Zahi Mitri, MD, MS, assistant professor of medicine, Oregon Health and Science University, discusses the promise of trastuzumab (Herceptin) biosimilars.

showed that neoadjuvant therapy with a trastuzumab biosimilar was safe, well tolerated, and there was no difference in the pathology of complete response. Mitri says that this is exciting, as it may cut the cost of treatment—which is important in the current healthcare climate.

There are many studies looking at multiple biosimilars for trastuzumab. In HER2-positive breast cancer, adding MYL-1401O (Ogivri; trastuzumab-dkst) to a taxane as initial therapy followed by MYL-1401O monotherapy as maintenance produced a nearly identical progression-free survival rate at 48 weeks compared with trastuzumab in patients.

Although, Mitri notes that there has been considerably more excitement in Europe for the trastuzumab biosimilars than in the US. If biosimilars are safe, well tolerated, and the efficacy is the same, Mitri says that the US will adopt biosimilars for cancer treatment in the near future.

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Zahi Mitri, MD, MS, assistant professor of medicine, Oregon Health and Science University, discusses the promise of trastuzumab (Herceptin) biosimilars.
 

Dr. Mitri Discusses the Promise of Trastuzumab Biosimilars

Zahi Mitri, MD, MS, assistant professor of medicine, Oregon Health and Science University, discusses adjuvant therapy for patients with HER2-postive breast cancer.

Although the APHINITY showed a statistically significant improvement in disease-free survival with the use of adjuvant pertuzumab (Perjeta), Mitri says that few physicians have changed their treatment regimen to include it. Pertuzumab is often used in the neoadjuvant setting, so the question now is what to do after. Mitri says that he gives pertuzumab for 1 year, sometimes neoadjuvantly and sometimes adjuvantly.

As for neratinib (Nerlynx), the phase III ExteNET trial was positive and led to the FDA approval for this agent in the adjuvant setting. Much of the benefit observed for neratinib was in the estrogen receptor (ER)-positive population. Mitri says that since none of these patients had previously received pertuzumab, there is question of the benefit of neratinib after 1 year of neoadjuvant pertuzumab—which most patients with HER2-positive disease receive.

Mitri says that if a patient who was ER-positive had received neoadjuvant pertuzumab and remained high-risk, he would recommend adjuvant neratinib.

Zahi Mitri, MD, MS, assistant professor of medicine, Oregon Health and Science University, discusses adjuvant therapy for patients with HER2-postive breast cancer.
 

Dr. Mitri Discusses Adjuvant Therapy for HER2+ Breast Cancer

Zahi Mitri, MD, MS, assistant professor of medicine, Oregon Health and Science University, discusses the impact of the FDA-approval of the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst).

In December 2017, the FDA approved the trastuzumab (Herceptin) biosimilar MYL-1401O (Ogivri; trastuzumab-dkst) for patients with HER2-positive breast cancer and HER2-positive metastatic gastric or gastroesophageal junction adenocarcinoma—the same indications as trastuzumab. MYL-1401O demonstrated an overall response rate (ORR) of 69.6% among women who received the biosimilar in combination with a taxane after 24 weeks, compared with a 64% ORR for patients who received trastuzumab plus a taxane. Mitri says that this approval shows that biosimilars can be developed and tested safely in patients with cancer.

Although a biosimilar will never be the same molecule as the originator drug, if the same efficacy is achieved it can be a positive contribution to the treatment landscape. Looking ahead, Mitri says that if the long-term outcomes between trastuzumab and MYL-1401O are similar, that may change the adoption of these drugs and the whole cost of care. This could be impactful because drugs like trastuzumab cost thousands of dollars, Mitri concludes.  

Zahi Mitri, MD

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Dr. Mitri Discusses the Promise of Trastuzumab Biosimilars

Dr. Mitri Discusses Adjuvant Therapy for HER2+ Breast Cancer

Dr. Mitri on Impact of Trastuzumab Biosimilar FDA Approval