At the American Society of Clinical Oncology (ASCO) Annual Meeting, 31 May to 4 June, 2024, primary results were presented for the LAURA study (NCT03521154) that investigated AstraZeneca’s Tagrisso (osimertinib) for stage III epidermal growth factor receptor mutated (EGFRm) non-small cell lung cancer (NSCLC).

The patients evaluated were ineligible for resection and had completed chemoradiotherapy without progression. The study sought to determine if Tagrisso, a 3rd generation tyrosine kinase inhibitor (TKI), the standard of care (SOC) adjuvant therapy for resectable EGFRm NSCLC, can also become a SOC for this population. Currently, AstraZeneca’s Imfinzi (durvalumab) is the SOC for this patient segment, but studies have shown that administering immunotherapy to patients with EGFRm is associated with very low response rates. If the investigators chose Imfinzi as the control, upon progression, patients would be forced to wait several months before receiving Tagrisso, as the overlap between the two leads to toxicities. Using platinum-based chemotherapy as the control allowed patients to crossover to the experimental arm, 81% of whom did, with limited toxicities and without the lag time required had they been on immunotherapy.

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Tagrisso impressively beat the placebo in progression-free survival (PFS), the study’s primary endpoint (39.1 months vs. 5.6) (hazard ratio [HR], 0.16). At 12 months, 74% of patients on Tagrisso had a PFS, while only 22% achieved this on the placebo. The PFS benefit was observed across subgroups such as age, sex, stage (IIIa–IIIc), and EGFRm. The objective response rate was almost two-fold higher in the Tagrisso group (57% vs. 33%), and the median duration of response was 36.9 months vs. 6.5 months. New lesion formation in the experimental group was 22%, compared with 68% in the chemotherapy group. Of special interest to investigators, brain lesion development occurred in 29% of patients on placebo compared to 8% in those who received Tagrisso. Median overall survival is currently immature, but investigators relate that it is trending toward the Tagrisso arm. Half the patients in the experimental group experienced a grade ≥ 3 adverse event (AE). The most prevalent AE was radiation pneumonitis, but only 2% had a grade ≥ 3.

What is unique about the LAURA design is that it requires indefinite TKI therapy until progression, demonstrating that for this patient segment, treatment is not curative. To illustrate, the ADAURA trial (NCT02511106) where stage Ib-IIIa patients received adjuvant maintenance Tagrisso for three years, showed improved overall survival but some experienced central nervous system recurrences following the course. Stakeholders will have to weigh the benefits of indefinite TKI therapy against the cost and associated low-grade side effects. Mature survival data will be needed to justify early palliative care with Tagrisso. Some stage III unresectable EGFRm patients may not require continuous treatment, so trials will need to be designed to distinguish these populations. For those patients who may be cured a method to de-escalate them off the TKI will have to be established. To this point, all stages of EGFRm NSCLC patients excluding unresectable stage III patients had access to a TKI, the LAURA study is considered practice-changing and will become the new SOC. In 2023, Tagrisso generated $5.8 billion in sales. GlobalData anticipates sales to reach $7.4 billion by 2030.

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