New lung cancer pill produces “unprecedented” results in human trial

Good news! Cancer is history (soon)! Apparently, in this study only two drugs were compared with each other, whether that is as valid/significant as other forms of studies I am not sure.

Any longer period of progression-free survival like six or twelve months or more can mean new treatments become available to further extend the patient's survival.

"... Lorlatinib is a third-generation ALK inhibitor, the newest in a class of drugs that are the standard first-line treatment for patients with ALK-positive NSCLC. A recent international clinical trial led by the Peter MacCallum Cancer Center (Peter Mac) in Melbourne, Australia, assessed the drug’s effect on long-term disease progression in patients with advanced ALK-positive NSCLC. The results were remarkable. ..."

"... Five-year, progression-free-survival data has just been published for the CROWN study which involved 296 patients with previously untreated ALK-positive, advanced Non-Small Cell Lung Cancer (NSCLC).

Patients in this Phase III trial were randomized to receive either the new drug lorlatinib or an earlier treatment crizotinib.  

Five years after treatment, 60% of patients treated with lorlatinib remained alive and without disease progression and this compared to just 8% for patients who received crizotinib.

The updated results also show an 81% reduction of risk of progression or death, and 94% reduction in progression of brain metastasis, compared to crizotinib. ..."

From the abstract:

"Abstract

Purpose

Lorlatinib improved progression-free survival (PFS) and intracranial activity versus crizotinib in patients with previously untreated, advanced, ALK-positive non–small cell lung cancer (NSCLC) in the phase III CROWN study. Here, we report long-term outcomes from CROWN after 5 years of follow-up.

Methods

Two hundred ninety-six patients with ALK-positive NSCLC were randomly assigned 1:1 to receive lorlatinib 100 mg once daily (n = 149) or crizotinib 250 mg twice daily (n = 147). This post hoc analysis presents updated investigator-assessed efficacy outcomes, safety, and biomarker analyses.

Results

With a median follow-up for PFS of 60.2 and 55.1 months, respectively, median PFS was not reached (NR [95% CI, 64.3 to NR]) with lorlatinib and 9.1 months (95% CI, 7.4 to 10.9) with crizotinib (hazard ratio [HR], 0.19 [95% CI, 0.13 to 0.27]); 5-year PFS was 60% (95% CI, 51 to 68) and 8% (95% CI, 3 to 14), respectively. Median time to intracranial progression was NR (95% CI, NR to NR) with lorlatinib and 16.4 months (95% CI, 12.7 to 21.9) with crizotinib (HR, 0.06 [95% CI, 0.03 to 0.12]). Safety profile was consistent with that in prior analyses. Emerging new ALK resistance mutations were not detected in circulating tumor DNA collected at the end of lorlatinib treatment.

Conclusion

After 5 years of follow-up, median PFS has yet to be reached in the lorlatinib group, corresponding to the longest PFS ever reported with any single-agent molecular targeted treatment in advanced NSCLC and across all metastatic solid tumors. These results coupled with prolonged intracranial efficacy and 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."

New lung cancer pill produces “unprecedented” results in human trial Lung cancer is the number one cause of cancer-related deaths worldwide. A trial of a new anti-cancer drug has found that five years after treatment, 60% of patients with a very common form of the disease are still alive, and the cancer has not progressed.

New drug a “remarkable advancement in lung cancer” (original news release)

Lorlatinib Versus Crizotinib in Patients With Advanced ALK-Positive Non–Small Cell Lung Cancer: 5-Year Outcomes From the Phase III CROWN Study (open access)