Pfizer’s therapy marks longest PFS ever reported in advanced solid tumours

Pharma News: Anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) therapies are the standard first-line therapy recommended for patients with ALK-positive non-small cell lung cancer (NSCLC). An international clinical trial led by Peter MacCallum Cancer Centre has revealed that Pfizer’s third-generation ALK TKI is setting “a new benchmark” in lung cancer treatment.

Patients in the phase III CROWN trial were randomised to receive either Pfizer’s new drug Lorbrena (lorlatinib) or an earlier Pfizer treatment Xalkori (crizotinib) which is currently on the PBS.

Remarkably, five years post-treatment, 60% of patients treated with Lorbrena remained alive without disease progression, compared to just 8% of those who received Xalkori. The results also indicate an 81% reduction in the risk of progression or death and a 94% reduction in the progression of brain metastasis.

Professor Ben Solomon, a medical oncologist at Peter Mac and the principal investigator of the study, presented the results at the American Society of Clinical Oncology (ASCO) congress last week.

“ALK-positive advanced NSCLC is typically aggressive and often impacts younger people in the prime of their lives,” Prof Solomon said. “This updated analysis shows that lorlatinib helped patients live longer without disease progression, with the majority of patients experiencing sustained benefit for over five years, including nearly all patients having protection from progression of disease in the brain. These improvements in outcomes for patients with ALK-positive NSCLC represent a remarkable advancement in lung cancer.”

The authors highlighted that after five years of follow-up, the median progression-free survival (PFS) has yet to be reached in the Lorbrena group, corresponding to the “longest PFS ever reported with any single-agent molecular targeted treatment in advanced NSCLC and across all metastatic solid tumours.” These results, combined with prolonged intracranial efficacy and the absence of new safety signals, represent an “unprecedented outcome for patients with advanced ALK-positive NSCLC and set a new benchmark for targeted therapies in cancer.”

Lung cancer remains the leading cause of cancer-related deaths. NSCLC accounts for approximately 80-85% of lung cancers, with ALK-positive tumours occurring in about 3-5% of NSCLC cases. Patients with this form of lung cancer are known to be at high risk of developing brain metastases.

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