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New outcomes from the ACROSS 2 Section III trial show that aumolertinib mixed with platinum-pemetrexed chemotherapy considerably improves progression-free survival in comparison with aumolertinib monotherapy in sufferers with superior/metastatic non-small cell lung most cancers (NSCLC) harboring EGFR sensitizing mutations and concomitant tumor suppressor gene mutations.
The outcomes had been introduced by Dr. Jie Wang, Nationwide Most cancers Middle, Nationwide Scientific Analysis Middle for Most cancers, Most cancers Hospital in China, on the Worldwide Affiliation for the Examine of Lung Most cancers (IASLC) 2025 World Convention on Lung Most cancers (WCLC).
Aumolertinib is an oral, third-generation epidermal progress issue receptor tyrosine kinase inhibitor (EGFR-TKI) used to deal with EGFR-mutated NSCLC.
Sufferers with EGFR concomitant mutations sometimes face a poor prognosis and, till now, have had no customary remedy routine in scientific follow. Earlier research have advised that an EGFR-TKI mixed with chemotherapy might present higher efficacy than an EGFR-TKI alone.
ACROSS 2 is the primary world, multicenter, open-label, randomized, managed Section III trial to handle this query, in response to Dr. Wang.
In ACROSS 2 (NCT04500717), sufferers with histologically confirmed stage IIIB–IV NSCLC harboring EGFR sensitizing mutations and tumor suppressor gene mutations, and with ECOG efficiency standing 0–1, had been randomized 1:1 to obtain both aumolertinib 110 mg day by day plus carboplatin (AUC=5) and pemetrexed 500 mg/m2 each three weeks, or aumolertinib monotherapy till illness development. Stratification components included EGFR mutation sort (Ex19del/L858R) and presence of CNS metastases.
The first endpoint was progression-free survival (PFS); secondary endpoints included goal response charge (ORR), illness management charge (DCR), length of response (DoR), total survival (OS), and security.
Dr. Wang reported that:
Median follow-up: 25.3 months.
Median PFS: 19.78 months (mixture) vs. 16.53 months (monotherapy); HR = 0.55 (95% CI: 0.339–0.910; p=0.0205).
Baseline traits had been properly balanced between remedy arms.
OS information stay immature.
Most typical treatment-emergent opposed occasions (≥20%): decreased white blood cell rely, decreased neutrophil rely, decreased platelet rely, anemia, AST/ALT improve, CK improve, elevated serum creatinine, nausea, constipation, and rash.
Dr. Wang reported that the addition of chemotherapy didn’t alter aumolertinib’s security profile and no new security alerts had been noticed.
“This Phase III trial provides the first evidence that aumolertinib combined with platinum-pemetrexed offers a statistically significant PFS benefit over monotherapy for this patient population, with a manageable safety profile,” he stated.
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Worldwide Affiliation for the Examine of Lung Most cancers
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Aumolertinib + chemotherapy improves progression-free survival in NSCLC: Scientific trial (2025, September 7)
retrieved 7 September 2025
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