An evaluation of aumolertinib for the treatment of EGFR T790M mutation-positive non-small cell lung cancer

Figures & data

Table 1. Comparison of efficacy of the third-generation EGFR-TKIs

	Osimertinib (AURA 17) N = 171 [24–27]	Aumolertinib (APOLLO) N = 244 [18,21–23]	Furmonertinib (ALSC003) N = 220 [28]
ORR	63%	68.9%	74%
DCR	89%	93.4%	94%
mPFS	9.7 months	12.4 months	9.6 months
mDoR	9.9 months	15.1 months	8.3 months
mOS	23.2 months	NR	NR

objective response rate, ORR; disease control rate, DCR; median progression-free survival, mPFS; median duration of response, mDoR; median overall survival, mOS; not reached, NR.

Table 2. Comparison of safety of the third-generation EGFR-TKIs

	Osimertinib (AURA 17) N = 171 [24–27]	Aumolertinib (APOLLO) N = 244 [18,21–23]	Furmonertinib (ALSC003) N = 220 [28]
Any AE	165 (96%)	229 (93.9%)	214 (97%)
Treatment-related AE	142 (83%)	187 (76.6%)	171 (78%)
Any AE grade≥3	43 (25%)	82 (33.6%)	58 (26%)
Treatment-related AE grade≥3	18 (11%)	40 (16.4%)	25 (11%)
SAE	28 (16%)	NA	52 (24%)
Treatment-related SAE	6 (4%)	NA	12 (5%)
Any AE leading to dose interruption	10 (6%)	32 (13.1%)	24 (11%)
Any AE leading to dose reduction	1 (1%)	5 (2.0%)	5 (2%)
Any AE leading to discontinuation	6 (4%)	13 (5.3%)	8 (4%)
Treatment-related AE leading to discontinuation	2 (1%)	7 (2.9%)	4 (2%)
Any AE leading to death	8 (5%)	NA	4 (2%)
Treatment-related AE leading to death	2 (1%)	NA	1 (<1%)

adverse event, AE; serious adverse event, SAE; not applicable, NA.

Box 1. Drug summary

Drug name	Aumolertinib
Phase	Launched
Indication	Second-line treatment for EGFR T790M mutation-positive NSCLC
Pharmacology description	The third generation EGFR-TKI
Route of administration	Oral
Chemical structure
Pivotal trial(s)	NCT0298110 [14], NCT02981108 [18]

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Table 3. Clinical trials of Aumolertinib in NSCLC (https://www.clinicaltrials.gov)

Clinical trial	Treatment	Patients	Design
Aumolertinib as Neo-adjuvant or postoperative adjuvant treatment in stage IA-IIIB NSCLC
NCT04455594	Aumolertinib Vs. Erlotinib/Platinum doublet chemotherapy	Neo-adjuvant Treatment of Stage IIIA-N2 EGFR-mutated NSCLC	Phase II,randomized, open-lable
NCT04922138	Aumolertinib	postoperative adjuvant treatment of stage IA NSCLC patients with EGFR 19del/21L858R.	Phase II,single group,open-label
NCT04687241	Aumolertinib Vs. Placebo	stage II–IIIB EGFR-mutated NSCLC following complete tumor resection with or without adjuvant chemotherapy	Phase III,randomized, double-blind
Aumolertinib as maintenance therapy in stage III unresectable NSCLC after chemoradiotherapy
NCT04951635	Aumolertinib Vs. Placebo	stage III unresectable NSCLC with sensitizing EGFR mutation following chemoradiation	Phase III,randomized, double-blind
Aumolertinib as first-line treatment in advanced NSCLC
NCT03904823	Aumolertinib+Famitinib	Advanced EGFR-mutated NSCLC	Phase II,single group,open-label
NCT04951648	Aumolertinib Vs. Platinum-based chemotherapy	Locally advanced or metastatic NSCLC with uncommon EGFR Mutation	Phase III,randomized, open-lable
NCT03849768	Aumolertinib Vs. Gefitinib	Locally advanced or metastatic EGFR-mutated NSCLC	Phase III,randomized, open-lable
NCT04923906	Aumolertinib Vs. Aumolertinib+chemotherapy	Locally advanced or metastatic NSCLC with sensitizing EGFR mutation	Phase III,randomized, open-lable
NCT04643847	Aumolertinib+Upfront radiotherapy	Advanced EGFR-mutated NSCLC with brain metastases	Phase II,single group,open-label
NCT04808752	Aumolertinib	Advanced NSCLC with sensitizing EGFR mutation and brain metastases	Phase II,single group,open-label
Aumolertinib as second-line or beyond treatment in advanced NSCLC
NCT02981108	Aumolertinib	Locally advanced or metastatic EGFR-mutated NSCLC after failure of EGFR-TKIs	Phase I/II,single group,open-label
NCT04870190	Aumolertinib Vs. Osimertinib	Advanced EGFR-mutated NSCLC with brain metastases after failure of EGFR-TKIs	Phase III,randomized, double-blind
NCT04882345	Aumolertinib	Advanced EGFR-mutated NSCLC who are intolerant to the safety of osimertinib treatment	Phase II,single group,open-label

non-small cell lung cancer,NSCLC.

Lu S, Wang Q, Zhang G, et al., Efficacy of Aumolertinib (HS-10296) in patients with advanced EGFR T790M+ NSCLC: updated post-National medical products administration approval results from the APOLLO registrational trial. J Thorac Oncol. 2022;17(3): 411–422.

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Yang JCH, Camidge DR, Yang CT, et al., Safety, efficacy, and pharmacokinetics of almonertinib (HS-10296) in pretreated patients with EGFR-mutated advanced NSCLC: a multicenter, open-label, phase 1 trial. J Thorac Oncol. 2020;15(12): 1907–1918.

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