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ASCO 2022 | CROWN: lorlatinib in treatment-naïve patients with ALK-positive advanced NSCLC

Alessandra Bearz, MD, CRO National Cancer Institute, Aviano, Italy, discusses CROWN (NCT03052608) a randomized Phase III trial which compared the progression-free survival of patients with advanced non-small cell lung cancer treated with lorlatinib, a third-generation ALK tyrosine kinase inhibitor, to those treated with crizotinib. Molecular profiling of circulating tumor DNA (ctDNA) and tumor tissue was performed to identify molecular correlates of response. It was found that treatment naïve patients with ALK-positive advanced non-small cell lung cancer had a longer progression-free survival when treated with lorlatinib compared to those treated with crizotinib. This interview took place at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting in Chicago, IL.

Transcript (edited for clarity)

On behalf of the investigators of the Phase 3 CROWN Trial, we presented data, I presented the data about the comprehensive genomic analysis both in the ctDNA and tumor tissue. And the CROWN Phase 3 Trial was a trial exploring the role of lorlatinib in comparison with crizotinib in previously treated ALK fusion positive advanced non-small cell lung cancer, and the lorlatinib improved the PFS versus crizotinib, and we identify molecular correlates of response...

On behalf of the investigators of the Phase 3 CROWN Trial, we presented data, I presented the data about the comprehensive genomic analysis both in the ctDNA and tumor tissue. And the CROWN Phase 3 Trial was a trial exploring the role of lorlatinib in comparison with crizotinib in previously treated ALK fusion positive advanced non-small cell lung cancer, and the lorlatinib improved the PFS versus crizotinib, and we identify molecular correlates of response. And in particular, the PFS of lorlatinib was much of significantly superior than the PFS in the crizotinib arm, irrespectively of the EML4-ALK variants, and both in the ctDNA and in the tumor tissue and was significantly superior even in patients with bypass preexisting aberrations like MAP kinase, or RTK, or a PI 3-Kinase mTOR. And was significantly superior even in patients with TP53 positive mutation, although the presence of a patient in the TP53 might reduce slightly the efficacy of lorlatinib.

So the strength of lorlatinib as first line treatment for this patients has been demonstrated by the strength of the PFS, but also by the evidence that the efficacy is irrespective of the ALK variants, TP53, maybe. And also bypass preexisting mutations.

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