Nerlynx (neratinib) vs Enhertu (fam-trastuzumab deruxtecan-nxki)

Nerlynx (neratinib) vs Enhertu (fam-trastuzumab deruxtecan-nxki)

Nerlynx (neratinib) is an oral tyrosine kinase inhibitor specifically designed to block certain enzymes that promote cancer cell growth, and it is primarily used as an extended adjuvant treatment for HER2-positive breast cancer following trastuzumab therapy. Enhertu (fam-trastuzumab deruxtecan-nxki) is a different type of drug; it is an antibody-drug conjugate that combines an HER2-targeted antibody with a chemotherapy drug, allowing for the direct delivery of the chemotherapy to HER2-expressing cancer cells, and it is used for the treatment of patients with HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens. The choice between Nerlynx and Enhertu would depend on the individual's specific cancer characteristics, prior treatments, and the presence of metastasis, as well as the patient’s overall health and treatment goals, and should be made in consultation with an oncologist.

Difference between Nerlynx and Enhertu

Metric Nerlynx (neratinib) Enhertu (fam-trastuzumab deruxtecan-nxki)
Generic name Neratinib Fam-trastuzumab deruxtecan-nxki
Indications Extended adjuvant treatment of HER2-positive breast cancer Treatment of HER2-positive breast cancer and metastatic gastric or gastroesophageal junction adenocarcinoma
Mechanism of action Tyrosine kinase inhibitor HER2-directed antibody and topoisomerase inhibitor conjugate
Brand names Nerlynx Enhertu
Administrative route Oral Intravenous
Side effects Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT elevation, nail disorders, dry skin, abdominal distention, weight loss, urinary tract infection Nausea, fatigue, vomiting, alopecia, constipation, decreased appetite, anemia, neutropenia, diarrhea, leukopenia, cough, thrombocytopenia
Contraindications None known History of interstitial lung disease, pneumonitis, severe hypersensitivity to trastuzumab deruxtecan or any of its excipients
Drug class Tyrosine kinase inhibitor Antibody-drug conjugate
Manufacturer Puma Biotechnology Daiichi Sankyo and AstraZeneca

Efficacy

Nerlynx (neratinib) Efficacy in Breast Cancer

Nerlynx (neratinib) is an oral tyrosine kinase inhibitor that targets the human epidermal growth factor receptor 2 (HER2) and is used in the treatment of breast cancer. Specifically, it is indicated for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy. Clinical trials have shown that Nerlynx, when taken for a duration of 12 months, can significantly reduce the risk of breast cancer recurrence in patients who have completed trastuzumab therapy. The most compelling evidence of its efficacy comes from the ExteNET study, which demonstrated a 2-year invasive disease-free survival rate of 94.2% in patients treated with Nerlynx compared to 91.9% in the placebo group.

Enhertu (fam-trastuzumab deruxtecan-nxki) Efficacy in Breast Cancer

Enhertu (fam-trastuzumab deruxtecan-nxki) is an antibody-drug conjugate that also targets HER2-positive cancers. Its mechanism involves the delivery of a cytotoxic payload directly to the cancer cells that express HER2, thereby allowing for a targeted treatment approach. Enhertu has shown significant efficacy in the treatment of HER2-positive metastatic breast cancer, particularly in patients who have previously received two or more anti-HER2 therapies. The pivotal trial that led to its approval, the DESTINY-Breast01 trial, reported an impressive objective response rate of 60.9% in patients treated with Enhertu. Moreover, the median progression-free survival was 16.4 months, indicating a substantial delay in disease progression for patients on this treatment.

Comparative Efficacy in Different Stages of Breast Cancer

While both Nerlynx and Enhertu are used in the treatment of HER2-positive breast cancer, their indications differ based on the stage of cancer. Nerlynx is primarily used in the early-stage setting as an extended adjuvant therapy, whereas Enhertu is utilized for metastatic disease after the failure of other treatments. The efficacy of Nerlynx hinges on its ability to prevent recurrence post-primary treatment, whereas Enhertu's efficacy is measured by its response rate and ability to extend progression-free survival in a metastatic setting. Both drugs represent significant advancements in the targeted therapy of HER2-positive breast cancer, offering hope for improved outcomes in different stages of the disease.

Considerations and Ongoing Research

It is important to note that the efficacy of both Nerlynx and Enhertu can be affected by factors such as prior treatments, tumor biology, and patient characteristics. Ongoing research and clinical trials continue to refine the understanding of how best to use these drugs, including optimal sequencing with other therapies, management of side effects, and identification of patient populations that will benefit the most from these treatments. As the landscape of breast cancer treatment evolves, Nerlynx and Enhertu are poised to play critical roles in the management of HER2-positive breast cancer, offering patients targeted options that can improve their prognosis and quality of life.

Regulatory Agency Approvals

Nerlynx
  • European Medical Agency (EMA), European Union
  • Food and Drug Administration (FDA), USA
  • Health Canada
  • Therapeutic Goods Administration (TGA), Australia
Enhertu
  • European Medical Agency (EMA), European Union
  • Food and Drug Administration (FDA), USA
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

Access Nerlynx or Enhertu today

If Nerlynx or Enhertu are not approved or available in your country (e.g. due to supply issues), you can access them via Everyone.org.

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