2020-02-27| Trials & Approvals

NERLYNX-XELODA Combo Bags FDA Approval for HER2 Positive Breast Cancer Treatment

by Ruchi Jhonsa
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By Ruchi Jhonsa, Ph.D.

HER2 positive metastatic breast cancer is an aggressive cancer type with a high rate of recurrence and mortality. An estimated 20-30% of breast cancer tumors have been found positive for the HER2 receptor. Currently, the most effective method for treatment is by reducing receptor-ligand interaction with Trastuzumab, a humanized monoclonal antibody against the HER2 receptor. Despite the positive outcome with this post-surgery treatment, research shows that up to 25% of patients experience recurrence. To combat this problem, the FDA had previously approved the long-term use of NERLYNX, a HER2 inhibitor along with Trastuzumab for the treatment of recurrent breast cancer.

Yesterday, the FDA announced the approval of yet another combination of drugs for treating adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting. In the phase III NALA trial, NERLYNX (neratinib) developed by Puma Biotechnology, showed improvement in progression-free survival as well as overall survival when combined with first-line treatment drug, Xeloda (capecitabine). Along with FDA approval, NERLYNX was also approved in Europe for long-term use in HER2-positive breast cancer patients who are less than one year from the completion of prior treatment with trastuzumab. NERLYNX has also been approved for long-term use in Canada, Australia, Hong Kong, Singapore, and Argentina.

Adam M. Brufsky, MD, Ph.D., of Magee-Women’s Hospital and the Hillman Cancer Center at the University of Pittsburgh Medical Center expressed his excitement at this approval. “Together with the NALA investigators around the world, I am pleased to see the FDA approval of NERLYNX for the treatment of advanced HER2-positive metastatic breast cancer. This approval is based on data from the NALA trial, which we presented at ASCO last year, demonstrating that neratinib in combination with capecitabine offers a significant improvement over currently available therapies in this heavily pretreated patient population and can be added to NERLYNX’s established role in the treatment of early breast cancer” he said.

In collaboration with its global licensing partners, Puma expects to seek approval of this combination in all countries where NERLYNX is currently approved.


NERLYNX and XELODA – An Effective Combo

HER2 positive breast cancers express the HER2 receptors on the surface of the cell. This receptor comes from the EGF family of receptor and dimerizes upon ligand binding. NERLYNX is an irreversible pan-HER inhibitor that prevents ligand binding and stops growth signals in the midst, thereby regulating cancer cell growth. However, XELODA works on a different principle. It is a prodrug that is converted to Fluorouracil by thymidine phosphorylase, which is majorly overexpressed in cancer cells. Fluorouracil inhibits cancer growth by inhibiting the formation of deoxythymidine monophosphate, which is essential for DNA replication and repair and the absence of the same leads to an imbalance in the pool of DNA nucleotides.


The NALA Trial Results

NALA trial is a multicenter, open-label, randomized Phase III trial that evaluated the efficacy of the drug combo in 621 patients with metastatic HER2 positive breast cancer who received two or more prior anti-HER2 based regimens in the metastatic setting. Patients were randomized (1:1) to receive a combination of NERLYNX and XELODA or combination of TYKERB (lapatinib) and XELODA in defined concentrations and time. After treatment with either of the combinations, the NALA trial determined primary outcomes by calculating the proportion of individuals whose disease remained stable after 12 and 24 months as well as overall survival (OS) of the individuals. Besides, secondary outcomes measured objective response rate and duration of response. NERLYNX showed great improvement in the PFS rate at 12 months when combined with XELODA (29%) in comparison to the other combination (15%). Moreover, the median overall survival was better for NERLYNX-XELODA combination (21 months) in comparison to the other (18.7 months). However, these positive effects were accompanied by common adverse events like diarrhea, nausea, vomiting, constipation, fatigue, dizziness and urinary tract infection.

“Although there have been many new treatment options for patients with HER2-positive breast cancer, patients still need additional treatment options once they progress,” said Alan H. Auerbach, Chief Executive Officer and President of Puma. “Based on the results of our NALA data, we believe NERLYNX® could be a promising therapeutic opportunity for these patients.”




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