Emergent Treatment Options in ER+ Breast Cancer

Dr Novik on Emergent Treatment Options in ER+ Breast Cancer

Yelena Novik, MD, professor, Department of Medicine, New York University (NYU) Grossman School of Medicine, NYU Langone Health, discusses advancements and emerging trends that have been seen in the treatment of patients with advanced estrogen-receptor (ER)–positive breast cancer, citing clinical trials that have helped push the treatment armamentarium forward.

Novik begins by saying that breast cancer oncologists take pride in the current state-of-the-art approaches available for the treatment of patients with ER-positive/ER-sensitive breast cancer. Collaborating closely with scientific colleagues, she states that investigators are fortunate to have explored novel pathways that significantly enhance the effectiveness of breast cancer treatment.

® State of the Science Summit™ on breast cancer, Novik gave a presentation centered on the management of advanced ER-positive breast cancer, denoting metastatic breast cancer. Over the years, oncologists have transitioned toward managing breast cancer as a chronic disease, and recent trials affirm this paradigm shift, she explains. Notably, patients diagnosed with ER-positive advanced breast cancer now have the potential to live for extended periods because of estrogen-directed therapies, Novik states.

Therapeutic advancements, such as tamoxifen, boast a nearly 5-decade history, and aromatase inhibitors have had a robust track record for over 2 decades, she expands. However, the ER-positive breast cancer treatment armamentarium has evolved dramatically in the past 7 to 8 years with the advent of cell cycle inhibitors, including CDK4/6 inhibitors.

, a regulatory decision that was followed by investigation into other CDK4/6 inhibitors, she adds. Despite subtle differences in chemical structure and targeted cell cycle molecules between these agents, palbociclib, ribociclib (Kisqali), and abemaciclib (Verzenio) have demonstrated notable efficacy in prolonging progression-free survival based on the positive outcomes observed in the phase 3 PALOMA-2 (NCT01740427), MONALEESA-2 (NCT01958021), and monarchE (NCT03155997) trials, respectively, for patients with ER-positive breast cancer, Novik concludes.

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Yelena Novik, MD, discusses advancements and emerging trends that have been seen in the treatment of patients with advanced estrogen-receptor–positive breast cancer, citing clinical trials that have helped push the treatment armamentarium forward.


Yelena Novik, MD, associate professor, NYU Langone’s Perlmutter Cancer Center, discusses the benefits and challenges of the global implementation of biosimilars.

Novik says she is a big proponent of people worldwide having access to life-saving drugs and that biosimilars are a way of making this reality. In breast cancer, there are some biosimilars being developed that target the HER2 molecule, among others. There is currently great hope that these drugs will soon become available in parts of the world that lack them. Overall, biosimilars can have a significant impact on the outcomes of breast cancer on a global scale, and Novik predicts the vast majority of her colleagues will vote in favor of their implementation.

Some challenges in the way of biosimilars are related to drug manufacturers. While there is no legislation against developing an agent similar to a company’s product, patent law could get in the way. The biggest thing in terms of getting oncologists on board is the quality assurance of these drugs, Novik says.

Yelena Novik, MD, associate professor, New York University’s Perlmutter Cancer Center, discusses the benefits and challenges of the global implementation of biosimilars.

Dr. Novik on Benefits/Challenges of Implementing Biosimilars

Yelena Novik, MD, associate professor, NYU Langone’s Perlmutter Cancer Center, discusses CDK4/6 inhibitor combinations in breast cancer.

Updated data on the MONARCH studies with abemaciclib (Verzenio) were presented at the 2018 ASCO Annual Meeting. Physicians saw some concern in cost issues related to cell-cycle inhibitors, notes Novik, but says they will remain the treatment paradigm as their role as a first- and potentially second-line treatment for patients with advanced breast cancer is uncontested. They prolong disease-free survival and improve quality of life, says Novik, and managing toxicity does not seem to be too challenging.

Premenopausal women should be offered the combination with ovarian suppression as their first-line treatment, says Novik. If these patients did not receive it in the second-line setting, hormonal therapy can also extend their longevity and time to progression. As time goes on, there may be an uptick of neoadjuvant therapy with this combination with hormonal therapy, Novik says. However, that is a relatively unexplored area, especially in older women.

Dr. Novik on CDK4/6 Inhibitor Combinations in Breast Cancer

Yelena Novik, MD, associate professor, New York University’s Perlmutter Cancer Center, discusses the potential impact of biosimilars on the treatment of cancer.

Biosimilars and generic drugs differ in the complexity of production, says Novik. Additionally, clinical trials are very expensive, and trying to reproduce something off an identical molecule—like a generic&mdash;will have a high cost without contributing anything new intellectually to society, Novik says.

It is a very complex issue, but at this point in time, medications need to be available for the wider population, Novik states. Although an oncologist’s primary responsibility is to get drugs for their individual patients, the overall goal in oncology is to provide the world’s population with the best treatment possible, which may be reached with biosimilars.

Yelena Novik, MD, associate professor, New York University’s Perlmutter Cancer Center, discusses the potential impact of biosimilars on the treatment of cancer.
 

Dr. Novik on the Potential Impact of Biosimilars on Cancer Treatment

Yelena Novik, MD, associate professor, New York University Langone’s Perlmutter Cancer Center, discusses the sustainability of drug development in oncology.

Progress in the development of new therapeutic options is a big part of oncology, and physicians understand that there is need for investment in order to development these treatments, says Novik. However, Novik states that the current progression of drug development in oncology is unsustainable.

There are 3 new FDA-approved drugs for the treatment of patients with estrogen receptor-positive breast cancer. These drugs have out-of-pocket costs upwards of $10,000 a month. The average person could not afford these drugs, says Novik.

The development and approval process of a biosimilar likewise costs millions of dollars. But, by the time a biosimilar is developed and approved, it will cost upwards of 30% less than the originator drug.

Dr. Novik on the Sustainability of Drug Development

Yelena Novik, MD, associate professor, New York University’s Perlmutter Cancer Center, discusses the adoption of biosimilars in breast cancer.

Novik says that she is a big proponent of making drugs that will be accessible to all patients across the world. Filgrastim-sndz (Zarxio), a biosimilar for the G-CSF analog filgrastim (Neupogen), is the only biosimilar commonly used in oncology practice. Although, there have been some recent biosimilar approvals that have not entered practice yet. Some biosimilars have been approved in European regulatory societies and may at some point be approved the United States.

Having access to these agents can change the outcomes of patients with breast cancer who do not have access to the originator drug. It is a difficult subject as a whole, states Novik. In addition to pharmaceutical legislation and patent law, physicians want to be sure that biosimilars produce the same effect as the originator drug.

Although biosimilars must go through a rigorous process before approval, Novik states that the vast majority of her colleagues will vote for the adoption of biosimilars.

Yelena Novik, MD, associate professor, Department of Medicine, New York University’s Perlmutter Cancer Center, discusses the adoption of biosimilars in breast cancer.

Yelena Novik, MD

Articles

Dr Novik on Emergent Treatment Options in ER+ Breast Cancer

Dr. Novik on Benefits/Challenges of Implementing Biosimilars

Dr. Novik on CDK4/6 Inhibitor Combinations in Breast Cancer

Dr. Novik on the Potential Impact of Biosimilars on Cancer Treatment

Dr. Novik on the Sustainability of Drug Development

Dr. Novik on the Adoption of Biosimilars in Breast Cancer