Following this approval, the FDA approved pertuzumab (Perjeta) in combination with trastuzumab and chemotherapy as an adjuvant treatment for patients with HER2-positive early breast cancer at high risk for recurrence in December 2017.

Clinicians can now choose between 2 adjuvant therapeutic regimens—trastuzumab plus pertuzumab, or neratinib. Both of these are dose-escalation strategies, says Ali, so clinicians should focus on patients who will benefit the most. Focusing on higher-risk patients, the small amount of benefit that adjuvant therapy provides is more impactful, he explains. The question is, which high-risk patients receive which dosage strategy? The subgroup analyses from these trials may help clinicians make their decision, Ali says.

Dr. Ali on Choosing Adjuvant Treatment for HER2+ Breast Cancer

Haythem Y. Ali, MD, senior medical oncologist, Henry Ford Hospital, discusses the incorporation of biosimilars into cancer treatment.

With the approval of the bevacizumab (Avastin) biosimilar ABP-215 (bevacizumab-awwb; Mvasi), and the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst), physicians have begun to think about the possibility of incorporating these agents into practice. The choice whether to incorporate biosimilars into clinical practice will most likely be up to payers as opposed to physicians, says Ali. He adds that physicians should understand and not be afraid of using FDA-approved biosimilars. If the biosimilar meets the criteria set forth by the regulatory agencies, then there should be no reason to discriminate against it, he adds.

In the metastatic setting, it is easy to see whether an agent is working or not, Ali says. However, in the neoadjuvant and adjuvant setting it is not as clear—making the integration of biosimilars intimidating for some physicians. Ali says that he believes biosimilars will be used in the metastatic setting first, and then once physicians become more comfortable with the agents, they will be moved to other lines of treatment.