Tagrisso (osimertinib) vs Opdivo (Nivolumab)

Tagrisso (osimertinib) is a targeted therapy specifically designed to inhibit the activity of the epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC), and is typically used when the cancer has specific genetic mutations that are responsive to this medication. Opdivo (nivolumab), on the other hand, is an immunotherapy drug that works by blocking the PD-1 protein on T cells, thereby enhancing the immune system's ability to attack cancer cells, and is used for a broader range of cancers, including melanoma, kidney cancer, and certain types of NSCLC without the need for specific genetic mutations. When deciding which medicine is right for an individual, it is crucial to consider the type and genetic characteristics of the cancer, the patient's overall health, and the potential side effects, as well as consulting with a healthcare professional who can provide personalized medical advice based on the patient's unique medical history and condition.

Difference between Tagrisso and Opdivo

Metric	Tagrisso (osimertinib)	Opdivo (Nivolumab)
Generic name	Osimertinib	Nivolumab
Indications	Non-small cell lung cancer (NSCLC) with specific EGFR mutations	Various types of cancers including melanoma, NSCLC, renal cell carcinoma, Hodgkin lymphoma, head and neck cancer, urothelial carcinoma, and colorectal cancer
Mechanism of action	EGFR tyrosine kinase inhibitor	Programmed death receptor-1 (PD-1) blocking antibody
Brand names	Tagrisso	Opdivo
Administrative route	Oral	Intravenous
Side effects	Diarrhea, rash, dry skin, nail toxicity, stomatitis	Fatigue, rash, musculoskeletal pain, decreased appetite, nausea
Contraindications	Hypersensitivity to osimertinib or any component of the formulation	Hypersensitivity to nivolumab or any component of the formulation, complications with immune-mediated adverse reactions
Drug class	Antineoplastic agent, tyrosine kinase inhibitor	Immune checkpoint inhibitor, antineoplastic agent
Manufacturer	AstraZeneca	Bristol-Myers Squibb

Efficacy

Efficacy of Tagrisso (Osimertinib) in Lung Cancer

Tagrisso (osimertinib) is a third-generation, irreversible epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) designed to inhibit both EGFR-sensitizing and EGFR T790M resistance mutations, with clinical efficacy in non-small cell lung cancer (NSCLC). The FLAURA trial, a pivotal phase III study, demonstrated that osimertinib significantly improved progression-free survival (PFS) compared to standard EGFR TKIs (erlotinib or gefitinib) in patients with previously untreated, EGFR mutation-positive NSCLC. Moreover, osimertinib has shown central nervous system (CNS) activity, which is critical as brain metastases are common in patients with EGFR-mutated NSCLC.

Additionally, osimertinib has been studied in the adjuvant setting for early-stage NSCLC. The ADAURA trial revealed that osimertinib provided a substantial benefit in disease-free survival (DFS) among patients with stage IB to IIIA EGFR-mutated NSCLC after tumor resection, suggesting a potential role for osimertinib as a standard adjuvant therapy in this patient population. These findings underscore the importance of EGFR mutation testing in the management of NSCLC to identify patients who may benefit from osimertinib.

Efficacy of Opdivo (Nivolumab) in Lung Cancer

Opdivo (nivolumab) is a programmed death-1 (PD-1) immune checkpoint inhibitor that has been approved for the treatment of several types of cancer, including NSCLC. In the CheckMate-057 trial, nivolumab demonstrated a survival benefit over docetaxel in previously treated patients with advanced non-squamous NSCLC. The subsequent CheckMate-017 study showed similar results in patients with squamous NSCLC. These trials established nivolumab as a treatment option for patients with previously treated advanced NSCLC, regardless of PD-L1 expression levels.

Furthermore, nivolumab has been evaluated in combination with other therapies. The CheckMate-227 trial assessed nivolumab plus ipilimumab, another immune checkpoint inhibitor, versus chemotherapy in first-line treatment for advanced NSCLC. The results indicated that the combination provided a significant improvement in overall survival for patients with a high tumor mutational burden, irrespective of PD-L1 expression. This suggests that nivolumab, particularly in combination with ipilimumab, may offer a valuable treatment alternative for a subset of patients with advanced NSCLC.

Regulatory Agency Approvals

Tagrisso

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA
Health Canada
Therapeutic Goods Administration (TGA), Australia
Medsafe (NZ)

Opdivo

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

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