Promising efficacy of neoadjuvant osimertinib in EGFR-mutated NSCLC

The final results of the phase 2 NEOS trial demonstrated promising efficacy and good tolerability of neoadjuvant treatment with osimertinib in patients with stage II–IIIB, EGFR-mutated non-small cell lung cancer (NSCLC).

Osimertinib is a third-generation tyrosine kinase inhibitor approved for adjuvant therapy in patients with stage IB–IIIA, EGFR-mutated NSCLC. The Chinese, prospective, multicentre, single-arm, phase 2 NEOS trial (ChiCTR1800016948) aimed to determine the safety and efficacy of osimertinib as neoadjuvant therapy for the treatment of patients with resectable EGFR-mutated NSCLC.

NEOS enrolled a total of 40 patients with stage II–IIIB, EGFR-mutated NSCLC. Participants were treated with osimertinib 80 mg once daily for 6 weeks followed by surgical resection; 38 participants completed neoadjuvant osimertinib, 32 participants underwent surgery (6 patients refused, 1 because of treatment-related adverse events). The primary endpoint of the study was objective response rate (ORR); secondary endpoints were safety, disease control rate (DCR), R0 resection rate, major pathological response (MPR), and pathological complete response (pCR). Previously, an interim analysis (n=15) of NEOS showed promising efficacy (ORR 73%) and tolerable safety of neoadjuvant osimertinib [1]. Dr Chao Lyu (Beijing Cancer Hospital, China) presented the final results of the NEOS trial [2].

In the participants who completed neoadjuvant therapy, ORR was 71% (27/38) and DCR was 100%. R0 resection was achieved in 94% (30/32). Of the pathologically evaluable participants, 11% (3/28) achieved MPR, including 1 pCR (4%); 46% (13/28) had a pathological response of ≥50% (see Figure).

Figure: Efficacy of neoadjuvant osimertinib in NEOS [2]



Treatment-related adverse events were reported in 75% of participants, the most common were rash (50%), diarrhoea (30%), and oral ulceration (30%); 3 participants (7.5%) had treatment-related adverse events of grade 3 (rash, hypertension, and renal disease).

“This phase 2 NEOS study demonstrated promising efficacy and tolerability of neoadjuvant osimertinib,” concluded Dr Lyu. “Phase 3 trials including larger numbers of patients are warranted to further validate the benefit of osimertinib in the neoadjuvant setting.”

1. Lyu C, et al. Abstract 8524. ASCO Annual Meeting 2021, 04–08 June.


2. Lyu C, et al. Osimertinib as neoadjuvant therapy in patients with EGFR mutated resectable stage II-IIIB lung adenocarcinoma (NEOS): Updated results. Abstract 81MO. ELCC 2022 Virtual Meeting, 30 March–02 April.

 

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Posted on 25 May, 2022