Roberto A. Leon Ferre, MD, oncologist, Mayo Clinic, discusses reasons to explore biosimilars in oncology.

Biosimilars should be explored as a potential alternative to biologic therapy, especially if these products can be marketed at a lower cost than the reference products, says Leon Ferre. Potential cost savings is the principle reason to pursue biosimilars, he adds.

If a biosimilar costs the same as the reference product, there is no incentive to use it in practice, explains Leon Ferre. If a biosimilar can display similar efficacy to a biologic product at a reduced cost, it should be embraced, he adds. Before biosimilars can be marketed, the patent for the originator biologic has to expire. Pending such expirations, insurance companies may decide to select biosimilars over biologics.

Recently, UnitedHealthcare announced that Amgen’s biosimilars—the trastuzumab (Herceptin) biosimilar trastuzumab-anns (Kanjinti) and a bevacizumab (Avastin) biosimilar bevacizumab-awwb (Mvasi)&mdash;will be preferred products for commercial, community, and Medicare Advantage plans, effective October 1, 2019.

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Dr. Leon Ferre on Reasons to Explore Biosimilars in Oncology

Roberto A. Leon Ferre, MD, oncologist, Mayo Clinic, discusses emerging therapies for the treatment of patients with triple-negative breast cancer (TNBC).

Physicians are starting to see a lot of preclinical work and laboratory research being translated to the clinic, says Leon Ferre. For example, findings from the phase III IMpassion130 trial demonstrated that the combination of atezolizumab (Tecentriq) and nab-paclitaxel (Abraxane) reduced the risk of progression or death by 38% (HR, 0.62; 95% CI, 0.49-0.78; 

<.0001) versus nab-paclitaxel alone in patients with unresectable locally advanced or metastatic PD-L1—positive TNBC. This is the first immunotherapy to prove beneficial in the clinic, says Leon Ferre.

In the last couple of years, several targeted therapies have been approved for TNBC, including PARP inhibitors for patients who have germline 

 mutations. That approval set an important precedent in TNBC, as it was the first nonchemotherapy drug to be approved for this patient population, he adds. A lot of activity has also been observed with antibody-drug conjugates, several of which have been granted breakthrough therapy designations by the FDA.

Dr. Leon Ferre on Emerging Therapies in TNBC

Roberto A. Leon Ferre, MD, oncologist, Mayo Clinic, discusses the randomized trial evaluating the effectiveness of oxybutynin chloride in the management of hot flashes in patients with breast cancer at the 2018 San Antonio Breast Cancer Symposium.

At the meeting, results of the randomized, double-blind, placebo-controlled trial (ACCRU study SC-1603) evaluating the use of the antispasmodic and anticholinergic agent in patients who are not candidates for, or are not interested in hormone replacement therapy were presented. Patients were randomized to receive 5 mg of oxybutynin twice daily or 2.5 mg twice daily. A third arm was included to evaluate the role of placebo as there is a 20% to 30% reduction in the incidence of hot flashes with placebo, notes Leon Ferre.

Over the course of the study, patients filled out questionnaires. Patients were also asked to fill out a survey prior to starting therapy to establish a baseline and then continued to do so on a daily or weekly basis. The study took place over the course of 6 weeks, after which the changes in reported outcomes were assessed. Researchers found that patients on both oxybutynin arms, regardless of dose, experienced a reduction in the severity and frequency of hot flashes. An improvement in the degree of interference with work, leisure, and overall quality of life, was also observed, says Leon Ferre.

Dr. Leon Ferre on the Results of the Randomized Trial of Oxybutynin for Hot Flashes

Roberto A. Leon Ferre, MD, oncologist, Mayo Clinic, discusses ongoing research in triple-negative breast cancer (TNBC).

Physicians do not have great insight into the drivers behind the growth of TNBC cells, says Leon Ferre. Though there has been progress with targeted therapies for specific subsets of patients, they comprise the minority of the overall TNBC population. Patients with PD-L1 expression account for up to 20% of the population, and those with germline 

 mutations account for an even smaller percentage of patients. The majority of patients are given cytotoxic chemotherapy.

Ongoing research is further investigating the genomics and proteomics of TNBC with the hope of developing additional targets for those patients who do not fit under those categories. Historically, research focused on the tumor, but more effort is being devoted to understanding the tumor microenvironment, explains Leon Ferre. That may lend greater insight into the biology of the disease and help direct treatment towards a tumor cell and the microenvironment that supports that tumor cell, Leon Ferre concludes.

Roberto A. Leon Ferre, MD

Articles

Dr. Leon Ferre on Reasons to Explore Biosimilars in Oncology

Dr. Leon Ferre on Emerging Therapies in TNBC

Dr. Leon Ferre on the Results of the Randomized Trial of Oxybutynin for Hot Flashes

Dr. Leon Ferre Discusses Ongoing Research in TNBC